[en] During galenic formulation development, homogeneity of distribution is a critical parameter to check since it may influence activity and safety of the drug. Raman hyperspectral imaging is a technique of choice for assessing the distributional homogeneity of compounds of interest. Indeed, the combination of both spectroscopic and spatial information provides a detailed knowledge of chemical composition and component distribution.
Actually, most authors assess homogeneity using parameters of the histogram of intensities (e.g. mean, skewness and kurtosis). However, this approach does not take into account spatial information and loses the main advantage of imaging. To overcome this limitation, we propose a new criterion: Distributional Homogeneity Index (DHI). DHI has been tested on simulated maps and formulation development samples. The distribution maps of the samples were obtained without validated calibration model since different formulations were under investigation. The results obtained showed a linear relationship between content uniformity values and DHI values of distribution maps. Therefore, DHI methodology appears to be a suitable tool for the analysis of homogeneity of distribution maps even without calibration during formulation development.
Research center :
Centre Interfacultaire de Recherche du Médicament - CIRM
Disciplines :
Pharmacy, pharmacology & toxicology
Author, co-author :
Sacre, Pierre-Yves ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Lebrun, Pierre ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Chavez, Pierre-François ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
De Bleye, Charlotte ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Netchacovitch, Lauranne ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Rozet, Eric ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Klinkenberg, Régis
Streel, Bruno
Hubert, Philippe ; Université de Liège - ULiège > Département de pharmacie > Chimie analytique
Ziemons, Eric ; Université de Liège - ULiège > Département de pharmacie > Département de pharmacie
Language :
English
Title :
A new criterion to assess distributional homogeneity in hyperspectral images of solid pharmaceutical dosage forms
Publication date :
2014
Journal title :
Analytica Chimica Acta
ISSN :
0003-2670
eISSN :
1873-4324
Publisher :
Elsevier, Amsterdam, Netherlands
Volume :
818
Pages :
7-14
Peer reviewed :
Peer Reviewed verified by ORBi
Funders :
Région wallonne : Direction générale opérationnelle de l'Economie, de l'Emploi et de la Recherche (DGO 6)
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