Formulation and In-Vivo Pharmacokinetic Evaluation of BCS Class 2 Drug Loaded Fast Disintegrating Oro dispersible Film

Abstract

Zaltoprofen (ZLT), a poorly water-soluble non-steroidal anti-inflammatory drug (NSAID), exhibits limited dissolution, which can affect its oral bioavailability and therapeutic performance. The present study aimed to develop and evaluate zaltoprofen-loaded fast dissolving orodispersible films (ZFDOFs) to enhance drug solubility, dissolution, ease of administration, and patient compliance. The films were prepared by the solvent casting method using suitable film-forming polymers and excipients. The developed formulations were characterized by Fourier-transform infrared (FT-IR) spectroscopy, thermal analysis, X-ray diffraction (XRD), scanning electron microscopy (SEM), in vitro disintegration studies, mechanical property evaluation, and in vitro drug release studies. FT-IR analysis confirmed the compatibility between zaltoprofen and the selected excipients. The prepared films exhibited rapid disintegration and enhanced drug release compared with pure zaltoprofen. The formulations also demonstrated satisfactory tensile strength and folding endurance, indicating good flexibility and mechanical stability. XRD and SEM studies revealed a reduction in the crystallinity of zaltoprofen and its uniform dispersion within the polymeric film matrix. Overall, the developed fast dissolving orodispersible films represent a promising oral drug delivery system for improving the solubility and dissolution behavior of zaltoprofen while offering convenient administration and the potential for enhanced patient compliance. The study suggests that ZFDOFs could serve as an effective alternative to conventional solid oral dosage forms for the delivery of zaltoprofen.