Design and Evaluation of Oral Thin Films of Ondansetron Hydrochloride for Rapid Onset of Action

Abstract

This study focuses on the design and comprehensive evaluation of oral thin films of Ondansetron Hydrochloride, targeting a rapid onset of antiemetic action to address limitations associated with conventional tablets and injections. Ondansetron Hydrochloride, a selective 5-HT₃ receptor antagonist, is highly effective in preventing chemotherapy-, radiotherapy-, and surgery-induced nausea and vomiting but suffers from delayed action due to first-pass metabolism and swallowing difficulties in certain patient groups. The developed oral thin films utilize hydrophilic polymers—HPMC E5 and PVA—and glycerin as a plasticizer, prepared via solvent casting to ensure uniformity, rapid disintegration, and robust mechanical strength. Preformulation studies, including FTIR and DSC, confirmed drug-excipient compatibility, while in-vitro characterization demonstrated desirable physical properties, uniform drug content, and rapid disintegration within 28 seconds. Dissolution studies revealed over 80% drug release within five minutes, following Korsmeyer-Peppas kinetics, indicating a combined diffusion and erosion mechanism. Stability testing confirmed maintained integrity over three months. Compared to conventional tablets, the oral thin films showed significant improvements in onset of action, ease of administration without water, and patient compliance, particularly benefiting pediatric, geriatric, and bedridden patients. This innovative formulation holds promise for improving antiemetic therapy outcomes through enhanced convenience, faster therapeutic response, and better patient acceptability. Overall, the study demonstrates that oral thin films of Ondansetron Hydrochloride represent a viable alternative drug delivery system, addressing key challenges of traditional dosage forms. Further in-vivo studies are recommended to validate clinical efficacy and establish bioequivalence.