Claims for Patent: 9,144,559

Summary for Patent: 9,144,559

Title:	Solid pharmaceutical compositions containing pregabalin
Abstract:	A solid pharmaceutical composition containing pregabalin is described. The composition includes a matrix forming agent and a swelling agent and is suitable for once daily oral administration. Exemplary matrix forming agents include mixtures of polyvinyl acetate and polyvinylpyrrolidone, and exemplary swelling agents include cross-linked polymers of polyvinylpyrrolidone.
Inventor(s):	Bockbrader; Howard N. (Ann Arbor, MI), Cho; Yun Hyung (Lexington, MA), Diaz Santiago; Steven (Martinsville, NJ), Mahjour; Majid (Schwenksville, PA), Reynolds; Thomas Daniel (Morgantown, WV), Shao; Pushpa Ganapathi (San Diego, CA), Shao; Zezhi Jesse (San Diego, CA), Wan; Jiansheng (Short Hills, NJ)
Assignee:	Warner-Lambert Company LLC (New York, NY)
Application Number:	14/570,115
Patent Claims:	1. A pharmaceutical composition comprising an active pharmaceutical ingredient and excipients, the active pharmaceutical ingredient comprising pregabalin, or a pharmaceutically acceptable complex, salt, solvate or hydrate thereof, and the excipients comprising a matrix forming agent and a swelling agent, the matrix forming agent comprising polyvinyl acetate and polyvinylpyrrolidone, and the swelling agent comprising crosslinked polyvinylpyrrolidone, wherein the pharmaceutical composition is adapted for once-daily oral dosing; wherein the pregabalin comprises from about 5% to about 60% of the pharmaceutical composition by weight; the matrix forming agent comprises from about 5% to about 45% of the pharmaceutical composition by weight, and the swelling agent comprises from about 15% to about 70% of the pharmaceutical composition by weight. 2. The pharmaceutical composition according to claim 1 in which: a) said matrix forming agent comprises about 20% to about 35% of the pharmaceutical composition by weight, and; b) said swelling agent comprises about 20% to about 55% of the pharmaceutical composition by weight. 3. The pharmaceutical composition according to claim 1 in which the polyvinyl acetate is present in the quantity of about 60% to about 90% by weight based on the total weight of the polyvinyl acetate and polyvinylpyrrolidone. 4. The pharmaceutical composition according to claim 1 in which the polyvinyl acetate is present in the quantity of about 70% to about 90% by weight based on the total weight of the polyvinyl acetate and polyvinylpyrrolidone. 5. A pharmaceutical formulation suitable for once-a-day administration comprising: a) pregabalin, or a pharmaceutically acceptable complex, salt, solvate or hydrate thereof, present in the quantity of from about 5% to about 60%, based on the total weight of the formulation; b) a matrix of polyvinyl acetate and polyvinylpyrrolidone, in which the polyvinyl acetate is present in the quantity of about 70% to about 90% based on the total weight of the polyvinyl acetate and polyvinylpyrrolidine and the matrix is present in the quantity of about 20% to 35% by weight, based on the total weight of the formulation, and; c) cross linked polyvinylpyrrolidone, present in the quantity of about 10% to about 35% by weight, based on the total weight of the formulation. 6. The formulation according to claim 5 in which the cross linked polyvinylpyrrolidone is present in the quantity of from about 20% to about 30% by weight, based on the total weight of the formulation.