Comparative assessment of different marketed brands of atorvastatin tablets in Asir region, Saudi Arabia

Abstract

The main purpose of the study is to evaluate the quality of different marketed products of Atorvastatin calcium tablets available in the Middle East in Asir region, Kingdom of saudi Arabia, with a view to determine their interchangeability in clinical practice. Survey of the assessed Atorvastatin brands was carried out in south western cities of Saudi Arabia based on their prices. Drug products’ quality assessment included visual examination for their organoleptic properties; official and non-official quality control tests, dissolution profile, mechanism and kinetics release. The results show that Code A (Liptor TM, European sourced) samples were more expensive than the other samples, it is almost double the price of sample B (Lorvast) and C (Lipomax). All the results of marketed brands pass the tests. Comparison of in vitro drug dissolution profile of all samples shows approximately 90% drug release within 1hr, whereas sample A and C show 100% . The release mechanism and kinetics from the samples A and D (Astatin) are Non-fickian diffusion and 1st order release, sample B and C shows Fickian diffusion and 1st order and peppas release respectively. From these results it was concluded that all samples of Atorvastatin calcium tablets may be interchangeable with other in Asir region.