Eli Lilly and Company

Michael Vincent Mullen

Gregory Alan Stephenson

Frank Brown, Jr

Arlette Faye Kreager

Robert Alan Forbes

Gerold L Mosher

The present invention provides a process for producing cefaclor crystalline bulk material having a dissolution rate in a capsule of &gE;80% in water in 30 minutes. One process route includes reducing the water content of cefaclor dihydrates or bulk material containing cefaclor dihydrate to produce a cefaclor form having a water content &lE;2%. The cefaclor having the lower water content can then be rehydrated to a water content from 3.0 to 6.5% without adversely affecting the dissolution rate. An alternative process includes the addition of at least 0.05% of cefaclor related substances to inhibit conversion of the monohydate to the dihydate form.

Process for preparing pharmaceutical bulk material having uniform dissolution

R-Cefuroxime axetil which is substantially free of the S-isomer is readily absorbed from the stomach and gastro-intestinal track of animals, and is therefore ideally suited to oral therapy of bacterial infections.

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Fishers, IN, United States of America

Michael Vincent Mullen