Biography:
Dr. Yogeshwar Bachhav is associated with AiCuris Anti-infective Cures GmbH Wuppertal (Germany) for around 9 years. AiCuris (name derived from 'anti-infective cures') is focused exclusively on the discovery, research and development of novel antiviral and antibacterial drugs.
Yogeshwar has around 16 years of experience in Pharmaceutical development (CMC) of poorly soluble/stable drugs for oral, parenteral and topical route from the start-up and mid-size Pharmaceutical companies in Europe. In his current role at AiCuris, he is responsible for the outsourcing of drug product for preclinical and clinical trials up to phase II. His experience involves both in house and external Pharmaceutical development of poorly soluble/labile APIs for oral parenteral and topical route.
Abstract:
The present talk will focus on the CQAs of parenteral formulations including but not limited to pH, osmolality, drug load, absence of excipients with irritation potential, absence of precipitation upon injection. Other alternative options to develop parenteral formulations of poorly soluble drugs or difficult to formulate drugs such as Cyclodextrins (Captisol, HPBCD), Liposomes, Mixed micelles/miceller solutions (use of surfactants), Intralipid emulsion, Nanosuspension will also be discussed. Author will also present some case studies involving difficulty in formulating parenteral formulation od complex compounds such as potent/cytotoxic drugs (case studies) e.g. anticancer drugs and Penicillin or cephalosporin type of compounds.