CA2461354A1 - Fondant-based pharmaceutical composition - Google Patents
Fondant-based pharmaceutical composition Download PDFInfo
- Publication number
- CA2461354A1 CA2461354A1 CA002461354A CA2461354A CA2461354A1 CA 2461354 A1 CA2461354 A1 CA 2461354A1 CA 002461354 A CA002461354 A CA 002461354A CA 2461354 A CA2461354 A CA 2461354A CA 2461354 A1 CA2461354 A1 CA 2461354A1
- Authority
- CA
- Canada
- Prior art keywords
- composition
- carbohydrate
- dosage form
- tablet
- coating
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/02—Apparatus specially adapted for manufacture or treatment of sweetmeats or confectionery; Accessories therefor
- A23G3/04—Sugar-cookers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G1/00—Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
- A23G1/30—Cocoa products, e.g. chocolate; Substitutes therefor
- A23G1/50—Cocoa products, e.g. chocolate; Substitutes therefor characterised by shape, structure or physical form, e.g. products with an inedible support
- A23G1/54—Composite products, e.g. layered laminated, coated, filled
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/0002—Processes of manufacture not relating to composition and compounding ingredients
- A23G3/0004—Processes specially adapted for manufacture or treatment of sweetmeats or confectionery
- A23G3/0019—Shaping of liquid, paste, powder; Manufacture of moulded articles, e.g. modelling, moulding, calendering
- A23G3/0025—Processes in which the material is shaped at least partially in a mould in the hollows of a surface, a drum, an endless band, or by a drop-by-drop casting or dispensing of the material on a surface, e.g. injection moulding, transfer moulding
- A23G3/0029—Moulding processes for hollow products, e.g. opened shell
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
- A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
- A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
- A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
- A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
- A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
- A23G3/54—Composite products, e.g. layered, coated, filled
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/06—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
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- A—HUMAN NECESSITIES
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- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
- B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
- B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B30—PRESSES
- B30B—PRESSES IN GENERAL
- B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
- B30B11/34—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses for coating articles, e.g. tablets
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
- B30B15/30—Feeding material to presses
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- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y10T428/00—Stock material or miscellaneous articles
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Abstract
Fondant-based pharmaceutical compositions comprising active ingredients and dosage forms made therefrom are provided.
Claims (19)
1. A fondant-based pharmaceutical composition comprising an active ingredient and a carbohydrate, at least a portion of which carbohydrate is crystallized and has an average particle size of about 2 to about 35 microns, said composition having a moisture content in the range of about 10 to about 13 percent.
2. The composition of claim 1, wherein said active ingredient is in the form of particles having an average particle size of about 200 to about 1200 microns.
3. The composition of claim 2, wherein said active ingredient is in the form of particles having an average particle size of about 250 to about 350 microns.
4. The composition of claim 1 substantially free of fats.
5. The composition of claim 1 having a yield stress of about 100 to about 100,000 Pascals.
6. The composition of claim 1 further comprising at least one hydrolase in an amount sufficient to cause hydrolysis of at least a portion of the carbohydrate.
7. The composition of claim 6, wherein the hydrolase is a glycosidase selected from the group consisting of invertase, galactosidase, lactase, maltase, xylase, and beta amylase, and mixtures thereof.
8. A dosage form comprising: a) a fondant-based pharmaceutical composition comprising an active ingredient and a carbohydrate, at least a portion of which carbohydrate is crystallized and has an average particle size of about 2 to about 35 microns, said composition having a moisture content in the range of about 10 to about 13 percent; and b) at least one coating overlying said composition.
9. The dosage form of claim 8, wherein at least one coating comprises a water impermeable material.
10. The dosage form of claim 9, wherein the water impermeable material is selected from the group consisting of fats, waxes, and chocolate.
11. The dosage form of claim 8, wherein at least one coating is in the form of a hard shell.
12. The dosage form of claim 11, wherein the hard shell comprises a material selected from the group consisting of sugars and polyhedric alcohols.
13. The dosage form of claim 8 further comprising at least one hydrolase in an amount sufficient to cause hydrolysis of at least a portion of the carbohydrate.
14. The dosage form of claim 13, wherein the hydrolase is a glycosidase selected from the group consisting of invertase, galactosidase, lactase, maltase, xylase, and beta amylase, and mixtures thereof.
15. A method for making a soft tablet comprising:
a. forming a tablet containing an active ingredient and a hydrolyzable carbohydrate to a hardness of about 3 to about 10 kp/cm2;
b. adding water to the tablet before, during or after step (a); and c. adding a hydrolase to the tablet before, during of after step (a).
a. forming a tablet containing an active ingredient and a hydrolyzable carbohydrate to a hardness of about 3 to about 10 kp/cm2;
b. adding water to the tablet before, during or after step (a); and c. adding a hydrolase to the tablet before, during of after step (a).
16. The method of claim 15, wherein the tablet is made by compression.
17. The method of claim 15, wherein the tablet is made by molding.
18. The method of claim 15 further comprising applying at least one coating to the tablet.
19. A dosage form comprising:
a) a core comprising the fondant based pharmaceutical composition of claim 1;
b) a first coating surrounding at least a portion of the core, wherein the first coating comprises an insoluble edible material; and c) an outer shell surrounding at least a portion of the core and the first coating, wherein the outer shell comprises a crystallizable carbohydrate.
a) a core comprising the fondant based pharmaceutical composition of claim 1;
b) a first coating surrounding at least a portion of the core, wherein the first coating comprises an insoluble edible material; and c) an outer shell surrounding at least a portion of the core and the first coating, wherein the outer shell comprises a crystallizable carbohydrate.
Applications Claiming Priority (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/966,497 US7122143B2 (en) | 2001-09-28 | 2001-09-28 | Methods for manufacturing dosage forms |
US09/966,450 US6982094B2 (en) | 2001-09-28 | 2001-09-28 | Systems, methods and apparatuses for manufacturing dosage forms |
US09/967,414 US6742646B2 (en) | 2001-09-28 | 2001-09-28 | Systems, methods and apparatuses for manufacturing dosage forms |
US09/966,509 | 2001-09-28 | ||
US09/966,509 US6767200B2 (en) | 2001-09-28 | 2001-09-28 | Systems, methods and apparatuses for manufacturing dosage forms |
US09/966,939 | 2001-09-28 | ||
US09/966,939 US6837696B2 (en) | 2001-09-28 | 2001-09-28 | Apparatus for manufacturing dosage forms |
US09/967,414 | 2001-09-28 | ||
US09/966,497 | 2001-09-28 | ||
US09/966,450 | 2001-09-28 | ||
PCT/US2002/031067 WO2003026613A1 (en) | 2001-09-28 | 2002-09-28 | Fondant-based pharmaceutical composition |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2461354A1 true CA2461354A1 (en) | 2003-04-03 |
CA2461354C CA2461354C (en) | 2010-04-27 |
Family
ID=27542311
Family Applications (12)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002461684A Abandoned CA2461684A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002461682A Abandoned CA2461682A1 (en) | 2001-09-28 | 2002-09-28 | Composite dosage forms |
CA002461653A Abandoned CA2461653A1 (en) | 2001-09-28 | 2002-09-28 | Edible composition and dosage form comprising an edible shell |
CA002446759A Abandoned CA2446759A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002446760A Abandoned CA2446760A1 (en) | 2001-09-28 | 2002-09-28 | Dosage forms having an inner core and outer shell |
CA2461659A Expired - Fee Related CA2461659C (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002461870A Abandoned CA2461870A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA2461354A Expired - Fee Related CA2461354C (en) | 2001-09-28 | 2002-09-28 | Fondant-based pharmaceutical composition |
CA002447984A Abandoned CA2447984A1 (en) | 2001-09-28 | 2002-09-28 | Dosage forms having an inner core and outer shell with different shapes |
CA002461865A Abandoned CA2461865A1 (en) | 2001-09-28 | 2002-09-28 | Dosage form containing a confectionery composition |
CA002461616A Abandoned CA2461616A1 (en) | 2001-09-28 | 2002-09-28 | Composite dosage forms having an inlaid portion |
CA002461656A Abandoned CA2461656A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
Family Applications Before (7)
Application Number | Title | Priority Date | Filing Date |
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CA002461684A Abandoned CA2461684A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002461682A Abandoned CA2461682A1 (en) | 2001-09-28 | 2002-09-28 | Composite dosage forms |
CA002461653A Abandoned CA2461653A1 (en) | 2001-09-28 | 2002-09-28 | Edible composition and dosage form comprising an edible shell |
CA002446759A Abandoned CA2446759A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002446760A Abandoned CA2446760A1 (en) | 2001-09-28 | 2002-09-28 | Dosage forms having an inner core and outer shell |
CA2461659A Expired - Fee Related CA2461659C (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
CA002461870A Abandoned CA2461870A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
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Application Number | Title | Priority Date | Filing Date |
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CA002447984A Abandoned CA2447984A1 (en) | 2001-09-28 | 2002-09-28 | Dosage forms having an inner core and outer shell with different shapes |
CA002461865A Abandoned CA2461865A1 (en) | 2001-09-28 | 2002-09-28 | Dosage form containing a confectionery composition |
CA002461616A Abandoned CA2461616A1 (en) | 2001-09-28 | 2002-09-28 | Composite dosage forms having an inlaid portion |
CA002461656A Abandoned CA2461656A1 (en) | 2001-09-28 | 2002-09-28 | Modified release dosage forms |
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US (15) | US7968120B2 (en) |
EP (12) | EP1429746B1 (en) |
JP (11) | JP2005509605A (en) |
KR (11) | KR20040037206A (en) |
CN (10) | CN1638740A (en) |
AT (4) | ATE476957T1 (en) |
AU (1) | AU2002330164A1 (en) |
BR (11) | BR0213589A (en) |
CA (12) | CA2461684A1 (en) |
CO (1) | CO5570655A2 (en) |
DE (4) | DE60228281D1 (en) |
ES (3) | ES2295427T3 (en) |
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NZ (3) | NZ532097A (en) |
PL (1) | PL369134A1 (en) |
PT (1) | PT1429738E (en) |
WO (12) | WO2003026625A1 (en) |
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2002
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2003
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2004
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2005
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2008
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2009
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