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Published on: June 7, 2015
Baicalein and hydroxypropyl-γ-cyclodextrin complex in poloxamer thermal sensitive hydrogel for vaginal administration
Qiuna Zhou1, Lin Zhong, Xiaohui Wei
1The MOE Key Laboratory for Standardization of Chinese Medicines and the SATCM Key Laboratory for New Resources and Quality Evaluation of Chinese Medicines, Institute of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201210, China.
International Journal of Pharmaceutics
|July 16, 2013
Summary
This study developed a stable baicalein (Ba) thermosensitive hydrogel for vaginal delivery using hydroxypropyl-γ-cyclodextrin (HP-γ-CD). The novel formulation showed promising tissue restoration in animal models, suggesting it could treat cervicitis.
Area of Science:
- Pharmaceutical Sciences
- Biomaterials Engineering
- Drug Delivery Systems
Background:
- Baicalein (Ba) is a natural compound with therapeutic potential but suffers from poor stability and solubility.
- Developing stable and effective drug delivery systems is crucial for utilizing Ba's medicinal properties.
- Vaginal administration offers a targeted and convenient route for treating local conditions like cervicitis.
Purpose of the Study:
- To formulate a chemically and physically stable baicalein (Ba) in situ thermally sensitive hydrogel for vaginal administration.
- To enhance the solubility and stability of Ba by forming an inclusion complex with hydroxypropyl-γ-cyclodextrin (HP-γ-CD).
- To evaluate the therapeutic efficacy of the developed hydrogel formulation in an animal model of cervicitis.
Main Methods:
- Formation of baicalein-hydroxypropyl-γ-cyclodextrin (Ba-HP-γ-CD) inclusion complex.
- Characterization of the complex using SEM, DSC, and XRPD.
- Formulation of a thermosensitive hydrogel using poloxamers (P407, P188), sodium alginate, HPMC, and benzalkonium bromide.
- Evaluation of gelation temperature, drug release kinetics (Peppas equation), and in vivo efficacy in an animal model.
Main Results:
- The Ba-HP-γ-CD complex was successfully formed and characterized.
- A stable thermosensitive hydrogel (P407/Ba-HP-γ-CD/HPMC/P188/benzalkonium bromide at 18/0.96/0.5/4.0/0.02%) with appropriate gelation temperature and drug release profile was developed.
- Drug release followed the Peppas equation, indicating a coupled corrosion-diffusion mechanism with corrosion as the primary release mode.
- The Ba-HP-γ-CD thermosensitive hydrogel demonstrated significant tissue restoration in an animal study.
Conclusions:
- The Ba-HP-γ-CD inclusion complex significantly improved baicalein stability and solubility.
- The developed thermosensitive hydrogel is a viable and effective system for vaginal drug delivery.
- This formulation shows promise as a novel therapeutic agent for cervicitis, evidenced by its tissue-healing capabilities.
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