A COMPARATIVE QUALITATIVE STUDY OF COMMERCIALLY AVAILABLE BRANDS OF LOVASTATIN TABLETS IN MALAYSIA

Lee Xin Huai, *Nabila Perveen and Naeem Hasan Khan

ABSTRACT

Introduction: Lovastatin (LVS) is a commonly prescribed group of statins used to lower cholesterol levels and reduce the risk of cardiovascular diseases (CVD). Despite its widespread use, variations in the quality of different commercial brands can affect their efficacy and patient outcomes. This study aims to evaluate and compare the quality of various LVS tablet brands available in Malaysia. Objectives: The primary objective was to assess the consistency and efficacy of different LVS brands by examining their physical characteristics, disintegration strength, and dissolution rates. Specifically, the study seeks to determine if there are significant variations in weight, diameter, thickness, and drug release profiles among the brands. Method: The study involved a series of evaluations on multiple brands of LVS tablets. Physical tests included measurements of weight, diameter, and thickness. Chemical characterization was conducted using Fourier Transform Infrared (FTIR) spectroscopy. Disintegration tests assessed the time taken for the tablets to break down, while dissolution tests measured the rate and extent of drug release using a USP Type 2 apparatus and UV-visible spectroscopy. Result: The findings revealed significant differences among the brands in terms of physical attributes and drug release profiles. Variations were observed in weight, diameter, and thickness, indicating slight inconsistencies in manufacturing processes. FTIR spectroscopy confirmed the chemical composition of the brands. Disintegration tests showed varying times, with some brands disintegrating faster than others. Dissolution studies highlighted that the drug release rates were not uniform, with some brands demonstrating faster and more complete dissolution compared to others. Conclusion: The study concludes that there are notable disparities in the quality of different LVS brands available in Malaysia. These variations can potentially impact the drug's efficacy and patient outcomes. Therefore, stricter regulatory oversight and quality control measures are recommended to ensure consistency and effectiveness of LVS tablets in the market.

Keywords: Lovastatin, quality assessment, disintegration, dissolution, FTIR spectroscopy, pharmaceutical tablets, Malaysia.