Title of Invention

"A DRY FILM COATING COMPOSITION FOR FORMING A COATING SUSPENSION FOR FILM COATING TABLETS"

Abstract A dry film coating composition for forming a coating suspension for film coating nutritional supplements, pharmaceutical tablets, and the like, comprising a dextrin and a detackiffier.
Full Text The present invention relates to a dry film coating composition for forming a coating suspension for film-coating tablets of nutritional supplements and pharmaceutical substances.
This invention also relates to a field of aqueous film coating of nutritional supplements and pharmaceutical tablets, and is specifically concerned with providing film coatings based on dextrin for coating nutritional supplements, such as vitamin tablets and herbal tablets, and pharmaceutical tablets, such as acetaminophen (APAP), aspirin (ASA), and Ibuprofen.
Description of the Prior Art
Hydroxypropyl methylcellulose, maltodextrin, and lactose have all been used in coatings for substrates such as pharmaceutical tablets. For example, such coatings made from coating compositions manufactured by Colorcon and disclosed in U.S. Patent Nos. 4,543,370, 4,683,256, 4,643,894, 4,725,441 and 4,828,841, and in
allowed U.S. Patent Application Serial No. 08/400,134, all of said patents and said patent application being incorporated herein by reference, have proven especially effective when used on pharmaceutical tablets.
However, coatings baaed on hydroxypropyl methylcellulose, maltodextrin, and lactose, especially clear coats (clear non-pigmented coatings), sometimes suffer from a "frosting" problem (the formation of a white frost-like appearance in the coating) when used to coat nutritional supplements like vitamins and herbal tablets. Also, coatings based on hydroxypropyl methyl cellulose,, raaltodextrin, and lactose sometimes suffer from a "frosting" problem when used to coat pharmaceutical tablets (e.g. color-coded APAP tablets) at a 1% weight gain.
Further, coatings based on hydroxypropyl methylcellulose sometime become too brittle and dried out when used to coat herbal tablets, resulting in coatings peeling off the herbal tablets.
Also, coatings based on hydroxypropyl nethylcellulose sometimes have a dull matte finish with low gloss, rather than a desirable glossy i'inish, when used to coat nutritional supplements like vitamins and herbal tablets.
Tapioca dextrin has been used as an ingredient in a sealant layer for chocolates, nuts, etc. in the food/confectionery field, and the sealant layer
containing tapioca dextrin is covered with a coating such as a sugar shell. Tapioca dextrin in recognized to be very brittle and very tacky.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a film coating that possesses long-lasting gloss, good film adhesion, and good film clarity.
Another abject of the invention is to provide a film coating that may be used as a gloss coating for vitamin tablets, herbal tablets, and pharmaceutical tablets that possesses long-lasting gloss, that, adheres well to difficult substrates such as calcium-oyster shell, and that is non-frosting and clear.
Another object of the invention is to provide a film coating that eases tablet flow in the bed of a coating pan.
These and other objects are accomplished by our invention, which is described below.
Therefore, the present invention provides for a dry film coating composition for forming a coating suspension for film-coating tablets of nutritional supplements and pharmaceutical substances, the composition comprising:
5-97% by weight of dextrin obtained from tapioca; 1-15% by weight of at least one component selected from a group comprising mineral oil, carnauba wax, acetylated monoglyceride, lecithin and magnesium stearate as a detackifier; and
the balance, comprising at least one conventional component selected from a group comprising auxiliary film-former, plasticizer, surfactant, flow aid, preservative, titanium dioxide and colorant.
The composition of the invention is not a mere admixture resulting in the aggregeite properties of the components thereof. The composition exhibits unexpected and improved properties over and above the aggregate properties of the components. Further, the composition is not a product of a chemical reaction.
The benefits obtained by coating tablets with the compositions mclude, for example, improving the appearance of the tablets, providing hard and slippery outer layer that protects the tablets during handling and storage, and providing a coating that keeps the tablets slippery for ease of handling. Problems known to the prror art as described at page 3 of the specification have been overcome by the composition of the invention. Therefore, previously known film coatings that were based on hydroxypropyl methylcellulose, maltodextrin and lactose suffered from problems such as frosting or white frost-like appearance. In the passage bridging pages 3 and 4 of the specification, use of tapioca dextrin has been described. None of the previous uses are known to include compositions for film coating cablets. Lines 2 and 3 on page 4 states that tapioca dextrin is known to be brittle and very tacky (sticky) when employed alone. Despite the clear disadvantages of tapioca dextrin as a coating i or tablets and pills the specification reports successful production of well coated, hard, shiny, and non-tacky coated tablets as described, for instance, at page 18 of the specification, using compositions according to the invention. In fact, a number of unexpected advantages ace provided by the composition of the
invention compared to tapioca dextrin alone, or compared to previously employed tablet coating materials. As detailed at pages 43-45 of the specification, these include, for example, a lower viscosity of the composition in solution that results in lesser likelihood of clogging the spraying equipment, less weight added to the treated tablets by the coating, and an improved appearance of the tablets with the finished coating. Pages 39-42, and photographs of Figures 1-7 confirm that the tablets are unexpectedly more slippery than the uncoated tablets. The black line at the back of the pan shown in each photograph indicates the level to which the batch of tablets settled without the coating. Each photograph confirms that the coated tablets settled to a lower level than did uncoated tablets. Therefore, the above passage lends support to the statement that the composition according to the invention, essentially comprising tapioca dextrin and a detackifier, is one that does not merely exhibit aggregate properties of the two components but improved and unexpected ones that have been exemplified though not in an exhaustive fashion. The following disclosure, hereinafter, proceeds to fully describe the invention.
The composition of the invention essentially comprises tapioca dextrin and a detackifier. Dextrin is obtained from starch as has been described later in this disclosure. Hydrolysis of starch results in dextrin. Dextrin has not been reported to have nutritive value. In fact, it is an excipient. An excipient is an inert ingredient that passes through the alimentary canal without any change in its chemical structure. Therefore, unlike starch it is not an article of nourishment. Consequently, the composition of the invention is not capable of being used, and indeed, is not intended to be used as an article of nourishment or food.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Fig. 1 shows a coating pan containing 3.5 kg of uncoated tablets. A line is drawn on the back wall of the coating pan which follows the plane bordering and parallel to the top of the tablet bed of the uncoated tablets.
Fig. 2 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using
Formulation A. this figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 3 shows a coating pan containing 3,5 kg of tablets coated with a film coating made using Formulation B. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. l.
Fig. 4 shows, a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation C. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 5 shows a coating pan containing 3-5 kg of tablets coated with a film coating made using Formulation D. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 6 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation E. This figure illustrates a alight drop in the tablet bed geometry compared with the tablet bed geometry shown in Fig. 1.
Fig. 7 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation F. This figure illustrates a significant drop In the tablet bed geometry compared with the tablet bed geometry shown in Fig. 1.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the invention, our dry film coating compositions for use in forming coating suspensions for film coating nutritional supplements, pharmaceutical tablets, and the like, comprise a dextrin and a detackifier,
Advantageously, the inventive dry film coating compositions may include one or more of the following components: auxiliary film-former (•) , a plasticizer, a surfactant, colorant, a flow aid, and a preservative.
In accordance with the invention, a method of coating substrates such as nutritional supplements, pharmaceutical tablets, and the like, comprises making dextrin and a detackifier into water to form an inventive aqueous coating suspension, applying the Inventive coating suspension into said substrates to form a film coating on said substrates, and drying the film coating on said substrates. Optionally, but advantageously, the following components may be mixed Into water with the dextrin and the detackifier to form the inventive coating suspension: auxiliary film-former(s), a plasticizer, a surfactant, colorant, a flow aid, and n preservative.
The invention also includes the coated substrates, such as coated vitamins, coated herbal tablets, and coated pharmaceutical tablets;, and the method of making the dry film coating compositions and the method of
making the coating wuspensions of the invention.
Dextrin Preferably, desetrin is about 5% to about 97% by weight of the inventive dry film coating composition
and of the non-water ingredients of the inventive aqueous coating suspension.
For clear coatings (coatings without colorant), a range of about 35% to about 75% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred, and a range of about 65% to about 73% of dextrin by weight of the Inventive dry film coating composition and of the non-water ingredients of the Lnventive aqueous coating suspension is even more preferred.
For white coatings (coatings containing titanium dioxide as the colorant), a range of about 30% to about £0% of dextrin by weight of the inventive dry film coating composition and of the non-water Ingredients of the inventive equeous coating suspension is more preferred, and a range of about 35% to about 401 of
dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is even more preferred.
For colored coatings (having lakes, dyes, and the like as a colorant), a range of about 35% to about 75% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred, and a range of about 45% to about 55% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is even more preferred.
Examples of the detackifier are mineral oil, carnauba wax, acetyiated monogiycerides (Myvacet), lecithin (Alcolec), and magnesium stearate.
For clear coatings (coatings without colorant), a range of about 1% to about 15% of detackifier by weight cf the inventive dry film coating composition and of the non-water ingredients of the inventive aquecus coating suspension is preferred, and a range of about
7.5% to about 10% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating (suspension is more preferred.
For white coatings (coatings containing titanium dioxide as the colorant), a range of about 1% to about 15% of detackifier by weight cf the inventive dry film
coating composition and of the non-water ingredients of the inv«ntiv« aqueous coating suspension is preferred, and a range of about 2% to about 5% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred.
For colored coatings (having lakes, dyes, and the 1Lke as a colorant), a range of about 1% to about 10% oC detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is preferred, and a range of about 2% to about 5% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the Inventive aqueous coating suspension is more preferred. When using mineral oil as the detac'Kifier in colored formulations, a range of about 1% to about 7.5% of wineral oil by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is preferred, and a range of about 2% to about 4% of mineral oil by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous water suspension is even more preferred, in order to avoid color bleeding of the coating if the amount of titanium dioxide in the coating is low.
The auxiliary film-former(s) may be dextrose, polyvinylpyrrolidone (PVP) , hydroxypropyl

mothylcellulosie, stethylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (Sodium CMC), maltodextrin, sodium alginate, PG alginate, polyvinyl alcohol (PVA), and combinations thereof. The auxiliary film-former(•) act as strength enhancers for the filia coating. Their presence in the coatings help prevent cracking of the film coating, as well as helping to prevent edge wear/chipping of the coated tablet. The preferred and the more preferred ranges for the auxiliary film-former(a) by weight of the inventive dry film forming composition and by weight of the non-water ingredients of the inventive aqueous coating suspension are 0% - about 55% (preferred) and 3.5 to 10% (more preferred) for clear formulations, 5% - 50% (preferred) and 5% to 30% (more preferred,* for white formulations, and 5 to 50% (preferred) and 5 to ;>o% (more preferred) for colored formulations. The preferred ranges and the more preferred ranges i!or various exemplary auxiliary i!ilm-former(s) are «et out below.
When coating extremely friable tablets! with a clear co.stting made from a clear formulation, a preferred auxiliary film-former is NacMC in an amount up to 50% by weight of the inventive dry film forming composition and by weight of the non-water ingredients cf the inventive aqueous coating suspension, and preferably in an amount of about 40% to about 45% by weight of the inventive dry film rorming composition
and by weight of the non-water ingredients, of the inventive aqueous coating suspension. The NaCMC improves the film strength of the inventive coating, which results in the coated tablet being less friable than th« uncoated tablet.
Exemplary of the plasticizer are polyethylene glycol having a molecular weight in the range of 200 to 8000, propylene glycol, glycerine, triacetin, acetyltriethyl citrate, triethyl citrate (Citroflex A2) , trlbutyleitrate (Citroflex 4), and acetyltributylcitrate (Citroflex A4), and the preferred ranges for the plaaticizer are set out below, together with preferred and more prreferred ranges for various exemplary plas1:iciz;ers.
Exemplary of the surfactant is Polysorbate 80, and the preferred ranges for the surfactant are set out below, together with preferred and more preferred ranges for a exemplary surfactant,
A colorant may be any approved colors, opacifiers, or dyes. For example, the colorant may be FD&C lakes, D&C lakea, titanium dioxide, magnesium carbonate:, talc, pyrogenic silica, iron oxides;, channel black, riboflavin, carmine 40, ponceau 4R, patent blue V5, caramel, curcuain, annatto, dyes, and combinations thereof. The preferred range and the more preferred range for the color ant (the Ti02) in the white formulations are 20% to 50% (preferred) and 25% to 40% (more preferred) by weight of the inventive coating

composition and by weight of the non-water ingredients of the inventivs coating suspension. The preferred range and the more preferred range for the colorant in the colored formulations are 0.1% to 40% (preferred) and 15% to 25% (more preferred) by weight of the inventive coating composition and by weight of the non-water ingredients of the inventive coating suspension.
Exemplary of the flow aid is stearic acid/ and the preferred ranges and the more preferred ranges for the flow aid are set out below, together with the preferred and the more preferred ranges for stearic acid.
Exemplary of the preservative is sodium citrate, and the preferred ranges for the preservative are set out below, together with the preferred and the more preferred ranges for sodium citrate.
CEAR WHITE PIGMENT AUXILIARY FILM FORMERS
Preferred 0-55% 5-50% 5-50%
More Preferred 3,5-10% 5-20% 5-2 0%
Dextrose
Preferred 0-20% 25-50% 5-2.0%
More Preferred 1 -5-10% 30-35% 7.5-15%
PVP
Preferred o-ioi 0-10% 0-10%
More Preferred 3.5-7. !>% 3.5-7.5% :». 5-7. 5%
HPMC/Methylcelluloee/
HPC
Preferred 0-10% 5-50% 5-50%
More Preferred 3.5-7*5% 5-20% 5-20%
Ma Alginate/ PG Alginate
Preferred 0-10% 1-10% 1-10%
More Preferred 3.5-7.5% 3,5-7.5% 3.5-7.5%
Na CMC
Preferred 0-50% 1-10% 1-10%
Mora Preferred 3,!>-7.!»% 3.5-7.5% 3.5-7.5%
for tablet* with
low friability
More Preferred for 40-45** 3.5-7.5% 3.5-7.5%
tablets with high
friability
Maltodextrin
Preferred o-2!>% 5-50% 5-50%
More Preferred 15-50% 5-20% 5-20%
SURFACTANT
Preferred 0-LI>% 0-15% 0-15%
Polyeorbate 80
Preferred 0-2* 0-2% 0-2%
More Preferred 0.5-1% 0.5-1% 0.5-1%
FLOW AID
Preferred 0-10% 0-10% 0-10%
More Preferred 2-5% 2-5% 2-5%
Stearic Acid
Preferred 0-101 0-10% 0-10%
More Preferred 2-5% 2-5% 2-5%
PLASTICIZKR
Preferred 0-15% 0-15% 0-15%
Polyethylene Glycol 8000
Preferred 0-15% 0-15% 0-15%
More Preferred 7.5-10% 7.5-10% 7.5-:io%
Glycerine
Preferred 0-10% 0-10% 0-10%
More Preferred 3.5-7.;.% 3.&-7.5% 3.5-7.5%
PRESERVATIVE
Preferred 0-5% 0-5% 0-5%
Sodium Citrate
Preferred 0-4% 0-4% 0-4%
More Preferred 1-2% 2-3% 2-3%
The range© set out above are all by weight of the dry film coating composition of the invention and of the non-vater ingredients of the aqueous coating suspension of the invention.
The following examples illustrate the invention, all ingrodients being by weight.

EXAMPLE-1
The dry components of the following formulation were blended together for five minutes in a food processor to form a mixture. Then, the liquid components were added to the mixture of dry components and blended therein by mixing for an additional two minutes.
optionally, the components of the formulation are granulated using a planetary mixer, such as a Hobart
planetary mixer. After the dry film coating composition is load (id into the mixer and the mixer is switched on, sufficient water is slowly added until the composition forms slightly adherent granules. These granules are then passed through a 1-2 mm screen and then driod in a 30*C oven until the moisture content is below 5%, The composition is then sieved again through a 1-2 mm screen and is then ready for use in a non-dusting, granular form. If not optionally granulated, the composition may be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example.
Other methods of granulation which may be used are spray granulation and roller compaction.
20 grams of the resulting film coating composition Was dispersed Into 180 grams of distilled viater to form an inventive coating solution/suspension (10% sclids), and 30 grams of this solution/suspension was sprayed using an Aerostatic Strea I coater onto 1000 grazrs of color-coated placebos to form the inventive coating
thereon having a theoretical weight gain of 1.0%.
This produced a film coating on the tablet that possessed an excellent long-lanting ahiny gloss, minimal tackiness, good film adhesion, good non-frosty film clarity.
The above desccibed coating procedures was repeated, except that a 15% solids coating solution/suspension was used, obtained by mixing 3 0 grams of the formulation of this example into 170 grams of distilled water to form the aqueous coating solution/suspension, and then spraying 20 grams of the solution/suspension onto 1000 grams of color-coated placebos. Again, the resulting coating possessed an excellent long'-lasting shiny gloss, minimal tackiness, good film adhesion, and good nDn-frosty film clarity.
Tapioca Dextrin (A. 12. Staley) 70% 700.00
Dextrose (A.E. Stalay) 10% 100.00
Mineral Oil (Eastech 10% 100.00
Chemical Inc.)
Polyethylene Glycol 8000 8% 80.00
(Union Carbide)
Sodium Citrate, Anhydrous
(ADM Corn Processing) 2% 20.00
100% 1000
Examples 2-20 further illustrate the invention, fill percentages baling by weight.
In Examples 2-12, the components of each formulatLon ara mixed together, formed into a coating
suspension, and applied to tablets, as in Example 1, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grama
Tapioca Dextrin (A.E. Staley) 72% 720.00
Dextrose (A.E, Staley) 10% 100.00
Mineral Oil (Pennreco) 15% 150.00
Sodium Citrate, Anhydrous 2% 20.00
(ADM corn Processing)
Polysorbate 80
(ICI Surfactants) 1—%. .10,00
100% 1000
EXAMPLE-3
component Percentages Grams
Tapioca Dextrin (A.E. Staley) 72% 720.00
Dextrose (A.E. StaLey) 10% 100.00
PVP (Pennreco) 5% 50.00
Mineral Oil (Pennreco) 10% 100.00
Sodium Citrate, Anhydrous 2% 20.00
(ADM Corn Processing)
Polysorbate 80
(ICI Surfactants) 1% 10.00
100% 1000
EXAMPLE-1
Component Percentages: Grams
Tapioca Dextrin (A.E. Staley) 69.5% 695^,00
Oextrose (A.E. Staley) 10% 100.00
HPMC E-15 (DOW) 7.*;* 75.00
Mineral Oil (Pennreco) 10k 100.00
Sodiun citrate, Anhydrous 2% 20.00
(ADM Corn Processing)
Polyaorbat* so
(ICI surfactant©) ll 10.00
100% 1ooo
Component Percentages Grms
Tapioca Dextrin (JUB. Staley) 63.5% 635.00
Dextrose (A.E. st.uley) io% 100.00
Mlnerm mi { PH"" xo*
Sodium Citrate, Anhydrous 2% 20.00
(ADW Corn Process ing)
CarnauJta Wax (Rosai) ln5% 15.00
100% 1rtftn
Component percentages Grams
Tapioca Davtcin (A.B. 6«:nl«y) 30* 3BQ.OO
SuUium CMC (Aquaion) 18% 180.00
Oextroae (A.E- Staley) 16* 160.00
Maltodaxtrin (A.E. staley) 16% 160.00
Hittoial Oil (PennxecQ) 10% 100.00
Sodium Citrate, Anhydrous
(ADM Corn Procra*«ing) 2% 2Q.0Q
100% 1000
Tapioca Dexrtrln (A.E. Staley) 95% 950.00
Mineral oil (Pennreco) 5% 50.00
100% 1000
EXAMPLE 8
Tapioca Dextrin Carnuba wax 24 30.00
100% 1000
Tapioca Dextrin (A„E, Statay) 97% 970.00
11ck^riit«!iAuni Statary 3% 30» pO
100% 1000
ftX&MSlJL-Uai
component Percentages grams
Tapioca Dextrin (A.E. Stalty) 95% 950.00
Alcolec 5% 50. P.O.
100% 1000
EXAMPlE 11
Component Percentages Gras
Tapioca Dextrin 37.9% 379
Dextrose 10.1% 101
ane 10% 100
Na Citratft a* *°
Na CMC 4P* -JUlft
100% 1000
Example 12
C omponent Percentages Grams
Tapioca Dextrin 32.9% 329
Dextrose 10.1% 101
Alcolec 10% 100
Na Citrate 2% 20
Na CMC 45%
1OO% 1OOO
EXAMPLS 13
The dry components of the following formulation were blended together for five minutes in a PK blender (Paterson Kelly) to form a mixture. Then, the liquid components of the formulation were added to the mixture of the dry components via the r-bar of the blender and bLended therein by mixing for an additional five minutes.
140 grams of the resulting film coating composition was dispersed into 1260 grams of distilled water and stirred until dispensed (about 20 minutes) to form an inventive coating solution (10% solids), and all of the solution was sprayed using a 24' Accela Cota coater (Thomas Engineering) onto 14 kg of herbal tublets (black walnut tablets from B&c Nutritional Products) to form the inventive coating thereon having a theoretical weight gain of 1.0%.
This produced a film coating on tha tablets that possessed long-lasting gloss, good film adhesion, and good film clarity.
The above-described coating procedure was repeated, except that a 151 solids coating solution was used, obtained by mixing 140 grams of the formulation of thin example into 793.33 grams of distilled water to form the aqueous coating solution. Again, the resulting coating possessed, long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grams
Tapiocu Dextrin (A.E. Staley) 70% 3500.00
Dextroise (A.E. Staley) 10% 500.00
Mineral Oil (Eastach
Chemical Inc.) 10% 500.00
Polyethylene Glycol 8000
(Union Carbide) 8% 400.00
Sodium Citrate, Anhydrous
(ADM Corn Processing) 21 1QP.P.P
100% 5000
In this example, the coaponents of the formulation of Example 13 axe mixed together, formed into a coating suspension, and applied to tublets, as in Example 13, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that the tablets are vitamins (Pharmavite) rather than herbale.
in. this example, the components of the formulation
of Example 13 are mixed together, formed into a coating suspension, and applied to tablets, as in Exampla 13, to obtain film coatings possessing long-lusting gloss, good film adhesion, and good film clarity, axcept that the tablets are oyster shell (Delavau) rather than herbals,
Example
In this example, the components of the formulation of Example 13 are mixed together, formed into a coating suspension, and applied to tablets, as in Example 13, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, uxcept that the tablets are APAl' rather them herbals.
Example 17 (PEARL WHITE)
In this example, the components of the formulation of this example are mixed together, formed into a suspension, and applied to tablets as in Exarople 13, to obtain non-tacky, smooth film coatings possessing long-lasting, very shiny gloss, good film adhesion, and good film clarity, except, that 450 grams of the coating composition of this example was dispersed into 1800 grams of distilled water and stirred until dispersed (about 30 minutes) to form the inventive coating dispersion, and all of the dispersion was sprayed onto l5. kg of vitamins (Pharmavite) , rather than 14 kef of" herbal tablets, to obtain a theoretical 3.0% weight gain (20% solids).

Tapioca Dextrin (Stalky) 39% 1950.00
HPMC/Pharaacoat. E~50 10% 500. 00
(DOW/ShinEteu)
PolyethyUna Glycol 8000 8% 400.00
(Union Carbide)
HPMC/Fharmacoat E-15 5% 250.00
(DOW/ShinEtnu)
Sodiua citrate, Anhydrous 3t iso.oo
(ADM Corn Procesaing)
Mineral Oil (Pennreco) 3% 150.00
Titanium dioxida
(water) (Kronoa) 32% 1600.oo
100% 5000
EXAMPLE is (Orange)
In this example, the components of the formulation of this example are mixed together, formed into a coating suspension, and applied to tablets, as in Example 17 to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that the coated tablets wore provided with a clear overcoat made from dispersing 37.5 grams of the formulation of Example into 212,5 grams of distilled water, and applying said clear overcoat solution as in Example 1 onto the coated tablets of this example for a theorotical 0.2 5% weight gain at 15% solids. This resulted in a clear overcoat over the colored coating of the invention having a very nice gloss.

Component Percentages Grams
Tapioca Dextrin (staley) 43.55% 2177.50
Polyethylene Glycol 8000 8% 400 on
(Union Carbida) 400.00
HPMC/Pharnaacoat E-50 10% 500 00
(DOW/ShinEtsu) 5 °'°Q
HPMC/pharmacoat E-1S 5.31% 265.50
(DOW/ShiniEtsu)
Mineral oil (Ponnreco) 3% 150.00
FD4C Yallow No. 6, 0,62% 31.00
HT 15-18%
Titanium dioxide
(water) (Kronos) ?9.52% 1476.Og
100% 5000
EEMJELE 19 (Red)
The components of the formulation of this example are mixed together, formed into a coating suspension, and applied to tablets, as in Example 17 to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that 450 grama or coating composition of thin example was dispersed in 2550 grams of distilled water to form the inventive coating dispersion. As in Example 18, a clear overcoat in applied to the coated tablets of this example following the procedures set out in Example 18, resulting in a clear overcoat over the inventive colored coating on the coated tablets which had a. very nice glosu.
Components Percentages Grams
Tapioca Dextrin (Staiey) 50% v 2500.00

Polyethylene Glycol 8000 10% 500.00
(Union earblde)
HFMC/Pharmacoat E-50 8% 400.00
(DOW/ShlnEtBU)
tftearic Acid (Witco) 4% 200.00
Alcolec F-100 3% 150.00
(American Lecithin)
stodium Alginate (Kelco) 5% 250.00
Titanium dioxide 5.05% 252.50
(water) (Kronos)
FDSC Red NO. 40, HT, 38-42% 13.53% 676.50
I'D&C Bluo NO. 2, HT, 3-5% 1,42* 11-dlfl
100% 5000
Example 20 (Maroon)
In this exmaple, the components of the formulation of this example are mixed together, formed into a suspension, and applied to tablets as in Example 13, to obtain film coatingn possessing long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grams
Tapioca Dextrin 29* 1450.00
Dextrose 10% 500.00
PEG 8000 10* 500*0°
Stearic Aold 4% 200,00
HPMC E-5C 8* 400'00
Alcolec F-100 3% 150.00
Sodium Alginate XL 5% 250.00
FD&C Red NO. 40, HTf 38-42% 24.56% 1228.00
Titanium Dioxid* 4.43% 221.50
FDfiC Blue No. 2, HI", 11-155% _2,01% 100,50.
100% 5000
The inventive film coating causes a unique phenomenon, the reduction of the coefficient of tablet friction, which we refer to act "slip factor" or "slip". The inventive film coating reduces the coefficient of Friction of the tablets, thereby reducing the friction between tablets, both during1 and after application of the coating onto the tablets , such that the tablets
slip or glide or Slip pant each other as they tumble in the coating pan during application of the film coating and as they are poured during packaging procedures aft«r being coated. In other words, the Inventive film coating imparts a slipperiness onto the tablet and permits the tablets to flow more easily over
l one another.
We have discovered that the inventive film coating causes a reduction of the coefficient of tablet friction. With a reduction of the coefficient of tablet friction, tablets flow better in the bed of a
coating pan creating spaces for more tableta to be placed in the coating pan to; be coated with the Inventive* coating. To maintain the optimun bed geometry and bed flow desired for coating the teblets in the coating pan, a larger tablet charge (10-^0% increase in pan load) is used when coating with the inventive coating,. Accordingly, an increase in
productivity is achieved since more tablets are coated at once.
Further, tablets provided with "slip" (that in, tablets having a reduced coefficient of tablet friction) slide/glide past each other, which is particularly advantageous when coating bulky tablets and tablets having friable edges that h&ve a tendency to chip off as the tablets tumble in the coating pan.
Tablets with '"slip" also increase productivity by lessening the time needed for processing the coated tablets from the coating pan to packaging of the coated tablets since tablets with the inventive; film coating flow better than tablets coated with other film coatings.
The following Tests 1, 2, and 3 were conducts.! to carapace "slip5' obtained from the inventive film coating with "slip" (if any) obtained from other film coatings. Film coatings (3% weight gain) having the* following coating formulations were used in each test:
Formulation A
1PMC 6 CPS-Methoeel E-6 31,720'
HPMC 3 CPS-Methocel 1-3 31.720
Titanium Dioxide (water) 2 6.420'
Peg 400 NF 8.000
FD6C ¥«lloW No. 6 ET 15%-:i8%„ 1.150
Polysorbat* 80 NF l.opg
100.000
Formulation B
(An) opadry II Coating Composition )

Component Portion by weight
HPMC 3 CPS~Mathoc*l E-3 30.330
Titanium Dioxid* (water) 39.490
Maltodextrin (Star-Dri 5) 18.000
HPMC 6 CPS~M*thocel E-6 9.340
Triacetin USP/EP/JPE-Ea*t»an 7.500
Peg 8000 NF 2.500
HPMC~Methoe*l E50-LV Premium 2.330
FDfiC Yellow No. 6 H't 15%-1B% -5§Q
100.000
Formulation C (An) opadry II Coating Composition )
Component portion by weight
Titanium Dioxide (water) 31.200
Folydextrose powder 23.600
HPMC 3 CPS-M*t«OCel E-3 15.200
HPMC 6 CPS~Metboce»l E-6 15.200
Triacetin USP/BP/JPE-Eaetnan 6.000
HFMC-Methocel ESO-LV Premium 5.000
Peg 8000 NF 2.000
FD&C Yellow No, 6 HT 15t-lS* 1.800
100.000
Formulation D
(An) opadry II Coating Composition )

Component portion by Weight
lactose Honohyd. #3 16, NF, FF 40.000
KPMC 15 CP-Pharmaco.it 615 28.000
Titanium Dioxide (water) 22,500
Triacetin usP/EP/JPE-Eastaan 13.000
FD*C Yellow No. 6 HT 15%-18% 1.500
100.000
Formulation E
(An) opadry XD Coating Composition )

Component Portion by weight
Titanium Dioxid* (wnter) 30.860
CwBxt rose 28.084
Waltodextrin (Star-Dri 1) 21.216
Sodium Alginate Ked:jin-XL 5.440
HPMC 15 OPS-Kethocel E-15 5.100
Triacetin USP/EP/JPI5/Eastoan 4.760
Stearic Acid PDR (Kosher) 2.720
FD&C Yellow NO. 6 HT 15*-18% 1.140
AlCOlec F-100 ., ,$ftfl.
100.000
Formulation F
(An) opadry ns Coating Composition )
Titanium Dioxide (water) 36.516
Tapioca Dextrin 955 SR 30.670
HPMC-Methocel E50-LV Premium, 10,000
Peg 8000 NF ' 7.000
PB-15Y-Y6-17 4.7 68
HPMC 15 CPS-Methocial E-15 4.046
Alcol'&c F-100 4.000
Peg 400 NF . 3,Q&fl
100.000
Formulation F is an exemplary formulation for the
inventive film coating.
Test 1-Measurememt of Flow Rate
A first set of vitamins was coated with a film
i
coating using Formulation A, a second set of vitamins was coated with a film coating using Formulation B, a third set of vitamins was coated with a film coating using Formulation 0, a fourth set of vitamins was coated with a film coating using Formulation D, a fifth set of vitamins was coated with a film cating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F. The flow rate for each set of coated vitamins was then measured using the following procedure to determine which film coating provided the highest flow rata
For each set of vitanina,, the chamber of a Flodex Tester flow meter (manufactured by Hanson Research) was
fillad with the coated vitamins but without packing the tablets down into the chamber. Then, the release lever for the release door of the Flodex Tester flow meter was pulled to release the tablets from the chamber through a 46mm orifice, and the time was measured from the start of tablet flow to the end of tablet flow. This procedure was followed 5 times for each set of vitamins, and the average length of time of flow and the standard deviation were determined. A constant weight (in this test 173 grams of vitamin tablets) of vitamins was used throughout the testing. The vitamin tablets coated with film coatings made using Formulations A, B, and D did not flow from the Flowdex Tester's chamber unassisted, but rather needed to be coerced into flowing by banging on the side of the Flodex Tester's chamber.
The results of this test are shown in Table 1(a) and Graph 1(a).

Table 1(a) (Table Removed)
GRAPH I (a) (Figure Removed)
A seventh set of vitamin* was coated (3% weight
gain) with a film coating using an exemplary
formulation (Formulation G) for the inventive film
coating. Then, a first subset of these Formulation G
coated vitamins warn coated with a gloss coat (0.25%
weight gain) using Formulation H, and a second Bubset
of Formulation G coated vitamin tablets vras coated with
a clear gloss coat (0.25% weight gain) using
Formulation I, which is an exemplary formuLatioa for
the inventive film coating. The flow rate for the
coated vitamins provided with a clear gloss coat based
on Formulation H and the Cloy rate for the coated
vitamins provided with a gloa« coat based on
Formulation I were then measured using the Test l
procedure set out above to determine which vitamins
nave the highest flow rates. 'The results are shown in
Table l(b) and Graph 1(b).
Formulation G
(Table Removed)
Formulation H
HPMC 6 CPS-Pharaacoat 60 P£G 400 NF 4.550
PEG 8000 NF ^jLciSC
100.000
Formulation I
Tapioca Dextrin 955 SR 72.900
Dextrose 10.100
Alcolec F-lOo 10.000
Sodium CMC 5.000
Sodium citrate, FCC, USP JUQQQ.
100.000
Formulation Time (Second)
H 1.36
* 1.26
(Figure Removed)
As shown by the above test results, vitamin tablets coated with the Inventive film coating (Formulation F and Formulation I) flowed better than the vitamin tablets coated with the other film coatings, illustrating the slip factor provided by the inventive film coating.
Test-2-Angle of Repose
A first Bet of vitamins was coated with a film coating using Formulation A, a second set of vitamins was coated with a film coating using Formulation B, a third set of vitamins wast coated with a film coating using Formulation c, a fourth set of vitamins was coated with a film coating using Formulation D, a fifth set of vitamins was coated with a film coating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F.
The angle of repose for each set of coated vitamins was then measured using the following procedure.
For each set of vitamins, 1.0 kg of vitamins were placed in a funnel having a 2.75 cm diameter orifice, which was initially plugged, The funnel was supported in a support ring mounted on a stand such that the bottom of the funnel was 4 1/2 inches above a countertop. With the vitamins in place in the funnel, the stopper was removed from the orifice to permit the tablets to flow from the funnel through the orifice to
form a pile of tablats on the countartop. The angla of the pila (the angle of the repose) was measured. This procedure vac followed three time* for each sat of vitamins, and the average angle of repose for each »at of vitamin* was-atenairied, The sat of tablets coated with the inventive film coating (Formulation F) was the only a«>t of tablats that flowed uninhibited through the funnel.
The results of this test are shown in Table 2 and Graph 2.
Xftfetlfi.2 ForgflilatJQn Angle of Repose (daaraaH
h 44.33
B 41.33
C 41.67
D 40.67
E 29
F 2 0
Graph 2
(Figure Removed)
As shown by the above test results, vitamin tablets coated with the inventive film coating (Formulation F) created the smallest angle of repose illustrating the slip factor provided by the inventive film coating.
Test 3- Measurement of Degree Differential
A first set of vitamins was coated with a film coating using Formulation A,, a second set of vitamins was coated with a film coating using Formulation 8, a third set of vitamins was coated with a film coating using Formulation C, a fourth set of vitamins was coated with a film coating using Formulation D,, a fifth set of vitamins was coated with a film coating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F.
A seventh set of vitamins was coated (31 weight gain) with a film coating using an exemplary
formulation (Formulation G) for the Inventive film coating. Then, a first subset of these Formulation G coated vitamins was coated with a gloss coat (0.25% weight gain) using Formulation H, and a second subset of these Formulation G coated vitamins was coated with a gloss coat (0.25% weight gain) using Formulation I, which is an exemplary formulation of the inventive film coating.
Tha degree differential for each set (sets 1-6 and subsets l and 2 of set 7) of coated vitamins was
measured using the following procedure to establish numerical data on slip. The degree differential is the degree of drop between the top of a tablet bed of uncoated tablets and the top of a tablet bed of coated tablets.
3.5 kg of uncoated vitamins were placed in a O'Hara Labcoat I coating pan (a 15 inch pan), and the uncoated tablets were tumbled in the coating pan for two revolutions at a pan speed of three revolutions per minute. As shown in Fig. 1, a first line was drawn on the back wall of this coating pan following the plane bordering and parallel to the top of the tablet bed of the uncoated tablets.
The uncoated tablets were then removed from the coating pan.
Then, for each set (sets 1-6 and subsets l and 2 cf set 7] of coated vitamin tablets, 3.5 kg of coated vitamins were placed into the coating pan, and the coated tablets were tumbled in the coating pan for two revolutions at a pan speed of three revolutions per minute. A second line was drawn on the back wall of the coating pan following the plane bordering and parallel to the top of the tablet bed of the coated tablets if the bed geometry did not match the bed geometry of the uncoated tablets narked by the first line.
To determine the degree differential (the degree of drop in the level of the high end of the tablet bed)
between uncoated tablets and coated tablets, we Measured the angle forsed between i) a horizontal
along the back wall of the coating pan that intersects
the end portion of the high end of the uncoated tablet,
bed and 2) a line from the end portion of the high end
of the coated tablet bed to the point on the back wall
of the coating pan where the horizontal lire mentioned
above intersects a vertical line along the back wall
the coating pan that bisects the coating pan.
The test procedure set out above was followed for
vitamins, and the results of this test are shown in
Table 3, and are illustrated in Figs. 1-7.
Referring to the data in Table 3, and to Figs. 1-
7, film coatings based on Formulations A, B, c, and D
did not xeduce the coefficient of friction of the
coated tablets based on Formulations A, B, C, and D matches the bed geometry of the uncoated tablets, as shown in Figs* 1-5.
Film coatings based on Formulations E and H only sLightly reduced the.- coefficient of friction of the tablets, and, accordingly, there is only a slight drop in the tablet bed geometry (Degree Differential of only 7 degrees) for coated tablots based on Formulations E (ses Fig. 6) and H compared with the tablet bed gaometry for uncoated tablets.
Film coatings based on Formulations F and I made
in accordance with the invention significantly reduced the coefficient of friction of the tablets, and, accordingly, there is a significant drop in the tablet bed geometry (Degree Differential of 19 degrees for Formulation F (see Fig. 7) and 20 degrees for formulation z) of the coated tablets based on Formulations F and I compared with the tablet bed geometry for uncoated tablets.
Formulation Degree Differential (degrees)
A 0
B 0
C 0
D 0
E 7
F 19
H 7
I 20
As shown by the above test results, tablets coated With the inventive film coating (Formulation F and I) provided the largest degree differential, illustrating the degree of slip provided thereby.
ADVANTAGES
The invention provides a film coating that possesses long-lasting gloss, good film adhesion, and good film clarity.
Our invention also provides a film coating that may be used as a gloss coating for vitamin tablets, herbal tablets, and pharmaceutical tablets that possesses long-lasting gloss, that adheres well to difficult substrates such as calcium-oyster shell, and that is non-frosty and clear.
The coatings produced in accordance with the invention mask the odor off the substrates coated thereby, which is particularly advantageous when dealing with vitamine and horbal tablets that do not
have a pleasant odor.
The inventive coating provides a glossy, elegant finish on pharmaceutical tablets without the need of applying a clear overcoat on the coated colored tablets. However, applying a clear overcoeat on the coated colored tablets coated with the inventive coating further enhances the finish on the tablets.
The inventive coating promotes a very fine logo definition on pharmaceutical tablets.
The inventive aqueous coating solution/suspension/dispersion has a viscosity that is markedly lower than the viscosities of coating suspensions based on hydroxypropyl methylcellulose, and
maltodextrin. For example, the viscosity of the formulation of Example l at a 30% solids level is 18.5 cP, at 40% solids is 87.5 cP, and at 50% solids is 381 cP. Accordingly, the tablet weight gain due to coating may be reduced to (1.5% to 0.75%, which is substantially tower than the tablet weight gain associated with prior art coating systems, and still obtain a coated tablet having an excellent gloss, Also, due to the lower viscosity of the coating
solutions/suspensions/dispersions of the invention, there is less of a likelihood of clogging of spraying equipment during the coating process/ and the ability to use higher solids content in the inventive coating (suspension than that may be advisable to use in the prior art systems,
The inventive film coating also causes a reduction of the coefficient of tablet friction, and as a result of this, tablets flow better in the bed of a coating pan. Due to this better tablet flow, the pan load may be increased by 10-20% while naintaining the optimum bed geometry and bed flow desired for coating the tablets. Accordingly, an increase in productivity is achieved since more tablets may be coated at once.
further, with a reduction of the coefficient of tablet friction obtained by the inventive film coating, tablets flow batter in the bed of a coating pan which results in a reduction of edge chipping/edge wear during the coating process.
Tablets provided with the inventive "slip" also increase productivity by lessening the time needed to process the coated tablets from the coating, pan to packaging of the coated tablets since the tablets with the inventive ifilia coating flow better than tablets coated with other film coatings.
The present invention relates to a dry film coating composition for forming a coating suspension for film-coating tablets of nutritional supplements and pharmaceutical substances.
This invention also relates to a field of aqueous film coating of nutritional supplements and pharmaceutical tablets, and is specifically concerned with providing film coatings based on dextrin for coating nutritional supplements, such as vitamin tablets and herbal tablets, and pharmaceutical tablets, such as acetaminophen (APAP), aspirin (ASA), and Ibuprofen.
Description of the Prior Art
Hydroxypropyl methylcellulose, maltodextrin, and lactose have all been used in coatings for substrates such as pharmaceutical tablets. For example, such coatings made from coating compositions manufactured by Colorcon and disclosed in U.S. Patent Nos. 4,543,370, 4,683,256, 4,643,894, 4,725,441 and 4,828,841, and in
allowed U.S. Patent Application Serial No. 08/400,134, all of said patents and said patent application being incorporated herein by reference, have proven especially effective when used on pharmaceutical tablets.
However, coatings baaed on hydroxypropyl methylcellulose, maltodextrin, and lactose, especially clear coats (clear non-pigmented coatings), sometimes suffer from a "frosting" problem (the formation of a white frost-like appearance in the coating) when used to coat nutritional supplements like vitamins and herbal tablets. Also, coatings based on hydroxypropyl methyl cellulose,, raaltodextrin, and lactose sometimes suffer from a "frosting" problem when used to coat pharmaceutical tablets (e.g. color-coded APAP tablets) at a 1% weight gain.
Further, coatings based on hydroxypropyl methylcellulose sometime become too brittle and dried out when used to coat herbal tablets, resulting in coatings peeling off the herbal tablets.
Also, coatings based on hydroxypropyl nethylcellulose sometimes have a dull matte finish with low gloss, rather than a desirable glossy i'inish, when used to coat nutritional supplements like vitamins and herbal tablets.
Tapioca dextrin has been used as an ingredient in a sealant layer for chocolates, nuts, etc. in the food/confectionery field, and the sealant layer
containing tapioca dextrin is covered with a coating such as a sugar shell. Tapioca dextrin in recognized to be very brittle and very tacky.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a film coating that possesses long-lasting gloss, good film adhesion, and good film clarity.
Another abject of the invention is to provide a film coating that may be used as a gloss coating for vitamin tablets, herbal tablets, and pharmaceutical tablets that possesses long-lasting gloss, that, adheres well to difficult substrates such as calcium-oyster shell, and that is non-frosting and clear.
Another object of the invention is to provide a film coating that eases tablet flow in the bed of a coating pan.
These and other objects are accomplished by our invention, which is described below.
Therefore, the present invention provides for a dry film coating composition for forming a coating suspension for film-coating tablets of nutritional supplements and pharmaceutical substances, the composition comprising:
5-97% by weight of dextrin obtained from tapioca; 1-15% by weight of at least one component selected from a group comprising mineral oil, carnauba wax, acetylated monoglyceride, lecithin and magnesium stearate as a detackifier; and
the balance, comprising at least one conventional component selected from a group comprising auxiliary film-former, plasticizer, surfactant, flow aid, preservative, titanium dioxide and colorant.
The composition of the invention is not a mere admixture resulting in the aggregeite properties of the components thereof. The composition exhibits unexpected and improved properties over and above the aggregate properties of the components. Further, the composition is not a product of a chemical reaction.
The benefits obtained by coating tablets with the compositions mclude, for example, improving the appearance of the tablets, providing hard and slippery outer layer that protects the tablets during handling and storage, and providing a coating that keeps the tablets slippery for ease of handling. Problems known to the prror art as described at page 3 of the specification have been overcome by the composition of the invention. Therefore, previously known film coatings that were based on hydroxypropyl methylcellulose, maltodextrin and lactose suffered from problems such as frosting or white frost-like appearance. In the passage bridging pages 3 and 4 of the specification, use of tapioca dextrin has been described. None of the previous uses are known to include compositions for film coating cablets. Lines 2 and 3 on page 4 states that tapioca dextrin is known to be brittle and very tacky (sticky) when employed alone. Despite the clear disadvantages of tapioca dextrin as a coating i or tablets and pills the specification reports successful production of well coated, hard, shiny, and non-tacky coated tablets as described, for instance, at page 18 of the specification, using compositions according to the invention. In fact, a number of unexpected advantages ace provided by the composition of the
invention compared to tapioca dextrin alone, or compared to previously employed tablet coating materials. As detailed at pages 43-45 of the specification, these include, for example, a lower viscosity of the composition in solution that results in lesser likelihood of clogging the spraying equipment, less weight added to the treated tablets by the coating, and an improved appearance of the tablets with the finished coating. Pages 39-42, and photographs of Figures 1-7 confirm that the tablets are unexpectedly more slippery than the uncoated tablets. The black line at the back of the pan shown in each photograph indicates the level to which the batch of tablets settled without the coating. Each photograph confirms that the coated tablets settled to a lower level than did uncoated tablets. Therefore, the above passage lends support to the statement that the composition according to the invention, essentially comprising tapioca dextrin and a detackifier, is one that does not merely exhibit aggregate properties of the two components but improved and unexpected ones that have been exemplified though not in an exhaustive fashion. The following disclosure, hereinafter, proceeds to fully describe the invention.
The composition of the invention essentially comprises tapioca dextrin and a detackifier. Dextrin is obtained from starch as has been described later in this disclosure. Hydrolysis of starch results in dextrin. Dextrin has not been reported to have nutritive value. In fact, it is an excipient. An excipient is an inert ingredient that passes through the alimentary canal without any change in its chemical structure. Therefore, unlike starch it is not an article of nourishment. Consequently, the composition of the invention is not capable of being used, and indeed, is not intended to be used as an article of nourishment or food.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Fig. 1 shows a coating pan containing 3.5 kg of uncoated tablets. A line is drawn on the back wall of the coating pan which follows the plane bordering and parallel to the top of the tablet bed of the uncoated tablets.
Fig. 2 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using
Formulation A. this figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 3 shows a coating pan containing 3,5 kg of tablets coated with a film coating made using Formulation B. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. l.
Fig. 4 shows, a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation C. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 5 shows a coating pan containing 3-5 kg of tablets coated with a film coating made using Formulation D. This figure illustrates that the bed geometry for the coated tablets matches the bed geometry of the uncoated tablets shown in Fig. 1.
Fig. 6 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation E. This figure illustrates a alight drop in the tablet bed geometry compared with the tablet bed geometry shown in Fig. 1.
Fig. 7 shows a coating pan containing 3.5 kg of tablets coated with a film coating made using Formulation F. This figure illustrates a significant drop In the tablet bed geometry compared with the tablet bed geometry shown in Fig. 1.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the invention, our dry film coating compositions for use in forming coating suspensions for film coating nutritional supplements, pharmaceutical tablets, and the like, comprise a dextrin and a detackifier,
Advantageously, the inventive dry film coating compositions may include one or more of the following components: auxiliary film-former (•) , a plasticizer, a surfactant, colorant, a flow aid, and a preservative.
In accordance with the invention, a method of coating substrates such as nutritional supplements, pharmaceutical tablets, and the like, comprises making dextrin and a detackifier into water to form an inventive aqueous coating suspension, applying the Inventive coating suspension into said substrates to form a film coating on said substrates, and drying the film coating on said substrates. Optionally, but advantageously, the following components may be mixed Into water with the dextrin and the detackifier to form the inventive coating suspension: auxiliary film-former(s), a plasticizer, a surfactant, colorant, a flow aid, and n preservative.
The invention also includes the coated substrates, such as coated vitamins, coated herbal tablets, and coated pharmaceutical tablets;, and the method of making the dry film coating compositions and the method of
making the coating wuspensions of the invention.
Dextrin Preferably, desetrin is about 5% to about 97% by weight of the inventive dry film coating composition
and of the non-water ingredients of the inventive aqueous coating suspension.
For clear coatings (coatings without colorant), a range of about 35% to about 75% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred, and a range of about 65% to about 73% of dextrin by weight of the Inventive dry film coating composition and of the non-water ingredients of the Lnventive aqueous coating suspension is even more preferred.
For white coatings (coatings containing titanium dioxide as the colorant), a range of about 30% to about £0% of dextrin by weight of the inventive dry film coating composition and of the non-water Ingredients of the inventive equeous coating suspension is more preferred, and a range of about 35% to about 401 of
dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is even more preferred.
For colored coatings (having lakes, dyes, and the like as a colorant), a range of about 35% to about 75% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred, and a range of about 45% to about 55% of dextrin by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is even more preferred.
Examples of the detackifier are mineral oil, carnauba wax, acetyiated monogiycerides (Myvacet), lecithin (Alcolec), and magnesium stearate.
For clear coatings (coatings without colorant), a range of about 1% to about 15% of detackifier by weight cf the inventive dry film coating composition and of the non-water ingredients of the inventive aquecus coating suspension is preferred, and a range of about
7.5% to about 10% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating (suspension is more preferred.
For white coatings (coatings containing titanium dioxide as the colorant), a range of about 1% to about 15% of detackifier by weight cf the inventive dry film
coating composition and of the non-water ingredients of the inv«ntiv« aqueous coating suspension is preferred, and a range of about 2% to about 5% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is more preferred.
For colored coatings (having lakes, dyes, and the 1Lke as a colorant), a range of about 1% to about 10% oC detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is preferred, and a range of about 2% to about 5% of detackifier by weight of the inventive dry film coating composition and of the non-water ingredients of the Inventive aqueous coating suspension is more preferred. When using mineral oil as the detac'Kifier in colored formulations, a range of about 1% to about 7.5% of wineral oil by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating suspension is preferred, and a range of about 2% to about 4% of mineral oil by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous water suspension is even more preferred, in order to avoid color bleeding of the coating if the amount of titanium dioxide in the coating is low.
The auxiliary film-former(s) may be dextrose, polyvinylpyrrolidone (PVP) , hydroxypropyl

mothylcellulosie, stethylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (Sodium CMC), maltodextrin, sodium alginate, PG alginate, polyvinyl alcohol (PVA), and combinations thereof. The auxiliary film-former(•) act as strength enhancers for the filia coating. Their presence in the coatings help prevent cracking of the film coating, as well as helping to prevent edge wear/chipping of the coated tablet. The preferred and the more preferred ranges for the auxiliary film-former(a) by weight of the inventive dry film forming composition and by weight of the non-water ingredients of the inventive aqueous coating suspension are 0% - about 55% (preferred) and 3.5 to 10% (more preferred) for clear formulations, 5% - 50% (preferred) and 5% to 30% (more preferred,* for white formulations, and 5 to 50% (preferred) and 5 to ;>o% (more preferred) for colored formulations. The preferred ranges and the more preferred ranges i!or various exemplary auxiliary i!ilm-former(s) are «et out below.
When coating extremely friable tablets! with a clear co.stting made from a clear formulation, a preferred auxiliary film-former is NacMC in an amount up to 50% by weight of the inventive dry film forming composition and by weight of the non-water ingredients cf the inventive aqueous coating suspension, and preferably in an amount of about 40% to about 45% by weight of the inventive dry film rorming composition
and by weight of the non-water ingredients, of the inventive aqueous coating suspension. The NaCMC improves the film strength of the inventive coating, which results in the coated tablet being less friable than th« uncoated tablet.
Exemplary of the plasticizer are polyethylene glycol having a molecular weight in the range of 200 to 8000, propylene glycol, glycerine, triacetin, acetyltriethyl citrate, triethyl citrate (Citroflex A2) , trlbutyleitrate (Citroflex 4), and acetyltributylcitrate (Citroflex A4), and the preferred ranges for the plaaticizer are set out below, together with preferred and more prreferred ranges for various exemplary plas1:iciz;ers.
Exemplary of the surfactant is Polysorbate 80, and the preferred ranges for the surfactant are set out below, together with preferred and more preferred ranges for a exemplary surfactant,
A colorant may be any approved colors, opacifiers, or dyes. For example, the colorant may be FD&C lakes, D&C lakea, titanium dioxide, magnesium carbonate:, talc, pyrogenic silica, iron oxides;, channel black, riboflavin, carmine 40, ponceau 4R, patent blue V5, caramel, curcuain, annatto, dyes, and combinations thereof. The preferred range and the more preferred range for the color ant (the Ti02) in the white formulations are 20% to 50% (preferred) and 25% to 40% (more preferred) by weight of the inventive coating

composition and by weight of the non-water ingredients of the inventivs coating suspension. The preferred range and the more preferred range for the colorant in the colored formulations are 0.1% to 40% (preferred) and 15% to 25% (more preferred) by weight of the inventive coating composition and by weight of the non-water ingredients of the inventive coating suspension.
Exemplary of the flow aid is stearic acid/ and the preferred ranges and the more preferred ranges for the flow aid are set out below, together with the preferred and the more preferred ranges for stearic acid.
Exemplary of the preservative is sodium citrate, and the preferred ranges for the preservative are set out below, together with the preferred and the more preferred ranges for sodium citrate.
CEAR WHITE PIGMENT AUXILIARY FILM FORMERS
Preferred 0-55% 5-50% 5-50%
More Preferred 3,5-10% 5-20% 5-2 0%
Dextrose
Preferred 0-20% 25-50% 5-2.0%
More Preferred 1 -5-10% 30-35% 7.5-15%
PVP
Preferred o-ioi 0-10% 0-10%
More Preferred 3.5-7. !>% 3.5-7.5% :». 5-7. 5%
HPMC/Methylcelluloee/
HPC
Preferred 0-10% 5-50% 5-50%
More Preferred 3.5-7*5% 5-20% 5-20%
Ma Alginate/ PG Alginate
Preferred 0-10% 1-10% 1-10%
More Preferred 3.5-7.5% 3,5-7.5% 3.5-7.5%
Na CMC
Preferred 0-50% 1-10% 1-10%
Mora Preferred 3,!>-7.!»% 3.5-7.5% 3.5-7.5%
for tablet* with
low friability
More Preferred for 40-45** 3.5-7.5% 3.5-7.5%
tablets with high
friability
Maltodextrin
Preferred o-2!>% 5-50% 5-50%
More Preferred 15-50% 5-20% 5-20%
SURFACTANT
Preferred 0-LI>% 0-15% 0-15%
Polyeorbate 80
Preferred 0-2* 0-2% 0-2%
More Preferred 0.5-1% 0.5-1% 0.5-1%
FLOW AID
Preferred 0-10% 0-10% 0-10%
More Preferred 2-5% 2-5% 2-5%
Stearic Acid
Preferred 0-101 0-10% 0-10%
More Preferred 2-5% 2-5% 2-5%
PLASTICIZKR
Preferred 0-15% 0-15% 0-15%
Polyethylene Glycol 8000
Preferred 0-15% 0-15% 0-15%
More Preferred 7.5-10% 7.5-10% 7.5-:io%
Glycerine
Preferred 0-10% 0-10% 0-10%
More Preferred 3.5-7.;.% 3.&-7.5% 3.5-7.5%
PRESERVATIVE
Preferred 0-5% 0-5% 0-5%
Sodium Citrate
Preferred 0-4% 0-4% 0-4%
More Preferred 1-2% 2-3% 2-3%
The range© set out above are all by weight of the dry film coating composition of the invention and of the non-vater ingredients of the aqueous coating suspension of the invention.
The following examples illustrate the invention, all ingrodients being by weight.

EXAMPLE-1
The dry components of the following formulation were blended together for five minutes in a food processor to form a mixture. Then, the liquid components were added to the mixture of dry components and blended therein by mixing for an additional two minutes.
optionally, the components of the formulation are granulated using a planetary mixer, such as a Hobart
planetary mixer. After the dry film coating composition is load (id into the mixer and the mixer is switched on, sufficient water is slowly added until the composition forms slightly adherent granules. These granules are then passed through a 1-2 mm screen and then driod in a 30*C oven until the moisture content is below 5%, The composition is then sieved again through a 1-2 mm screen and is then ready for use in a non-dusting, granular form. If not optionally granulated, the composition may be milled such as in a hammer mill (Apex Machinery, Dartford, England), for example.
Other methods of granulation which may be used are spray granulation and roller compaction.
20 grams of the resulting film coating composition Was dispersed Into 180 grams of distilled viater to form an inventive coating solution/suspension (10% sclids), and 30 grams of this solution/suspension was sprayed using an Aerostatic Strea I coater onto 1000 grazrs of color-coated placebos to form the inventive coating
thereon having a theoretical weight gain of 1.0%.
This produced a film coating on the tablet that possessed an excellent long-lanting ahiny gloss, minimal tackiness, good film adhesion, good non-frosty film clarity.
The above desccibed coating procedures was repeated, except that a 15% solids coating solution/suspension was used, obtained by mixing 3 0 grams of the formulation of this example into 170 grams of distilled water to form the aqueous coating solution/suspension, and then spraying 20 grams of the solution/suspension onto 1000 grams of color-coated placebos. Again, the resulting coating possessed an excellent long'-lasting shiny gloss, minimal tackiness, good film adhesion, and good nDn-frosty film clarity.
Tapioca Dextrin (A. 12. Staley) 70% 700.00
Dextrose (A.E. Stalay) 10% 100.00
Mineral Oil (Eastech 10% 100.00
Chemical Inc.)
Polyethylene Glycol 8000 8% 80.00
(Union Carbide)
Sodium Citrate, Anhydrous
(ADM Corn Processing) 2% 20.00
100% 1000
Examples 2-20 further illustrate the invention, fill percentages baling by weight.
In Examples 2-12, the components of each formulatLon ara mixed together, formed into a coating
suspension, and applied to tablets, as in Example 1, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grama
Tapioca Dextrin (A.E. Staley) 72% 720.00
Dextrose (A.E, Staley) 10% 100.00
Mineral Oil (Pennreco) 15% 150.00
Sodium Citrate, Anhydrous 2% 20.00
(ADM corn Processing)
Polysorbate 80
(ICI Surfactants) 1—%. .10,00
100% 1000
EXAMPLE-3
component Percentages Grams
Tapioca Dextrin (A.E. Staley) 72% 720.00
Dextrose (A.E. StaLey) 10% 100.00
PVP (Pennreco) 5% 50.00
Mineral Oil (Pennreco) 10% 100.00
Sodium Citrate, Anhydrous 2% 20.00
(ADM Corn Processing)
Polysorbate 80
(ICI Surfactants) 1% 10.00
100% 1000
EXAMPLE-1
Component Percentages: Grams
Tapioca Dextrin (A.E. Staley) 69.5% 695^,00
Oextrose (A.E. Staley) 10% 100.00
HPMC E-15 (DOW) 7.*;* 75.00
Mineral Oil (Pennreco) 10k 100.00
Sodiun citrate, Anhydrous 2% 20.00
(ADM Corn Processing)
Polyaorbat* so
(ICI surfactant©) ll 10.00
100% 1ooo
Component Percentages Grms
Tapioca Dextrin (JUB. Staley) 63.5% 635.00
Dextrose (A.E. st.uley) io% 100.00
Mlnerm mi { PH"" xo*
Sodium Citrate, Anhydrous 2% 20.00
(ADW Corn Process ing)
CarnauJta Wax (Rosai) ln5% 15.00
100% 1rtftn
Component percentages Grams
Tapioca Davtcin (A.B. 6«:nl«y) 30* 3BQ.OO
SuUium CMC (Aquaion) 18% 180.00
Oextroae (A.E- Staley) 16* 160.00
Maltodaxtrin (A.E. staley) 16% 160.00
Hittoial Oil (PennxecQ) 10% 100.00
Sodium Citrate, Anhydrous
(ADM Corn Procra*«ing) 2% 2Q.0Q
100% 1000
Tapioca Dexrtrln (A.E. Staley) 95% 950.00
Mineral oil (Pennreco) 5% 50.00
100% 1000
EXAMPLE 8
Tapioca Dextrin Carnuba wax 24 30.00
100% 1000
Tapioca Dextrin (A„E, Statay) 97% 970.00
11ck^riit«!iAuni Statary 3% 30» pO
100% 1000
ftX&MSlJL-Uai
component Percentages grams
Tapioca Dextrin (A.E. Stalty) 95% 950.00
Alcolec 5% 50. P.O.
100% 1000
EXAMPlE 11
Component Percentages Gras
Tapioca Dextrin 37.9% 379
Dextrose 10.1% 101
ane 10% 100
Na Citratft a* *°
Na CMC 4P* -JUlft
100% 1000
Example 12
C omponent Percentages Grams
Tapioca Dextrin 32.9% 329
Dextrose 10.1% 101
Alcolec 10% 100
Na Citrate 2% 20
Na CMC 45%
1OO% 1OOO
EXAMPLS 13
The dry components of the following formulation were blended together for five minutes in a PK blender (Paterson Kelly) to form a mixture. Then, the liquid components of the formulation were added to the mixture of the dry components via the r-bar of the blender and bLended therein by mixing for an additional five minutes.
140 grams of the resulting film coating composition was dispersed into 1260 grams of distilled water and stirred until dispensed (about 20 minutes) to form an inventive coating solution (10% solids), and all of the solution was sprayed using a 24' Accela Cota coater (Thomas Engineering) onto 14 kg of herbal tublets (black walnut tablets from B&c Nutritional Products) to form the inventive coating thereon having a theoretical weight gain of 1.0%.
This produced a film coating on tha tablets that possessed long-lasting gloss, good film adhesion, and good film clarity.
The above-described coating procedure was repeated, except that a 151 solids coating solution was used, obtained by mixing 140 grams of the formulation of thin example into 793.33 grams of distilled water to form the aqueous coating solution. Again, the resulting coating possessed, long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grams
Tapiocu Dextrin (A.E. Staley) 70% 3500.00
Dextroise (A.E. Staley) 10% 500.00
Mineral Oil (Eastach
Chemical Inc.) 10% 500.00
Polyethylene Glycol 8000
(Union Carbide) 8% 400.00
Sodium Citrate, Anhydrous
(ADM Corn Processing) 21 1QP.P.P
100% 5000
In this example, the coaponents of the formulation of Example 13 axe mixed together, formed into a coating suspension, and applied to tublets, as in Example 13, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that the tablets are vitamins (Pharmavite) rather than herbale.
in. this example, the components of the formulation
of Example 13 are mixed together, formed into a coating suspension, and applied to tablets, as in Exampla 13, to obtain film coatings possessing long-lusting gloss, good film adhesion, and good film clarity, axcept that the tablets are oyster shell (Delavau) rather than herbals,
Example
In this example, the components of the formulation of Example 13 are mixed together, formed into a coating suspension, and applied to tablets, as in Example 13, to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, uxcept that the tablets are APAl' rather them herbals.
Example 17 (PEARL WHITE)
In this example, the components of the formulation of this example are mixed together, formed into a suspension, and applied to tablets as in Exarople 13, to obtain non-tacky, smooth film coatings possessing long-lasting, very shiny gloss, good film adhesion, and good film clarity, except, that 450 grams of the coating composition of this example was dispersed into 1800 grams of distilled water and stirred until dispersed (about 30 minutes) to form the inventive coating dispersion, and all of the dispersion was sprayed onto l5. kg of vitamins (Pharmavite) , rather than 14 kef of" herbal tablets, to obtain a theoretical 3.0% weight gain (20% solids).

Tapioca Dextrin (Stalky) 39% 1950.00
HPMC/Pharaacoat. E~50 10% 500. 00
(DOW/ShinEteu)
PolyethyUna Glycol 8000 8% 400.00
(Union Carbide)
HPMC/Fharmacoat E-15 5% 250.00
(DOW/ShinEtnu)
Sodiua citrate, Anhydrous 3t iso.oo
(ADM Corn Procesaing)
Mineral Oil (Pennreco) 3% 150.00
Titanium dioxida
(water) (Kronoa) 32% 1600.oo
100% 5000
EXAMPLE is (Orange)
In this example, the components of the formulation of this example are mixed together, formed into a coating suspension, and applied to tablets, as in Example 17 to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that the coated tablets wore provided with a clear overcoat made from dispersing 37.5 grams of the formulation of Example into 212,5 grams of distilled water, and applying said clear overcoat solution as in Example 1 onto the coated tablets of this example for a theorotical 0.2 5% weight gain at 15% solids. This resulted in a clear overcoat over the colored coating of the invention having a very nice gloss.

Component Percentages Grams
Tapioca Dextrin (staley) 43.55% 2177.50
Polyethylene Glycol 8000 8% 400 on
(Union Carbida) 400.00
HPMC/Pharnaacoat E-50 10% 500 00
(DOW/ShinEtsu) 5 °'°Q
HPMC/pharmacoat E-1S 5.31% 265.50
(DOW/ShiniEtsu)
Mineral oil (Ponnreco) 3% 150.00
FD4C Yallow No. 6, 0,62% 31.00
HT 15-18%
Titanium dioxide
(water) (Kronos) ?9.52% 1476.Og
100% 5000
EEMJELE 19 (Red)
The components of the formulation of this example are mixed together, formed into a coating suspension, and applied to tablets, as in Example 17 to obtain film coatings possessing long-lasting gloss, good film adhesion, and good film clarity, except that 450 grama or coating composition of thin example was dispersed in 2550 grams of distilled water to form the inventive coating dispersion. As in Example 18, a clear overcoat in applied to the coated tablets of this example following the procedures set out in Example 18, resulting in a clear overcoat over the inventive colored coating on the coated tablets which had a. very nice glosu.
Components Percentages Grams
Tapioca Dextrin (Staiey) 50% v 2500.00

Polyethylene Glycol 8000 10% 500.00
(Union earblde)
HFMC/Pharmacoat E-50 8% 400.00
(DOW/ShlnEtBU)
tftearic Acid (Witco) 4% 200.00
Alcolec F-100 3% 150.00
(American Lecithin)
stodium Alginate (Kelco) 5% 250.00
Titanium dioxide 5.05% 252.50
(water) (Kronos)
FDSC Red NO. 40, HT, 38-42% 13.53% 676.50
I'D&C Bluo NO. 2, HT, 3-5% 1,42* 11-dlfl
100% 5000
Example 20 (Maroon)
In this exmaple, the components of the formulation of this example are mixed together, formed into a suspension, and applied to tablets as in Example 13, to obtain film coatingn possessing long-lasting gloss, good film adhesion, and good film clarity.
Component Percentages Grams
Tapioca Dextrin 29* 1450.00
Dextrose 10% 500.00
PEG 8000 10* 500*0°
Stearic Aold 4% 200,00
HPMC E-5C 8* 400'00
Alcolec F-100 3% 150.00
Sodium Alginate XL 5% 250.00
FD&C Red NO. 40, HTf 38-42% 24.56% 1228.00
Titanium Dioxid* 4.43% 221.50
FDfiC Blue No. 2, HI", 11-155% _2,01% 100,50.
100% 5000
The inventive film coating causes a unique phenomenon, the reduction of the coefficient of tablet friction, which we refer to act "slip factor" or "slip". The inventive film coating reduces the coefficient of Friction of the tablets, thereby reducing the friction between tablets, both during1 and after application of the coating onto the tablets , such that the tablets
slip or glide or Slip pant each other as they tumble in the coating pan during application of the film coating and as they are poured during packaging procedures aft«r being coated. In other words, the Inventive film coating imparts a slipperiness onto the tablet and permits the tablets to flow more easily over
l one another.
We have discovered that the inventive film coating causes a reduction of the coefficient of tablet friction. With a reduction of the coefficient of tablet friction, tablets flow better in the bed of a
coating pan creating spaces for more tableta to be placed in the coating pan to; be coated with the Inventive* coating. To maintain the optimun bed geometry and bed flow desired for coating the teblets in the coating pan, a larger tablet charge (10-^0% increase in pan load) is used when coating with the inventive coating,. Accordingly, an increase in
productivity is achieved since more tablets are coated at once.
Further, tablets provided with "slip" (that in, tablets having a reduced coefficient of tablet friction) slide/glide past each other, which is particularly advantageous when coating bulky tablets and tablets having friable edges that h&ve a tendency to chip off as the tablets tumble in the coating pan.
Tablets with '"slip" also increase productivity by lessening the time needed for processing the coated tablets from the coating pan to packaging of the coated tablets since tablets with the inventive; film coating flow better than tablets coated with other film coatings.
The following Tests 1, 2, and 3 were conducts.! to carapace "slip5' obtained from the inventive film coating with "slip" (if any) obtained from other film coatings. Film coatings (3% weight gain) having the* following coating formulations were used in each test:
Formulation A
1PMC 6 CPS-Methoeel E-6 31,720'
HPMC 3 CPS-Methocel 1-3 31.720
Titanium Dioxide (water) 2 6.420'
Peg 400 NF 8.000
FD6C ¥«lloW No. 6 ET 15%-:i8%„ 1.150
Polysorbat* 80 NF l.opg
100.000
Formulation B
(An) opadry II Coating Composition )

Component Portion by weight
HPMC 3 CPS~Mathoc*l E-3 30.330
Titanium Dioxid* (water) 39.490
Maltodextrin (Star-Dri 5) 18.000
HPMC 6 CPS~M*thocel E-6 9.340
Triacetin USP/EP/JPE-Ea*t»an 7.500
Peg 8000 NF 2.500
HPMC~Methoe*l E50-LV Premium 2.330
FDfiC Yellow No. 6 H't 15%-1B% -5§Q
100.000
Formulation C (An) opadry II Coating Composition )
Component portion by weight
Titanium Dioxide (water) 31.200
Folydextrose powder 23.600
HPMC 3 CPS-M*t«OCel E-3 15.200
HPMC 6 CPS~Metboce»l E-6 15.200
Triacetin USP/BP/JPE-Eaetnan 6.000
HFMC-Methocel ESO-LV Premium 5.000
Peg 8000 NF 2.000
FD&C Yellow No, 6 HT 15t-lS* 1.800
100.000
Formulation D
(An) opadry II Coating Composition )

Component portion by Weight
lactose Honohyd. #3 16, NF, FF 40.000
KPMC 15 CP-Pharmaco.it 615 28.000
Titanium Dioxide (water) 22,500
Triacetin usP/EP/JPE-Eastaan 13.000
FD*C Yellow No. 6 HT 15%-18% 1.500
100.000
Formulation E
(An) opadry XD Coating Composition )

Component Portion by weight
Titanium Dioxid* (wnter) 30.860
CwBxt rose 28.084
Waltodextrin (Star-Dri 1) 21.216
Sodium Alginate Ked:jin-XL 5.440
HPMC 15 OPS-Kethocel E-15 5.100
Triacetin USP/EP/JPI5/Eastoan 4.760
Stearic Acid PDR (Kosher) 2.720
FD&C Yellow NO. 6 HT 15*-18% 1.140
AlCOlec F-100 ., ,$ftfl.
100.000
Formulation F
(An) opadry ns Coating Composition )
Titanium Dioxide (water) 36.516
Tapioca Dextrin 955 SR 30.670
HPMC-Methocel E50-LV Premium, 10,000
Peg 8000 NF ' 7.000
PB-15Y-Y6-17 4.7 68
HPMC 15 CPS-Methocial E-15 4.046
Alcol'&c F-100 4.000
Peg 400 NF . 3,Q&fl
100.000
Formulation F is an exemplary formulation for the
inventive film coating.
Test 1-Measurememt of Flow Rate
A first set of vitamins was coated with a film
i
coating using Formulation A, a second set of vitamins was coated with a film coating using Formulation B, a third set of vitamins was coated with a film coating using Formulation 0, a fourth set of vitamins was coated with a film coating using Formulation D, a fifth set of vitamins was coated with a film cating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F. The flow rate for each set of coated vitamins was then measured using the following procedure to determine which film coating provided the highest flow rata
For each set of vitanina,, the chamber of a Flodex Tester flow meter (manufactured by Hanson Research) was
fillad with the coated vitamins but without packing the tablets down into the chamber. Then, the release lever for the release door of the Flodex Tester flow meter was pulled to release the tablets from the chamber through a 46mm orifice, and the time was measured from the start of tablet flow to the end of tablet flow. This procedure was followed 5 times for each set of vitamins, and the average length of time of flow and the standard deviation were determined. A constant weight (in this test 173 grams of vitamin tablets) of vitamins was used throughout the testing. The vitamin tablets coated with film coatings made using Formulations A, B, and D did not flow from the Flowdex Tester's chamber unassisted, but rather needed to be coerced into flowing by banging on the side of the Flodex Tester's chamber.
The results of this test are shown in Table 1(a) and Graph 1(a).

Table 1(a) (Table Removed)
GRAPH I (a) (Figure Removed)
A seventh set of vitamin* was coated (3% weight
gain) with a film coating using an exemplary
formulation (Formulation G) for the inventive film
coating. Then, a first subset of these Formulation G
coated vitamins warn coated with a gloss coat (0.25%
weight gain) using Formulation H, and a second Bubset
of Formulation G coated vitamin tablets vras coated with
a clear gloss coat (0.25% weight gain) using
Formulation I, which is an exemplary formuLatioa for
the inventive film coating. The flow rate for the
coated vitamins provided with a clear gloss coat based
on Formulation H and the Cloy rate for the coated
vitamins provided with a gloa« coat based on
Formulation I were then measured using the Test l
procedure set out above to determine which vitamins
nave the highest flow rates. 'The results are shown in
Table l(b) and Graph 1(b).
Formulation G
(Table Removed)
Formulation H
HPMC 6 CPS-Pharaacoat 60 P£G 400 NF 4.550
PEG 8000 NF ^jLciSC
100.000
Formulation I
Tapioca Dextrin 955 SR 72.900
Dextrose 10.100
Alcolec F-lOo 10.000
Sodium CMC 5.000
Sodium citrate, FCC, USP JUQQQ.
100.000
Formulation Time (Second)
H 1.36
* 1.26
(Figure Removed)
As shown by the above test results, vitamin tablets coated with the Inventive film coating (Formulation F and Formulation I) flowed better than the vitamin tablets coated with the other film coatings, illustrating the slip factor provided by the inventive film coating.
Test-2-Angle of Repose
A first Bet of vitamins was coated with a film coating using Formulation A, a second set of vitamins was coated with a film coating using Formulation B, a third set of vitamins wast coated with a film coating using Formulation c, a fourth set of vitamins was coated with a film coating using Formulation D, a fifth set of vitamins was coated with a film coating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F.
The angle of repose for each set of coated vitamins was then measured using the following procedure.
For each set of vitamins, 1.0 kg of vitamins were placed in a funnel having a 2.75 cm diameter orifice, which was initially plugged, The funnel was supported in a support ring mounted on a stand such that the bottom of the funnel was 4 1/2 inches above a countertop. With the vitamins in place in the funnel, the stopper was removed from the orifice to permit the tablets to flow from the funnel through the orifice to
form a pile of tablats on the countartop. The angla of the pila (the angle of the repose) was measured. This procedure vac followed three time* for each sat of vitamins, and the average angle of repose for each »at of vitamin* was-atenairied, The sat of tablets coated with the inventive film coating (Formulation F) was the only a«>t of tablats that flowed uninhibited through the funnel.
The results of this test are shown in Table 2 and Graph 2.
Xftfetlfi.2 ForgflilatJQn Angle of Repose (daaraaH
h 44.33
B 41.33
C 41.67
D 40.67
E 29
F 2 0
Graph 2
(Figure Removed)
As shown by the above test results, vitamin tablets coated with the inventive film coating (Formulation F) created the smallest angle of repose illustrating the slip factor provided by the inventive film coating.
Test 3- Measurement of Degree Differential
A first set of vitamins was coated with a film coating using Formulation A,, a second set of vitamins was coated with a film coating using Formulation 8, a third set of vitamins was coated with a film coating using Formulation C, a fourth set of vitamins was coated with a film coating using Formulation D,, a fifth set of vitamins was coated with a film coating using Formulation E, and a sixth set of vitamins was coated with a film coating using Formulation F.
A seventh set of vitamins was coated (31 weight gain) with a film coating using an exemplary
formulation (Formulation G) for the Inventive film coating. Then, a first subset of these Formulation G coated vitamins was coated with a gloss coat (0.25% weight gain) using Formulation H, and a second subset of these Formulation G coated vitamins was coated with a gloss coat (0.25% weight gain) using Formulation I, which is an exemplary formulation of the inventive film coating.
Tha degree differential for each set (sets 1-6 and subsets l and 2 of set 7) of coated vitamins was
measured using the following procedure to establish numerical data on slip. The degree differential is the degree of drop between the top of a tablet bed of uncoated tablets and the top of a tablet bed of coated tablets.
3.5 kg of uncoated vitamins were placed in a O'Hara Labcoat I coating pan (a 15 inch pan), and the uncoated tablets were tumbled in the coating pan for two revolutions at a pan speed of three revolutions per minute. As shown in Fig. 1, a first line was drawn on the back wall of this coating pan following the plane bordering and parallel to the top of the tablet bed of the uncoated tablets.
The uncoated tablets were then removed from the coating pan.
Then, for each set (sets 1-6 and subsets l and 2 cf set 7] of coated vitamin tablets, 3.5 kg of coated vitamins were placed into the coating pan, and the coated tablets were tumbled in the coating pan for two revolutions at a pan speed of three revolutions per minute. A second line was drawn on the back wall of the coating pan following the plane bordering and parallel to the top of the tablet bed of the coated tablets if the bed geometry did not match the bed geometry of the uncoated tablets narked by the first line.
To determine the degree differential (the degree of drop in the level of the high end of the tablet bed)
between uncoated tablets and coated tablets, we Measured the angle forsed between i) a horizontal
along the back wall of the coating pan that intersects
the end portion of the high end of the uncoated tablet,
bed and 2) a line from the end portion of the high end
of the coated tablet bed to the point on the back wall
of the coating pan where the horizontal lire mentioned
above intersects a vertical line along the back wall
the coating pan that bisects the coating pan.
The test procedure set out above was followed for
vitamins, and the results of this test are shown in
Table 3, and are illustrated in Figs. 1-7.
Referring to the data in Table 3, and to Figs. 1-
7, film coatings based on Formulations A, B, c, and D
did not xeduce the coefficient of friction of the
coated tablets based on Formulations A, B, C, and D matches the bed geometry of the uncoated tablets, as shown in Figs* 1-5.
Film coatings based on Formulations E and H only sLightly reduced the.- coefficient of friction of the tablets, and, accordingly, there is only a slight drop in the tablet bed geometry (Degree Differential of only 7 degrees) for coated tablots based on Formulations E (ses Fig. 6) and H compared with the tablet bed gaometry for uncoated tablets.
Film coatings based on Formulations F and I made
in accordance with the invention significantly reduced the coefficient of friction of the tablets, and, accordingly, there is a significant drop in the tablet bed geometry (Degree Differential of 19 degrees for Formulation F (see Fig. 7) and 20 degrees for formulation z) of the coated tablets based on Formulations F and I compared with the tablet bed geometry for uncoated tablets.
Formulation Degree Differential (degrees)
A 0
B 0
C 0
D 0
E 7
F 19
H 7
I 20
As shown by the above test results, tablets coated With the inventive film coating (Formulation F and I) provided the largest degree differential, illustrating the degree of slip provided thereby.
ADVANTAGES
The invention provides a film coating that possesses long-lasting gloss, good film adhesion, and good film clarity.
Our invention also provides a film coating that may be used as a gloss coating for vitamin tablets, herbal tablets, and pharmaceutical tablets that possesses long-lasting gloss, that adheres well to difficult substrates such as calcium-oyster shell, and that is non-frosty and clear.
The coatings produced in accordance with the invention mask the odor off the substrates coated thereby, which is particularly advantageous when dealing with vitamine and horbal tablets that do not
have a pleasant odor.
The inventive coating provides a glossy, elegant finish on pharmaceutical tablets without the need of applying a clear overcoat on the coated colored tablets. However, applying a clear overcoeat on the coated colored tablets coated with the inventive coating further enhances the finish on the tablets.
The inventive coating promotes a very fine logo definition on pharmaceutical tablets.
The inventive aqueous coating solution/suspension/dispersion has a viscosity that is markedly lower than the viscosities of coating suspensions based on hydroxypropyl methylcellulose, and
maltodextrin. For example, the viscosity of the formulation of Example l at a 30% solids level is 18.5 cP, at 40% solids is 87.5 cP, and at 50% solids is 381 cP. Accordingly, the tablet weight gain due to coating may be reduced to (1.5% to 0.75%, which is substantially tower than the tablet weight gain associated with prior art coating systems, and still obtain a coated tablet having an excellent gloss, Also, due to the lower viscosity of the coating
solutions/suspensions/dispersions of the invention, there is less of a likelihood of clogging of spraying equipment during the coating process/ and the ability to use higher solids content in the inventive coating (suspension than that may be advisable to use in the prior art systems,
The inventive film coating also causes a reduction of the coefficient of tablet friction, and as a result of this, tablets flow better in the bed of a coating pan. Due to this better tablet flow, the pan load may be increased by 10-20% while naintaining the optimum bed geometry and bed flow desired for coating the tablets. Accordingly, an increase in productivity is achieved since more tablets may be coated at once.
further, with a reduction of the coefficient of tablet friction obtained by the inventive film coating, tablets flow batter in the bed of a coating pan which results in a reduction of edge chipping/edge wear during the coating process.
Tablets provided with the inventive "slip" also increase productivity by lessening the time needed to process the coated tablets from the coating, pan to packaging of the coated tablets since the tablets with the inventive ifilia coating flow better than tablets coated with other film coatings.





WE CLAIM:
1. A dry film coating composition for forming a coating suspension for
film-coating tablets of nutritional supplements and pharmaceutical
substances, the composition comprising:
5-97% by weight of dextrin obtained from tapioca;
1-15% by weight of at least one component selected from a group comprising mineral oil, carnauba wax, acetylated monoglyceride, lecithin and magnesium stearate as a detackifier; and the balance, comprising at least one conventional component selected from a group comprising auxiliary film-former, plasticizer, surfactant, flow aid, preservative, titanium dioxide and colorant.
2. A dry film coating composition as claimed in claim 1, wherein said dextrin is in the range of 35% to 75% by weight of the composition.
3. A dry film coating composition as claimed in claim 2, wherein said dextrin is in the range of 65% to 75% by weight of the composition.
4. A dry film coating composition as claimed in claim 1, wherein said detackifier is in a range of 7.5% to 10% by weight of the composition.
5. A dry film coating composition as claimed in claim 1, wherein said auxiliary film-former is a polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (sodium CMC), maltodextrin, sodium
alginate, PG alginate, polyvinyl alcohol (PVA), and combinations thereof.
6. A dry film coating composition as claimed in claim 1], wherein said auxiliary film-former is in a range of greater than 0% to 55% by weight of the composition.
7. A dry film coating composition as claimed in claim 6, wherein said auxiliary film-former is in a range of 3.5% to 10% by weight of the composition.
8. A dry film coating composition as claimed in claim 6, wherein said auxiliary film-former is sodium carboxymethylcellulose (sodium CMC) in a range of 40-45% by weight of the composition.
9. A dry film coating composition as claimed in claim 1, wherein said plasticizer is a polyethylene glycol, propylene glycol, glycerine, triacetin, acetyltriethyl citrate, triethyl citrate, tributylcitrate, or acetyltributylcitrate.
10. A dry film coating composition as claimed in claim 1, wherein said
plasticizer is in a range of greater than 0% to 15% by weight of the
composition.
11. A dry film coating composition as claimed in claim 10, wherein said plasticizer is in a range of 7.5% to 10% by weight of the composition.
12. A dry film coating composition as claimed in claim 11, wherein said plasticizer is in a range of 3.5% to 7.5% by weight of the composition.
13. A dry film coating composition as claimed in claim 1, wherein said surfactant is polysorbate 80.
14. A dry film coating composition as claimed in claim 1, wherein said surfactant is in a range of greater than 0% to 2% by weight of the composition.
15. A dry film coating composition as claimed in claim 14, wherein said surfactant is in a range of 0.5% to 1% by weight of the composition.
16. A dry film coating composition as claimed in claim 1, wherein said flow aid is stearic acid.
17. A dry film coating composition as claimed in claim 1, wherein said flow aid is in a range of greater than 0% to 10% by weight of the composition.
18. A dry film coating composition as claimed in claim 1, wherein said flow aid is in a range of 2% to 5% by weight of the composition.
19. A dry film coating composition as claimed in claim 1, wherein said preservative is sodium citrate.
20. A dry film coating composition as claimed in claim 1, wherein said preservative is in a range of greater than 0% to 5% by weight of the composition.
21. A dry film coating composition as claimed in claim 20, wherein said preservative is in a range of 1% to 2% by weight of the composition.
22. A dry film coating composition as claimed in claim 1, wherein said titanium dioxide is employed with said auxiliary film-former, and any one or all of said plasticizer, surfactant, flow aid and preservative.
23. A dry film coating composition as claimed in claims 1 and 22, wherein when said dextrin is in a range of 30% to 50%, auxiliary film-former in 5% to 50%; said titanium dioxide is in a range of 20% to 50%, all percentages being by weight of the dry film coating composition.
24. A dry film coating composition as claimed in claims 1 and 22, wherein when said dextrin is in a range of 35% to 40%, said detackifier in 2% to 5%, and said auxiliary film-former in 5% to 20%; said titanium dioxide is in a range of 25% to 40%, all percentages being by weight of the dry film coating composition.
25. A dry film coating composition as claimed in claims 17 and 23, wherein when said composition comprises a plasticizer, a surfactant, a flow aid, and a preservative, and said plasticizer is in a range of 1% to 15%, said surfactant in 1% to 2%, said preservative is in a range of 1% to 4%; all percentages being by weight of the composition.
26. A dry film coating composition as claimed in claims 11, 15, 18 and 24, wherein said preservative is in a range of 2% to 3%; all percentages being by weight of the composition.
27. A dry film coating composition as claimed in claim 2, wherein said detackifier is in a range of 1% to 10%, said auxiliary film-former in 5% to 50%; said colorant is in a range of 0.1% to 40%; all percentages being by weight of the dry film coating composition.
28. A dry film coating composition as claimed in claim 1, wherein said dextrin is in a range of 45% to 55%, said detackifier in 2% to 5%, said auxiliary film-former in 5% to 20%; said colorant is in a range of 15% to 25%; all percentages being by weight of the dry film coating composition.
29. A dry film coating composition as claimed in claims 11, 15, 18 and 28, wherein said preservative is in a range of 2% to 3% by weight of the composition.

30. A dry film coating composition for forming a coating suspension for film-coating tablets of nutritional supplements and pharmaceutical substances substantially as herein described with reference to the accompanying drawings.

Documents:

23-del-1998-abstract.pdf

23-del-1998-assignment.pdf

23-del-1998-claims.pdf

23-del-1998-complete specification granted.pdf

23-del-1998-correspondence-others.pdf

23-del-1998-correspondence-po.pdf

23-del-1998-description (complete).pdf

23-del-1998-drawings.pdf

23-del-1998-form-1.pdf

23-del-1998-form-13.pdf

23-del-1998-form-2.pdf

23-del-1998-form-29.pdf

23-del-1998-form-3.pdf

23-del-1998-form-4.pdf

23-del-1998-form-6.pdf

23-del-1998-gpa.pdf

23-del-1998-pa.pdf

23-del-1998-pct-409.pdf

23-del-1998-petition-others.pdf


Patent Number 242715
Indian Patent Application Number 23/DEL/1998
PG Journal Number 37/2010
Publication Date 10-Sep-2010
Grant Date 07-Sep-2010
Date of Filing 05-Jan-1998
Name of Patentee BPSI HOLDINGS, INC.
Applicant Address 1300, P.O BOX 8985, WILMINGTON, DELAWARE 19899-8985, U.S.A
Inventors:
# Inventor's Name Inventor's Address
1 BRIAN KORCHOK 1811 SUPPLEE ROAD, LANSDALE, PA 19446, U.S.A
2 BRUCE KINSEY 436 STORE ROAD, HARLEYSVILLE, PA 19438, U.S.A
3 THOMAS J. BURKE 777 WEST GERMANTOWN PIKE, APT.833, PLYMOUTH MEETING, PA 19462, U.S.A
4 SUSAN MARIE GRILLO 1042 BIRCH STREET, LANSDALE, PA 19446, U.S.A
5 STUART C. PORTER 675 BRIGHTON DRIVE, HATFIELD, PA 19440, U.S.A
6 GEORGE REYES 1710 MORRIS COURT, NORTH WALES, PA 19454, U.S.A
7 CHARLES CUNNINGHAM 1213 JOSEPH ROAD, AMBLER, PA 19002, U.S.A
PCT International Classification Number A61K 9/62
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 08/778,944 1997-01-06 U.S.A.
2 09/002,462 1998-01-02 U.S.A.