DESIGN, OPTIMIZATION, AND EVALUATION OF SOLUBILITY-ENHANCED FAST DISSOLVING ORAL FILMS OF LORATADINE

The present study aimed to enhance the solubility and formulate fast dissolving oral films of Loratadine to improve its dissolution rate and therapeutic efficacy. Loratadine, a Biopharmaceutics Classification System (BCS) Class II drug, exhibits poor aqueous solubility, which limits its bioavailability and delays onset of action. To overcome this limitation, solubility enhancement was carried out using the solid dispersion technique with hydrophilic polymers. Preformulation studies, including solubility analysis and drug–excipient compatibility studies (FT-IR), confirmed the suitability of the drug for formulation. Fast dissolving oral films were prepared using the solvent casting method with polymers such as HPMC and PVA, along with suitable plasticizers, sweetening agents, and other excipients. The prepared films were evaluated for physicochemical properties including thickness, weight variation, folding endurance, surface pH, drug content uniformity, disintegration time, and in vitro dissolution. The results indicated that all formulations exhibited satisfactory physical characteristics and uniform drug distribution. The optimized formulation demonstrated rapid disintegration within seconds and showed significantly enhanced drug release compared to the pure drug, achieving nearly complete drug release within a short time. The improved performance was attributed to enhanced solubility, reduced crystallinity, and rapid film disintegration. In conclusion, the developed fast dissolving oral films of Loratadine offer a promising approach for improving solubility, enhancing bioavailability, and achieving rapid onset of action, thereby providing a patient-friendly alternative to conventional dosage forms.