Reproducibility study on the Efficiency of Packaging in Preventing Photolytic Degradation Of Easium® (Diazepam)Tablets

Abstract

This research work was aimed to evaluate the reproducibility of the data that was previously done in order to determine whether the packaging is effective to prevent the photolytic degradation of diazepam which is a photosensitive drug.To conduct the study 800 tablets Easium® from Opsonin Pharma were taken as a sample from the same batch. To determine the photolytic effect, all tablets were exposed 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 Easium® 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 ±0.001g, ±0.0009cm, ±0.2kg 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 34.53%, 7.15%, 27.87%, 31.66%. After the observation of 60 days, it was clearly visible that Easium® (diazepam) is a photosensitive drug.So it can be concluded that the Packaging system of Easium® (diazepam) is not efficient to protect the drug from light. Thus, Opaque packaging should be used for such drugs.