Objectives: This study aimed to enhance the aqueous solubility and dissolution rate of Etravirine, a poorly soluble antiretroviral agent, using solid dispersion with hydrophilic polymers and systematic optimization. Methods: Etravirine was characterized by FTIR, DSC, and XRD. Solid dispersions were prepared with HPMC 5 cps and PVP K30 via spray drying. A 2³ factorial Design of Experiments (DoE) was employed to optimize disintegration time, dissolution, and assay parameters. Standard pharmacopeial methods were followed for tablet evaluation. Results: HPMC 5 cps solid dispersion improved aqueous solubility ~3.4-fold compared to pure drug (0.409 vs. 0.12 mg/mL). The optimized formulation (ETR002) achieved over 93% drug release within 90 minutes, significantly outperforming the pure drug and comparable to the marketed reference (Intelence®, f2 = 75). Statistical analysis (ANOVA) confirmed the significance of Croscarmellose sodium and Crospovidone levels on dissolution and disintegration (p < 0.05). Conclusion: Solid dispersion with HPMC 5 cps via spray drying is an effective strategy for enhancing Etravirine solubility and dissolution. The approach eliminates hazardous solvents such as MDC, offering a safer and scalable industrial process. Further in vivo pharmacokinetic and bioequivalence studies are warranted.
Keywords: Etravirine, Solubility enhancement, Solid Dispersion, Liquisolid Method, Design of Experiment
How to cite this article: Parekh H; Chotaliya M; Design and Optimization of Etravirine Tablets via Solid Dispersion with Hydrophilic Polymers..Int J Drug Deliv Technol. 2025;15(4): 1591-1611, DOI: 10.25258/ijddt.15.4.13