Process for preparing a granulate containing orally active beta-lactam antibiotic and oral dosage-form containing the orally active beta-lactam antibiotic

摘要

In the present invention, there is disclosed a process for the preparation of a granulate, comprising a water soluble, orally active beta-lactam antibiotic, wherein water solubility ratio ranges within 1 to less than or equal to 10 and including the steps of: a. moistening components making up the granulate with an aqueous solution containing 0 to 0.5 percent by weight, preferably 0 to 0.1 percent by weight of a wet granulation binding agent, the percentage based on the granulate total weight; b. screening the wet mass through a 2 mm sieve; c. drying the product obtained in step b.; d. screening the dry product of step c. through an at least 0.71 mm sieve. The obtained granulate is suitable for the preparation of quickly disintegrating oral pharmaceutical composition.