The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms
Open accessAbstract
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.
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The use of bulk density measurements as flowability indicators
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Determination of the tensile strength of elongated tablets
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A review of disintegration mechanisms and measurement techniques
Markl, D., & Zeitler, J. A. (2017) · Pharmaceutical Research · doi:10.1007/s11095-017-2129-z · Cited by 439
Characterisation of pore structures of pharmaceutical tablets: A review
Markl, D., Strobel, A., Schlossnikl, R., Bøtker, J., Bawuah, P., Ridgway, C., Rantanen, J., Rades, T., Gane, P., Peiponen, K.-E., et al. (2018) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2018.01.017 · Cited by 154
Markl, D., Sauerwein, J., Goodwin, D. J., van den Ban, S., & Zeitler, J. A. (2017) · Pharmaceutical Research · doi:10.1007/s11095-017-2108-4 · Cited by 73
Metadata
- Authors
- Leane, M., Pitt, K., Reynolds, G., & The Manufacturing Classification System (MCS) Working Group
- Venue
- Pharmaceutical Development and Technology
- Publisher
- Informa UK Limited
- Published
- 2014-08-27
- Volume
- 20
- Issue
- 1
- Pages
- 12-21
- ISSN
- 1083-7450 (ISSN-L)
- 1097-9867
- OpenAlex
- W2041406898
- Cited by
- 277
- References
- 20
- FWCI
- 6.70
- Type
- journal article
- Language
- en
- Open access
- green
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- Leane, M., Pitt, K., Reynolds, G., & The Manufacturing Classification System (MCS) Working Group. (2015). A proposal for a drug product Manufacturing Classification System (MCS) for oral solid dosage forms. Pharmaceutical Development and Technology. https://doi.org/10.3109/10837450.2014.954728
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
