Date of Award
1-1-2024
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Soumyajit Majumdar
Second Advisor
Michael Repka
Third Advisor
Mohammed Maniruzzaman
Relational Format
dissertation/thesis
Abstract
Fingolimod (FTY) is a sphingosine-1-phosphate receptor agonist and an inhibitor of ceramide synthase, reducing cellular ceramide levels and mitigating photoreceptor degeneration. The current research focuses on enhancing the stability of a previously reported FTY nanoemulsion (FTY-NE) topical (eyedrop) ophthalmic formulation. However, FTY undergoes oxidative and base mediated hydrolytic degradation, and the previously reported formulation, although effective, failed within 90 days storage at room temperature. This study explores various approaches, such as addition of buffer, cosolvents, steric stabilizer, viscosity enhancer, emulsifying agent, and a chelating agent in the NE system to increase shelf-life. The FTY-NE formulations (0.3% drug load) were prepared with the homogenization method, using soybean oil as the lipid, and Tween® 80 and Poloxamer 188 as surfactants. The effect of formulation pH on the stability of FTY was also evaluated. FTY-NE was characterized with respect to particle size, zeta potential (ZP), Polydispersity Index (PDI) and content. Lead FTY-NE formulation had a globule size, PDI, ZP and assay of 166.2±0.2 nm, 0.27±0.2, 40.4±0.2 mV and 92.66 ± 0.29 %, respectively. The formulation was physically and chemically stable for 90 days, last time point checked, at 4°C, 25°C and 40°C storage conditions, respectively. Thus, a stable FTY-NE formulation has been developed, offering a promising topical treatment avenue for retinal degenerative conditions.
Recommended Citation
Naik, Mekhala Sharad, "Stabilized Fingolimod Nanoemulsion Ophthalmic Formulation for the Treatment of Retinal Degeneration" (2024). Electronic Theses and Dissertations. 2850.
https://egrove.olemiss.edu/etd/2850