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Near infrared (NIR)-spectroscopy and in-vitro dissolution absorption system 2 (IDAS2) can help detect changes in the quality of generic drugs.
Jiménez-Romero, Carlos; Simithy, Johayra; Severdia, Anthony; Álvarez, Daniel; Grosso, Manuel; Spivey, Nicole; Arias, Antonio; Solís, Pablo N; Li, Jibin; Hidalgo, Ismael J.
Afiliação
  • Jiménez-Romero C; Absorption Systems Panama, Inc, Panama City, Panama.
  • Simithy J; Absorption Systems Panama, Inc, Panama City, Panama.
  • Severdia A; Absorption Systems LP, Exton, PA, USA.
  • Álvarez D; Laboratorios MEDIPAN S.A, Panama City, Panama.
  • Grosso M; Absorption Systems Panama, Inc, Panama City, Panama.
  • Spivey N; Absorption Systems LP, Exton, PA, USA.
  • Arias A; Absorption Systems Panama, Inc, Panama City, Panama.
  • Solís PN; Laboratorios MEDIPAN S.A, Panama City, Panama.
  • Li J; Absorption Systems LP, Exton, PA, USA.
  • Hidalgo IJ; Absorption Systems Panama, Inc, Panama City, Panama.
Drug Dev Ind Pharm ; 46(1): 80-90, 2020 Jan.
Article em En | MEDLINE | ID: mdl-31794275
ABSTRACT
While Health authorities in Panama strive to increase generic drug use to contain the rising costs of medicines, there is still hesitation to embrace generic drugs. Thus, regulators and drug companies need to ensure the quality, safety and efficacy of generic drugs. One prevailing concern is the absence of control over lot-to-lot changes, which may impact consistent therapeutic performance. The objective of this work was to determine whether near-infrared spectroscopy (NIR) could detect product changes. Calibration models were built using reference (standard) tablets of two products Virax® (200 mg acyclovir) and Amlopin® (5 mg amlodipine). Then, to assess the sensitivity of NIR to product changes we compared reference versus deliberately-modified formulations of these products. Comparisons were made using principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) of NIR spectra. Several modified lots were different from reference lots, and 3D score plots showed greater discrimination by PLS-DA than PCA. The Kth nearest neighbor scores (KNN) of the modified batches were used to classify formulations as identical or not identical versus the reference. In addition, the differences detected by NIR were correlated with different in vitro dissolution and/or permeation in the in vitro dissolution absorption system 2 (IDAS2) NIR and IDAS2 yielded the same rank-order of difference for the modified lots tested. This study suggests that NIR and IDAS2 can help detect lots of generic drugs that differ from the reference lots. This strategy may help regulatory agencies in developing countries to safeguard patients against lot-to-lot changes in generic products.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos / Espectroscopia de Luz Próxima ao Infravermelho Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Medicamentos Genéricos / Espectroscopia de Luz Próxima ao Infravermelho Tipo de estudo: Prognostic_studies Idioma: En Ano de publicação: 2020 Tipo de documento: Article