Date of Award
1-1-2024
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Michael A. Repka
Second Advisor
Walter G. Chambliss
Third Advisor
Eman Ashour
Relational Format
dissertation/thesis
Abstract
Clotrimazole is a broad-spectrum antifungal /antimycotic, it is used topically in the treatment of oropharyngeal candidiasis. The oral route is the most preferred route of administration 60% of the conventional dosage forms are available as tablets and capsules. The main objective of the study was to develop and Formulate Clotrimazole oral film to get local effect for treating oropharyngeal candidiasis. Oral films are thin flexible strips which can be placed on the tongue, where it adheres to the surface of the tongue and dissolves releasing the drug into the oral cavity. Here, the films are formulated using hot melt extrusion over conventional method (solvent casting technique), which is a continuous process, where it melts the polymers and disperses the drug homogeneously, without the requirement of any solvents. Films were formulated with a constant drug loading of 10% with varying polymeric concentrations of PEO N-10& HPC-LF. Extruded films were evaluated for strength and bioadhesion. DSC and FTIR analysis were conducted on the excipients, physical mixtures, and HME extruded films to assess the compatibility between the components. In-vitro dissolution studies were performed for the films (USP apparatus V) and marketed lozenges (USP apparatus 2) using 500mL of 0.1N HCL. The quantity of drug release was analyzed using HPLC and the dissolution profiles of the films and the marked 10 mg troches were compared.
Recommended Citation
Kandhuri, Harish, "Formulation and Characterization of Clotrimazole Buccal Films Using Hot Melt Extrusion" (2024). Electronic Theses and Dissertations. 2825.
https://egrove.olemiss.edu/etd/2825