PHARMACEUTICAL DEVELOPMENT At Propharmex, pharmaceutical development is a logical, data-driven process, where the formulation strategy is the result of an analysis of the physiochemical characteristics of the API, Critical Quality Attributes(CQA) and Quality Target Product Profile (QTPP) A thorough understanding of the challenges faced during pharmaceutical development of various drug candidates, different dosage forms and delivery systems. The specific challenges, such as solubility enhancement, bio availability enhancement, release control and targeted delivery, controlled release, taste masking of impalatable drugs. Scale up and trouble free commercialization of the product developed. Time and cost being the most important aspects of generic market, we always aim for a cost effective and timely development of the generic products.
Brief execution steps of the formulation strategy: Pre-formulation solubility and stability evaluations Comprehensive excipient screening Prototype development Formulation optimization and finalization Process selection and optimization Biostrategy note Supporting documentation technical data package