An investigation on physical quality control parameters of dietary supplements tablets commercially available on the Kingdom of Saudi Arabia

Summary: The goal of this study was to investigate the physical quality control parameters of dietary supplements tablets commercially available on the Kingdom of Saudi Arabia by using weight variation, friability and disintegration tests. The impact of immersion medium pH and the use of disk during disintegration test of dietary supplements as well as a price comparison with respect to quality were investigated. All products were found to fulfill the USP >2091< weight variation and >1216< friability tests of dietary supplements. Results for disintegration test by using phosphate buffer or distilled water without disk showed that nine of seventeen tablets did not disintegrate within 30 minutes. Wile by using 0.1 HCl pH = 1.1 without disk 6 of seventeen tablets did not disintegrate. In all disintegration tests with different immersion medium in which disk has been used, only one of seventeen tablets did not disintegrate. The results of the disintegration study indicated that pH of immersion medium as well as the use of disk in the observation cylinder has an important impact on the ability of products to pass the disintegration test. Price comparison showed that product with higher price is not necessary to be the best. Some products with low price were shown rapid disintegration in different pH and they have higher number of tablets, vitamins and minerals in each container than other more expensive products that did not pass the disintegration test. Industrial relevance: Content uniformity requirement for drug product is an acknowledgment of the existence of a well-defined dose-response curve and, thus, dosing intervals, such a requirement is not possible for multivitamin-mineral combination products used as nutritional supplements. Alternatively, weight variation, friability and disintegration tests could be used to ensure that the product was indeed manufactured under good manufacturing practices.