A Pilot Study on Comparative Evaluation of Pharmaceutical Quality and Plasma Drug Concentration of Branded and Janaushadhi Formulations of Atorvastatin and Losartan Tablets

Abstract

Background: Affordable access to essential medicines being a major challenge in low- and middle-income countries, India has introduced affordable generics named Janaushadhi. Although branded formulations dominate the market, cost-effective alternatives while improving accessibility, raises concerns of quality and clinical performance among healthcare professionals and patients. Objectives: To compare the pharmaceutical quality attributes and exploratory plasma drug levels of branded and Janaushadhi formulations of atorvastatin (10 mg) and losartan (50 mg). Materials and Methods: This pilot, observational study evaluated pharmaceutical equivalence using standard pharmacopeial quality control tests and High-Performance Liquid Chromatography (HPLC). Parameters assessed included general appearance, weight variation, hardness, friability, disintegration, dissolution, and content uniformity. Additionally, plasma drug concentrations were measured in patients receiving either branded or Janaushadhi formulations. Results: Both branded and Jan Aushadhi tablets complied with pharmacopeial standards for all tested quality parameters. Parameters such as general appearance, weight variation, hardness, friability, disintegration, dissolution, and content uniformity were comparable between the two groups. At 30 min, the dissolution rate of atorvastatin was 76.26% (branded) versus 77.17% (Janaushadhi), while losartan showed 78.41% versus 79%, respectively. Assay values for both formulations were within acceptable limits. Mean plasma concentrations were also comparable, with atorvastatin showing 45.73 μg/mL (branded) versus 43.6 μg/mL (Jan Aushadhi), and losartan showing 32.73 μg/mL versus 36.84 μg/mL. Notably, Jan Aushadhi formulations were substantially more cost effective. Conclusion: The findings indicate comparable in vitro pharmaceutical quality between branded and Janaushadhi formulations. Observed plasma concentration data suggest similar drug exposure trends; however, these findings are exploratory and require confirmation through well-controlled pharmacokinetic and bioequivalence studies.