Original Articles
Rashmi Dahima, Amit Gupta and
Abstract
The main aim of the present study was to develop a robust and stable immediate release tablet formulation of Hydralazine hydrochloride using quality by design (QbD) approach. Critical material attributes and critical process parameters were identified and linked to the critical quality attributes (CQA’s) of the drug product/formulation. Experimental trials were designed using factorial design technique with considering critical material attributes (CMA’s) and critical process attributes (CPP’s). Physicochemical characterization and drug excipient compatibility studies were performed. Flow characteristics and compressibility of blend material were tested before tablets were compressed by direct compression method. Weight variation, diameter, thickness, hardness, %friability, disintegration time of compressed tablets were evaluated for physical characterization. Design space was identified and risk factors mitigated after the implementation of control strategy