PHARMACEUTICAL AND HISTOLOGICAL STUDIES OF NEW SOLUBLE DIAZEPAM

Document Type : Original Article

Authors

1 Department of Pharmaceutics, Faculty of Pharmacy, Assiut University, Assiut, Egypt

2 Department of Histology, Faculty of Medicine, Assiut University, Assiut, Egypt

Abstract

Lyophilization technique has been adopted to enhance the aqueous solubility of diazepam. Two hydrophilic polymers namely; polyvinyl pyrrolidone 44000 (PVP) and pluronic F-127 (PF-127) in different ratios were used as the adjuvents in preparing the freeze-dried samples. Of the tested ratios, diazepam: PVP (1:10) and diazepam: PF-127 (1:60) were found to gave the highest solubility of the drug.
The dissolution studies revealed that lyophilized diazepam samples required from 1-3 minutes to dissolve compared to 20 minutes in case of untreated drug.
Histological evaluations were performed after S.C. and I.M. injection into mice. A slight histological changes were induced. Consequently, the prepared lyophilized-diazepam product can be reconstituted with ease using phosphate buffer (pH 7.2) for parenteral administration, as well as it can met the requirement of zydis.