Date of Award

2026

Document Type

Thesis

Degree Name

MS in Pharmaceutical Science

Department

Pharmaceutical Sciences

First Advisor

Ketankumar Patel

Second Advisor

Abu Serajuddin

Third Advisor

Jeanette Perron

Abstract

Clostridioides difficile is a gram-positive, anaerobic, spore-forming bacterium, responsible for nearly 20,000 pediatric cases annually in the United States. Fidaxomicin (FDX), a narrow-spectrum macrocyclic antibiotic, recently received FDA approval for the treatment of C. difficile -associated diarrhea (CDAD) in children aged 6 months and older. Very low aqueous solubility (< 8 µg/mL) and acid-mediated hydrolysis often result in poor efficacy. To address these pharmaceutical challenges, this study aimed to develop a self-nanoemulsifying drug delivery system (SNEDDS) of fidaxomicin (FDX-SNEDDS) using excipients safe for pediatric patients. FDX-loaded SNEDDS were prepared using clove oil as the primary solubilizer to enhance drug loading and achieve synergistic antibacterial activity. The concentrations of FDX, clove oil, docosahexaenoic acid (DHA), and a vitamin E-based nonionic surfactant were optimized to achieve the desired particle size, stability, and dissolution profile. Capsule materials and dry carriers were screened to develop the final dosage form. The optimized formulation with a clove oil: DHA: surfactant ratio of 1:1:4 spontaneously formed nanoglobules with diameters < 160 nm. A rapidly solubilizing formulation of FDX is promising for eliminating C. difficile and its associated toxins in pediatric patients.

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