Application of hyperspectral Raman imaging to the analysis of a self-emulsifying drug delivery system (SEDDS).

Self-emulsifying drug delivery systems (SEDDS) are mixtures of drug and excipients that undergo emulsification when exposed to water. This pharmaceutical form is used to enhance the oral absorption of poorly water-soluble drugs. The API is finely dispersed in the excipients and forms a solid solution increasing its dissolution rate. Hyperspectral Raman imaging is a powerful tool that combines both spectral and spatial information. It returns qualitative and quantitative information useful during the development or the characterization of pharmaceutical preparations. The studied formulation consisted of a BCS 2 API (high permeability, low solubility) dispersed in excipients mainly composed of Lauroyl macrogol-32 glycerides (>50%). Two different preparations were analyzed: 100% of API dissolved and 70% of API dissolved with 30% of API powder added to the formulation. The two formulations have therefore exactly the same qualitative and quantitative composition but different spatial distribution and dispersion of the API mimicking a problem during the process. First a confocal Raman microscopic analysis was performed to evaluate the solid state of the API in the formulations. Then, an evaluation of the particle size was performed. These results are important since they can affect the bioavailability of the API and therefore its activity. Beside the microscopic scale analysis, a macroscopic imaging quantitative PLS model has been developed. The method has been validated within +/- 10% acceptance limits following the total error approach. This validated quantitative model enables reliable quantitative analysis at the pixel level of Raman images providing meaningful chemical images