- Title
- Development and assessment of a USP Apparatus 3 dissolution test method for sustained-release Nevirapine matrix tablets
- Creator
- Mwila, Chiluba
- Creator
- Khamanga, Sandile M M
- Creator
- Walker, Roderick B
- Subject
- To be catalogued
- Date Issued
- 2016
- Date
- 2016
- Type
- text
- Type
- article
- Identifier
- http://hdl.handle.net/10962/184779
- Identifier
- vital:44271
- Identifier
- xlink:href="https://doi.org/10.14227/dt230316p22"
- Description
- Dissolution testing is a quality control tool used to assess batch-to-batch performance of dosage forms, thereby providing continued assurance of product quality. Analytical methods for the assessment of pharmaceutical product quality must be validated according to regulatory guidelines to ensure that tests are reliable and valid. Agitation rate, mesh pore size, surfactant concentration, and dissolution medium molarity are experimental parameters that may affect nevirapine (NVP) release and were investigated and optimized to ensure that consistent, reliable, and valid results using Apparatus 3 were produced. Agitation rate was investigated to establish an equivalent response to that observed for NVP release using Apparatus 2 at 50 rpm. A reciprocation rate of 5–10 dpm produced dissolution profiles that were similar to those observed using Apparatus 2. An increase in the molarity of the dissolution medium slightly increased the release rate of NVP, and a 50 mM buffer maintained at pH values mimicking gastrointestinal tract (GIT) conditions was selected for all experiments. With the addition of 2% sodium lauryl sulfate (SLS) to the dissolution medium, >80% NVP was released from the tablets over the test period. The NVP release rate increased with an increase in the mesh pore size; however, the extent of release was not affected by this parameter. Dissolution test samples were analyzed using HPLC, and dissolution methods were validated for NVP stability in the dissolution medium, specificity, linearity and range, repeatability, intermediate precision, and accuracy as defined by ICH. The dissolution method used for testing NVP tablets can be regarded as an appropriate tool for the evaluation of sustained-release (SR) NVP formulations and the impact of formulation composition and product quality attributes on drug release.
- Format
- computer
- Format
- online resource
- Format
- application/pdf
- Format
- 1 online resource (9 pages)
- Format
- Publisher
- Dissolution Technologies Inc.
- Language
- English
- Relation
- Dissolution Technologies
- Relation
- Mwila, C., Khamanga, S.M. and Walker, R.B., 2016. Development and assessment of a USP Apparatus 3 dissolution test method for sustained-release Nevirapine matrix tablets. Dissolution Technologies, 23, pp.22-30
- Relation
- Dissolution Technologies volume 23 p.22 2016 1521-298X
- Rights
- Publisher
- Rights
- Use of this resource is governed by the terms and conditions of the Dissolution Technologies Inc. Publishing Copyright and licensing Statement (http://dissolutiontech.com/DTresour/Pages/Submissionguides.html)
- Rights
- Open Access
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Collections
Walker, Roderick Bryan (Prof)
RU Department of Pharmacy
Khamanga, Sandile S M (Assoc Prof)
| Thumbnail | File | Description | Size | Format | |||
|---|---|---|---|---|---|---|---|
| View Details Download | SOURCE1 | Development and assessment of a USP Apparatus 3 dissolution test method for sustained-release Nevirapine matrix tablets.pdf | 748 KB | Adobe Acrobat PDF | View Details Download |