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@article{208525,
        author = {Sara Karthik and Jimidi Bhaskar},
        title = {FORMULATION AND IN VITRO EVALUATION OF DARIDOREXANT SUSTAINED RELEASE TABLET},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {13},
        number = {4},
        pages = {1933-1941},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=208525},
        abstract = {The present study was aimed at the development and evaluation of sustained-release matrix tablets of Daridorexant using natural hydrophilic polymers, namely sodium alginate and tragacanth, by the direct compression method. Daridorexant, a dual orexin receptor antagonist used for the treatment of insomnia, possesses favourable pharmacokinetic properties that make it a suitable candidate for sustained-release drug delivery. FTIR studies confirmed the compatibility of Daridorexant with the selected excipients, indicating the absence of significant drug–excipient interactions. Eight formulations (F1–F8) were prepared using varying concentrations of sodium alginate and tragacanth. The compressed tablets were evaluated for post-compression parameters such as weight variation, thickness, hardness, friability, drug content, and disintegration time. All formulations complied with acceptable quality standards for tablet evaluation. In-vitro dissolution studies demonstrated sustained drug release over an 8-hour period. Among all formulations, F7 exhibited the most desirable release profile with 98.68% cumulative drug release at the end of 8 hours, along with satisfactory hardness (3.60 kg/cm²), drug content (95.58%), and the shortest disintegration time (13 minutes). Drug release kinetic analysis revealed that the optimized formulation followed Zero-order kinetics (R² = 0.978) and closely fitted the Higuchi diffusion model (R² = 0.975), indicating diffusion-controlled drug release from the hydrated polymer matrix. Stability studies conducted under long-term and accelerated storage conditions for three months showed no significant changes in the dissolution profile, confirming the stability of the optimized formulation. In conclusion, the study demonstrated that sustained-release matrix tablets of Daridorexant can be successfully formulated using sodium alginate and tragacanth. The optimized formulation F7 provided controlled drug release, satisfactory physicochemical characteristics, and excellent stability, suggesting its potential as a once-daily sustained-release dosage form for the effective management of insomnia.},
        keywords = {Daridorexant, Natural polymers, FTIR Studies, Direct compression method, In vitro drug release studies},
        month = {September},
        }