Captopril 25 mg tablets stability assessment in different primary packing materials

• Autor(a) principal: Paiva, Flávia Costa Mendes
• Data de Publicação: 2017
• Outros Autores: Rocha, Helvécio Vinicius Antunes
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• DOI: 10.22239/2317-269X.00945
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/945
• topic: Packaging; Stability; Captopril; Tablets; Embalagem; Estabilidade; Captopril; Comprimidos

Introduction: Packaging is used to provide protection and information, from the production to the administration of a formulation. It is essential to define the primary packaging, for keeping the therapeutic efficacy of drugs, safety of users and for protecting drugs from instability. Objectives: The main objective of this study was to assess the stability of captopril 25 mg tablets in different primary packaging materials. Method: The characterization (IR, DSC and physical tests) of the packaging materials used for captopril was carried out prior to the manufacture of tablets. Tablets were also characterized by physical-chemical analysis, comparative dissolution profile and stability studies. Results: The characterization of packaging materials was crucial for understanding the behavior of captopril when packed in each material. Materials with significant barrier, as blisters PVC/PVdC 90 g.m-² and hard aluminum and PVC/PE/PVdC and hard aluminum showed satisfactory results in a second stage, S2. On the contrary, lower barrier materials as blisters PVC/PVdC 40 g.m-² and hard aluminum did not present dissolution analysis S2. Conclusions: The aluminum strip presented the best results. And the batch in glass bottle, although packaged in excellent material, was disapproved in accelerated stability.