Peer-Reviewed Journal Details
Mandatory Fields
Leane, M;Pitt, K;Reynolds, G
2015
January
Pharmaceutical Development And Technology
A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms
Validated
Optional Fields
ACTIVE PHARMACEUTICAL INGREDIENT PARTICLE-SIZE CONTENT UNIFORMITY ADHESION BEHAVIOR TRANSFORMATION FORMULATIONS POWDERS BIOAVAILABILITY FLOWABILITY GRANULATION
20
12
21
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 (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.
LONDON
1083-7450
10.3109/10837450.2014.954728
Grant Details