Department of Pharmaceutics, School of Pharmaceutical Sciences, Sandip University, Nashik, India
*Corresponding Author: Ms. Samruddhi Sunil Mahajan, Email: samruddhi13.99@gmail.com
Received: 12th Dec, 2025; Revised: 12th Feb 2026; Accepted: 13th Feb, 2026; Available Online: 10th March, 2026
Background: Enzalutamide is a potent androgen receptor inhibitor with great potency and limited aqueous solubility (approximately, 2.150 ± 0.18 µg/mL in water) since it belongs to BCS Class II. This leads to dissolution-restrained uptake and fluctuation in treatment reaction.
Methods: β-cyclodextrin nanosponges were prepared using diphenyl carbonate by the melt method at different molar ratios (1:2, 1:4, 1:6). The optimized batch (1:4) showed the highest yield (86.89%). A 3² factorial design was used for drug loading optimization. Preformulation studies confirmed a melting point of 199–202 °C and a linear UV calibration curve (R² = 0.9918). Characterization was performed using FTIR, DSC, SEM, particle size, and zeta potential analysis. In vitro drug release and stability studies were conducted as per ICH guidelines.
Results: The optimized nanosponge formulation showed a significant increase in solubility compared to the pure drug (~2.150 µg/mL). DSC analysis indicated reduced crystallinity, while FTIR confirmed the absence of drug–excipient interaction. The formulation exhibited high entrapment efficiency, nanoscale particle size, and uniform morphology. Dissolution studies demonstrated enhanced drug release compared to pure enzalutamide, following a non-Fickian diffusion mechanism. Stability studies under accelerated conditions (40 ± 2 °C / 75 ± 5% RH) showed no significant changes, confirming formulation stability.
Conclusion: The optimal formulation (1:4 ratio) showed better performance implying that it could be used in the management of prostate cancer by increasing oral bioavailability and therapeutic consistency.
Keywords: Enzalutamide, Nanosponges, β-cyclodextrin, Solubility enhancement, Factorial design, Drug delivery.
How to cite this article: Mahajan SS, Javvaji VR. Development, Optimization and Evaluation of β-Cyclodextrin-Based Nanosponges for Solubility Enhancement of Enzalutamide. Int J Drug Deliv Technol. 2026;16(16s): 573-582. DOI: 10.25258/ijddt.16.16s.61
Source of support: Nil.
Conflict of interest: None