Analysis of pharmaceutical pellets: An approach using near-infrared chemical imaging

Autor(es)

Sabin, Guilherme P. ^[1] ; Breitkreitz, Marcia C. ^[1] ; de Souza, Andre M. ^[1] ; da Fonseca, Patricia ^[2] ; Calefe, Lupercio ^[2] ; Moffa, Mario ^[2] ; Poppi, Ronei J. ^[1]

Afiliação do(s) autor(es)

^[1] Univ Estadual Campinas, Inst Chem, BR-13084971 Campinas, SP - Brazil

^[2] Zelus Serv Ind Farmaceut Ltda, Sao Paulo - Brazil

• Tipo de documento: Artigo Científico
• Fonte: Analytica Chimica Acta; v. 706, n. 1, p. 113-119, NOV 7 2011.
• Citações Web of Science: 23

Resumo

Pharmaceutical pellets are spherical or nearly spherical multi-unit dosage forms designed to optimize pharmacokinetics and pharmacodynamics features of drug release. The distribution of the pharmaceutical ingredients in the layers and core is a very important parameter for appropriate drug release, especially for pellets manufactured by the process of layer gain. Physical aspects of the sample are normally evaluated by Scanning Electron Microscopy (SEM), but it is in many cases unsuitable to provide conclusive chemical information about the distribution of the pharmaceutical ingredients in both layers and core. On the other hand, methods based on spectroscopic imaging can be very promising for this purpose. In this work, a Near-Infrared Chemical Imaging (NIR-CI) method was developed and applied to the analysis of diclophenac sodium pellets. Since all the compounds present in the sample were known in advance. Classical Least Squares (CLS) was used for calculations. The results have shown that the method was capable of providing chemical information about the distribution of the active ingredient and excipients in the core and coating layers and therefore can be complementary to SEM for the pharmaceutical development of pellets. (C) 2011 Elsevier B.V. All rights reserved. (AU)

• Processo FAPESP: 06/07309-3 - Novas estratégias analíticas para estudos envolvendo biomoléculas
• Beneficiário: Elias Ayres Guidetti Zagatto
• Modalidade de apoio: Auxílio à Pesquisa - Temático