Formulation and evaluation of diazepam hydrogel for rectal administration

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Pediatric Pharmacology

Background:

• Diazepam (DZP) is a key medication for managing acute repetitive epileptic seizures and febrile convulsions in children.
• Rectal administration offers advantages for drug delivery, particularly in pediatric populations.

Purpose of the Study:

• To formulate and evaluate rectal hydrogels containing diazepam (DZP) for pediatric use.
• To assess the physico-chemical properties, antimicrobial efficiency, and microbiological quality of the developed hydrogels.

Main Methods:

• Hydroxypropyl methylcellulose (HPMC) hydrogels were prepared with varying DZP concentrations (2, 4, and 6 mg/mL).
• Physico-chemical parameters (pH, drug content, viscosity), antimicrobial efficacy, and microbiological quality were evaluated.
• High-performance liquid chromatography (HPLC) was used for drug and preservative separation.
• In vitro drug release studies and stability testing at 26°C for four months were conducted.

Main Results:

• The prepared HPMC hydrogels exhibited favorable physico-chemical properties and antimicrobial effectiveness.
• HPLC analysis confirmed satisfactory separation of DZP and preservatives.
• In vitro studies demonstrated complete DZP release within 3 hours.
• Formulations remained stable for four months under ambient conditions.

Conclusions:

• Rectal diazepam hydrogels are a viable and stable drug delivery system for pediatric epilepsy and febrile convulsions.
• The developed hydrogels offer efficient and rapid delivery of diazepam.
• Further clinical evaluation is warranted to confirm efficacy and safety in pediatric patients.