Tobyn, M, Ferreira, AP, Lightfoot, J et al. (5 more authors) (2018) Multivariate analysis as a method to understand variability in a complex excipient, and its contribution to formulation performance. Pharmaceutical Development and Technology, 23 (10). pp. 1146-1155. ISSN 1083-7450
Abstract
A key part of the Risk Assessment of excipients is to understand how raw material variability could (or does) contribute to differences in performance of the drug product. Here we demonstrate an approach which achieves the necessary understanding for a complex, functional, excipient. Multivariate analysis (MVA) of the certificates of analysis of an ethylcellulose aqueous dispersion (Surelease) formulation revealed low overall variability of the properties of the systems. Review of the scores plot to highlight batches manufactured using the same ethylcellulose raw material in the formulation, indicated that these batches tend to be more closely related than other randomly selected batches. This variability could result in potential differences in the quality of drug product lots made from these batches. Manufacture of a model drug product from Surelease batches coated using different lots of starting material revealed small differences in the release of a model drug, which could be detected by certain model dependent dissolution modelling techniques, but they were not observed when using model-independent techniques. This illustrates that the techniques are suitable for detecting and understanding excipient variability, but that, in this case, the product was still robust.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | (c) 2018 Informa UK Limited, trading as Taylor & Francis Group. This is an Accepted Manuscript of an article published by Taylor & Francis in Pharmaceutical Development and Technology on 10 Oct 2018, available online: https://doi.org/10.1080/10837450.2018.1534862. |
Keywords: | Controlled release; Multivariate analysis; Formulation; Ethylcellulose |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Engineering & Physical Sciences (Leeds) > School of Chemical & Process Engineering (Leeds) |
Depositing User: | Symplectic Publications |
Date Deposited: | 16 Oct 2018 09:58 |
Last Modified: | 10 Oct 2019 00:38 |
Status: | Published |
Publisher: | Taylor & Francis |
Identification Number: | 10.1080/10837450.2018.1534862 |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:137138 |