Abstract

EFFECT OF TEMPERATURE AND MOISTURE ON THE PHYSICAL AND CHEMICAL PROPERTIES OF METFORMIN HYDROCHLORIDE TABLETS

M. Maheshwar*

ABSTRACT

Stability is an essential factor of quality, safety, and efficacy of a drug product and drug substance. The objective of this study was to investigate the effect of moisture and temperature on metformin hydrochloride tablets (1000 mg) marketed in India. Three commercial brands (A, B, C) were examined. Tablets were exposed to different storage conditions (RH=75% & 40°C), (RH=75% & 25°C), (RH=60% & 40°C), (RH=60% & 25°C) for six months and storage on shelf for 12 months. Changes in physicochemical properties of tablets were determined by hardness, friability test and drug assay. High humidity and temperature (RH=75% & 40°C) decreased in hardness and drug content of metformin hydrochloride and increased in friability (more than 1%) in all the three studied brands. The second condition also caused the same results, but less than the first condition because of normal temperature. The effect of temperature on stability is less than moisture as we saw in the third condition (RH=60% & 40°C). Physicochemical properties of tablets remained without changes when stored in (RH=60% & 25°C) condition. The storage of tablets on shelf caused changes in hardness, friability, and drug content of tablets according to climatic conditions during the total year.

Keywords: Moisture, temperature, metformin hydrochloride, physicochemical properties, stability.