title: Thorough characterization of a Self-Emulsifying Drug Delivery System with Raman hyperspectral imaging: a case study.
abstract: Newly developed drugs often have poor bioavailability due to their poor water solubility (BCS class 2 drugs). It is therefore necessary to develop new strategies to enhance their solubility and their activity, among which, Self-Emulsifying Drug Delivery System (SEDDS). The efficacy of the drugs contained in these preparations is mainly affected by the solid state and the particle size of the active pharmaceutical ingredient (API). However, it is quite complex, long and expensive to characterize these parameters with classical techniques such as X-ray powder diffraction, differential scanning calorimetry or hot stage microscopy. The present article presents, through a case study, the advantages of the Raman hyperspectral imaging in the characterization of such formulations. Indeed, Raman chemical imaging may fully characterize SEDDS with single equipment and operator in a non-destructive way allowing the follow-up of the formulation during stability studies. Raman imaging is therefore a tool of choice in the PAT framework since it increases the knowledge of the formulation and the process. A quantitative multivariate method using Raman hyperspectral imaging to assay the API in the lipid based formulation has been developed and fully validated following the "total error" approach.
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium. Electronic address: pysacre@ulg.ac.be.
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Sacré
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium.
authors.forename: Lauranne
authors.initials: L
authors.lastname: Netchacovitch
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium.
authors.forename: Charlotte
authors.initials: C
authors.lastname: De Bleye
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium.
authors.forename: Pierre-François
authors.initials: PF
authors.lastname: Chavez
authors.affiliation: Galephar Research Center M/F, rue du Parc Industriel 39, 6900 Marche en Famenne, Belgium.
authors.forename: Cécile
authors.initials: C
authors.lastname: Servais
authors.affiliation: Galephar Research Center M/F, rue du Parc Industriel 39, 6900 Marche en Famenne, Belgium.
authors.forename: Régis
authors.initials: R
authors.lastname: Klinkenberg
authors.affiliation: Galephar Research Center M/F, rue du Parc Industriel 39, 6900 Marche en Famenne, Belgium.
authors.forename: Bruno
authors.initials: B
authors.lastname: Streel
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Hubert
authors.affiliation: University of Liege (ULg), Department of Pharmacy, CIRM, Laboratory of Analytical Chemistry, CHU, B36, 4000 Liege, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Ziemons
mesh_terms: D016503:Drug Delivery Systems / Q000379:methods*; D045703:Emulsifying Agents / Q000008:administration & dosage / Q000032:analysis* / Q000737:chemistry*; D013059:Spectrum Analysis, Raman / Q000379:methods*
chemical_list: D045703:Emulsifying Agents
keywords: Hyperspectral imaging; PAT tool; Particle size; Raman spectroscopy; Self-Emulsifying Drug Delivery System