A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

Abstract

This paper proposes the development of a drug product Manufacturing Classification System (MCS) based on processing route. It summarizes conclusions from a dedicated APS conference and subsequent discussion within APS focus groups and the MCS working party. The MCS is intended as a tool for pharmaceutical scientists to rank the feasibility of different processing routes for the manufacture of oral solid dosage forms, based on selected properties of the API and the needs of the formulation. It has many applications in pharmaceutical development, in particular, it will provide a common understanding of risk by defining what the “right particles” are, enable the selection of the best process, and aid subsequent transfer to manufacturing. The ultimate aim is one of prediction of product developability and processability based upon previous experience.

This paper is intended to stimulate contribution from a broad range of stakeholders to develop the MCS concept further and apply it to practice. In particular, opinions are sought on what API properties are important when selecting or modifying materials to enable an efficient and robust pharmaceutical manufacturing process. Feedback can be given by replying to our dedicated e-mail address ([email protected]); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.

• Drug product manufacturing processes
• oral solid dosage forms
• pharmaceutical development
• quality by design
• robustness

Acknowledgements

The authors would like to acknowledge the contribution to this paper from the delegates to the Mat Sci/PEFDM seminar: BCS to MCS: “Predictions From Material Science to Manufacturing”, EMCC, Nottingham, May 2013. The authors would also like to thank Linda Hakes and Bruno Hancock for their helpful comments.

Declaration of interest

The authors report no declarations of interest.