Stability studies were undertaken at ambient (25ºC/60%RH) and accelerated conditions (40ºC/75%RH) to determine the effect of changing of hard gelatin capsule supplier on a phenytoin sodium (100 mg) capsule formulation. Three hard gelatin capsule suppliers: RP Scherer (Supplier A), Capsugel (supplier B) and Associated Caps (Supplier C) were used in the study. Capsules were analyzed just after filling of the capsules (T0), after 1 month (T1), after 2 months (T2) and after 3 months (T3) after being stored in securitainers under the above-mentioned conditions. The moisture content of the empty shells as well as the capsule contents were analysed at each time-point. The capsule disintegration time was recorded at each time point. Multi-point dissolution testing was performed at each time point to determine the release of the active substance in each case. Based on the achieved results, the best capsule shell supplier was recommended, and other suggestions were made to improve the capsule formulation.
| Identifer | oai:union.ndltd.org:netd.ac.za/oai:union.ndltd.org:nmmu/vital:10984 |
| Date | January 2004 |
| Creators | Marx, Amor |
| Publisher | Port Elizabeth Technikon, Faculty of Science |
| Source Sets | South African National ETD Portal |
| Language | English |
| Detected Language | English |
| Type | Thesis, Masters, MTech (Chemistry) |
| Format | 63 pages, pdf |
| Rights | Nelson Mandela Metropolitan University |
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