Title of Invention

METHODS AND COMPOSITIONS FOR PRODUCING ANTI - ANDROGENIC EFFECTS

Abstract The invention relates to a composition and method for producing an anti-androgenic effect in a mammal. The composition is a modified release pharmaceutical composition is a modified release pharmaceutical composition of bicalutamide, a non-steroidal anti-androgen, which can be administered with a reduced dosing frequency for improved patient convenience and compliance. The composition of the invention also provides for higher bioavailability and improved pharmacokinetic profile as compared to a conventional bicalutamide composition.
Full Text FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
Provisional Specification
(See section 10 and rule 13)
METHODS AND COMPOSITIONS FOR PRODUCING ANTI-ANDROGENIC
EFFECTS
PANACEA BIOTEC LIMITED
A COMPANY INCORPORATED UNDER THE LAWS OF INDIA HAVING THEIR
OFFICE AT 104, SAMARPAN COMPLEX, NEW-LINK ROAD, CHAKALA, ANDHERI
(E), MUMBAI400099, MAHARASHTRA, INDIA
The following specification describes the invention
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FIELD OF THE INVENTION
This invention belongs to the field of pharmaceutical science. It relates to methods for producing anti-androgenic effects in mammals. The present invention also relates to pharmaceutical compositions of Bicalutamide useful for carrying out these methods.
BACKGROUND OF THE INVENTION
Androgens are natural or synthetic compounds, usually steroid hormones, which stimulate or control the development and maintenance of masculine characteristics by binding to androgen receptors. Being anabolic steroids, they are known to stimulate growth of certain tissues like the prostate and other peripheral tissues, including primary or metastatic prostate tumor cells. Androgens like testosterone and dihydrotestosterone exert their influence on cell functions by binding to Androgen Receptors. The high response rate to first line 'Androgen deprivation therapy' and the presence of Androgen Receptors in both primary and metastatic prostate tumor cells support the idea that the Receptor is an important mediator of prostate cancer development and growth.
Because prostatic carcinomas are androgen dependent, various treatment strategies focus on negating the role of androgens (i.e., testosterone and dihydrotestosterone) in prostate tumor growth. These treatment strategies include use of luteinizing hormone-releasing hormone ("LHRH") analogues to suppress testicular androgen production (chemical castration) or orchiectomy (surgical castration) to eliminate androgen production.
In recent years, a class of drugs, known as anti-androgens, has widely been used for the treatment of prostate cancer. The biologic activity of androgens is mediated through the formation of a non-covalent androgen receptor-steroid complex. Anti-androgens inhibit
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formation of this complex and, thus, negate the role of endogenous steroids in androgen-dependent growth of the prostate.
Combinations of the above mentioned strategies have also been studied in a number of cases to evaluate the relative efficacies and survival benefits. A combination of anti-androgen drugs with castration (either chemical or surgical), not only prevents the action of testosterone produced by the testes but also the small, but important amount which is produced by other glands i.e. the adrenal glands. Such therapy is sometimes called Complete or Maximal Androgen Blockade (CAB or MAB). In advanced disease a combination of an LHRH analogue (e.g. goserelin, leuprolide) (generally administered as long acting injectable implants or depots) and a non-steroidal anti-androgen (e.g. Bicalutamide, given as oral tablets) can be used. Clinical trials identify that men treated with such combination therapy may live longer than those treated with an LHRH analogue alone. Combination therapy may sometimes also be used prior to surgery or radiotherapy (neoadjuvant) to reduce the size of the tumour.
Bicalutamide, a non-steroidal anti-androgen, is a 'second generation' anti-androgen, which has more advantageous properties than the other known anti-androgens, like Flutamide or Nilutamide. (For example, refer to Schellhammer PF et al., Urology, 50: 330-6, (1997); and to McLeod DG, Oncologist, 2:18-27, (1997).) The commercially available product by AstraZeneca is CASODEX(TM) and its chemical formula is 4-cyano-3-trifluoromethyl-N-(3-p-fluorophenylsulphony 1- 2- hydroxy-2-methylpropionyl) aniline. The compound has been disclosed in patents like US4636505 and EP100172. Its anti-androgenic activity resides almost exclusively in (R) - Bicalutamide, with little, if any, activity in (S) - Bicalutamide. It is used at a dosage of 50mg once daily in combination with a luteinising hormone-releasing
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hormone analogue or surgical castration for the treatment of advanced prostate cancer. It is also given at a dosage of 150 mg once daily as monotherapy for the treatment of early (localized or locally advanced) non-metastatic prostate cancer.
Prostate cancer most often advances very slowly and many patients often have no symptoms, particularly in the early stages. Most men with prostate cancer will live with their disease for many years. Hence it is important to consider their choice when faced with the androgen deprivation therapies mentioned above. For example, refer to Nyman, et al., BJU International, 96: 1014-1018, (2005), where a Swedish study in 150 patients was conducted to investigate their choice amongst the three androgen deprivation therapies: Bicalutamide, GnRH analogue and orchiectomy. Most men preferred oral tablets of anti-androgen Bicalutamide, but they also indicated dissatisfaction; one of the main reasons for which was the need to take the drug daily. Bicalutamide is often used for months to years together. Hence, in such situations, it becomes difficult to take medications daily and there is a need for a therapy which reduces the dosing frequency, thereby increasing patient comfort and compliance.
United States Application No. 2004067257 discloses Solid dispersions of Bicalutamide with enteric polymers having a pKa of 3 to 6 for increasing the bioavailability of the drug, for reducing inter-patient variability in plasma concentrations of Bicalutamide; or for treating and/or reducing the risk of prostate cancer in a patient. However, the patient has to take the pharmaceutical dose daily.
US Patent Publication No.: US20040138299 discloses pharmaceutical formulation of Bicalutamide in a solid dispersion with PVP. The solid dispersion formulation as described
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provides increased bioavailability of the drug; reduces inter-patient variability in plasma concentrations of the drug; enhances the storage stability of the drug; or treats and/or reduces the risk of prostate cancer in a patient. However, the solid dispersion is a daily pharmaceutical dosage formulation.
United States Application No 20050008691 discloses compositions having a high content of Bicalutamide, preferably prepared from a granulate that contains at least 50% of the drug. As per the application, commercially available Bicalutamide product and other prior art compositions produce tablets of a larger size which may be difficult to swallow; hence there is provided means to prepare capsules or smaller tablets by providing a composition made from micronized Bicalutamide in order to enhance the speed of dissolution.
International Publication No. WO2006069098 discloses nanoparticulate Bicalutamide formulations, having Bicalutamide particles with an effective average particle size of less than about 2000 nm and containing surface stabilizers, which target an increase in the bioavailability of the drug. The publication teaches compositions that can be formulated for parenteral injection (e. g., intravenous, intramuscular, or subcutaneous), oral administration in solid, liquid, or aerosol form, vaginal, nasal, rectal, ocular, local (powders, ointments or drops), buccal, intracisternal, intraperitoneal, or topical administration, and the like. The publication also teaches solid dosage forms for example, a fast melt dosage form, controlled release dosage form, lyophilized dosage form, delayed release dosage form, extended release dosage form, pulsatile release dosage form, mixed immediate release and controlled release dosage form, or a combination thereof. However, preparing nanoparticles require special equipments and expertise.
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It is desirable to have a method for producing oral anti-androgenic effects in mammals by providing Bicalutamide with a reduced dosing frequency. For such methods, although the dose administered during a dosing interval may be lesser as compared to the total dose given during the interval by conventional once-daily therapy, the methods may utilize a higher onetime dose as compared to a conventional once-daily dose. This dose may be 150mg or higher i.e. higher than the once-daily unit dose. However, for doses above 150mg, Bicalutamide is known to exhibit non-linear kinetics, possibly due to its saturable absorption. (Refer to Tyrell CJ et al., Eur Urol 33:39-53, (1998); and to Kolvenbag et al., Prostate, 34:61-72, (1998)). Hence, inclusion of such doses may result in part of the dose not being absorbed, leading to sub-therapeutic drug levels in the plasma. Furthermore, at higher doses, high inter-patient variability in the pharmacokinetics of Bicalutamide has been reported.
Therefore, there is a need in the art for a method for administering Bicalutamide with reduced dosing frequency that solves the above and other problems.
DESCRIPTION OF THE INVENTION
The present invention provides methods, preferably oral methods, for producing anti-androgenic effects in mammals in need thereof.
The present invention provides methods for producing anti-androgenic effects in mammals by administration of pharmaceutically effective amounts of Bicalutamide with a reduced dosing frequency.
The methods of the present invention may be provided by orally administering to a mammal, a pharmaceutical composition of Bicalutamide, useful for carrying out the above methods.
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The pharmaceutical compositions of the invention provide for prolonged maintenance of effective levels of Bicalutamide in the body. Thus, according to the present invention, the dosing interval may be reduced by providing a modified release pharmaceutical composition that reduces Bicalutamide losses due to saturation of absorption mechanisms. Moreover, the modified release pharmaceutical composition of Bicalutamide according to the present invention may also provide for reduced inter-patient variability.
The modified release pharmaceutical composition of Bicalutamide may be formulated as to reduce the frequency of the dosing for improving the patient compliance. Such pharmaceutical compositions may be formulated as, for example, thrice-a-week, twice-a-week, once-a-week, once-in-two weeks or once-a-month compositions.
Bicalutamide may be administered in the dose range of from about 150mg to about 1000 mg. Through administration of the above pharmaceutical compositions, there is provided a method for obtaining a plasma concentration time profile of Bicalutamide, which will allow for a dosing schedule of required reduced frequency.
The methods of the present invention are generally applicable to mammals in need of anti-androgen therapy. Preferably the mammals are human patients, more preferably males, and particularly those that have been identified as suffering from proliferative disorders, such as prostate cancer, benign prostate hyperplasia or possibly any other genito-urinary cancers.
A method of the present invention contemplates administering the Bicalutamide compositions of the present invention alone and in combination with other pharmaceutical agents such as anti-estrogens, for example tamoxifen; aromatase inhibitors, for example anastrazole; LH-RH
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analogues, for example goserelin; cytotoxic agents, such as cyclophosphamide; and any other suitable agents.
The term 'thrice-a-week' dosing or administration, as used herein, means that a dose of Bicalutamide is administered three times in a week i.e. three times during a seven day period, preferably on the same three days of each weekly period.
The term 'twice-a-week' dosing or administration, as used herein, means that a dose of Bicalutamide is administered two times in a week i.e. two times during a seven day period, preferably on the same two days of each weekly period.
The term 'once-a-week' dosing or administration, as used herein, means that a dose of Bicalutamide is administered once in a week i.e. one time during a seven day period, preferably on the same day of each week.
The term 'once-in-two weeks' dosing or administration, as used herein, means that a dose of Bicalutamide is administered once during a two week period i.e. one time during a fourteen day period, preferably on the same day during each two week period.
The term 'once-a-month' dosing or administration, as used herein, means that a dose of Bicalutamide is administered once in a month i.e. one time during a thirty or thirty-one day period, preferably on the same day of each month.
The term 'Bicalutamide' as used herein contemplates all forms of Bicalutamide, such as the free base, any pharmaceutically acceptable salts, esters, solvates thereof as well as the
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racemate, the individual isomers R-Bicalutamide and S-Bicalutamide and their pharmaceutical^ acceptable salts, esters and solvates. Accordingly, Bicalutamide is used in the pharmaceutical compositions of the present invention in the range of amounts equivalent to about 150mg to about lOOOmg of Bicalutamide.
The pharmaceutical compositions of the present invention may be in the form of a matrix composition, a coated composition, an osmotic system or other types of compositions known in the art. Also, the compositions may demonstrate any type of modified drug release profile commonly encountered in the art.
The modified drug release profile according to the invention may be a controlled release, sustained release, extended release, delayed release, pulsed release, dual release, timed release, site-specific release and others, including any combinations thereof.
In one embodiment of the invention, the pharmaceutical composition is in the form of an oral delayed release product, wherein the entire dose of Bicalutamide is released in the later part of the gastro-intestinal tract. That release may be either 'all-at-once' or in a sustained manner.
In an embodiment of the invention, the pharmaceutical composition is in the form of an oral pulsed release product, wherein part of the dose of Bicalutamide is released substantially immediately upon administration and the remaining part of the dose is released after a predetermined time interval.
In another embodiment of the invention, the pharmaceutical composition is in the form of an oral pulsed release product, wherein part of the dose of Bicalutamide is released substantially
9

immediately upon administration and the remaining dose is released in a sustained manner after a pre-determined time interval.
According to an aspect of the present invention, a method is provided for producing anti-androgenic effects in mammals by providing a modified release pharmaceutical composition where the composition is a once-a-week pharmaceutical composition containing Bicalutamide.
The present invention also provides a once-a-week composition containing Bicalutamide for producing anti androgenic effect in mammals.
An aspect of the invention relates to dose ranges which will be effective for Bicalutamide therapy with reduced dosing frequencies.
Another aspect of the invention relates to plasma concentration time profiles of Bicalutamide which allow for dosing schedules of reduced frequencies.
In the present invention, the site and rate of release of Bicalutamide is controlled by means of polymers. The polymers may belong, but are not limited to, categories such as celluloses, vinyl pyrrolidone polymers, alkylene oxide homopolymers, superdisintegrant polymers, acrylic acid polymers and gums of plant, animal, mineral or synthetic origin.
The polymers may be enteric polymers such as esters of cellulose and its derivatives, polyvinyl acetate phthalate, pH-sensitive methacrylic acid copolymers, shellac etc. A few examples are cellulose acetate phthalate, cellulose acetate succinate, methylcellulose
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phthalate, ethylhydroxycellulose phthalate, polyvinylacetatephthalate, polyvinylbutyrate acetate, vinyl acetate-maleic anhydride copolymer, styrene-maleic mono-ester copolymer, methyl acrylate-methacrylic acid copolymer, methacrylate-methacrylic acid-octyl acrylate copolymer, etc
The pharmaceutical compositions of the embodiments may also include various pharmaceutically acceptable excipients, for example, diluents such as microcrystalline cellulose, lactose, sucrose, calcium phosphates; disintegrants such as starch, cellulose derivatives, gums, crosslinked polymers and the like; binders such as starch, gelatin, sugars, cellulose derivatives, polyvinyl pyrrolidone and the like; lubricants such as talc, magnesium stearate, colloidal silicon dioxide, polyethylene glycol and mixtures thereof.
The pharmaceutical compositions of the embodiments may be formulated in the form of granules, tablets, and pellets or as capsules filled with powder, pellets, mini-tablets and/or tablets. The processes for the preparation of these compositions are well known to a person skilled in the art, and are included herein by reference.
Various modifications of the methods of the invention may be made without departing from the spirit or scope of the invention. The following non-limiting examples illustrate an embodiment of the invention and should not be construed to limit the scope of the invention.
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Example 1

Table 1 L: Formula (Core Tablet):
Sr. No. Ingredient Qty(mg/tab)
1 Bicalutamide 250.00
2 Lactose monohydrate 188.00
3 Sodium starch glycolate 35.00
4 Polyvinyl pyrrolidone 7.50
5 Purified water q.s.
6 Sodium starch glycolate 17.50
7 Magnesium stearate 2.00
Total 500 mg
Table 2: Formula (Sub-Coat Composition):
Sr.No. Ingredients Qty(gms/Kg)
1 Hydroxypropyl methylcellulose 50.00
2 Polyethylene Glycol (PEG 6000) 7.50
3 Methanol 628.30
4 Dichloromethane 314.20
Table 3: Formula (Enteric Coat Composition :
Sr.No. Ingredients Qty(gms/Kg)
1 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)) 53.85
2 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)) 23.07
3 Triethyl citrate 15.38
4 Acetone 276.92
5 Isopropyl alcohol 553.07
6 Purified water 39.23
7 Talc 38.46
Bicalutamide, Sodium starch glycolate (intra-granular portion) and lactose monohydrate were sifted and blended in the amounts mentioned in the Table 1 above. Polyvinyl pyrrolidone dissolved in sufficient quantity of purified water was used to granulate the dry powder blend.
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The blend was dried and sieved to obtain dry granules. The granules were then blended with the remaining amount of sodium starch glycolate and magnesium stearate. The lubricated blend was compressed into tablets using round punches.
The sub-coating solution was prepared by dissolving PEG 6000 and Hydroxypropyl Methyl Cellulose in the mixture of methanol and dichloromethane. The tablets were coated using the above solution, till a tablet weight gain of about 2-3 % w/w was achieved.
The enteric coating dispersion was prepared by mixing acetone, isopropanol and purified water, and dispersing the methacryclic acid co-polymers, talc and triethyl citrate in them. The sub-coated tablets were coated with the above solution till a weight gain of 10-11% w/w was achieved.
Example 2

Table A 1: Formula (Core Tablet):
Sr.No. Ingredient Qty(mg/tab)
1 Bicalutamide 50.00
2 Lactose monohydrate 37.60
3 Sodium starch glycolate 7.00
4 Polyvinyl pyrrolidone 1.50
5 Purified water q.s.
6 Sodium starch glycolate 3.50
7 Magnesium stearate 0.40
Total 100 mg
Table 5: Formula (Sub-Coat Composition):
Sr.No. Ingredients Qty(gms/Kg)
1 Hydroxypropyl methylcellulose 50.00
2 Polyethylene Glycol (PEG 6000) 7.50
3 Methanol 628.30
4 Dichloromethane 314.20
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Table ( >: Formula (Enteric Coat Composition^ :
Sr. No. Ingredients Qty (gms/Kg)
1 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)) 53.85
2 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)) 23.07
3 Triethyl citrate 15.38
4 Acetone 276.92
5 Isopropyl alcohol 553.07
6 Purified water 39.23
7 Talc 38.46
The process followed was the same as in Example 1. The tablets corresponding to a total dose of 250 mg Bicalutamide (i.e. five coated tablets/ capsule) were filled into empty hard gelatin capsule shells.
Example 3
Table 7: Formula (Core Tablet):
Sr.No. Ingredient Qty(mg/tab)
1 Bicalutamide 350.00
2 Lactose monohydrate 199.60
3 Polyvinyl pyrrolidone 18.00
4 Sodium starch glycolate 30.00
5 Magnesium stearate 2.40
Total 600.00

Table i 1: Formula (Sub-Coat Composition):
Sr.No. Ingredients Qty(gms/Kg)
1 Hydroxypropyl methylcellulose 50.00
2 Polyethylene Glycol 7.50
3 Methanol 628.30
4 Dichloromethane 314.20
14

Table S >: Formula (Enteric Coat Composition' :
Sr.No. Ingredients Qty(gms/Kg)
1 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)) 80.00
2 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)) 6.4
3 Triethyl citrate 16.80
4 Acetone 297.90
5 Isopropyl alcohol 515.60
6 Purified water 42.40
7 Talc 43.20
The process of manufacturing was similar to that in Example 1.
Example 4

Table ] L0: Formula (Core Tablet):
Sr.No. Ingredient Qty(mg/tab)
1 Bicalutamide 70.00
2 Lactose monohydrate 39.92
3 Polyvinyl pyrrolidone 3.60
4 Sodium starch glycolate 6.00
5 Magnesium stearate 0.48
Total 120 mg

Table ] 1: Formula (Sub-Coat Composition):
Sr.No. Ingredients Qty(gms/Kg)
1 Hydroxypropyl methylcellulose 50.00
2 Polyethylene Glycol 7.50
3 Methanol 628.30
4 Dichloromethane 314.20
15

Table 12: Formula (Enteric Coat Composition):

Sr.No. Ingredients Qty(gms/Kg)
1 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)) 80.00
2 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)) 6.4
3 Triethyl citrate 16.80
4 Acetone 297.90
5 Isopropyl alcohol 515.60
6 Purified water 42.40
7 Talc 43.20
The formula and process was similar to that in Example 1. The tablets corresponding to a total dose of 350 mg Bicalutamide (i.e. five coated tablets/ capsule) were filled into empty hard gelatin capsule shells.
Example 5

Table ] 13: Formula (Core Tablet):
Sr. No. Ingredient Qty(mg/tab)
1 Bicalutamide 50.00
2 Microcrystalline cellulose 36.10
3 Hydroxypropyl methylcellulose 60.00
4 Sodium starch glycolate 3.50
5 Magnesium stearate 0.40
Total 150 mg
Table 1 14: Formula (Sub-Coat Composition):
Sr. No. Ingredients Qty(gms/Kg)
1 Hydroxypropyl methylcellulose 50.00
2 Polyethylene Glycol 7.50
3 Methanol 628.30
4 Dichloromethane 314.20
16

Table 1 5: Formula (Enteric Coat Compositior i):
Sr.No. Ingredients Qty(gms/Kg)
1 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)) 80.00
2 Methacrylic acid co-polymer (Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)) 6.4
3 Triethyl citrate 16.80
4 Acetone 297.90
5 Isopropyl alcohol 515.60
6 Purified water 42.40
.7 Talc 43.20
Bicalutamide, microcrystalline cellulose, and Hydroxypropyl methylcellulose were sifted and blended in the amounts mentioned in the Table 1 above. The mixture was further blended with sodium starch glycolate and lubricated with magnesium stearate. The lubricated blend was compressed into tablets on a rotary tablet compression machine. The tablets were sub coated and then enteric coated according to the manufacturing procedure mentioned in Example 1. The tablets corresponding to a total dose of 250 mg Bicalutamide (i.e. five coated tablets/ capsule) were filled into empty hard gelatin capsule shells.
Example 6

Table 1 6: Formula (Immediate release Tablet):
Sr. No. Ingredient Qty(mg/tab)
1 Bicalutamide 100.00
2 Lactose monohydrate 75.20
3 Sodium starch glycolate 14.00
4 Polyvinyl pyrrolidone 3.00
5 Purified water q.s.
6 Sodium starch glycolate 7.00
7 Magnesium stearate 0.80
Total 200 mg
17

Table 1 17: Formula (Sustained release Tablet)
Sr.No. Ingredient Qty(mg/tab)
1 Bicalutamide 250.00
2 Microcrystalline cellulose 180.50
3 Hydroxypropyl methylcellulose 300.00
4 Sodium starch glycolate 17.50
5 Magnesium stearate 2.00
Total 750 mg
Immediate release Tablet: Bicalutamide, Sodium starch glycolate (intra-granular portion) and lactose monohydrate were sifted and blended in the amounts mentioned in the Table 1 above. Polyvinyl pyrrolidone dissolved in sufficient quantity of purified water was used to granulate the dry powder blend. The blend was dried and sieved to obtain dry granules. The granules were then blended with the remaining amount of sodium starch glycolate and magnesium stearate. The lubricated blend was compressed into tablets using 6 mm round punches.
Sustained release Tablet: Bicalutamide, microcrystalline cellulose, and Hydroxypropyl methylcellulose were sifted and blended in the amounts mentioned in the Table 1 above. The mixture was further blended with sodium starch glycolate and lubricated with magnesium stearate. The lubricated blend was compressed into tablets on a rotary tablet compression machine. The tablets were sub coated and then enteric coated according to the manufacturing procedure mentioned in Example 1. Both the tablets of the example were filled into an empty hard gelatin capsule shell.
Dated this 7th of July 2006
FOR PANACEA BIOTEC LIMITED

(Dr. MAHALAXMIANDHERIA)
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Documents:

1074-MUM-2006-ABSTRACT(5-7-2006).pdf

1074-MUM-2006-ABSTRACT(5-7-2007).pdf

1074-MUM-2006-ABSTRACT(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-ASSIGNMENT(14-8-2006).pdf

1074-MUM-2006-CANCELLED PAGE(5-7-2006).pdf

1074-MUM-2006-CLAIMS(5-7-2006).pdf

1074-MUM-2006-CLAIMS(AMENDED)-(16-12-2009).pdf

1074-MUM-2006-CLAIMS(COMPLETE)-(5-7-2007).pdf

1074-MUM-2006-CLAIMS(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-CLAIMS(RETYPE PAGE)-(22-9-2009).pdf

1074-MUM-2006-CORRESPONDENC(23-10-2007).pdf

1074-MUM-2006-CORRESPONDENC(IPO)-(19-5-2010).pdf

1074-MUM-2006-CORRESPONDENCE(13-3-2009).pdf

1074-MUM-2006-CORRESPONDENCE(18-8-2009)].pdf

1074-MUM-2006-CORRESPONDENCE(24-2-2010).pdf

1074-MUM-2006-CORRESPONDENCE(27-10-2008).pdf

1074-MUM-2006-CORRESPONDENCE(IPO)-(3-12-2008).pdf

1074-mum-2006-correspondence-others.pdf

1074-mum-2006-correspondence-po.pdf

1074-MUM-2006-DESCRIPTION(COMPLETE)-(5-7-2006).pdf

1074-MUM-2006-DESCRIPTION(COMPLETE)-(5-7-2007).pdf

1074-MUM-2006-DESCRIPTION(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-DESCRIPTION(PROVISIONAL)-(7-7-2006).pdf

1074-mum-2006-description(provisional).pdf

1074-MUM-2006-DRAWING(5-7-2006).pdf

1074-MUM-2006-DRAWING(5-7-2007).pdf

1074-MUM-2006-DRAWING(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-EXAMINATION REPORT(7-7-2006).pdf

1074-MUM-2006-FORM 1(7-7-2006).pdf

1074-mum-2006-form 13(1)-(5-7-2007).pdf

1074-mum-2006-form 13(1)-(5-7-2007).tif

1074-mum-2006-form 13(2)-(5-7-2007).pdf

1074-mum-2006-form 13(3)-(5-7-2007).pdf

1074-mum-2006-form 13(4)-(5-7-2007).pdf

1074-MUM-2006-FORM 18(17-7-2007).pdf

1074-MUM-2006-FORM 2(COMPLETE)-(5-7-2007).pdf

1074-MUM-2006-FORM 2(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-FORM 2(PROVISIONAL)-(7-7-2006).pdf

1074-MUM-2006-FORM 2(TITLE PAGE)-(16-12-2009).pdf

1074-MUM-2006-FORM 2(TITLE PAGE)-(5-7-2006).pdf

1074-MUM-2006-FORM 2(TITLE PAGE)-(COMPLETE)-(5-7-2007).pdf

1074-MUM-2006-FORM 2(TITLE PAGE)-(GRANTED)-(1-4-2010).pdf

1074-MUM-2006-FORM 2(TITLE PAGE)-(PROVISIONAL)-(7-7-2006).pdf

1074-MUM-2006-FORM 26(7-7-2006).pdf

1074-MUM-2006-FORM 3(13-3-2009).pdf

1074-MUM-2006-FORM 3(16-12-2009).pdf

1074-MUM-2006-FORM 3(18-8-2009)].pdf

1074-MUM-2006-FORM 3(22-9-2009).pdf

1074-MUM-2006-FORM 3(24-2-2010).pdf

1074-MUM-2006-FORM 3(27-10-2008).pdf

1074-mum-2006-form-1.pdf

1074-mum-2006-form-2.doc

1074-mum-2006-form-2.pdf

1074-mum-2006-form-3.pdf

1074-mum-2006-form-5.pdf

1074-MUM-2006-OTHER DOCUMENT(13-3-2009).pdf

1074-MUM-2006-PCT-IPEA-409(13-3-2009).pdf

1074-MUM-2006-PCT-IPEA-409-(22-9-2009).pdf

1074-MUM-2006-PCT-ISA(27-10-2008).pdf

1074-MUM-2006-PUBLICATION IN THE CHILEAN GAZETTE(27-10-2008).pdf

1074-MUM-2006-REPLY TO EXAMINATION REPORT(16-12-2009).pdf

1074-MUM-2006-REPLY TO FIRST EXAMINATION REPORT(22-9-2009).pdf

1074-MUM-2006-WO INERNATIONAL PUBLICATION REPORT A3(27-10-2008).pdf

abstract1.jpg


Patent Number 239822
Indian Patent Application Number 1074/MUM/2006
PG Journal Number 15/2010
Publication Date 09-Apr-2010
Grant Date 01-Apr-2010
Date of Filing 07-Jul-2006
Name of Patentee PANACEA BIOTEC LIMITED
Applicant Address 201,SAMARPAN COMPLEX, NEW-LINK ROAD, CHAKALA,ANDHERI(E), MUMBAI-400099,
Inventors:
# Inventor's Name Inventor's Address
1 PUTHLI, SHIVANAND 201,SAMARPAN COMPLEX, NEW-LINK ROAD, CHAKALA, ANDHERI(E), MUMBAI-400099,
2 SINGH, AMARJIT 201,SAMARPAN COMPLEX, NEW-LINK ROAD, CHAKALA, ANDHERI(E), MUMBAI-400099,
3 SINGH, SARABJIT 201,SAMARPAN COMPLEX, NEW-LINK ROAD, CHAKALA, ANDHERI(E), MUMBAI-400099,
PCT International Classification Number A61K31/167
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA