Claims for Patent: 7,776,358

Summary for Patent: 7,776,358

Title:	Extended release venlafaxine besylate tablets
Abstract:	Venlafaxine besylate is formulated into an extended release tablet in high loading rates by use of a coating that contains ammonio methacrylate copolymer(s).
Inventor(s):	Cucala Escoi; Joan (Barcelona, ES), Gallego Luengo; Montserrat (Barcelona, ES), Margallo Lana; Inocencia (Barcelona, ES)
Assignee:	Synthon IP Inc. (Gainesville, VA)
Application Number:	10/895,984
Patent Claims:	1. An extended release coated pharmaceutical tablet comprising: (a) a tablet core, which comprises at least 70% venlafaxine besylate; and (b) a coating over said tablet core which comprises an ammonio methacrylate copolymer component, wherein said coating is in an amount within the range of 3% to 25% of the weight of said tablet core. 2. The extended release tablet according to claim 1, wherein said tablet core comprises 75-99% venlafaxine besylate. 3. The extended release tablet according to claim 2, wherein said tablet core contains 80-95% venlafaxine besylate. 4. The extended release tablet according to claim 1, wherein said ammonio methacrylate copolymer component comprises at least 50% of said coating. 5. The extended release tablet according to claim 4, wherein said ammonio methacrylate copolymer component comprises 7 mol % to 14 mol % ammonio methacrylate units. 6. The extended release tablet according to claim 5, wherein said ammonio methacrylate copolymer component comprises 8 mol % to 12 mol % ammonio methacrylate units. 7. The extended release tablet according to claim 4, wherein said ammonio methacrylate copolymer component comprises 65-100% of a Type A ammonio methacrylate copolymer and 35-0% of a Type B ammonio methacrylate copolymer. 8. The extended release tablet according to claim 7, wherein said ammonio methacrylate copolymer component comprises 85-100% of a Type A ammonio methacrylate copolymer and 15-0% of a Type B ammonio methacrylate copolymer. 9. The extended release tablet according to claim 1, wherein said tablet core is free from extended release matrix excipients. 10. The extended release tablet according to claim 9, wherein said tablet core further comprises a lubricant and optionally a filler selected from the group consisting of sugars, microcrystalline cellulose, calcium phosphates, and mixtures thereof. 11. The extended release tablet according to claim 10, wherein said tablet core contains 150 to 300 mg of said venlafaxine besylate. 12. The extended release tablet according to claim 11, wherein said coating is in an amount within the range of 5% to 15% of the weight of said tablet core; said ammonio methacrylate copolymer component comprises at least 50% of said coating; and said ammonio methacrylate copolymer component comprises 85-100% of a Type A ammonio methacrylate copolymer and 15-0% of a Type B ammonio methacrylate copolymer. 13. The extended release tablet according to claim 1, wherein said tablet core further comprises a matrix material. 14. The extended release tablet according to claim 13, wherein said matrix material is a lipophilic matrix material. 15. The extended release tablet according to claim 14, wherein said matrix material is co-processed calcium phosphate and fatty acid wax having a ratio within the range of 85:15 to 65:35, respectively. 16. The extended release tablet according to claim 15, wherein said tablet core comprises 10-20% of said co-processed calcium phosphate and fatty acid wax excipient and 0.2 to 2% of a lubricant. 17. The extended release tablet according to claim 16, wherein said coating is in an amount within the range of 5% to 25% of the weight of said tablet core; said ammonio methacrylate copolymer component comprises at least 50% of said coating; and said ammonio methacrylate copolymer component comprises 70-100% of a Type A ammonio methacrylate copolymer and 30-0% of a Type B ammonio methacrylate copolymer. 18. The extended release tablet according to claim 17, wherein said tablet core comprises 50 to 150 mg of said venlafaxine besylate. 19. The extended release tablet according to claim 1, wherein said tablet exhibits a dissolution profile within the following ranges: TABLE-US-00027 Time Venlafaxine 2 hours <30% 4 hours 30-55% 8 hours 55-80% 12 hours 65-90% 24 hours >80% in USP 2 apparatus using SGF, pH 1.2, medium for hours 0-2 and then SIF, pH 6.8, medium for hours 2-24.