Determination of drug, excipients and coating distribution in pharmaceutical tablets using NIR-CI

The growing interest of the pharmaceutical industry in Near Infrared-Chemical Imaging (NIR-CI) is a result of its high usefulness for quality control analyses of drugs throughout their production process (particularly of its non-destructive nature and expeditious data acquisition). In this work, the...

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Detalles Bibliográficos
Autores: Palou Garcia, Anna, Cruz, Jordi|||0000-0001-8191-8689, Blanco Romía, Marcelo, Tomàs, Jaume, de los Ríos, Joaquín, Alcalà Bernàrdez, Manel|||0000-0001-9635-8987
Tipo de recurso: artículo
Fecha de publicación:2012
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:187823
Acceso en línea:https://ddd.uab.cat/record/187823
https://dx.doi.org/urn:doi:10.1016/j.jpha.2011.11.003
Access Level:acceso abierto
Palabra clave:Near infrared Chemical Imaging (NIR-CI)
Hyperspectral imaging
Component distribution
Tablet coating distribution
Partial Least Squares (PLS) regression
Descripción
Sumario:The growing interest of the pharmaceutical industry in Near Infrared-Chemical Imaging (NIR-CI) is a result of its high usefulness for quality control analyses of drugs throughout their production process (particularly of its non-destructive nature and expeditious data acquisition). In this work, the concentration and distribution of the major and minor components of pharmaceutical tablets are determined and the spatial distribution from the internal and external sides has been obtained. In addition, the same NIR-CI allowed the coating thickness and its surface distribution to be quantified. Images were processed to extract the target data and calibration models constructed using the Partial Least Squares (PLS) algorithms. The concentrations of Active Pharmaceutical Ingredient (API) and excipients obtained for uncoated cores were essentially identical to the nominal values of the pharmaceutical formulation. But the predictive ability of the calibration models applied to the coated tablets decreased as the coating thickness increased.