Research Journal of Pharmacy and Technology

SCOPUS
  • Year: 2025
  • Volume: 18
  • Issue: 9

Central Composite Design Augmented Quality-by-Design-Based Formulation of Ondansetron HCL Microemulsion Embedded Oral Thin Film

  • Author:
  • K. Karan Lokhande, P. Dhanashree Sanap*, R. Kisan Jadhav
  • Total Page Count: 10
  • Published Online: Dec 19, 2025
  • Page Number: 4297 to 4306

Bharati Vidyapeeth’s College of Pharmacy, Sector-8, CBD Belapur, Navi Mumbai400614, Maharashtra, India

Abstract

The present study aimed to develop an ondansetron microemulsion and incorporate it into an oral thin film. In the design of experiments, a central composite design was utilized to optimize the formulations, focusing on the concentrations of hydroxypropyl methylcellulose (HPMC K15) (X1) and HPMC K4 (X2) as independent variables. The optimized batch designated as FB-1, exhibited a drug content of 101±0.5%, a film weight of 49.8±0.8mg, a minimum disintegration time of 47±0.05 seconds, a thickness of 0.12±0.2mm, and a pH of 6.8±0.05, along with desirable mechanical properties, including a tensile strength of 150g/cm2. Characterization of the optimized film includes FTIR, DSC for drug interaction, SEM for morphology, and evaluations of in vitro drug release and ondansetron loading effectiveness. The optimized batch exhibited a remarkable drug release profile, achieving approximately 88.83% release at the 5 min mark. This rapid dissolution continued, surpassing 95 % within the first 10 min, demonstrating the highest dissolution rate observed. The developed ME-loaded OTFs significantly enhanced drug release compared to the marketed film Vomikind-Fast strip 4mg (Mankind Pharma) showed a 64% release at 5 min and 65% at 10min, while Emefilm 4mg (Delvin Formulations) had a release rate of 64% at 5 min and 68% at 10min. By improving the solubility and bioavailability of ondansetron, this microemulsion-embedded film technology offers a dosage form that is both easy to administer and improves compliance among patients.

Keywords

Microemulsion, Oral Thin Film, Ondansetron HCl, In Vitro Study, Design of Experiments (DoE), Central composite design