Formulation and evaluation of diazepam hydrogel for rectal administration.
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 degrees C (ambient temperature characteristic of the 2nd climate zone).
Dodov
Marija Glavas
MG
Department of Pharmaceutical Technology Faculty of Pharmacy, University Ss Cyril and Methodious, 1000 Skopje, Macedonia. magl@baba.ff.ukim.edu.mk
Goracinova
Katerina
K
Simonoska
Maja
M
Trajkovic-Jolevska
Suzana
S
Ribarska
Jasmina Tonic
JT
Mitevska
Marija Dastevska
MD
D000285:Administration, Rectal; D000927:Anticonvulsants / Q000008:administration & dosage / Q000737:chemistry*; D003975:Diazepam / Q000008:administration & dosage / Q000737:chemistry*; D004339:Drug Compounding; D004355:Drug Stability; D020100:Hydrogels; D006863:Hydrogen-Ion Concentration; D065347:Hypromellose Derivatives; D008747:Methylcellulose / Q000031:analogs & derivatives / Q000737:chemistry; D012212:Rheology; D012995:Solubility; D014783:Viscosity
D000927:Anticonvulsants; D020100:Hydrogels; D065347:Hypromellose Derivatives; D008747:Methylcellulose; D003975:Diazepam