Introduction and Overview: This report presents a summary of the pharmaceutical development of acetriptan (“ACE”) tablets. It emphasizes a science and risk-based approach to product and process development, and presents findings as a knowledge-based report. Where relevant, supporting data have been summarized in appropriate tables or illustrations The scientific approach used begins with identification of the desired dosage form and performance attributes through the target product profile. From this target product profile, an initial list of critical quality attributes was developed. A risk assessment was undertaken to identify the variables and unit operations which are most likely t-o impact the critical quality attributes.
This was then used to focus development activities on potential high risk areas. A risk assessment, starting with the physico-chemical characteristics of the API, led to the identification of a viable formulation and manufacturing approach. Formulation development involved the use of prior knowledge and structured experimentation to investigate the relationship between formulation component levels, API attributes and the drug product quality attributes. An interaction between API particle size and magnesium stearate level was demonstrated and acceptable formulation component levels and API particle size ranges were identified. Read more on ACE