Trovafloxacin mesylate tablet
AssigneePfizer Inc.
InventorsAlton D. Johnson, Christopher M. Sinko
Life of this patent
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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.
Claims16
A dry granulated composition comprising the polymorph II form of trovafloxacin mesylate, a lubricant, and at least 5% of microcrystalline cellulose (MC).
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° 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.
A composition comprising
- 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
Dependencies are inferred from the claim text.