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Claims for Patent: 6,306,900

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Claims for Patent: 6,306,900

Title: Enteric coated pharmaceutical compositions
Abstract:This invention provides a pharmaceutical composition comprising a mycophenolate salt, the composition being adapted to release mycophenolate in the upper part of the intestinal tract.
Inventor(s): Haeberlin; Barbara (Riehen, CH), Mak; Ching-Pong (Therwil, CH), Meinzer; Armin (Buggingen, DE), Vonderscher; Jacky (Riedisheim, FR)
Assignee: Novartis AG (Basel, CH)
Application Number:09/694,209
Patent Claims: 1. A pharmaceutical composition comprising a mycophenolate salt, the composition being adapted to prevent release of mycophenolate in the stomach.

2. The composition of claim 1 wherein the composition has an enteric coating and said enteric coating comprises cellulose acetate phthalate and trimellitate, or methacrylic acid copolymers containing at least 40% methacrylic acid, or hydroxypropyl methylcellulose phthalate.

3. The composition of claim 2 wherein said coating comprises methacrylic acid copolymers containing at least 40% methacrylic acid.

4. The composition of claim 2 wherein said composition is in a tablet form.

5. The composition of claim 4, wherein said tablet has a hardness between 10 and 70 N.

6. The composition of claim 2 wherein said composition is in a granule or pellet form.

7. The composition of claim 6 wherein said granule or pellet is contained in a capsule.

8. The composition of claim 1 wherein said salt is a mono-sodium salt.

9. The composition of claim 8 wherein said salt is in crystalline form.

10. The composition of claim 1 wherein said composition comprises from about 50 mg to 1.5 g of a pharmaceutically acceptable mycophenolate salt.

11. A pharmaceutical composition comprising a mycophenolate mono-sodium salt, the composition being adapted to prevent release mycophenolate in the stomach, wherein said composition has an enteric coating and said enteric coating comprises cellulose acetate phthalate and trimellitate, or methacrylic acid copolymers containing at least 40% methacrylic acid, or hydroxypropyl methylcellulose phthalate.

12. The composition of claim 11 wherein said mono-sodium salt is in crystalline form.

13. The composition of claim 11 herein said composition is in a tablet form and said tablet form has a hardness between 10 and 70 N.

14. The composition of claim 11 wherein said composition comprises from about 50 mg to 1.5 of a pharmaceutically acceptable mycophenolate salt.
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