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Claims for Patent: 8,580,302

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Claims for Patent: 8,580,302

Title:Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Abstract: The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
Inventor(s): Dittmar; Gregory Paul (Norwich, NY), Amante; Joseph Michael (Norwich, NY), Cronk; Tony Ryan (Mishawaka, IN), Newby; Daniel Gary (South New Berlin, NY)
Assignee: Warner Chilcott Company, LLC (Fajardo, PR)
Application Number:11/070,995
Patent Claims: 1. A pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a core comprising a safe and effective amount of a therapeutically active agent; and b. a coating, wherein the coating comprises an inner coating layer and an outer coating layer, wherein the outer coating layer comprises an enteric polymer or a film coating material, wherein said enteric polymer begins to dissolve in an aqueous medium at a pH of less than about 7, and said enteric polymer comprises a polymer selected from the group consisting of polymethacrylates, anionic polymethacrylates, poly(methacrylic acid, methyl methacrylate) 1:1, mixtures of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1, polyvinyl acetate phthalate, poly(methacrylic acid, ethyl acrylate) 1:1, and compatible mixtures thereof, wherein said film coating material comprises a component selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimelliate, hydroxypropyl methylcellulose phthalate (HPMCP), cellulose propionate phthalate, cellulose acetate maleate, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose hexahydrophthalate, and mixtures thereof, wherein the solid unit dosage form has a total weight from about 550 mg to about 1500 mg, wherein the inner coating layer is not the same as the outer coating layer, and wherein the inner coating layer and the outer coating layer do not contain said therapeutically active agent.

2. The composition of claim 1 wherein the inner coating layer comprises a polymer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof.

3. The composition of claim 2 wherein the solid dosage form is coated by continuous spray methods wherein the outer coating layer is applied after the inner coating layer but before the inner coating layer is dried or cured.

4. The composition of claim 1 wherein the outer coating layer comprises a polymer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1.

5. The composition of claim 4 wherein the outer coating layer comprises a mixture of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1.

6. The composition of claim 5 wherein the outer coating layer has a minimum thickness from about 10 .mu.m to about 50 .mu.m.

7. The composition of claim 1 wherein the therapeutically active agent is selected from the group consisting of laxatives, anti-diarrheals, nonsteroidal anti-inflammatory agents, glucocorticoids, antimicrobials, immunosuppressants, chemotherapeutics or anti-cancer drugs, peptides, proteins, cardiovascular drugs, psychotropic drugs, H2-blockers, antiasthmatic agents, and antihistamines.

8. The composition of claim 7 wherein the therapeutically active agent is a nonsteroidal anti-inflammatory agent.

9. The composition of claim 8 wherein the therapeutically active agent is 5-amino salicylic acid or a pharmaceutically acceptable salt or ester thereof.

10. The composition of claim 9 wherein the 5-amino salicylic acid or pharmaceutically acceptable salt or ester thereof is present in an amount of at least 400 mg per solid unit dosage form.

11. The composition of claim 1 wherein the outer coating layer has a minimum thickness from about 10 .mu.m to about 200 .mu.m.

12. The composition of claim 1 wherein the solid dosage form is a compressed tablet.

13. A method of consistent and reliable delivery and release of a therapeutically active agent to the desired region of delivery by orally administering the composition of claim 1.

14. The pharmaceutical composition of claim 1, wherein the coating consists essentially of an inner coating layer and an outer coating layer.

15. A pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a core comprising a safe and effective amount of 5-amino salicylic acid or a pharmaceutically acceptable salt or ester thereof; and b. a coating, wherein the coating comprises an inner coating layer and an outer coating layer, wherein the inner coating layer comprises a polymer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof, wherein the outer coating layer comprises an enteric polymer or a film coating material, wherein said enteric polymer begins to dissolve in an aqueous medium at a pH of less than about 7, and said enteric polymer comprises a polymer selected from the group consisting of polymethacrylates, anionic polymethacrylates, poly(methacrylic acid, methyl methacrylate) 1:1, mixtures of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1, polyvinyl acetate phthalate, poly(methacrylic acid, ethyl acrylate) 1:1, and compatible mixtures thereof, wherein said film coating material comprises a component selected from the group consisting of cellulose acetate phthalate, cellulose acetate trimelliate, hydroxypropyl methylcellulose phthalate (HPMCP), cellulose propionate phthalate, cellulose acetate maleate, hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose hexahydrophthalate, and mixtures thereof, wherein the solid unit dosage form has a total weight from about 550 mg to about 1500 mg, and wherein the inner coating layer is not the same as the outer coating layer.

16. The composition of claim 15 wherein the outer coating layer comprises a polymer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:1 and mixtures of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1.

17. The composition of claim 16 wherein the outer coating layer has a minimum thickness from about 10 .mu.m to about 50 .mu.m.

18. The composition of claim 17 wherein the outer coating layer has a minimum thickness from about 20 .mu.m to about 40 .mu.m.

19. The composition of claim 15 wherein the 5-amino salicylic acid or pharmaceutically acceptable salt or ester thereof is present in an amount of at least 400 mg per solid unit dosage form.

20. The composition of claim 15 wherein the outer coating layer has a minimum thickness from about 10 .mu.m to about 200 .mu.m.

21. A pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a core comprising a safe and effective amount of 5-amino salicylic acid or a pharmaceutically acceptable salt or ester thereof; and b. a coating, wherein the comprises an inner coating layer and an outer coating layer, wherein the inner coating layer comprises poly(methacrylic acid, methyl methacrylate) 1:2, and wherein the outer coating layer comprising a mixture of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1, wherein the solid unit dosage form has a total weight from about 550 mg to about 1500 mg.

22. The pharmaceutical composition of claim 21, wherein the coating consists essentially of an inner coating layer and an outer coating layer.
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