Development of Starch-based Orodispersible Films for Paracetamol Delivery: A Comparative Study

Abstract

Orodispersible films (ODFs) have emerged as practical dosage forms due to their ease of application, dosage flexibility, and rapid disintegration in the oral mucosa without water, enabling rapid drug release. Analgesics and antipyretics are expected to have rapid effects, particularly in pediatric patients. In this study, ODFs were produced using a simple method that provides rapid drug release and doesn't require additional components like cross-linking agents. The aim of the study was to develop paracetamol-loaded starch-based films useful for children, patients experiencing vomiting, or those having difficulties. Orodispersible films were prepared via the solvent casting method using wheat, rice, and corn starches. The films were evaluated for their physical properties, including thickness, mass, surface pH values, swelling index, and disintegration and dissolution time. The results revealed that all films exhibited dissolution times of under 3 min, with approximately 80% of paracetamol release, demonstrating rapid and efficient drug delivery. The surface pH values were close to the pH of the oral cavity, indicating minimal risk for irritation. The characterizations of films were determined using Fourier transform infrared spectroscopy-attenuated total reflectance (FTIR-ATR), X-ray diffraction (XRD), and thermogravimetric analysis (TGA) techniques. FTIR-ATR analysis showed no differences between starch types and paracetamol was physically bound to the films. XRD patterns indicated amorphous structures resulting from starch gelatinization. TGA analysis showed rice starch films exhibited the highest weight loss and the least thermal stability. The results demonstrated synthesized ODFs can be utilized as carriers for paracetamol and could potentially be used for other active ingredients.