Design, Formulation, and Evaluation of Fast Dissolving Oral Film Containing Lisinopril

Abstract

The present study aimed to design, formulate, and evaluate a fast dissolving oral film (FDOF) of Lisinopril to enhance patient compliance and achieve rapid onset of action in the management of hypertension. Lisinopril, an angiotensin-converting enzyme (ACE) inhibitor, suffers from low bioavailability due to extensive first-pass metabolism and poor patient adherence to conventional tablet formulations. The prepared films were evaluated for physicochemical parameters such as thickness, weight uniformity, surface pH, folding endurance, drug content, disintegration time, and in-vitro dissolution profile. Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) studies confirmed the absence of drug–polymer interactions. The optimized formulation exhibited smooth texture, uniform thickness, and rapid disintegration within 25 seconds. The drug content was found to be within the acceptable range (98–102%), ensuring uniform distribution. In-vitro dissolution studies showed more than 90% drug release within 5 minutes, indicating enhanced solubility and potential for rapid therapeutic action compared to conventional tablets.
The results demonstrate that fast dissolving oral films of Lisinopril can serve as a promising alternative drug delivery system, offering advantages such as improved patient compliance, rapid absorption, and convenience for geriatric and pediatric patients with swallowing difficulties. The developed formulation shows significant potential for further in-vivo evaluation and clinical application in hypertension management.