Immediate release dosage form comprising shell having openings therein

• US 20030219484A1
• Filed: 03/21/2003
• Published: 11/27/2003
• Est. Priority Date: 09/28/2001
• Status: Abandoned Application

• Current Assignee: OMJ Ireland Limited
• Original Assignee: OMJ Ireland Limited
• Inventors: Sowden, Harry S., McNally, Gerard P.
• Application Number:
  US10/393,610
• Publication Number:
  US 20030219484A1
• Time in Patent Office: Days
• US Class Current: 424/473
• CPC Class Codes: A23G 1/54 Composite products, e.g. layered laminated, coated, filled
• CPC Class Codes: A23G 3/0029 Moulding processes for hollow products, e.g. opened shell
• CPC Class Codes: A23G 3/04 Sugar-cookers
• CPC Class Codes: A23G 3/368 containing vitamins, antibiotics
• CPC Class Codes: A23G 3/54 Composite products, e.g. layered, coated, filled
• CPC Class Codes: A23L 29/30 containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin products from apiculture A23L21/20; artificial sweetening agents A23L27/30
• CPC Class Codes: A61J 3/005 Coating of tablets or the like coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• CPC Class Codes: A61J 3/10 into the form of compressed tablets tablet presses B30B11/00
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0056 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
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61K 9/2068 Compounds of unknown constitution, e.g. material from plants or animals oils, fats, waxes, shellac A61K9/2013
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50
• CPC Class Codes: A61K 9/209 containing drug in at least two layers or in the core and in at least one outer layer
• CPC Class Codes: A61K 9/2095 : 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 mechanical aspects A61J3/00
• CPC Class Codes: A61K 9/282 : Organic compounds, e.g. fats
• CPC Class Codes: A61K 9/2826 : Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
• CPC Class Codes: A61K 9/284 : obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
• CPC Class Codes: A61K 9/286 : Polysaccharides, e.g. gums; Cyclodextrin
• CPC Class Codes: A61K 9/2873 : Proteins, e.g. gelatin
• CPC Class Codes: A61K 9/2886 : having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer of the type active core-drug layer-inactive layer A61K9/209
• CPC Class Codes: A61K 9/2893 : Tablet coating processes mechanical aspects A61J3/06
• CPC Class Codes: A61K 9/5084 : 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 tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61P 11/00 : Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: B30B 11/08 : co-operating with moulds carried by a turntable
• CPC Class Codes: B30B 11/34 : for coating articles, e.g. tablets
• CPC Class Codes: B30B 15/302 : Feeding material in particulate or plastic state to moulding presses
• CPC Class Codes: Y10T 428/1352 : Polymer or resin containing [i.e., natural or synthetic]

Abstract

The invention provides an immediate release dosage form having a solid core and a shell readily soluble in gastrointestinal fluids. The dosage form also comprises one or more openings in the shell.

Claims

1. A dosage form containing at least one active ingredient, which comprises a core and a shell surrounding at least a portion of the core, wherein the core has a density of at least about 0.9 g/cc, the shell comprises one or more openings, the shell is readily soluble in gastrointestinal fluids, and the dosage form provides for immediate release of at least one active ingredient upon contact of the dosage form with a liquid medium.

2. The dosage form of claim 1, wherein the shell comprises a plurality of openings.

3. The dosage form of claim 1, wherein one or more openings contact the core.

4. The dosage form of claim 2, wherein a plurality of openings contact the core.

5. The dosage form of claim 1, wherein the core comprises at least one active ingredient.

6. The dosage form of claim 1, wherein the shell comprises at least one active ingredient.

7. The dosage form of claim 5 or 6, wherein the dosage form provides for immediate release of at least one active ingredient contained in the core.

8. The dosage form of claim 1, wherein the core comprises a compressed tablet.

9. The dosage form of claim 1, wherein the compressed tablet has a hardness from about 2 to about 30 kp/cm^2.

10. The dosage form of claim 1, wherein the shell is applied to the core by dipping.

11. The dosage form of claim 1, wherein the shell is applied to the core by molding.

12. The dosage form of claim 1, wherein the shell is applied to the core by enrobing.

13. The dosage form of claim 1, further comprising an outer coating covering at least a portion of the shell.

14. The dosage form of claim 12, wherein the outer coating comprises at least one active ingredient.

15. The dosage form of claim 12, wherein the outer coating covers at least a portion of the openings.

16. The dosage form of claim 12, wherein the outer coating is readily soluble in gastrointestinal fluids.

17. The dosage form of claim 1, wherein the shell comprises a film-former.

18. The dosage form of claim 17, wherein the film-former comprises gelatin.

19. The dosage form of claim 1, wherein the average shell thickness is in the range from about 100 to about 400 microns.

20. The dosage form of claim 1, wherein the relative standard deviation of the shell thickness on the dosage form is less than about 30%.

21. The dosage form of claim 1, wherein the shell comprises less than about 50% crystallizable carbohydrate.

22. The dosage form of claim 1, wherein the dosage form is substantially free of charge control agents.

23. The dosage form of claim 1, wherein the shell comprises first and second shell portions which are compositionally different.

24. The dosage form of claim 23, wherein the first and second shell portions are visually distinct.

25. The dosage form of claim 23, wherein the first and second shell portions are joined at an interface.

26. The dosage form of claim 23, wherein the first shell portion comprises one or more openings therein, and the second shell portion is substantially free of openings therein.

27. The dosage form of claim 23, wherein the first and second shell portions are in direct contact with the core.

28. The dosage form of claim 1 or 23, wherein the core is substantially surrounded by a subcoating.

29. The dosage form of claim 28, wherein the first and second shell portions are in direct contact with said subcoating.

30. The dosage form of claim 1 or claim 23, wherein the diameter or width of one or more openings is from about 200 to about 2000 microns.

31. A dosage form comprising a core having an outer surface and a shell having outer and inner surfaces, wherein at least a portion of the shell surrounds the core such that the shell inner surface resides substantially conformally upon the core outer surface, at least a portion of the shell comprises one or more openings therein, one or more of the openings are from about 200 to about 2000 microns in diameter or width, at least a portion of the shell is readily soluble in gastrointestinal fluids, the average shell thickness is in the range from about 100 to about 400 microns, the shell comprises less than about 50% crystallizable sugar, and the dosage form is substantially free of charge control agents and the dosage form provides for immediate release of at least one active ingredient upon contact of the dosage form with a liquid medium.