DEVELOPMENT AND ASSESSMENT OF A SELF-NANOEMULSIFYING DRUG DELIVERY SYSTEM FOR ENHANCED SOLUBILITY OF DASATINIB

PRAGATHI DEVANAND BANGERA; EESHA SHUKLA; DIVYA DHATRI KARA; RAJESHWARI ROYCHOWDHURY; MAHESHA KEERIKKADU; VAMSHI KRISHNA TIPPAVAJHALA; MAHALAXMI RATHNANAND

doi:10.22159/ijap.2025v17i1.52404

Authors

PRAGATHI DEVANAND BANGERA Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India https://orcid.org/0009-0009-3493-4825
EESHA SHUKLA Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
DIVYA DHATRI KARA Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
RAJESHWARI ROYCHOWDHURY Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India
MAHESHA KEERIKKADU Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India https://orcid.org/0009-0007-3599-7364
VAMSHI KRISHNA TIPPAVAJHALA Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India https://orcid.org/0000-0001-6540-9550
MAHALAXMI RATHNANAND Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal-576104, Karnataka, India

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52404

Keywords:

Self-nano emulsifying drug delivery system (SNEDDs), Dasatinib, Nano-emulsification, Oral bioavailability

Abstract

Objective:The objective of this study was to increase the water solubility of Dasatinib (DAS) by incorporating it into a Self-Nano Emulsifying Drug Delivery System (SNEDDS). Dasatinib, a Biopharmaceutics classification system (BCS)class II drug, has poor solubility in aqueous media, affecting its oral bioavailability. Various oils, surfactants, and co-surfactants were chosen based on solubility tests, with the highest solubility selected.

Methods: Various compositions of oils, surfactants and co-surfactants with Smix concentrations as 1:1, 1:2 and 2:1 and there were 9 formulations under each of these groups with Oil: Smix concentrations of 1:9, 2:8, 3:7, 4:6, 5:5, 6:4, 7:3, 8:2 and 9:1.Capmul MCM, Cremophor EL, and Tween 20 were selected as oil phase, surfactant, and co-surfactant, respectively. A pseudo-ternary phase diagram using the water titration technique optimized the nano-emulsification ratio.The optimized formulation was characterized and evaluated for thermodynamic stability, cloud point measurement, zeta potential, Poly dispersity Index (PDI), globule size, percent transmittance, robustness to dilution, and dissolution studies.

Results: Transmittance of 95% was demonstrated by the formulation, indicating transparency and stability. The zeta potential was over 30 mV, indicating strong electrical stability, and the average globule size was measured to be 85 nm. The formulation was shown to be stable at body temperature, as evidenced by the cloud point being reported above 95°C. The formulation maintained its stability when diluted in water, 0.1N acid, and phosphate buffer. The formulation contained 85% of the dasatinib, according to the drug content study. The optimized SNEDDS formulation significantly increased drug release in in vitro drug release experiments as compared to the pure medication. The oral bioavailability of dasatinib in the SNEDDS formulation was shown to be 3.24 times higher than that of the pure medication, according to in vivo pharmacokinetic tests.

Conclusion: Consequently, the findings indicated that the formulation of dasatinib SNEDDS functions as a means of achieving increased drug loading, better dissolving profiles, and increased bioavailability for the BCS Class II drug dasatinib.

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