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Mucoadhesive, thermosensitive, prolonged-release vaginal gel for clotrimazole:beta-cyclodextrin complex
Erem Bilensoy1, M Abdur Rouf, Imran Vural
1Hacettepe University, Faculty of Pharmacy, Department of Pharmaceutical Technology, 06100 Ankara/Turkey. eremino@hacettepe.edu.tr
This study developed a novel clotrimazole vaginal gel using beta-cyclodextrin complexation for enhanced solubility and controlled release. The optimized thermosensitive, mucoadhesive formulation improves therapeutic efficacy for vaginitis treatment.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Polymer Science
Background:
- Vaginitis treatment requires improved therapeutic efficacy and patient compliance.
- Current formulations may face challenges with drug solubility and sustained release.
- Thermosensitive and mucoadhesive gels offer potential for improved vaginal drug delivery.
Purpose of the Study:
- To formulate and characterize a clotrimazole vaginal gel with enhanced therapeutic properties.
- To improve clotrimazole aqueous solubility and achieve controlled, prolonged release.
- To develop a thermosensitive and mucoadhesive formulation for vaginitis treatment.
Main Methods:
- Clotrimazole was complexed with beta-cyclodextrin to enhance aqueous solubility.
- Formulation involved thermosensitive Pluronic F127 and mucoadhesive polymers (Carbopol 934, HPMC).
- Characterization included spectroscopic, thermal, morphological, and rheological analyses; in vitro release studies were performed.
Main Results:
- Beta-cyclodextrin complexation successfully increased clotrimazole solubility and slowed its release.
- Carbopol 934 showed interaction with beta-cyclodextrin, causing precipitation.
- Thermosensitive in situ gelling was achieved with the drug:cyclodextrin complex formulation.
Conclusions:
- An optimized clotrimazole:beta-cyclodextrin (1%) vaginal gel with HPMC (0.2%) in Pluronic F127 (20%) provides controlled, prolonged release.
- This formulation demonstrates potential for improved therapeutic efficacy and patient compliance in vaginitis treatment.
- The developed gel is thermosensitive and mucoadhesive, ensuring sustained drug release above minimum inhibitory concentrations.
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