Compact Crystallization, Filtration, and Drying for the Production of Active Pharmaceutical Ingredients

Abstract

With the growing problem of drug shortages worldwide, a solution could be a centralized compact pharmaceutical manufacturing platform that produces API and finished drug product. In this paper, the development of a combined crystallization, hybrid filtration-drying-dissolution apparatus to be used in such a compact platform is discussed. Experiments were conducted to evaluate each unit operation. Crystallization experiments using a conventional stirred tank and the newly designed scraped surface crystallizer demonstrated the advantages of the new design in terms of crystallization rates, yields and the ease of automation. Postcrystallization operations were operated stepwise using the custom hybrid device that delivered satisfactory results for each operation, e.g. after filtration, Fluoxetine HCl was dried in less than 20 min, with 99% yield after dissolution in the liquid excipient.