[Preparation and physicochemical evaluation of diazepam suppository in infantile febrile seizures]

Introduction and Objective: febrile seizures are the most common form of convulsions in childhood. Rectal diazepam in solution is very suitable for acute treatment of febrile convulsions. Furthermore, diazepam suppositories are used prophylactically. The aims of this study were to prepare a suitable and efficient formulation of diazepam suppository and to elucidate the influence of suppository base on dissolution rate using various techniques

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Materials and Methods: suppositories containing diazepam [5 mg] were manufactured with Witepsol H35, PEG300 plus PEG4000, PEG1000 plus PEG4000 and PEG1000 plus PEG6000, by the fusion method. Physical characteristics of suppositories such as weight variation, liquefaction time, mechanical strength, content uniformity and percent of drug released were studied and compared to a brand of diazepam suppository. Dissolution testing was done by three methods: the USP basket, paddle and dialysis cell

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Results: the results showed that the release of drug from PEG1000+4000, PEG1000+6000 and Witepsol H35 is greater than PEG300+4000 and brand one. In dialysis cell method drug was released slower than the paddle and basket methods

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Conclusions: it was recognized that a dissolution testing method would be useful in both formulation design and also in quality procedures relating to the products