ArticleTurkish journal of pharmaceutical sciences2025
Pre-Formulation Studies of Lipid-Based Formulation Approach for a Poorly Water-Soluble Biopharmaceutics Classification System Class II Model Drug: Bosentan.
Article in Turkish journal of pharmaceutical sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objectives: This study aimed to perform pre-formulation studies, formulation development, and formulation optimization for self-nanoemulsifying drug delivery systems (SNEDDS), a lipid-based formulation approach to improve the low solubility of bosentan monohydrate (BOS). Materials and Methods: Pseudo-ternary phase diagrams were created for pre-formulation studies and formulation design for SNEDDS. The SNEDDS was optimized with BBD. The optimized BOS-loaded SNEDDS formulation was characterized by droplet size (DS), polydispersity index (PDI), dispersibility, an efficiency test of self-nanoemulsification, % transmittance, turbidity, robustness, and the effects of pH, viscosity, and thermodynamic and long-term stability studies. The Results: The optimum BOS-loaded SNEDDS had a DS of 16.76 nm and PDI of 0.200. The characterization studies satisfied SNEDDS requirements (does not deteriorate when diluted at different pHs; resistant to thermodynamic changes; self-emulsifying within 1 minute; Grade A; and transparent) for both blank and BOS-loaded SNEDDS. In long-term stability studies, it was found to be stable for six months. When Conclusion: Pre-formulation and formulation studies were carried out successfully, and lipid-based optimum BOS-loaded SNEDDS were obtained. The present study confirms the potential of optimum BOS-loaded SNEDDS, which was found to be stable over the long term, to increase the drug's solubility,
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