Formulation and Evaluation of Diazepam as a Rectal Preparation

Abstract

Diazepam has become a commonly used drug for treatment of acute repetitive epileptic seizures and febrile convulsions in children. Considering the advantages of rectal administration of diazepam, the objective of this study was to formulate and evaluate rectal hydrogels containing diazepam as a drug substance in combination with suitable co - solvents and preservatives.Prepared HPMC (hydroxypropyl methylcellulose) hydrogels containing different concentrations of diazepam (2, 4 and 6 mg I ml) manifested good quality in respect to physicochemical parameters (pH value, drug content, ingredients content and viscosity), antimicrobial efficiency and microbiological quality. Under the proposed HPLC conditions, satisfactory separation of diazepam and the preservatives used was achieved. In vitro release studies have shown that the total amount ofdiazepam was released in a period of 3 hours. Prepared formulations were stable for four months at 26 C (ambient temperature characteristic of the second climate zone