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