Acta Pharm. 55 (2005) 251-261

Formulation and evaluation of diazepam hydrogel for rectal administration

MARIJA GLAVAS DODOV^1*, KATERINA GORACINOVA¹, MAJA SIMONOSKA¹, SUZANA TRAJKOVIC-JOLEVSKA²,
JASMINA TONIC RIBARSKA ²and MARIJA DASTEVSKA MITEVSKA¹

magl@baba.ff.ukim.edu.mk

¹Department of Pharmaceutical Technology, Faculty of Pharmacy, University "Ss Cyril and Methodious", 1000 Skopje, Macedonia
²Department of Quality Control, Faculty of Pharmacy, University "Ss Cyril and Methodious", 1000 Skopje, Macedonia

Diazepam (DZP) 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 DZP, the objective of our study was to formulate and evaluate rectal hydrogels containing DZP as a drug substance in combination with suitable co-solvents and preservatives. Prepared HPMC (hydroxypropyl methylcellulose) hydrogels containing different concentrations of DZP (2, 4 and 6 mg mL^-1) manifested good quality in respect to physico-chemical parameters (pH value, drug content, ingredients content and viscosity), antimicrobial efficiency and microbiological quality. Under the proposed HPLC conditions, satisfactory separation of DZP and the preservatives used was achieved. In vitro release studies have shown that the total amount of DZP was released in a period of 3 h. Prepared formulations were stable for four months at 26 ^oC (ambient temperature characteristic of the 2nd climate zone).

Keywords:, diazepam, HPMC hydrogel, rectal administration, HPLC determination, stability