Formulation, Statistical Optimization and Stability Study of Ondansetron Films

Abstract

Nausea and/or vomiting is common in patients of all ages. Nausea and vomiting can occur for a variety of reasons and may be related to illness or treatment. Careful study of the receptors involved has aided in the selection of drug classes to treat patients (34). This study aimed to prescribe an oral dissolving film of the antiemetic drug ondansetron for treating vomiting patients and nausea and vomiting (NVP) in pregnancy. The goal for optimizing the orally dissolving ondansetron film was to reduce disintegration time and maximize drug release from the film. The formulation of the mouth-dissolving film contains carefully selected additives to impart aesthetic and performance properties such as taste masking, rapid dissolution, physical mouth feel and tactility. From a regulatory perspective, all excipients used in the formulation of oral dissolution films are generally considered safe (i.e., on the GRAS list ) and are approved for use in oral pharmaceutical dosage forms.