Patent ID: 7011849

Claim:
A pharmaceutical formulation to provide a unit dosage of amoxicillin and potassium clavulanate, the formulation comprising in solid unit dosage form from about 100 to about 150 mg of potassium clavulanate and from about 1700 to about 2500 mg of amoxicillin; wherein all of the potassium clavulanate and from 0 to 50% of the amoxicillin are contained in a first release phase; and from 50 to 100% of the amoxicillin is contained in a second release phase; such that the composition upon administration to a human provides a T>MIC of at least 8 hours for an MIC of 2 μg/ml; and wherein the second release phase comprises a) a pharmaceutically acceptable soluble salt of amoxicillin, and at least one pharmaceutically acceptable organic acid which are admixed, as solids, in intimate contact at a ratio of from about 20:1 to about 1:2; or b) at least one release retarding excipient selected from pH sensitive polymers; release-retarding polymers which have a high degree of swelling in contact with water or aqueous media; polymeric materials which form a gel on contact with water or aqueous media; and polymeric materials which have both swelling and gelling characteristics in contact with water or aqueous media.