Browsing by Author "Dube Admire"

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    Investigation of the effects of temperature and humidity on yields of a complementary medicine product under regulatory stability conditions
    (University of the Western Cape, 2025) Singh Dillon; Dube Admire
    Background: The South African Health Products Regulatory Authority (SAHPRA) mandated that all complementary and alterna􀆟ve medicines (CAM) that were marketed and sold in the South African market be registered with the regulatory authority (RA) or have a submission for registra􀆟on under review with the RA by June 2021, star􀆟ng with submissions for registra􀆟on from February 2020(1). The deadline was extended to February 2022. In order to apply for registra􀆟on of the CAM and con􀆟nue marke􀆟ng the product within the South African market, stability data of the finished pharmaceu􀆟cal product (FPP) was required(2). The environmental storage condi􀆟ons for which stability data must be generated before registra􀆟on was s􀆟pulated 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 pharmaceu􀆟cal 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 gela􀆟n capsule (HGC) to deliver its effects. The batch manufacturing records (BMRs) required the recording of the environmental manufacturing temperatures (TME) and rela􀆟ve 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 registra􀆟on 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 condi􀆟ons for Product X being subjected to the condi􀆟ons 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 produc􀆟on excluding packaging(3), of Product X did not have any stability data for the product’s storage under the environmental storage condi􀆟ons as s􀆟pulated by SAHPRA, hence, there is no certainty as to how the FP would react under the s􀆟pulated environmental condi􀆟ons. There is no data on the bulk product, which is large quan􀆟􀆟es of FP prior to packaging, to indicate what effect the TME and % RH condi􀆟ons have on the product during manufacture. The hypothesis, based on available literature, is that high temperatures and high humidity would have a nega􀆟ve impact on the gela􀆟n 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.