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AssigneeLupin Limited
InventorsSachin Pundlik Kolhe, Subrata Kundu, Sanjay Chhagan Wagh, Makarand Krishnakumar Avachat, Himadri Sen
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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 α-crystalline and amorphous forms, where at least 30% of the Cefuroxime axetil is in the α-crystalline form, wherein the particle size distribution of the α-crystalline form being such that 100% of the particles have a particle size below 250μ. 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 15μ. 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.
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 and one or more coating layers.
A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising cefuroxime axetil and one or more coating layers.
A stable taste masked, pharmaceutical composition comprising a plurality of coated, non-disintegrating discrete dosage units, said units comprising of a core comprising cefpodoxime axetil and one or more coating layers.
A process of preparation of coated, non-disintegrating pellets, said pellets comprising of a core comprising one or more cephalosporins and one or more coating layers over said core, the said process 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.
A stable taste masked, pharmaceutical composition in the form of a plurality of coated, non-disintegrating pellets, said pellets comprising of a core comprising Cefuroxime axetil in α-crystalline and amorphous forms and one or more coating layers, wherein at least 30% of the said Cefuroxime is in the α-crystalline form having a particle size distribution such that 100% of the particles are below 250μ, wherein the said composition demonstrates bioequivalence to the commercially available suspension of Cefuroxime axetil, the said suspension being marketed under the brand name of ‘Ceftin®’.
Dependencies are inferred from the claim text.