Design, Development and In-Vitro Characterization of Rapidly Disintegrating Oral Solid Dosage Form

The objective of the present study was to design, develop, and evaluate rapidly disintegrating oral films (RDOFs) of Ketorolac Tromethamine for effective pain management, especially in patients with swallowing difficulties. Oral films offer a convenient and patient-friendly alternative to traditional solid dosage forms due to their rapid disintegration and absorption through the oral mucosa. Ketorolac Tromethamine, a potent non-steroidal anti-inflammatory drug (NSAID), was selected as the active pharmaceutical ingredient due to its rapid onset of action. Various film-forming polymers such as Hydroxypropyl Methylcellulose (HPMC E5) and Pullulan were used in different concentrations to optimize film properties. Super disintegrants including Sodium Starch Glycolate (SSG), Crospovidone, and Croscarmellose Sodium were incorporated to enhance disintegration time. Saccharin sodium was added as a sweetening agent to improve palatability. The prepared films were evaluated for physical characteristics, drug content uniformity, disintegration time, folding endurance, and in vitro drug release. The optimized formulation exhibited rapid disintegration within seconds, satisfactory mechanical strength, and enhanced drug release, suggesting its potential for use as a fast-acting analgesic dosage form. This study demonstrates the feasibility of oral films as a promising platform for immediate drug delivery of Ketorolac Tromethamine.