Physical & Chemical Factors of Drug Degradation | Lecture 02 | Physical Pharmacy | Drug Stability

Drug stability and degradation studies are integral parts of drug development. Preformulation studies aim to evaluate the intrinsic stability properties of a drug candidate by deliberate application of stress to cause degradation, and to provide guidance and suggest remedies for further formulation development. This chapter discusses the fundamental concepts of drug chemical stability, common pathways of drug degradation, experimental approaches to studying degradation, physical stability and phase transformations, and application of these concepts and techniques to the assessment of both the chemical and physical stability of pharmaceutical compounds.