Patent ID: 7632520

Claim:
An antibiotic formulation comprising (i) a core containing Cloxacillin sodium, cefixime trihydrate, lactobacillus sporogenes ant at least one pharmaceutically acceptable excipient said core coated with at least one layer of a polymeric coat; said core comprising a sustained release part and an immediate release part; said sustained release part comprising cloxacillin sodium incorporated in a hydroxypropyl methyl cellulose matrix and optionally a binder; said immediate release part comprises an intimate mixture of (i) cloxacillin sodium, (ii) cefixime trihydrate, (iii) lactobacillus sporogenes , (iv) a lubricant, and (v) optionally a disintegrant; said polymeric coat consisting of (i) a coating polymer in amount about 1 to 3% by mass of the core, (ii) a solvent for dissolving the polymer in amount about 5 to 45% by mass of the core, (iii) a plasticizer in amount about 0.05 to 2% by mass of the core, and (iv) a coloring agent in amount about 0.05 to 2% by mass of the core; wherein (i) the total amount of cloxacillin sodium is about 48.63 to 61.27% by mass of the total formulation, (ii) about 60 to 90% of total cloxacillin sodium in the formulation is present in the sustained release part, the remaining being in the immediate release part, (iii) the amount of cefixime trihydrate in the immediate release part is about 20 to 40% by mass of the total cloxacillin sodium in the formulation and (iv) the amount of lactobacillus sporogenes in the immediate release part is about 0.5 to 4% by mass of the total cloxacillin sodium in the formulation.