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

Research output: Contribution to Journal/Magazine › Journal article › peer-review

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A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. / Leane, Michael; Pitt, Kendal; Reynolds, Gavin et al.
In: Pharmaceutical Development and Technology, Vol. 20, No. 1, 01.2015, p. 12-21.

Research output: Contribution to Journal/Magazine › Journal article › peer-review

Harvard

Leane, M, Pitt, K, Reynolds, G & Anwar, J 2015, 'A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms', Pharmaceutical Development and Technology, vol. 20, no. 1, pp. 12-21. https://doi.org/10.3109/10837450.2014.954728

APA

Leane, M., Pitt, K., Reynolds, G., & Anwar, J. (2015). A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology, 20(1), 12-21. https://doi.org/10.3109/10837450.2014.954728

Vancouver

Leane M, Pitt K, Reynolds G, Anwar J. A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology. 2015 Jan;20(1):12-21. doi: 10.3109/10837450.2014.954728

Author

Leane, Michael ; Pitt, Kendal ; Reynolds, Gavin et al. / A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. In: Pharmaceutical Development and Technology. 2015 ; Vol. 20, No. 1. pp. 12-21.

Bibtex

@article{0d781a6f767d4edea804ad69f2ece117,
title = "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 (mcs@apsgb.org); completing the survey on our LinkedIn site; or by attending one of our planned conference roundtable sessions.",
keywords = "Drug product manufacturing processes, oral dosage forms, Pharmaceutical development, quality by design",
author = "Michael Leane and Kendal Pitt and Gavin Reynolds and Jamshed Anwar",
year = "2015",
month = jan,
doi = "10.3109/10837450.2014.954728",
language = "English",
volume = "20",
pages = "12--21",
journal = "Pharmaceutical Development and Technology",
issn = "1083-7450",
publisher = "INFORMA HEALTHCARE",
number = "1",

}

RIS

TY - JOUR

T1 - A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms

AU - Leane, Michael

AU - Pitt, Kendal

AU - Reynolds, Gavin

AU - Anwar, Jamshed

PY - 2015/1

Y1 - 2015/1

N2 - 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.

AB - 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.

KW - Drug product manufacturing processes

KW - oral dosage forms

KW - Pharmaceutical development

KW - quality by design

U2 - 10.3109/10837450.2014.954728

DO - 10.3109/10837450.2014.954728

M3 - Journal article

VL - 20

SP - 12

EP - 21

JO - Pharmaceutical Development and Technology

JF - Pharmaceutical Development and Technology

SN - 1083-7450

IS - 1

ER -