IN-VITRO PHARMACEUTICAL QUALITY CONTROL TESTING: A COMPARITIVE STUDY OF JANAUSHADHI ORAL ANTIDIABETIC DRUGS WITH REPUTED BRANDS AVAILABLE IN INDIA
AbstractThis study evaluates the pharmaceutical quality of metformin tablets, both generic and branded, available in India. Metformin, a primary medication for managing type 2 diabetes was chosen due to its widespread use and critical role in diabetes treatment. Using in-vitro methods compliant with Indian Pharmacopoeia standards, several quality control parameters were assessed, including hardness, friability, disintegration time, dissolution profile, and weight variation. The research addresses a common misconception that branded drugs outperform generics in therapeutic efficacy. It aims to demonstrate that generic drugs, when meeting established pharmacopeial standards, are bioequivalent to their branded counterparts. Tablets were sourced from the market and government supply, and rigorous testing was performed to ensure the consistency of active ingredients and adherence to pharmaceutical standards. Results showed that all tested samples met the required quality benchmarks. Generic tablets exhibited comparable performance in disintegration time, dissolution rate, and other physical and chemical parameters. These findings highlight the safety, efficacy, and interchangeability of generic metformin tablets with branded alternatives. This study underscores the importance of stringent quality control measures to ensure patient safety and drug effectiveness. By validating the bioequivalence of generic drugs, this research supports their use as cost-effective alternatives to branded medications, particularly for resource-limited populations. It further encourages the adoption of generics in healthcare systems, promoting affordability without compromising quality. These findings advocate for the broader acceptance of generics in combating diseases like diabetes, where medication adherence and affordability are critical.
Article Information
25
1388-1395
985 KB
22
English
IJPSR
M. D. Mohammad Yosuf *, A. M. Amulya, C. C. Pratiksha and S. A. Rakesh
Department of Pharmacology, G. M. Institute of Pharmaceutical Sciences and Research, Davanagere, Karnataka, India.
yusufdamani@gmail.com
02 December 2024
28 December 2024
31 December 2024
10.13040/IJPSR.0975-8232.16(5).1388-95
01 May 2025