Development and In Vitro Evaluation of Rizatriptan Benzoate Oral Disintegrating Tablets Using Superdisintegrants for Enhanced Patient Compliance

Abstract

Background: Migraine is a prevalent neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by nausea, vomiting, and sensitivity to light and sound. Oral drug administration during migraine attacks is frequently compromised due to dysphagia, nausea, and delayed gastric emptying. Oral disintegrating tablets (ODTs) provide a patient-friendly dosage form that rapidly disintegrates in the oral cavity without the need for water, thereby improving convenience and compliance. Rizatriptan benzoate, a selective 5-hydroxytryptamine (5-HT1B/1D) receptor agonist, is widely prescribed for the acute treatment of migraine and is an ideal candidate for ODT formulation. Objective: The present study aimed to formulate and evaluate oral disintegrating tablets of rizatriptan benzoate using different superdisintegrants to achieve rapid tablet disintegration, enhanced dissolution, and improved patient acceptability. Materials and Methods: Oral disintegrating tablets were prepared by the direct compression method employing various concentrations of crospovidone, croscarmellose sodium, and sodium starch glycolate. The prepared formulations were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr's compressibility index, and Hausner's ratio. Post-compression evaluation included weight variation, hardness, thickness, friability, drug content uniformity, wetting time, water absorption ratio, disintegration time, in vitro dissolution studies, Fourier-transform infrared spectroscopy (FTIR), and accelerated stability studies. Results: The powder blends exhibited satisfactory flow properties suitable for direct compression. All tablet formulations complied with pharmacopeial specifications for physical quality attributes. Formulations containing crospovidone demonstrated the shortest disintegration time, rapid wetting, and superior dissolution characteristics. The optimized formulation disintegrated within approximately 20–30 seconds and released more than 90% of the drug within 15 minutes. FTIR analysis confirmed the absence of significant drug–excipient interactions, while accelerated stability studies indicated that the optimized formulation remained physically and chemically stable throughout the study period. Conclusion: The optimized rizatriptan benzoate oral disintegrating tablet demonstrated excellentpharmaceutical performance with rapid disintegration and enhanced dissolution. The developed formulation offers a promising alternative to conventional tablets by improving patient convenience, compliance, and the potential for a faster onset of therapeutic action in migraine management.