Reproducibility Study of the Packaging Efficiency on Preventing Photolytic Degradation of Evalin®(Diazepam) Tablets

Abstract

This research work was aimed to check the reproducibility of the experiment that was previously done to evaluate the packaging efficiency of a one of the photosensitive drug Diazepam. To conduct the study 700 tablets from Evalin® were taken as a sample from the same batch. To determine the photolytic effect, all tablets were exposed 3 times in various lighting conditions (control, sunlight, normal room light, 25watt & 40watt bulb). Besides this physical parameters were tested for evaluation of color change, weight variation, thickness and hardness of the Evalin® tablets. Physical tests were performed according to the specification of United States Pharmacopeia (USP) and British Pharmacopoeia (BP). The standard deviations for the weight variation, thickness and hardness are respectively ± 0.21, ± 0.14cm, ± 0.47kg and the percent variation of the decreased concentration of the samples for normal lightening condition, 25 watt & 40 watt light exposure and sunlight exposure were found respectively 20.61%, 17.56%, 26.05% & 29.02% After the observation of 60 days, it was clearly visible that the potency of the diazepam decreased gradually in various light conditions like above conditions due to photolytic degradation. So it can be concluded that the transperant packaging system is not efficient so further steps like using opaque packaging system should be done to prevent photolytic degradation.