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US 9,820,943 B2Granted
Micronized amoxicillin
AssigneeDSM Sinochem Pharmaceuticals Netherlands B.V.
InventorsRajinder Kapoor, Naresh Sharma, Neeraj Tewari
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Abstract
The present invention relates to amoxicillin trihydrate compositions having a surface area of from 1.0 to 2.5 m2·g−1 that are free of organic contaminants such as dichloromethane, isopropanol, pivalic acid and triethyl amine and that have a purity of from 97.0% to 99.99%. Furthermore, the present invention relates to a method for the preparation of said amoxicillin trihydrate compositions and to the use of said compositions for the treatment of a bacterial infection.
Claims20
A composition comprising:
- (i) from 97.0% to 99.99% (w/w) of amoxicillin trihydrate having a surface area of from 1.0 to 2.5 m2·g−1 having an average particle size distribution of D10 from 1 μm to 3 μm, D50 from 5 μm to 15 μm, D90 from 15 μm to 30 μm, and D100 from 30 μm to 100 μm, and
- less than 500 ppm of at least one compound selected from the group consisting of dichloromethane, isopropanol, pivalic acid and triethyl amine.
A composition comprising:
- (iii) from 97.0% to 99.99% (w/w) of amoxicillin trihydrate having a surface area of from 1.0 to 2.5 m2·g−1 having an average particle size distribution of D10 from 1 μm to 3 μm, D50 from 5 μm to 15 μm, D90 from 15 μm to 30 μm and D100 from 30 μm to 100 μm, and
- (iv) less than 500 ppm of at least one compound selected from the group consisting of dichloromethane, isopropanol, pivalic acid and triethyl amine,
- wherein the composition has a purity of 99.4±0.5%, a contact angle from 80-130, and less than 500 ppm of protein.
Dependencies are inferred from the claim text.