A Review on Significance of Identifying an Appropriate Solid Form Duringdrug Discovery and Product Development

Abstract

In recent years, solid form screening has become an integral and mandatory part of drug development. Solid form screening typically involves producing and characterizingmaximum possible solid forms of a potential drug candidate. Different types of solid forms for future drug product development includes salt screening, co-crystal screening, crystallization process development, polymorph screening as well as amorphous solid dispersion screening.Screening studies of a solid form is a set of carefully designed experiments that requires use of advanced analytical techniques to collect analytical data followed by a thoughtful data analysis.This solid form screening studies guide an important decision-making of lead solid form whichis likely to play a vital role during the pharmaceutical product development lifecycle. The selection criteria include pharmaceutically relevant properties, such as therapeutic efficacy and processing characteristics as well as role of physicochemical properties (i.e. solubility, dissolution rate, hygroscopicity, physical stability and chemical purity) in drug product development. A selected solid form, if thermodynamically unstable, it may undergo solid form changes upon exposure to environmental conditions such as temperature and relative humidity as well as manufacturing stress during the pharmaceutical unit operations. In thepresent work, fundamentals of solid form screening are discussed, including the experimental screening methodologies as well as characterization and analysis of solid forms. The importance of drug product risk assessment pertaining to the desired solid form are also discussed here.