Formulation and In Vitro Evaluation of Propranolol Hydrochloride Sublingual Films for Effective Hypertension Control

Abstract

The objective of the present investigation was the formulation and evaluation of an oral fast-dissolving sublingual film of Propranolol HCl. This study aimed to formulate a rapid dissolving sublingual film of propranolol HCl by employing HPMC E15 as a film-forming agent, propylene glycol as a plasticizer, and cross-povidone as a disintegration agent. A fast-dissolving film was fabricated using the solvent casting technique. The stability studies of the patch were conducted for the optimized batch in accordance with the ICH guidelines. The medication and excipients underwent characterization according to the Indian Pharmacopoeia (IP). Investigation of drugs and excipients using Fourier Transform Infrared Spectroscopy (FT-IR). The films underwent physicochemical characterization, including assessment of weight Variation, thickness, tack test, drug content homogeneity, surface pH, folding endurance, disintegration time, in vitro drug release, and stability testing. Out of all the formulas (F1 to F9) that were created, batches F4 and F5 exhibited the highest quality, with a release of 109.86% and 104.73%, respectively during a 10-minute timeframe. The statistically optimized formulation was assessed using FT-IR (Fourier transform-infrared spectroscopy) investigations, which revealed no chemical interactions between the medication and polymer. Therefore, the propranolol HCl quick-dissolving film may serve as a superior substitute for tablets and capsules in achieving better oral bioavailability for the management of hypertension.

Keywords: Fast dissolving sublingual film, Propranolol HCl, solvent casting method, Drug release, Fast onset of action.