Formulation of a capsule preparation with high active ingredient content using re-crystallized drug compound

摘要

Richter Gedeon Company aimed to manufacture and launch a generic product, that's original is already on market in Hungary. The goal of a generic development is to produce an essentially similar product to the original one. It seems to be simple and routine work, but during the formulation a couple of problems have to be solved. Our active agent was voluminous therefore we could not fill the whole quantity of the active, even without any excipients. In addition the flow property of the powder mixture were very bad, and it may cause inaccurate capsule filling and significant differences in the weight of the filled capsules. During the formulation we managed to assure the appropriate physical properties of the agent by re-crystallisation. We changed the excipients used in the first trials. Chemically these were the same, but with different physical features.