Lupin, Inc.

Subrata Kundu

Himadri Sen

Makarand Krishnakumar Avachat

Sanjay Chhagan Wagh

Sachin Pundlik Kolhe

A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising one or more cephalosporins such as cefuroxime axetil and cefpodoxime proxetil and one or more coating layers. Cefuroxime axetil is in &#x3b1;-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the &#x3b1;-crystalline form, wherein the particle size distribution of the &#x3b1;-crystalline form being such that 100% of the particles have a particle size below 250&#x3bc;. The ratio of the crystalline fraction to the amorphous fraction ranges from 0.3:0.7 to 0.99:0.01. The particle size of cefpodoxime proxetil is such that 90% of the particles are below 15&#x3bc;. The process of preparation of coated, non-disintegrating pellets comprising the steps of reducing the particle size of the one or more cephalosporins, blending with the other excipients, wet granulation, extrusion, spheronization, drying and screening to obtain pellets, said pellets being further coated with one or more layers of film coating to achieve taste masking.

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Pune, India

Subrata Kundu