Rahamatullah Shaikh pictured with Dr Denise Croker, SSPC GM
Congratulations to SSPC researchers on their contribution to the Process Systems Engineering for Pharmaceutical Manufacturing, 41st volume. The focus of this chapter provides insight into each aspect of oral solid dosage development including pre formulation, drug product development and manufacturing. Rahamatullah Shaikh, PMTC, Donald P O Brien, DPTC, Denise M. Croker & Gavin M. Walker, SPPC.
Rahamatullah Shaikh, Donald P O Brien, Denise M. Croker & Gavin M. Walker, The Development of a Pharmaceutical Oral Solid Dosage Forms (Chapter 2). In: Ravendra. S, Yuanzhi. H eds. Computer Aided Chemical Engineering. vol. 41. p 27-65, New York: Elsevier, March 2018.
Among the various drug delivery routes, the oral route has long been the most popular and convenient route. In this chapter, we focus on the development of oral solid dosage forms including preformulation, drug product development, and manufacturing. Preformulation addresses the impact of physicochemical characteristics of the API and excipients on the goal of designing the optimum formulation. Formulation development outlines the key aspects of the different methods used for tablet production. Further development of the manufacturing process focuses on the process system engineering applied to unit operation design (process development and manufacturing of tablet formulation) and how particular unit operations can be optimized to drive down the cost and increase process robustness.