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Abstract

THE EFFECT OF TEMPERATURE AND MOISTURE ON THE PHYSICAL AND CHEMICAL STABILITY OF FUROSEMIDE TABLETS (40 MG) MARKETED IN SYRIA

*Oussama Mansour, Mostafa Isbera, Ghenwa Ismail and Ghazal Mayya

ABSTRACT

Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of this study was to investigate the effect of moisture and temperature on furosemide tablets (40 mg) marketed in Syria. 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 6 months and storage on shelf for 12 months. Changes in physicochemical properties of tablets were determined by hardness, friability tests and assay the content. High humidity and temperature (RH=75% & 40°C) decreased in hardness and content of furosemide tablets(less than 90%) and increased in friability (more than 1%) in all studied brands. 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 content of tablets according to climatic changes during the year.

Keywords: Moisture, temperature, furosemide, physicochemical properties, storage, stability.


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