Physicochemical Properties and In Vitro Dissolution of Edible Film Based on Starch-Chitosan Used as a Potential Oral Drug Carrier: Model Using Acetaminophen

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Abstract

This work aimed to evaluate the effect of incorporating a type model active pharmaceutical ingredient in an orally disintegrating film (ODF) based on starch and chitosan on the physicochemical and thermodynamic surface properties. The ODFs were formed using the solvent casting method, with a thickness of 0.04 mm. Chemical analysis performed by vibrational spectroscopy showed strong intermolecular interactions between the components of the polymeric matrix. XRD structural analysis confirmed these interactions from the decrease in crystallinity in the biopolymeric compounds; the active pharmaceutical ingredient did not present changes in the ordering. The inclusion of the drug maintained the hydrophilicity with contact angle values around 62°. However, the water absorption values had increased for the TPS-CH-M-A film by ~90%. The adequate particle dispersion was shown in the SEM of acetaminophen which facilitated the opening of the polymer chains, which increased the soluble solids content in contact with water. Also, the mechanical properties were not affected by the incorporation of acetaminophen particles, the tensile strength values of the polymeric blend were around 24 MPa and the elongation at break was around 4.0%, in the ODF the toughness increased by 8%. These factors allowed disintegration times of 48 s, in vitro dissolution times of 10 min to release ~73% of acetaminophen, and 15 min to release all the active ingredients. Therefore, the chitosan starch-based ODF containing acetaminophen represents a promising system for use in the delivery of pharmaceutical active ingredients.

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