eprintid: 1461695
rev_number: 24
eprint_status: archive
userid: 608
dir: disk0/01/46/16/95
datestamp: 2015-02-10 06:51:37
lastmod: 2021-09-26 22:38:40
status_changed: 2015-02-10 06:51:37
type: article
metadata_visibility: show
item_issues_count: 0
creators_name: Leane, M
creators_name: Pitt, K
creators_name: Reynolds, G
title: A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms
ispublished: pub
divisions: UCL
divisions: B02
divisions: C08
divisions: D10
divisions: G08
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 (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.
date: 2015-01
official_url: http://dx.doi.org/10.3109/10837450.2014.954728
vfaculties: VFLS
oa_status: green
full_text_type: other
language: eng
primo: open
primo_central: open_green
verified: verified_manual
elements_source: crossref
elements_id: 1011021
doi: 10.3109/10837450.2014.954728
lyricists_name: Gaisford, Simon
lyricists_id: SGAIS88
full_text_status: public
publication: Pharmaceutical Development and Technology
volume: 20
number: 1
pagerange: 12 - 21
issn: 1083-7450
citation:        Leane, M;    Pitt, K;    Reynolds, G;      (2015)    A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms.                   Pharmaceutical Development and Technology , 20  (1)   12 - 21.    10.3109/10837450.2014.954728 <https://doi.org/10.3109/10837450.2014.954728>.       Green open access   
 
document_url: https://discovery.ucl.ac.uk/id/eprint/1461695/1/Gaisford%20MCS%20proof.pdf