Formulation and Evaluation of Oral Thin Film of Drug for Gastroesophageal Reflux Disease (GERD)

Abstract

The present investigation focused on the formulation and assessment of fast-dissolving oral thin films (OTFs) incorporating Famotidine and Domperidone for improved therapeutic management of gastroesophageal reflux disease (GERD). Comprehensive analytical evaluation of the drugs was carried out through organoleptic examination, Fourier Transform Infrared (FTIR) spectroscopy, ultraviolet spectrophotometry, melting point analysis, solubility studies, and HPLC analysis, confirming the authenticity, purity, and suitability of the drugs for formulation development. Compatibility studies indicated the absence of any significant interaction between the active pharmaceutical ingredients and selected excipients. The oral thin films were prepared using the solvent casting technique with Hypromellose and Polyvinyl Alcohol serving as film-forming agents, while Polyethylene Glycol 400 was utilized as a plasticizer to enhance flexibility and film integrity. The developed formulations were characterized for various quality control parameters including film thickness, uniformity of weight, folding endurance, surface pH, tensile strength, disintegration behavior, drug content, and in-vitro dissolution performance. The optimized batch demonstrated satisfactory mechanical properties, consistent film dimensions, excellent drug distribution, and rapid disintegration in less than 15 seconds. In-vitro release studies showed that both Famotidine and Domperidone were released rapidly, with cumulative drug release exceeding 97% within 25 minutes, and the release pattern predominantly followed first-order kinetics. The developed oral thin films exhibited desirable stability, ease of handling, and the advantage of administration without the need for water, making them particularly beneficial for patients experiencing swallowing difficulties or requiring convenient on-demand therapy. Overall, the study highlights the potential of Famotidine and Domperidone-loaded OTFs as an effective and patient-compliant alternative dosage form capable of delivering rapid symptomatic relief in GERD management, with promising prospects for future large-scale production and clinical utilization.

Keywords: Oral Thin Films (OTFs), Famotidine, Domperidone, Drug Delivery, Bioavailability, Rapid Disintegration, Drug Release.