Abstract:
Metformin, being noteworthy, is used in the management of Type 2 Diabetes. It is
available in different brands in Sri Lanka. Several studies have shown that different brands of the
drug varied qualities, which could impact the treatment efficacy. This study was conducted to
analyse the quantity of different brands of metformin hydrochloride tablets available in the
Jaffna municipal area, Sri Lanka. It was a laboratory-based exploratory study conducted in State
Pharmaceutical Manufacturing Corporation, Sri Lanka. Based on most available brands at
pharmacies in the Jaffna Municipal area, fifteen brands of conventional metformin tablets were
selected for this study. They were coded as M1, M2, M3… M15. The uniformity of weight,
hardness, friability, disintegration, uniformity of content, and dissolution tests were performed in
accordance with the British Pharmacopeia (BP). Two out of fifteen brands were locally
manufactured, and the remaining were imported. All brands were conformed to BP specifications
in uniformity of weight. The hardness test showed optimum withstanding strength in all brands.
All brands excluding M1 (108.95%), M6 (111.58%), M7 (94.27%) and M11 (93.91%) were
comprised of values falling under monograph specifications (95% -105%) for uniformity of
content. Twelve brands satisfied Pharmacopeia requirements in the friability test, while two
brands, M7 (40.45 min) and M10 (34.5 minutes), failed in the disintegration test. The dissolution
of one brand showed the least drug release (61.40%), and the remaining passed the dissolution
test. In conclusion, of all the metformin hydrochloride brands, nine brands passed all the official
tests according to BP specifications.
