Commercial and Process Development of Pharmaceutical New Formulation and Optimization Technologies / 中国药学杂志

ABSTRACT

In order to get fast approval and market access, innovator pharmaceutical companies usually adopt the most mature and relatively simple formulations for their first generation new drug products. This leaves the opportunities for these products to improve their clinical performance, safety profiles and/or patient adherenceby switching to more sophisticated new formulations, which usually happen around the time when the patents for the new drugs expire. This approach may also work for older drugs. On the other hand, the task of new formulation and process development are more challenging forhigh-technology drug products based on, for examples, various controlled release formulations. In this article, the authors give a discussion regarding the thinking behind initiating the endeavor of new-formulation based development project. Based on the principles of Quality-by-Design, the authors also give a review regarding the trend of using experimental design, statistical and chemometric data analysis and multivariate modeling in formulation and process development. By analyzing examples in the literature, the authors try to demonstrate the advantages of designed studies vs. the traditional univariate methods.