Challenges in parenteral formulation development studies and an evaluation from QbD point of view
Gulay Yelken Demirel
Sanovel Pharmaceuticals, Turkey
: J Pharm Drug Deliv Res
Abstract
Parenteral dosage forms differ from all other pharmaceutical dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body; the skin and mucous membranes. They have many advantages like routes of administration, elimination of first pass effect, better absorption. They can be in a solution, suspension, emulsions, dry powders with freeze drying as well as microcapsules, nanoparticules or microemulsions. But there are some limitations for formulation development studies like drug stability, poor solubility, packaging, controlling the quality of these unique products, sterilization methods, evaluation of parenteral dosage forms issues. So, What are the main formulation development steps for a new parenteral drug products? And what about QbD development approach for parenteral dosage forms? Parenteral dosage forms represent excellent opportunities for life cycle management to the pharmaceutical companies. What about the future of parenteral dosage forms formulations? Sustained release drug delivery, such as depot formulations which are already available at the market, may be a good alternative.
Biography
Gulay Yelken Demirel has a degree in Department of Chemistry from University of Gazi (Ankara, Turkey) followed by a Master’s degree at Medicinal and Pharmaceutical Chemistry (faculty of pharmacy) from same university. She is also a Turkish Patent Attorney. She has nine years experience in R&D department of generic pharmaceutical companies. She worked as formulation scientist at the Pharmaceutical Technology Department of Nobel Pharmaceuticals.
gulayelken@gmail.com
