Comparative in Vitro and in Vivo Bioequivalence Analysis of Some Brands of Film Coated Atorvastatin (A Bcs Class II Compound) Tablets Marketed In Nigeria
Journal Title: Journal of Reports in Pharmaceutical Sciences - Year 2016, Vol 5, Issue 2
Abstract
The study is aimed at assessing the bioequivalence/quality of different brands of atorvastatin calcium 10mg tablets marketed in Nigeria. Physical parameters of the tablets, drug content, dissolution and pharmacokinetics data were assessed. The in vivo bioavailability study was carried out using a single dose randomized two period cross-over designs measuring the concentrations in plasma. Plasma samples before dosing and at various time intervals up to 48 hours after dosing were analysed using High-Performance Liquid Chromatography together with UV detector. Pharmacokinetics parameters (Cmax and AUC) were determined and subjected to statistical analysis. All brands complied with the official specification for uniformity of weight and disintegration time. Assay of atorvastatin tablets revealed that all samples contained atorvastatin calcium as their active ingredient between 91.4-102.1% (w/w) of labelled potency. The dissolution profiles showed inter brand variability. Four brands attained 70% dissolution within 45 minutes, however, at 60 minutes, all the brands released over 80% of the drug. In vivo bioavailability study showed that three out of the four brands were bioequivalent to the innovator brand and can be substituted for each other in their prescription. Chemical equivalence does not indicate bioequivalence and one brand substituted on assumption of chemical equivalence with another brand may not give the desired onset of action and therapeutic effectiveness. Moreover, dissolution test might not be enough for ascertaining bioequivalence of atorvastatin and in vivo tests may be required to ensure the quality of marketed brands of atorvastatin.
DNA Binding Study of Dihydropyrano [3, 4-C] Chromene Derivative by Some Spectroscopic Techniques
This study was designed to examine the interaction of dihydropyranochromene derivative, 2-amino-4-phenyl-5-oxo-4H, 5H-pyrano-[3, 2-c] chromene-3-carbonitrile (4-PC) with calf thymus DNA (ctDNA) by absorption spectroscopy...
Design of Intelligent Polymer of Gelatin-Pnipaam under Gamma Radiation for Cellular Applications
Thermo-sensitive polymers were prepared by graft copolymerization of gelatin with N-Isopropylacrylamide via gamma radiation. Characterization of polymers such as DSC analysis, swelling in different ratios and cell assays...
The Effect of Cis and Trans Vaccenic Acids on Expression of ICAM-1 And VCAM-1 in Human Microvascular Endothelial Cells (HMEC)
Trans-fatty acids (TFA) are known as a risk factor for coronary artery diseases. Trans-11 vaccenic acid [VA; 18:1(n-9)], known as the major trans fatty acid in milk fat, is a positional and geometric isomer of oleic acid...
Evaluation of Cytotoxic Effects of A Dinuclear palladacycle Derivative, Biphosphinic Complex, on Cisplatin-Resistant Ht-29 Cells
Previous studies showed that palladacycle complexes with three phenyl phosphine ligands and piperidine or biphosphinic based palladacycle complexes were cytotoxic on K562, HT29, and Hela cell lines. In the present study,...
The Antiproliferative Effects of Petroleum Ether Extract of Artemisia Aucheri on Human Cancerous Cell Lines
Different species of Artemisia (Asteraceae) have shown to exhibit antitumor activity. The aim of this study was to identify the antiproliferative effect of Artemisia aucheri Boiss (A.aucheri) from Iran on cultured human...