Process for manufacturing a pharmaceutical dosage form comprising nifedipine and candesartan cilexetil

摘要

The present invention relates to manufacturing processes for the preparation of a pharmaceutical dosage form comprising nifedipine and candesartan cilexetil and optionally at least one diuretic characterized in that nifedipine is released in the body in a controlled (modified) manner and the candesartan cilexetil is released rapidly (immediate release (IR)) and optionally the diuretic is released rapidly (immediate release (IR)) and the pharmaceutical dosage forms obtainable by these processes.

主权项

1. A process for the manufacture of tablets comprising a nifedipine in the core and candesartan cilexetil in the active coating layer with mean candesartan cilexetil content of 95-105%, comprising spraying an active coating suspension comprising candesartan cilexetil onto tablet cores comprising nifedipine using at least 4 spray nozzles until the desired amount of candesartan cilexetil has been applied to tablet cores as determined by in-line Raman spectroscopy.