Date of Award
1-1-2023
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Michael A. Repka
Second Advisor
Dr. Walter Chambliss
Third Advisor
Eman Ashour
School
University of Mississippi
Relational Format
dissertation/thesis
Abstract
Vaginal Candidiasis (VC) is one of the most common health problems in women. Indeed, one of the most convenient approaches for its treatment is an appropriate mucoadhesive vaginal film. This approach provides a local treatment modality, which inevitably decreases the dosing frequency and improves patient compliance. Clotrimazole is one of the drugs that are extensively used to treat Vaginal candidiasis and therefore, it is used in this research. The current study aimed to produce a novel extended-release film using Hot-Melt Extrusion (HME). Two different polyethylene oxide (PEO) polymer grades (PEO N10, PEO N750) were utilized to optimize the drug release from the films. The bioadhesion film study using porcine vaginal tissue indicated the films had reasonable adhesiveness. The vaginal films demonstrated appropriate mechanical properties in terms of strength and stiffness. The DSC results indicate Clotrimazole was dispersed in the polymer used since the characteristic endothermic peak was absent in all the formulations investigated. Further, the FTIR results revealed no interaction between the API and the excipients. The cumulative in vitro release data indicated that the extruded films released Clotrimazole up to 80% in 5 hours. HME successfully produced a patient-centric and Clotrimazole immediate and sustained-release vaginal film with a longer dosing interval.
Recommended Citation
Sawant, Kirti Pradeep, "Experimental Studies on Developing and Characterising Vaginal Films Using Hot-Melt Extrusion Technology" (2023). Electronic Theses and Dissertations. 2576.
https://egrove.olemiss.edu/etd/2576