(M1330-06-38) Optimization of Thermoresponsive SNEDDS Formulation Loaded with Dapagliflozin Using Box-Behnken Design Approach: Overcome Manufacturing Challenges

Purpose: Developing a solidified form of liquid self-nanoemulsifying drug delivery system (L-SNEDDS) presents a considerable challenge in pharmaceutical formulation. Therefore, this study aimed to develop a thermoresponsive self-nanoemulsifying drug delivery system (T-SNEDDS) as a promising approach to solidify L-SNEDDS formulation and enhance dapagliflozin dissolution

Methods: Solubility and emulsification studies were performed to select oil and surfactant. Box-Behnken design was used to investigate the influences of three independent variables (pluronic F127 propylene glycol and dapagliflozin concentration) on liquefying temperature and time. Zetasizer was used to measure particle size and zeta potential for optimized T-SNEDDS. The in-vitro dissolution test was performed to compare the dissolution profile of optimized T-SNEDDS with raw drugs and marketed tablets. Imwitor 308 and cremophor EL were selected as oil and surfactant, respectively.

Results: The suggested optimized T-SNEDDS formulation consisted of 8.60% w/w pluronic F127, 10% w/w propylene glycol, and 5% w/w dapagliflozin. The prepared optimized T-SNEDDS had a liquefying temperature of 33.5°C and a liquefying time of 100.3 seconds. In vitro dissolution studies revealed that the optimized T-SNEDDS significantly enhanced dapagliflozin dissolution efficiency (97.4%) compared to the raw drug (65.2%). Moreover, it showed comparable performance to the marketed formulation (90.8%).

Conclusion: The developed T-SNEDDS offers a promising approach for improving the oral delivery of dapagliflozin while addressing manufacturing and scale-up challenges associated with conventional solidification techniques.

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Suggested 17 T-SNEDDS formulation by Design of Experiments.


The measured response values for the prepared seventeen formulations


(A) In-vitro dissolution profiles and (B) dissolution efficiency of raw Dapa, T-SNEDDS, and marketed tablet.