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Claims for Patent: 6,004,996

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Claims for Patent: 6,004,996

Title: Tetrahydrolipstatin containing compositions
Abstract:Product containing tetrahydrolipstatin as the active ingredient and pharmaceutically acceptable excipients, characterized in that it is in the form of particles with a diameter of 0.25 to 2 mm; and pharmaceutical preparation s or compositions for oral administration containing the product.
Inventor(s): Shah; Navnit Hargovindas (Clifton, NJ), Zeller; Max (Fullinsdorf, CH)
Assignee: Hoffman-La Roche Inc. (Nutley, NJ)
Application Number:09/003,137
Patent Claims: 1. A pharmaceutical composition comprising a plurality of pellets having a diameter in the range of from about 0.25 mm to about 2 mm, and at most only a trace amount of pellets outside this range, each pellet comprising about 50% by weight tetrahydrolipstatin; polyvinylpyrrolidone; microcrystalline cellulose; and at least one pharmaceutically acceptable excipient.

2. The composition of claim 1, wherein the pellets have a diameter of from about 0.5 mm to about 1.5 mm.

3. The composition of claim 1, wherein at least 5% by weight of the composition is polyvinylpyrrolidone.

4. The composition of claim 1, wherein the pharmaceutically acceptable excipient is a surfactant, diluent, or disintegrant.

5. The composition of claim 4, wherein the pharmaceutically acceptable excipient is a surfactant.

6. The composition of claim 5, wherein the surfactant is sodium lauryl sulfate or sodium dioctylsulfosuccinate.

7. The composition of claim 4, wherein the pharmaceutically acceptable excipient is a diluent.

8. The composition of claim 7, wherein the diluent is sucrose or corn starch.

9. The composition of claim 4, wherein the excipient is a disintegrant.

10. The composition of claim 9, wherein the disintegrant is sodium starch glycolate, cross-linked polyvinyl pyrrolidone, cross-carmolose sodium, or a hydroxypropyl cellulose.

11. The composition of claim 1 which comprises about 50% by weight tetrahydrolipstatin; about 39% by weight microcrystalline cellulose; about 3% by weight sodium starch glycolate; about 3% by weight sodium lauryl sulfate; about 5% by weight polyvinylpyrrolidone; and about 0.1% by weight talc.

12. The composition of claim 1 which is in unit dosage form.

13. The composition of claim 11 which is in unit dosage form.

14. The composition of claim 1 which comprises about 120 mg of tetrahydrolipstatin; about 93.6 mg of microcrystalline cellulose; about 7.2 mg of sodium starch glycolate; about 7.2 mg of sodium lauryl sulfate; about 12 mg of polyvinylpyrrolidone; and about 0.24 mg of talc.

15. The composition of claim 14 which is in unit dosage form.
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