Effect of aging on the physico-chemical stability of acetazolamide and phylpropanolamine hydrochloride tablets

ABSTRACT

The effect of ageing on the physicochemical stability of acetazolamide and phenylpropanolamine HCl tablets, directly compressed with Dynasan 114 and 118, was studied. Three temperature levels [25, 40 and 60C] at 75% relative humidity were adopted, either in closed or open containers over a 6-month storage period. The results revealed that the tablets stored in closed containers did not exhibit any significant changes in properties. However, tablets containing Dynasan 114 and stored at 60C were completely deformed after 4 months. All tablets stored at 75% relative humidity showed a significant increase in their weights and decrease in hardness values. The disintegration time and dissolution profiles [t 50%] of acetazolamide tablets containing Dynasan 114 or 118 were not affected by phenylpropanolamine HCl tablets, containing Dynasan 114 or 118, caused a decrease in their disintegration times and t 50%. The drug content and uniformity of weight of both drug content and uniformity of weight of both tablets were not affected in all formulations under the tested storage conditions