spectroscopic methods, but also allowed the estimations of the size, shape and spatial distribution of different phases and revealed the distinct interior microstructure difference between dispersions with different drug loadings. Due to the complex nature of the phase behavior, Figure 11 is used to illustrate the micron-structure of an under-saturated patch containing such drug-solubilization Tween-rich compartments. Conclusion Formation of phase separated micro-compartments in-situ with different functionalities that can improve the bioavailability of poorly soluble drugs was the main formulation strategy this study was attempted to demonstrate. The characterisation results confirmed the formation of the phase-separated systems with drug being solubilised predominately in the Tween phase. The results of this study have also shown the feasibility of using HME-IM as a simple pharmaceutical process to produce patches that are suitable for the buccal route of administration which can provide the advantage of avoiding first-pass metabolism. Using the solubility difference between the excipients and drug, Tween-rich compartments with primary function of solubilizing drug and PEG-PEO-rich phase with primary function of providing mucoadhesion and acting as hydrophilic carrier for easing dissolution were successfully created in-situ. To be able to formulate such phase separated systems requires a clear understanding of the miscibility and solubility between ingredients. With this information, formulations with the desired level and type of phase separation can be designed and produced through varying the composition of the different ingredients in the material. In addition, the results of this study demonstrated the potential of X-ray micro-CT as a characterisation method for studying phase separation in solid formulations. Acknowledgement
spectroscopic methods, but also allowed the estimations of the size, shape and spatial distribution of different phases and revealed the distinct interior microstructure difference between dispersions with different drug loadings. Due to the complex nature of the phase behavior, Figure 11 is used to illustrate the micron-structure of an under-saturated patch containing such drug-solubilization Tween-rich compartments. Conclusion Formation of phase separated micro-compartments in-situ with different functionalities that can improve the bioavailability of poorly soluble drugs was the main formulation strategy this study was attempted to demonstrate. The characterisation results confirmed the formation of the phase-separated systems with drug being solubilised predominately in the Tween phase. The results of this study have also shown the feasibility of using HME-IM as a simple pharmaceutical process to produce patches that are suitable for the buccal route of administration which can provide the advantage of avoiding first-pass metabolism. Using the solubility difference between the excipients and drug, Tween-rich compartments with primary function of solubilizing drug and PEG-PEO-rich phase with primary function of providing mucoadhesion and acting as hydrophilic carrier for easing dissolution were successfully created in-situ. To be able to formulate such phase separated systems requires a clear understanding of the miscibility and solubility between ingredients. With this information, formulations with the desired level and type of phase separation can be designed and produced through varying the composition of the different ingredients in the material. In addition, the results of this study demonstrated the potential of X-ray micro-CT as a characterisation method for studying phase separation in solid formulations. Acknowledgement
Tween_paper_0211_revised_sq.docx