Dietary supplements, particularly nutraceuticals, are an expanding sector on the South African market, especially since the beginning of the COVID-19 pandemic. However, regulatory authorities do not regulate nutraceuticals and concern arose regarding safety, quality and efficacy of the product reaching the end-user. The aim of the study was to evaluate the pharmaceutical quality, specifically the physical and the in-vitro release properties of two commonly marketed L-lysine products in South Africa. An experimental design was used. Two L-lysine products, a tablet and a capsule, available on the South African market were evaluated for pharmaceutical quality. Tests performed were: Weight variation test, dimensions test, friability test, hardness test, assay, and drug release studies. The quality of products was compared to official USP standards. Tablets were of consistent diameter, length and thickness. Not more than 2 tablets had weights outside the 5% deviation range for each sample. Tablets had an average friability of 17.56%, although their hardness was greater than the acceptable range. All tablets disintegrated within the 15 min. Two out of three samples had amount of lysine below the acceptable range. Tablets sampled released just about 70% of the contained L-lysine by 45 min. Capsules had inconsistent powder weight and contained an amount of L-lysine less than the label claim. Capsules disintegrated within 4 min and released just over 75% of drug by 45 min. There seems to be inconsistences in the characteristics of L-lysine products and their quality cannot be guaranteed. More investigations on other marketed L-lysine products are suggested, to further advice on the necessity of a relook of their quality assurance procedures and labelling.
To some Cannabis is antisocial anathema, to others it is a harmless sedative-hypnotic, or narcotic analgesic and to others it occupies a cultural position as religious sacrament. Some fear its use leads to psychosis and addiction; to others still it is a legal anomaly and should be decriminalized. Whatever the case may be, in Africa where Cannabis is a recreational drug. It is caught in a bizarrely legal and regulatory maze. Regulations are changing internationally and the Cannabis industry is growing. African, National Medicines Regulatory Authorities, NMRs, have to catch up. But unfortunately some lack competent professionals who require to understand regulatory science, RS, in general, and in particular as it pertains to cannabis products with complex pharmacology. RS is "a range of scientific disciplines that are applied -intellectually and practically -to the quality, safety and efficacy assessment of medical products and that inform regulatory decision making, throughout the life cycle of a medical/health product". RS helps to answer the following questions: Is there a pathway that will lead cannabis to mainstream medicine in Africa? Will cannabis as a botanical agent have to follow the same time-honoured process that any pharmaceutical must attain to receive regulatory approval?There is no doubt the cannabis and regulatory sciences are going to influence the future shaping and implementation of pharmaceutical medicine laws and regulations in Africa. The aim of the article is to highlight the key regulatory science challenges, in Africa, that belong to either a societal or a biomedical sphere regarding Cannabis for adult use or medicinal purposes or nutrition.
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