Title of Invention	A CHEWABLE SOFT GELATIN CAPSULE
Abstract	A ‘twist off’ chewable soft gelatine capsule defined by a shell-wall enclosing a medicament, said shell-wall having at least one neck region and bulbous region extending from the neck region and said shell-wall being made of a composition comprising water being 8 to 13% in the final composition, gelatine of bloom strength 120 to 250 and a plasticizer formulation comprising glycerine and sorbitol, the ratio of the quantity of plasticizer to the quantity of gelatine being in the range of 1:1.8 to 1:2.1 and the ratio of quantity of sorbitol to glycerine being in the range of 0:17 to 1:2.5, the composition including sweeter being 0.01 to 0.25% and a preservative being 0.2 to 0.3% of the composition.

Title of Invention

A CHEWABLE SOFT GELATIN CAPSULE

Abstract

A ‘twist off’ chewable soft gelatine capsule defined by a shell-wall enclosing a medicament, said shell-wall having at least one neck region and bulbous region extending from the neck region and said shell-wall being made of a composition comprising water being 8 to 13% in the final composition, gelatine of bloom strength 120 to 250 and a plasticizer formulation comprising glycerine and sorbitol, the ratio of the quantity of plasticizer to the quantity of gelatine being in the range of 1:1.8 to 1:2.1 and the ratio of quantity of sorbitol to glycerine being in the range of 0:17 to 1:2.5, the composition including sweeter being 0.01 to 0.25% and a preservative being 0.2 to 0.3% of the composition.

Full Text	FORM-2 THE PATENT ACT, 1970 (39 of 1970) & THE PATENT RULES, 2003 PROVISIONAL SPECIFICATION (See section 10 and Rule 13) "DRUG DELIVERY SYSTEMS" THAKKAR JATIN VASANT An Indian National of L-3/4, Eden Hall, Dr. Annie Besant Road, Worli, Mumbai-400 018, Maharashtra, India. THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION This invention relates to drug delivery systems. In particular, this invention relates to delivery of drugs via the oral route. Drugs are delivered via various routes. For instance, these routes may be oral route, parenteral route, topical route and the like. Conventionally, for drugs to be delivered orally, they are converted into tablets, capsules, liquids of various forms. These capsules may be hard gelatine or soft gelatine capsules and the tablets may be coated or uncoated. Many patients have difficulties in swallowing tablets and capsules. They often break these tablets and capsules thereby destroying the integrity of the drugs in question. This invention envisages a soft gelatine capsule for delivery of a drug via the buccal cavity in which the capsule has a twist off portion which therefore adapts the capsule for delivery of the drug in the buccal cavity or swallowing of the capsule whole or chewing of the capsule with the drug contained in it. The novelty of the product of this invention lies in its versatility of being able to give choice to the patient to release the drug without the capsule after twisting off the neck, chewing the capsule or swallowing the capsule whole without breaking of any portion thereof. The capsule can be filled with a variety of drugs and nutritional supplements for a variety of ailments and body conditions for human as well as animal use. Such drugs can include antacids, reflux suppressants, antiflatulents, antidopaminergics, proton pump inhibitors, H2-receptor antagonists, cytoprotectants, prostaglandin analogues, laxatives, 2 antispasmodics, antidiarrhoeals, bile acid sequestrants, opioids, beta-receptor blocker, calcium channel blockers, diuretics, cardiac glycosides, antiarrhythmics, nitrate, antianginals, vasoconstrictor, vasodilator, peripheral activator, ACE inhibitors, angiotensin receptor blockers, alpha blocker, anticoagulant, heparin, antiplatelet drug, fibrinolytic, antihemophilic factor, haemostatic drugs, hypolipidaemic agents, statins, hypnotic, anaesthetics, antipsychotic, antidepressant (including tricyclic antidepressants, monoamine oxidase inhibitor, lithium salt, selective serotonin reuptake inhibitor), anti-emetic, anticonvulsant and antiepileptic, anxiolytic, barbiturate, movement disorder drug, stimulant (including amphetamines), benzodiazepine, cyclopyrrolone, dopamine antagonist, antihistamine, cholinergic, anticholinergic, emetic, cannabinoids, 5-HT antagonist, tricyclic antidepressants and anticonvulsants, NSAIDs (including COX-2 selective inhibitors), muscle relaxant, neuromuscular drug, anticholinesterase, adrenergic neurone blocker, astringent, ocular lubricant, topical anesthetics, sympathomimetics, parasympatholytics, mydriatics, cycloplegics, Anti-bacterial: antibiotics, topical antibiotics, sulfa drugs, aminoglycosides, fluoroquinolones, Anti-viral, Anti-fungal: imidazoles, polyenes, Anti-inflammatory: NSAIDs, corticosteroids, Anti-allergy: mast cell inhibitors, Anti-glaucoma: adrenergic agonists, beta-blockers, carbonic anhydrase inhibitors/hyperosmotics, cholinergics, miotics, parasympathomimetics, prostaglandin agonists/prostaglandin inhibitors. Nitroglycerin, sympathomimetic, antihistamine, anticholinergic, NSAIDs, steroid, antiseptic, local anesthetic, antifungal, cerumenolytic, bronchodilator, NSAIDs, anti-allergic, antitussive, mucolytic, decongestant, corticosteroid, beta-receptor antagonist, anticholinergic, steroid, androgen, antiandrogen, gonadotropin, corticosteroid, growth hormone, insulin, antidiabetic (sulfonylurea, biguanide/metformin, thiazolidinedione, insulin), thyroid hormones, antithyroid drugs, calcitonin, 3 diphosponate, vasopressin analogues, antifungal, alkalising agent, quinolones, antibiotic, cholinergic, anticholinergic, anticholinesterase, antispasmodic, 5-alpha reductase inhibitor, selective alpha-1 blocker, sildenafil, contraceptive, oral contraceptives, spermicide, depot contraceptives, NSAIDs, anticholinergic, haemostatic drug, antifibrinolytic, Hormone Replacement Therapy, bone regulator, beta-receptor agonist, follicle stimulating hormone, luteinising hormone, LHRH, gamolenic acid, gonadotropin release inhibitor, progestogen, dopamine agonist, oestrogen, prostaglandin, gonadorelin, clomiphene, tamoxifen, Diethylstilbestrol, emollient, anti-pruritic, antifungal, disinfectant, scabicide, pediculicide, tar products, vitamin A derivatives, vitamin D analogue, keratolytic, abrasive, systemic antibiotic, topical antibiotic, hormones, desloughing agent, exudate absorbent, fibrinolytic, proteolytic, sunscreen, antiperspirant, corticosteroid, antibiotic, antifungal, antileprotic, antituberculous drug, antimalarial, anthelmintic, amoebicide, antiviral, antiprotozoal, antiserum, vaccine, immunoglobulin, immunosuppressant, interferon, monoclonal antibody, anti-allergic, antihistamine, NSAIDs, tonic, iron preparation, electrolyte, parenteral nutritional supplement, vitamins, anti-obesity drug, anabolic drug, haematopoietic drug, food product drug, cytotoxic drug, sex hormones, aromatase inhibitor, somatostatin inhibitor, recombinant interleukins, G-CSF, erythropoietin, barbiturates. According to a preferred embodiment of the invention, the wall of the soft gelatine capsule consists of gelatine or a gelatine type material including careeganan along with a plasticizer such as glycerine either alone or in combination with sorbitol. In addition, the composition contains preservatives, sweeteners, flavouring agents, colour and water. In accordance with the preferred embodiment of the invention, the gelatine or gelatine type material may range between 30 to 55% of the total mass of 4 the combination and having a bloom number ranging between 100 to 250 with a preferable quantity being 45%. The plasticizer may be a combination of glycerine and sorbitol, the glycerine ranging between 10 to 25%, preferably 17% and the sorbitol being sorbitol 70% being in the range of 0 to 15% and preferably being 5%. Typical preservatives are sodium methyl paraben or sodium propyl paraben in the preferred range of 0.03 to 0.12%. The colours, sweeteners and flavours are optional ingredients. The sweeteners may range between lmg to 10mg per capsule with a preferred quantity being 4mg and could be any sweetener including Brazzein, Curculin, Erythritol, Fructose, Glycyrrhizin, Glycerol, Hydrogenated starch hydrolysates, Isomalt, Lactitol, Mabinlin,Maltitol, Mannitol, Miraculin, Monellin, Pentadin, Sorbitol, Stevia, Tagatose, Thaumatin, Xylitol, Acesulfame potassium, Alitame, Aspartame, Aspartame-Acesulfame-Salt, Cyclamate 1, Dulcin,Neohesperidine dihydrochalcone, Neotame, P-4000, Saccharin, Sucralose. In addition, the capsule wall contains water in the range of 25 to 40% with the preferred quantity being 33%. The advantage of the drug delivery system in accordance with the present invention is that it improves patient compliance and immediately reduces the physical quantity of the medicine to be taken which includes the drug and filler materials. It will also reduce the quantity of sweetening agent to be taken in the case of liquid orals. The capsule can be suitably tailored for use by infants, children and geriatric patients. Further, the drug delivery 5 system can also be suitably used for vaccines, such as, oral vaccines typically polio vaccine. In the twist of configuration, the capsule may be used for dispensing single or multiple dosages to one or more patients. It is envisaged that the drug delivery system in accordance with this invention will concurrently improve patient compliance and possibly bioavailability of the drug in question. While considerable emphasis has been placed herein on the composition of the preferred embodiments, it will be appreciated that many permutations -and combinations of the process steps can be made in the preferred process steps without departing from the principles of the invention. These and other changes in the preferred process steps as well as other process steps 6 of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Full Text

FORM-2
THE PATENT ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
PROVISIONAL SPECIFICATION
(See section 10 and Rule 13)
"DRUG DELIVERY SYSTEMS"
THAKKAR JATIN VASANT
An Indian National
of L-3/4, Eden Hall, Dr. Annie Besant Road,
Worli, Mumbai-400 018,
Maharashtra, India.
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION

This invention relates to drug delivery systems.
In particular, this invention relates to delivery of drugs via the oral route.
Drugs are delivered via various routes. For instance, these routes may be oral route, parenteral route, topical route and the like.
Conventionally, for drugs to be delivered orally, they are converted into tablets, capsules, liquids of various forms. These capsules may be hard gelatine or soft gelatine capsules and the tablets may be coated or uncoated.
Many patients have difficulties in swallowing tablets and capsules. They often break these tablets and capsules thereby destroying the integrity of the drugs in question.
This invention envisages a soft gelatine capsule for delivery of a drug via the buccal cavity in which the capsule has a twist off portion which therefore adapts the capsule for delivery of the drug in the buccal cavity or swallowing of the capsule whole or chewing of the capsule with the drug contained in it. The novelty of the product of this invention lies in its versatility of being able to give choice to the patient to release the drug without the capsule after twisting off the neck, chewing the capsule or swallowing the capsule whole without breaking of any portion thereof.
The capsule can be filled with a variety of drugs and nutritional supplements for a variety of ailments and body conditions for human as well as animal use. Such drugs can include antacids, reflux suppressants, antiflatulents, antidopaminergics, proton pump inhibitors, H2-receptor antagonists, cytoprotectants, prostaglandin analogues, laxatives,
2

antispasmodics, antidiarrhoeals, bile acid sequestrants, opioids, beta-receptor blocker, calcium channel blockers, diuretics, cardiac glycosides, antiarrhythmics, nitrate, antianginals, vasoconstrictor, vasodilator, peripheral activator, ACE inhibitors, angiotensin receptor blockers, alpha blocker, anticoagulant, heparin, antiplatelet drug, fibrinolytic, antihemophilic factor, haemostatic drugs, hypolipidaemic agents, statins, hypnotic, anaesthetics, antipsychotic, antidepressant (including tricyclic antidepressants, monoamine oxidase inhibitor, lithium salt, selective serotonin reuptake inhibitor), anti-emetic, anticonvulsant and antiepileptic, anxiolytic, barbiturate, movement disorder drug, stimulant (including amphetamines), benzodiazepine, cyclopyrrolone, dopamine antagonist, antihistamine, cholinergic, anticholinergic, emetic, cannabinoids, 5-HT antagonist, tricyclic antidepressants and anticonvulsants, NSAIDs (including COX-2 selective inhibitors), muscle relaxant, neuromuscular drug, anticholinesterase, adrenergic neurone blocker, astringent, ocular lubricant, topical anesthetics, sympathomimetics, parasympatholytics, mydriatics, cycloplegics, Anti-bacterial: antibiotics, topical antibiotics, sulfa drugs, aminoglycosides, fluoroquinolones, Anti-viral, Anti-fungal: imidazoles, polyenes, Anti-inflammatory: NSAIDs, corticosteroids, Anti-allergy: mast cell inhibitors, Anti-glaucoma: adrenergic agonists, beta-blockers, carbonic anhydrase inhibitors/hyperosmotics, cholinergics, miotics, parasympathomimetics, prostaglandin agonists/prostaglandin inhibitors. Nitroglycerin, sympathomimetic, antihistamine, anticholinergic, NSAIDs, steroid, antiseptic, local anesthetic, antifungal, cerumenolytic, bronchodilator, NSAIDs, anti-allergic, antitussive, mucolytic, decongestant, corticosteroid, beta-receptor antagonist, anticholinergic, steroid, androgen, antiandrogen, gonadotropin, corticosteroid, growth hormone, insulin, antidiabetic (sulfonylurea, biguanide/metformin, thiazolidinedione, insulin), thyroid hormones, antithyroid drugs, calcitonin,
3

diphosponate, vasopressin analogues, antifungal, alkalising agent, quinolones, antibiotic, cholinergic, anticholinergic, anticholinesterase, antispasmodic, 5-alpha reductase inhibitor, selective alpha-1 blocker,
sildenafil, contraceptive, oral contraceptives, spermicide, depot contraceptives, NSAIDs, anticholinergic, haemostatic drug, antifibrinolytic, Hormone Replacement Therapy, bone regulator, beta-receptor agonist, follicle stimulating hormone, luteinising hormone, LHRH, gamolenic acid, gonadotropin release inhibitor, progestogen, dopamine agonist, oestrogen, prostaglandin, gonadorelin, clomiphene, tamoxifen, Diethylstilbestrol, emollient, anti-pruritic, antifungal, disinfectant, scabicide, pediculicide, tar products, vitamin A derivatives, vitamin D analogue, keratolytic, abrasive, systemic antibiotic, topical antibiotic, hormones, desloughing agent, exudate absorbent, fibrinolytic, proteolytic, sunscreen, antiperspirant, corticosteroid, antibiotic, antifungal, antileprotic, antituberculous drug, antimalarial, anthelmintic, amoebicide, antiviral, antiprotozoal, antiserum, vaccine, immunoglobulin, immunosuppressant, interferon, monoclonal antibody, anti-allergic, antihistamine, NSAIDs, tonic, iron preparation, electrolyte, parenteral nutritional supplement, vitamins, anti-obesity drug, anabolic drug, haematopoietic drug, food product drug, cytotoxic drug, sex hormones, aromatase inhibitor, somatostatin inhibitor, recombinant interleukins, G-CSF, erythropoietin, barbiturates.
According to a preferred embodiment of the invention, the wall of the soft gelatine capsule consists of gelatine or a gelatine type material including careeganan along with a plasticizer such as glycerine either alone or in combination with sorbitol. In addition, the composition contains preservatives, sweeteners, flavouring agents, colour and water.
In accordance with the preferred embodiment of the invention, the gelatine or gelatine type material may range between 30 to 55% of the total mass of
4

the combination and having a bloom number ranging between 100 to 250 with a preferable quantity being 45%.
The plasticizer may be a combination of glycerine and sorbitol, the glycerine ranging between 10 to 25%, preferably 17% and the sorbitol being sorbitol 70% being in the range of 0 to 15% and preferably being 5%.
Typical preservatives are sodium methyl paraben or sodium propyl paraben in the preferred range of 0.03 to 0.12%.
The colours, sweeteners and flavours are optional ingredients. The
sweeteners may range between lmg to 10mg per capsule with a preferred
quantity being 4mg and could be any sweetener including Brazzein,
Curculin, Erythritol, Fructose, Glycyrrhizin, Glycerol, Hydrogenated
starch hydrolysates, Isomalt, Lactitol, Mabinlin,Maltitol, Mannitol,
Miraculin, Monellin, Pentadin, Sorbitol, Stevia, Tagatose,
Thaumatin, Xylitol, Acesulfame potassium, Alitame, Aspartame,
Aspartame-Acesulfame-Salt, Cyclamate 1, Dulcin,Neohesperidine
dihydrochalcone, Neotame, P-4000, Saccharin, Sucralose.
In addition, the capsule wall contains water in the range of 25 to 40% with the preferred quantity being 33%.
The advantage of the drug delivery system in accordance with the present invention is that it improves patient compliance and immediately reduces the physical quantity of the medicine to be taken which includes the drug
and filler materials. It will also reduce the quantity of sweetening agent to be taken in the case of liquid orals. The capsule can be suitably tailored for use by infants, children and geriatric patients. Further, the drug delivery
5

system can also be suitably used for vaccines, such as, oral vaccines typically polio vaccine.
In the twist of configuration, the capsule may be used for dispensing single or multiple dosages to one or more patients.
It is envisaged that the drug delivery system in accordance with this invention will concurrently improve patient compliance and possibly bioavailability of the drug in question.
While considerable emphasis has been placed herein on the composition of
the preferred embodiments, it will be appreciated that many permutations -and combinations of the process steps can be made in the preferred process
steps without departing from the principles of the invention. These and other changes in the preferred process steps as well as other process steps
6
of the invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Documents:

14-MUM-2007-ABSTRACT(31-12-2007).pdf

14-mum-2007-abstract(granted)-(20-5-2010).pdf

14-MUM-2007-CANCELLED PAGES(1-7-2009).pdf

14-MUM-2007-CLAIMS(1-7-2009).pdf

14-mum-2007-claims(31-12-2007).pdf

14-mum-2007-claims(amended)-(1-7-2009).pdf

14-MUM-2007-CLAIMS(AMENDED)-(7-5-2010).pdf

14-mum-2007-claims(granted)-(20-5-2010).pdf

14-MUM-2007-CORRESPONDENCE(1-7-2009).pdf

14-mum-2007-correspondence(27-5-2008).pdf

14-MUM-2007-CORRESPONDENCE(29-12-2009).pdf

14-MUM-2007-CORRESPONDENCE(7-5-2010).pdf

14-mum-2007-correspondence(ipo)-(20-5-2010).pdf

14-mum-2007-description (provisional).pdf

14-MUM-2007-DESCRIPTION(COMPLETE)-(1-7-2009).pdf

14-mum-2007-description(complete)-(31-12-2007).pdf

14-mum-2007-description(granted)-(20-5-2010).pdf

14-MUM-2007-DESCRIPTION(PROVISIONAL)-(4-1-2007).pdf

14-MUM-2007-DRAWING(31-12-2007).pdf

14-mum-2007-drawing(granted)-(20-5-2010).pdf

14-mum-2007-form 1(1-7-2009).pdf

14-MUM-2007-FORM 1(4-1-2007).pdf

14-MUM-2007-FORM 1(7-5-2010).pdf

14-mum-2007-form 18(31-5-2008).pdf

14-mum-2007-form 2(1-7-2009).pdf

14-mum-2007-form 2(complete)-(31-12-2007).pdf

14-mum-2007-form 2(granted)-(20-5-2010).pdf

14-MUM-2007-FORM 2(PROVISIONAL)-(4-1-2007).pdf

14-MUM-2007-FORM 2(TITLE PAGE)-(1-7-2009).pdf

14-MUM-2007-FORM 2(TITLE PAGE)-(7-5-2010).pdf

14-mum-2007-form 2(title page)-(complete)-(1-7-2009).pdf

14-mum-2007-form 2(title page)-(complete)-(31-12-2007).pdf

14-mum-2007-form 2(title page)-(granted)-(20-5-2010).pdf

14-MUM-2007-FORM 2(TITLE PAGE)-(PROVISIONAL)-(4-1-2007).pdf

14-mum-2007-form 5(31-12-2007).pdf

14-mum-2007-form-2.doc

14-mum-2007-form-2.pdf

14-mum-2007-form-26.pdf

14-mum-2007-form-3.pdf

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Patent Number

240638

Indian Patent Application Number

14/MUM/2007

PG Journal Number

22/2010

Publication Date

28-May-2010

Grant Date

20-May-2010

Date of Filing

04-Jan-2007

Name of Patentee

THAKKAR JATIN VASANT

Applicant Address

L-3/4, EDEN HALL, DR. ANNIE BESANT ROAD, WORLI, MUMBAI - 400 018,

Inventors:

#	Inventor's Name	Inventor's Address
1	THAKKAR JATIN VASANT	L-3/4, EDEN HALL, DR. ANNIE BESANT ROAD, WORLI, MUMBAI - 400 018,

PCT International Classification Number

A61K9/20

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA