Development and Optimization of a Super Saturable Self-Nanoemulsifying Drug Delivery System for Ibrutinib: Enhancing Solubility and Anticancer Potential

ABSTRACT

Aim: This study explores the development and optimization of a Super saturable Self-Nanoemulsifying Drug Delivery System to enhance the solubility, bioavailability, and anticancer efficacy of ibrutinib. Materials and Methods: Saturation solubility studies identified Kolliphor® RH 40, castor oil, and PEG-600 as the optimal surfactant, oil, and co-surfactant, respectively. Formulation optimization was performed using a Box-Behnken design, with droplet size and encapsulation efficiency as key response variables. Characterization included particle size analysis, zeta potential, FTIR, DSC, and XRPD studies, while in vitro drug release was assessed through diffusion studies. The MTT assay on MCF-7 and PANC-1 cell lines evaluated the cytotoxicity and therapeutic potential of the formulation. Results: The optimized S-SNEDDS for Ibrutinib demonstrated favorable characteristics, including a small droplet size (71.12-76.38 nm), high encapsulation efficiency (61.56-87.22%), and stability under stress conditions. The formulation exhibited rapid drug release, with over 50% of Ibrutinib released within 240 min. Characterization studies, including FTIR and DSC, confirmed the amorphous nature of the encapsulated drug. Kinetic studies suggested a zero-order drug release mechanism. Cytotoxicity evaluation via MTT assay indicated that the nanoformulation had lower cytotoxicity on MCF-7 and PANC-1 cells compared to pure Ibrutinib​. Conclusion: These findings underscore the potential of S-SNEDDS as a promising approach to enhance the oral bioavailability of poorly water-soluble drugs like ibrutinib.

KEYWORDS

• Super saturable SNEDDS
• Ibrutinib
• Box-Behnken design
• Nanocarriers
• Drug
• solubility
• Cytotoxicity
• Cell lines

Showing references and in-text citations exactly as published.

• DOI10.5530/ijper.20262420Copy

RELATED ARTICLES

Matched on section and article type within this issue of IJPER.

• Article · VOLUME 60, ISSUE 3SDevelopment and evaluation of Dry Powder Inhalation Formulation of Remdesivir Nanosuspension by Spray Drying TechniqueArshad Shaikh, Mukesh Pandurang Ratnaparkhi, Sayali Vilas Jadhav, Shailendra Salvankar · pp. s1–s9Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 3SOptimized Green Synthesis Approaches of Phenytoin Using Divalent Sulfate Salts and Chromatographic Purity Assessment via A Novel RP-HPLC MethodArka Chakraborty, Rajarshi Nath, Biplab Debnath, Arijit Das, Anindya Bose, Shambo Panda · pp. s1–s8Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 3SFormulation and Evaluation of Beclomethasone Dipropionate Loaded Niosomal Gel for Topical UseMahesh Birajdar, Rohit Sarda, Shradha Tiwari, Dnyaneshwari Jadhav, Sameep Sonvane, Prakash Shivnechari, Kranti Satpute · pp. s918–s928Original ArticleSame type: Article
• Article · VOLUME 60, ISSUE 3SDesign and Development of Self-Micro Emulsifying Drug Delivery Systems of Rifaximin Using 32 Factorial DesignOnkar Vilas Jadhav, Twarita Dilip Deshpande, Udaykumar Baburao Bolmal, Anuj Jagannath Shinde, Shital Vishwas Patil · pp. s929–s943Original ArticleSame type: Article