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Abstract

Behaviour Of Marketed Packaged Formulations Under Accelerated Conditions Of Temperature And Humidity In The Absence And The Presence Of Light

Author(s): Ashwani Gaur, H Bhutani, T. T Mariappan, S Singh

The authors tested 27 formulations, picked up randomly from local market under WHO and ICH prescribed accelerated stability test conditions of 40°/75% RH for 3 months in the presence and the absence of light. In several formulations, the physical changes were stronger in light than in dark, though examples existed where results were similar in the two conditions. Under light, both primary and secondary packaging was affected, and fading of container color and the print fading were the common problems. Even formulations within the packs were affected in some cases, and the changes were in the form of gain of moisture and loss of integrity in case of effervescent tablets, color fading of capsules in blisters, sticking of capsules in a glass bottle and spread of powder within strip pockets. There were other changes, that include softening of suppositories; change in viscosity of a gel, jelly, cream and ointment; melting of lozenges and phase separation of emulsions, but these were among those expected to occur normally under accelerated storage conditions.