Enhancement of Solubility and Formulation of Fast Dissolving Oral Films of an Antiemetic Drug

Abstract

This study investigates the development of a fast-dissolving oral film formulation (F3) for efficient delivery of Astemizole, an antiemetic drug. The formulation incorporates solubility enhancers, PEG 400 and PVP K-90, to improve the solubility and bioavailability of the drug. The solubility enhancement study revealed significant improvements, especially at higher concentrations, ensuring rapid dissolution and enhancing therapeutic efficacy. The drug content analysis of formulation F3 demonstrated 98.50% of the label claim, indicating high uniformity and reliable dosing. Further characterization of formulation F3 showed superior folding endurance (235 folds), the fastest disintegration time (63 minutes), and a high assay value (99.12%), reflecting excellent mechanical properties and rapid drug release. The in-vitro release study revealed nearly complete drug dissolution (98.85%) within 15 minutes, making the formulation ideal for drugs requiring a rapid onset of action. Stability studies over three months confirmed the formulation's minimal degradation and stable drug content (98.32%). In conclusion, formulation F3 is a promising candidate for fast-dissolving oral films, with excellent drug release, stability, and consistency. Further clinical trials and stability assessments are recommended to validate its efficacy and optimize its clinical application.

Keywords:
Fast-dissolving oral film, Astemizole, Solubility enhancement, PEG 400, PVP K-90, Bioavailability, Drug content analysis, Folding endurance, Disintegration time, In-vitro release, Stability studies, Patient compliance, Pharmaceutical formulations.