Title: Application of design of experiments to pharmaceutical formulation development

Authors: Richard Hwang, Robert M. Noack

Addresses: World Wide Pharmaceutical Sciences, Pfizer Global Research and Development, Groton, CT 06340, USA. ' World Wide Pharmaceutical Sciences, Pfizer Global Research and Development, Groton, CT 06340, USA

Abstract: The pharmaceutical industry has come under immense pressure from shareholders and consumers to continuously improve product quality, reduce manufacturing costs and increase speed to develop new medicines. One area that impacts all of these quality, cost, and speed attributes is formulation development. The formulation of a pharmaceutical product includes the active pharmaceutical ingredient (API) and inactive ingredients that enable manufacturability and help the medicine achieve its effectiveness. Formulation scientists need to develop robust formulations while meeting aggressive timelines with limited amount of API. In order to achieve these challenging goals, formulation scientists must utilise proper experimental designs to develop formulations effectively. This article will provide a background on the formulation development process and explore one approach to use design of experiments (DOE) in the development of a tablet formulation. When the formulation and manufacturing process of a pharmaceutical product are optimised by a systematic approach using DOE, the product quality and cost can be effectively optimised.

Keywords: formulation development; pharmaceutical tablets; design of experiments; DOE; tablet formulation; product quality; product costs; manufacturing costs; experimental design.

DOI: 10.1504/IJEDPO.2011.038051

International Journal of Experimental Design and Process Optimisation, 2011 Vol.2 No.1, pp.58 - 65

Available online: 14 Jan 2011 *

Full-text access for editors Access for subscribers Purchase this article Comment on this article