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
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