Claims
- 1. A dosage form comprising:
(a) a core having an outer surface, wherein the core comprises at least one active ingredient and at least one disintegrant; and (b) a shell which resides upon at least a portion of the core outer surface, wherein the shell comprises at least a first shell portion comprising (i) at least one water insoluble film forming polymer, and (ii) at least one water insoluble lipid, and the weight ratio of film forming polymer to lipid is in the range of about 40:60 to about 60:40.
- 2. The dosage form of claim 1, in which the disintegrant is selected from the group consisting of sodium starch glycolate, cross-linked polyvinylpyrrolidone, cross-linked carboxymethylcellulose, starches, microcrystalline cellulose, and the like and mixtures thereof.
- 3. The dosage form of claim 1, in which the shell or first shell portion weight is about 10% to about 30% of the total weight of the dosage form.
- 4. The dosage form of claim 1, in which the film forming polymer is selected from the group consisting of ethylcellulose, cellulose acetate, polymethacrylic acid, methyl methacrylate, cellulose acetate butyrate, cellulose acetate propionate, polyvinyl alcohol, polyvinyl acetate, polycaprolactone, and mixtures thereof.
- 5. The dosage form of claim 1, in which at least a portion of at least one active ingredient is released from the dosage form in a delayed manner upon contacting of the dosage form with a liquid medium.
- 6. The dosage form of claim 1, in which the lipid is selected from the group consisting of glyceryl behenate, fats, waxes, cocoa butter, hydrogenated vegetable oils, palm kernel oil, cottonseed oil, sunflower oil, soybean oil, long chain fatty acids having a chain length of about C10-C40, fatty acid esters having a fatty acid chain length of about C10-C40, and mixtures thereof.
- 7. The dosage form of claim 1, in which the shell or first shell portion is a single layer in contact with the core outer surface.
- 8. The dosage form of claim 1, in which the release profile of at least one active ingredient upon contacting of the dosage form with a liquid medium is a delayed burst release.
- 9. The dosage form of claim 1, in which the release profile of at least one active ingredient upon contacting of the dosage form with a liquid medium is a delayed then sustained release.
- 10. The dosage form of claim 8 or 9 in which the delay time prior to the release of at least one active ingredient is independent of the pH of the liquid medium.
- 11. The dosage form of claim 8 or 9, in which a first dose of at least one active ingredient is released essentially immediately upon contacting of the dosage form with a liquid medium.
- 12. The dosage form of claim 1, in which the shell or first shell portion additionally comprises up to about 20% by weight of the shell or shell portion of at least one additional component selected from the group consisting of a water soluble polymer, a water soluble crystalline material, a water swellable material, and mixtures thereof.
- 13. The dosage form of claim 12, in which the additional component is a water soluble polymer selected from the group consisting of hydroxypropyl methylcellulose, polyvinyl pyrrolidone and mixtures thereof.
- 14. The dosage form of claim 13, in which the additional component is a crystalline material selected from the group consisting of sugars, water soluble inorganic salts, polyhedric alcohols, and mixtures thereof.
- 15. The dosage form of claim 14, in which the additional component is a water swellable material selected from the group consisting of water swellable cellulose derivatives, polyalkalene glycols, polyalkalene oxides, acrylic polymers, hydrocolloids, gelling starches, swelling cross-linked polymers, and derivatives, copolymers, and combinations thereof.
- 16. The dosage form of claim 15, in which the additional component is a pore former.
- 17. A method of providing a delayed burst release of an active ingredient from a dosage form, wherein the method comprises:
(I) providing a dosage form comprising:
(a) a core having an outer surface, wherein the core comprises at least one active ingredient and at least one disintegrant, and (b) a shell comprising at least a first shell portion which resides upon at least a portion of the core outer surface, wherein the shell or first shell portion comprises (i) at least one water insoluble film forming polymer, and (ii) at least one water insoluble lipid, and the weight ratio of film forming polymer to lipid is in the range of about 40:60 to about 60:40; and (II) contacting the dosage form with a liquid medium.
- 18. The method of claim 17, in which at least a portion of at least one active ingredient is released from the dosage form in a delayed manner upon contacting of the dosage form with a liquid medium.
- 19. The dosage form of claim 1 wherein the shell comprises first and second shell portions that are compositionally different and in contact with each other at an interface.
- 20. The dosage form of claim 19, wherein the shell substantially surrounds the core.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation-in-part of PCT Application Nos. PCT/US02/31129, filed Sep. 28, 2002; PCT/US02/31117, filed Sep. 28, 2002; PCT/US02/31062, filed Sep. 28, 2002; PCT/US02/31024, filed Sep.28, 2002; and PCT/US02/31163, filed Sep. 28, 2002, which are each continuations-in-part of U.S. Ser. No. 09/966,939, filed Sept. 28, 2001; U.S. Ser. No. 09/966,509, filed Sep. 28, 2001; U.S. Ser. No. 09/966,497, filed Sep. 28, 2001; U.S. Ser. No. 09/967,414, filed Sep. 28, 2001; and U.S. Ser. No. 09/966,450, filed September 28, the disclosures of all of the above being incorporated herein by reference in their entirety.
Continuation in Parts (10)
|
Number |
Date |
Country |
Parent |
PCT/US02/31129 |
Sep 2002 |
US |
Child |
10393765 |
Mar 2003 |
US |
Parent |
PCT/US02/31117 |
Sep 2002 |
US |
Child |
10393765 |
Mar 2003 |
US |
Parent |
PCT/US02/31062 |
Sep 2002 |
US |
Child |
10393765 |
Mar 2003 |
US |
Parent |
PCT/US02/31024 |
Sep 2002 |
US |
Child |
10393765 |
Mar 2003 |
US |
Parent |
PCT/US02/31163 |
Sep 2002 |
US |
Child |
10393765 |
Mar 2003 |
US |
Parent |
09966939 |
Sep 2001 |
US |
Child |
PCT/US02/31163 |
Sep 2002 |
US |
Parent |
09966509 |
Sep 2001 |
US |
Child |
09966939 |
Sep 2001 |
US |
Parent |
09966497 |
Sep 2001 |
US |
Child |
09966509 |
Sep 2001 |
US |
Parent |
09967414 |
Sep 2001 |
US |
Child |
09966497 |
Sep 2001 |
US |
Parent |
09966450 |
Sep 2001 |
US |
Child |
09966497 |
Sep 2001 |
US |