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Claims for Patent: 6,187,341

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Claims for Patent: 6,187,341

Title: Trovafloxacin mesylate tablet
Abstract:Compositions, especially in the form of tablets containing the polymorph II form of trovafloxacin mesylate, a lubricant, and microcrystalline cellulose (MC) as the diluent. Such compositions employing MC as a diluent exhibit good storage stability properties and dissolution.
Inventor(s): Johnson; Alton D. (New York, NY), Sinko; Christopher M. (Niantic, CT)
Assignee: Pfizer Inc. (New York, NY)
Application Number:09/233,823
Patent Claims: 1. A dry granulated composition comprising the polymorph II form of trovafloxacin mesylate, a lubricant, and at least 5% of microcrystalline cellulose (MC).

2. A composition as defined in claim 1, in the form of a tablet.

3. A composition as defined in claim 1 which passes USP, .sub.23 rd Edition, Stage 1 (S.sub.1) acceptance criteria.

4. A composition as defined in claim 2, further comprising a film coating.

5. A composition as defined in claim 4, wherein said coating comprises hydroxypropyl cellulose.

6. A composition as defined in claim 1, comprising at least 20% by weight of microcrystalline cellulose.

7. A composition as defined in claim 6, comprising at least 30% by weight of microcrystalline cellulose.

8. A composition as defined in claim 2, further comprising a disintegrant.

9. A composition as defined in claim 2, having a hardness of at least 8 kP.

10. A composition of matter comprising trovafloxacin mesylate in the form of a pharmaceutical tablet which, after having been stability tested by being stored for 12 weeks in an open container at constant conditions of 40.degree. C and 75% relative humidity, exhibits the following degradant levels:

A. less than 0.5% by weight of each of N-stearoyltrovafloxacin and N-palimitoyltrovafloxacin;

B. less than 0.2% by weight of any other degradant; and

C. the total of (A)+(B) is less than 1.0% by weight.

11. A composition as defined in claim 10, further comprising a film coating.

12. A composition as defined in claim 11, wherein said coating comprises hydroxypropyl cellulose.

13. A composition as defined in claim 10, comprising at least 5% by weight of microcrystalline cellulose.

14. A composition as defined in claim 13, comprising at least 20% by weight of microcrystalline cellulose.

15. A composition as defined in claim 14, comprising at least 30% by weight of microcrystalline cellulose.

16. A composition comprising

TBL Component %, w:w Trovafloxacin Mesylate* 52.7 Microcrystalline Cellulose 36.8 Sodium Croscarmellose 4.8 Magnesium Stearate 1.9 Film Coating 3.8 *polymorph II
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