Investigation of the effects of temperature and humidity on yields of a complementary medicine product under regulatory stability conditions
| dc.contributor.author | Singh Dillon | |
| dc.contributor.author | Dube Admire | |
| dc.date.accessioned | 2025-09-09T09:09:39Z | |
| dc.date.available | 2025-09-09T09:09:39Z | |
| dc.date.issued | 2025 | |
| dc.description.abstract | Background: The South African Health Products Regulatory Authority (SAHPRA) mandated that all complementary and alternave medicines (CAM) that were marketed and sold in the South African market be registered with the regulatory authority (RA) or have a submission for registraon under review with the RA by June 2021, starng with submissions for registraon from February 2020(1). The deadline was extended to February 2022. In order to apply for registraon of the CAM and connue markeng the product within the South African market, stability data of the finished pharmaceucal product (FPP) was required(2). The environmental storage condions for which stability data must be generated before registraon was spulated as 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH for 6 months and 40°C ± 2°C/75% RH ± 5% RH for 6 months. Product X is a CAM product that has been manufactured at a South African local pharmaceucal manufacturing company since 2020 and sold in the South African market for more than 3 years. The product uses herbal material encapsulated in a hard gelan capsule (HGC) to deliver its effects. The batch manufacturing records (BMRs) required the recording of the environmental manufacturing temperatures (TME) and relave humidity percentage (RH %) at the me of manufacture of Product X. The percentage yield of capsules manufactured was also calculated and recorded to ensure quality control of the product during manufacture. Problem: There is no formal stability data for the bulk of Product X to support a submission for registraon with SAHPRA as a CAM. The bulk is defined as the material-filled capsules of Product X. The product was not developed using a formal stability program which would have generated the required stability data of environmental storage condions for Product X being subjected to the condions 25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH for 6 months and 40°C ± 2°C/75% RH ± 5% RH for 6 months of during its product development. The final product (FP), which is a product that has undergone all stages of producon excluding packaging(3), of Product X did not have any stability data for the product’s storage under the environmental storage condions as spulated by SAHPRA, hence, there is no certainty as to how the FP would react under the spulated environmental condions. There is no data on the bulk product, which is large quanes of FP prior to packaging, to indicate what effect the TME and % RH condions have on the product during manufacture. The hypothesis, based on available literature, is that high temperatures and high humidity would have a negave impact on the gelan capsules used during Product X’s manufacture, causing cross-linking and swelling. This would cause the capsules to lose stability and become unsuitable for use. | |
| dc.identifier.citation | N/A | |
| dc.identifier.uri | https://hdl.handle.net/10566/20853 | |
| dc.language.iso | en | |
| dc.publisher | University of the Western Cape | |
| dc.relation.ispartofseries | N/A | |
| dc.subject | Complementary Medicine | |
| dc.subject | Capsule | |
| dc.subject | Temperature | |
| dc.subject | Humidity | |
| dc.subject | SAHPRA | |
| dc.title | Investigation of the effects of temperature and humidity on yields of a complementary medicine product under regulatory stability conditions | |
| dc.type | Thesis |