ABSTRACT
Consider the fact that the large majority of injectable and ophthalmic drugs are in the solution state, either “ready-to-use” or reconstituted. If not solutions, injectables or ophthalmics exist in a dispersed system state (e.g., suspensions, emulsions, gels) where the drug does not exist in a dry state environment. Therefore, sterile drugs are much more prone to chemical and physical degradation mechanisms than their oral solid dosage form counterparts. Major degradation mechanisms include hydrolysis, oxidation, and physical deterioration such as protein aggregation and visible particle formation. Other degradation mechanisms include photolysis and compatibility problems with packaging surfaces. Stability issues and stabilization have been covered in previous chapters (8-11). This chapter discusses good manufacturing practice (GMP) requirements for stability studies and submission of stability data for new drug applications or abbreviated new drug applications. Also, good practices for storage and distribution of sterile drug products will be covered.
