Forced degradation studies for Drug Substances and Drug Products- Scientific Considerations
Introduction – Forced degradation or stress testing is commenced to determine specificity when developing stabilityindicating methods, particularly when little information is available about potential degradation products. These studies also provide information about the degradation pathways and degradation products that could form during storage of drug substance and drug products. Forced degradation studies may help facilitate in pharmaceutical development at various stages as well in areas such as formulation development, manufacturing, and packaging, stability studies in which knowledge of chemical behavior can be used to improve a drug product. Objective of forced degradation – 1. Development of the degradation pathways of drug substance and drug products. 2. To identify the chemical characteristics of drug molecules. 3. Structure elucidation the structure of degradation products. 4. To resolve stability-related problems and establishment of the intrinsic stability of a drug substance in the formulation. 5. To generate stability indicating nature of a developed method. 6. More stable formulations are generated by these studies and shelf life of drug products Experimental approach for forced degradation studiesForced degradation is carried out to produce representative samples for developing stability indicating methods for drug substances and drug products. The criteria of selecting stress condition should be depend upon the products decomposition under normal manufacturing, uses condition and storage specifications which are specific and different for each drug substance and drug product. Stress factors