title: NIR hyperspectral imaging to evaluate degradation in captopril commercial tablets.
abstract: Pharmaceutical quality control is important for improving the effectiveness, purity and safety of drugs, as well as for the prevention or control of drug degradation. In the present work, near infrared hyperspectral images (HSI-NIR) of tablets with different expiration dates were employed to evaluate the degradation of captopril into captopril disulfide in different layers, on the top and on the bottom surfaces of the tablets. Multivariate curve resolution (MCR) models were used to extract the concentration distribution maps from the hyperspectral images. Afterward, multivariate image techniques were applied to the concentration distribution maps (CDMs), to extract features and build models relating the main characteristics of the images to their corresponding manufacturing dates. Resolution methods followed by extracting features were able to estimate the tablet manufacture date with a prediction error of 120days. The model developed could be useful to evaluate whether a sample shows a degradation pattern consistent with the date of manufacturing or to detect abnormal behaviors in the natural degradation process of the sample. The information provided by the HIS-NIR is important for the development of the process (QbD), looking inside the formulation, revealing the behavior of the active pharmaceutical ingredient (API) during the product's shelf life.
authors.affiliation: Departamento de Química Fundamental, Universidade Federal de Pernambuco, Prof. Moraes Rego, 1235, Cidade Universitária, Recife, Pernambuco 50670-901, Brazil. Electronic address: leandrodemouraf@gmail.com.
authors.forename: Leandro de Moura
authors.initials: Lde M
authors.lastname: França
authors.affiliation: Departamento de Engenharia Química, Universidade Federal de Pernambuco, Av. Artur de Sá, S/N, Cidade Universitária, Recife, Pernambuco 50740-521, Brazil. Electronic address: mfp@ufpe.br.
authors.forename: Maria Fernanda
authors.initials: MF
authors.lastname: Pimentel
authors.affiliation: R. Baraúnas, Universidade Estadual da Paraíba, Campina Grande, Paraíba CEP: 58429-500, Brazil. Electronic address: simonesimoes@yahoo.com.
authors.forename: Simone da Silva
authors.initials: Sda S
authors.lastname: Simões
authors.affiliation: Largo de Dois Irmãos, 1117, Laboratório Farmacêutico do Estado de Pernambuco Miguel Arraes, Recife, Pernambuco 52171-010, Brazil. Electronic address: severino.grangeiro@lafepe.pe.gov.br.
authors.forename: Severino
authors.initials: S
authors.lastname: Grangeiro
authors.affiliation: Universitat Politècnica de València, Camino de Vera s/n, Edificio 7A, 46022 Valencia, Spain. Electronic address: jopramon@eio.upv.es.
authors.forename: José M
authors.initials: JM
authors.lastname: Prats-Montalbán
authors.affiliation: Universitat Politècnica de València, Camino de Vera s/n, Edificio 7A, 46022 Valencia, Spain. Electronic address: aferrer@eio.upv.es.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ferrer
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000493:pharmacokinetics*; D002216:Captopril / Q000493:pharmacokinetics*; D002626:Chemistry, Pharmaceutical; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013607:Tablets
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D013607:Tablets; D002216:Captopril
keywords: Degradation product; Feature extraction; Imaging analysis; Near infrared spectroscopy; Process analytical technology