Abstract

Computer-aided pharmaceutical formulation represents a major change in drug development by using advanced computational tools to optimize formulation and manufacturing processes. These components integrated with experimental design methodologies (factorial and response surface methodologies) allow for the rapid evaluation of a number of variables, which facilitates the evaluation of an entire experimental system, eliminating a substantial number of experimental trials, lowering times and costs compared to traditional experimental practices. In addition, in silico modeling supports and facilitates early-stage development by enabling virtual predictions of compatibility/ stability, which eliminates or minimizes laboratory work, while improving quality assurance. In general, computer-aided formulation promotes reproducibility, innovation, and provides robust validation for design and process.

Key words: Computer-Aided Pharmaceutical Formulation, Drug Development, Computational Tools, Experimental Design, Cost-Effective Manufacturing, Formulation Optimization