Storage-Stable Oral Dosage Form of Amoxicillin and Clavulanic Acid

摘要

An airtight-packaged system including:(1) a combination of two independently prepared pharmaceutical drug forms composed of a first drug form in aqueous formulation containing amoxicillin trihydrate as active pharmaceutical ingredient and a second drug form prepared separately from the first and containing potassium clavulanate as active pharmaceutical ingredient, in which the active ingredients in the combination of the first and second drug forms are present in a nominal weight ratio of amoxicillin to clavulanic acid of from 20:1 to 1:1, and(2) a preparation containing at least one desiccant in amounts such that when the packaged system is stored under stress conditions at 40° C. and 75% relative humidity for up to 3 months, the dimerization of amoxicillin trihydrate does not exceed 1.5% by weight, and the degradation of clavulanic acid does not exceed 10% by weight.