Determination of drug, excipients and coating distribution in pharmaceutical tablets using NIR-CI
Palou Garcia, Anna (Universitat Autònoma de Barcelona. Departament de Química)
Cruz, Jordi (Escola Universitària Salessiana de Sarrià)
Blanco Romía, Marcelo (Universitat Autònoma de Barcelona. Departament de Química)
Tomàs, Jaume (Esteve Farma)
de los Ríos, Joaquín (Esteve Farma)
Alcalà Bernàrdez, Manel (Universitat Autònoma de Barcelona. Departament de Química)

Data:	2012
Resum:	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.
Ajuts:	Ministerio de Ciencia e Innovación CTQ2009-08312
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Near infrared Chemical Imaging (NIR-CI) ; Hyperspectral imaging ; Component distribution ; Tablet coating distribution ; Partial Least Squares (PLS) regression
Publicat a:	Journal of pharmaceutical analysis, Vol. 2, issue 2 (April 2012) , p. 90-97, ISSN 2214-0883

DOI: 10.1016/j.jpha.2011.11.003
PMID: 29403727

8 p, 1.2 MB

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