Application of failure mode and effects analysis in quality by design approach for formulation of carvedilol compression coated tablets

24. February 2016

Benefits of an Optimal Tabletability DC Mannitol on Compression Setting Parameters

Amorphous – state Characterization and Dissolution Behaviour of Efavirenz – Tocopheryl Polyethylene Glycol Succinate (TPGS)-1000 Solid Dispersions

Enabling superior drug loading in lipid-based formulations with lipophilic salts for a brick dust molecule: Exploration of lipophilic counterions and in vitro-in vivo evaluation

Compression coating technique has been used in formulation of chronotherapeutic drug delivery systems with pulsatile carvedilol release with polyethylene oxide as controlling release agent. FMEA, risk analysis tool, was applied within Quality by Design approach with aim to detect process and formulation parameters affecting the carvedilol release profile from compression coated tablets. It gives Risk Priority Numbers (RPNs) for each failure mode. Also, using experimental designs, statistical significance of the formulation parameters influence was estimated.