Most of the drugs used in modern medicine are organic molecules, which have, apart from their pharmacological properties, diverse physical and chemical properties. The utility of a drug depends on the availability of the active molecule in blood circulation for curing or controlling the disease. Due to various factors including the structure of the molecule, the formulation the packing and environmental factors these molecules undergo decomposition and degradation over time.
To determine the period over which the degradation will lead to reduction in the availability of the drug to levels below what is required, studies are conducted under what are called accelerated stability tests.
These tests simulate the long term effects of these factors on the stability of the active drug and the formulation in acute experiments lasting up to 45 days at temperatures of 45 degrees or more and humidity of 70 per cent or more. From the correlative data available, it is possible to predict the stability of the drug over long periods of even up to five years.
Courtesy : The Hindu
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