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Nanoemulsion Loaded with Clotrimazole Based on Rapeseed Oil for Potential Vaginal Application-Development, Initial
Michał Smoleński1, Susanne Muschert2, Dorota Haznar-Garbacz1
1Department of Drug Form Technology, Faculty of Pharmacy, Wroclaw Medical University, Borowska 211A, 50-556 Wroclaw, Poland.
Pharmaceutics
|May 27, 2023
Summary
This study developed a stable clotrimazole (CLT) nanoemulsion for vaginal candidiasis treatment. While promising for drug delivery, further research is needed to optimize dosage and testing methods.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Nanotechnology
Background:
- Vaginal candidiasis (VC) is a prevalent and challenging global health issue.
- Millions of women are affected by VC, necessitating improved treatment options.
Purpose of the Study:
- To prepare and characterize a clotrimazole (CLT) nanoemulsion (NE) for vaginal drug delivery.
- To evaluate the stability and drug release profile of the developed NE.
Main Methods:
- Nanoemulsions were formulated using high-speed and high-pressure homogenization.
- Characterization included droplet size, polydispersity index (PDI), and osmolality.
- Stability was assessed over 28 weeks, and drug release was studied using stationary and dynamic methods (USP apparatus IV).
Main Results:
- Nanoemulsions exhibited an average droplet size of 52-56 nm with a PDI < 0.2.
- The formulations were stable for 28 weeks and met WHO osmolality recommendations.
- Drug release results were inconsistent: stationary method showed up to 27% CLT release in 5 h, while USP apparatus IV showed up to 10%.
Conclusions:
- Clotrimazole nanoemulsions show potential as carriers for vaginal candidiasis treatment.
- Further development of the final dosage form and standardized release testing protocols are required.
