Editor-in-Chief Hatice Kübra Elçioğlu Vice Editors Levent Kabasakal Esra Tatar Online ISSN 2630-6344 Publisher Marmara University Frequency Bimonthly (Six issues / year) Abbreviation J.Res.Pharm. Former Name Marmara Pharmaceutical Journal
Journal of Research in Pharmacy 2024 , Vol 28 , Issue 5
Thermosensitive and mucoadhesive polymer variables affecting development of miconazole nitrate vaginal in situ gelling system
Omar Mohammed ALWAN1,Iman Sabah JAFAR1
1Department of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, Iraq DOI : 10.29228/jrp.825 Miconazole nitrate (MNN) is an efficient local antifungal agent with fungistatic and fungicidal activity used for vaginal candidiasis treatment. This study was aimed to formulate and evaluate MNN vaginal in situ thermosensitive mucoadhesive gel to enhance the residence time and potentiate its activity at the infection site. In situ gel formulas of MNN were formulated by employing the cold method using different concentrations of poloxamer P 407 and P188 alone or in combination as thermosensitive polymers and hydroxypropyl methylcellulose K4M (HPMCK4M), HPMCK15M and gellan gum (GG) as mucoadhesive polymers. The developed formulas were evaluated for different in vitro parameters such as gelation time and temperature, clarity, syrangability, pH, content uniformity, viscosity, bioadhesive force, and drug release profile. The results indicated that there is a direct association between the concentrations of poloxamer 188 with gelation temperature while further incorporation of mucoadhesive polymers caused a reduction in gelation temperature. An inverse relationship was observed between polymer molecular weight and concentration with the drug released and a direct relationship with viscosity and mucoadhesive strength. Formula 2 with 18 % P407, 2 % P188 and 0.6% HPMC K4M was selected as the optimal formula with gelation temperature of (34 ±0.033°C), gelation time (4.90 ± 0.012 min), pH value (6.13±0.05), gel spreadability (4.55± 0.02 cm), drug content (99.1 ±0.13 w/v%), mucoadhesion force (0.3136 N) and drug release of (79.5%) over 12 hours. In conclusions and according to obtained results formula 2 could be considered as a doable substitute to ordinary vaginally administered drug delivery systems. Keywords : In situ gel; mucoadhesion; Miconazole Nitrate; Poloxamers; thermoresponsive
Marmara University