Anand Kulkarni
Director, BioDuro- LLC, China
Title: Formulation selection matrix in early clinical formulation
Biography
Biography: Anand Kulkarni
Abstract
The pharmaceutical formulation development of early stage pre-clinical and clinical formulations poses various unique challenges during development. These challenges are mainly related to limited physicochemical data, limited availability of drug substances, uncertainty on dosage ranges, solubilization/ in-vivo exposure challenges, further scalability considerations for clinical manufacturing etc. The presentation covers an opportunity area for formulation selection matrix based on Data Driven Decision (DDD) making during developability assessment and solution engine that can facilitates overall development approach. Over 60% of New Chemical Entities (NCE’s) under development are poorly soluble therefore, it is always challenging to select appropriate development platform. The presentation covers and describes technology selection such as microevaporation, amorphous solid dispersions using spray drying or hot melt extrusion (HME) and few case studies describing the same. Overall, appropriate assessment of early stage data can help to successfully develop formulations within defined timeframe with limited usage of drug substances. These formulations can be further evaluated in animal models or first in human (FIH) clinical studies to understand in-vivo performance followed by phase appropriate scale up.