Avaliação da estabilidade de comprimidos de captopril 25 mg em distintos materiais de embalagem primária

Abstract

Pharmaceutical products have restrictive technological requirements for medicines packaging. The packaging for pharmaceutical products can be defined as an economical mean to provide protection, presentation, identification, information and convenience for a pharmaceutical product since the production until the final administration. It is essential to make a criteria analysis of the primary packaging, forkeep the therapeutic efficacy of drug, safety of users and protect the drug from possible influence onstability. So, the main objective of the present study was the evaluation of the stability of captopril 25 mg tablets in different primary packaging materials, once during stability studies it was observed a tendency to the second-stage dissolution test (S2). Therefore, characterization was performed (IR, DSC and physical tests) of the primary packaging materials used for the packaging of captopril 25mg, followed by the manufacture of tablets. As for packaging, the tablets of captopril 25 mg were also characterized by physical-chemical analysis, comparative dissolution profile and stability studies, when packaged in blister laminate distinct, aluminum strip and amber glass bottle with lid polypropylene. Knowing the structure of the packaging materials and their properties, was concluded that though these materials show effect on the packaged product behavior, the second-stage trend analysis (S2) during the dissolution studies may be not related to the physico-chemical composition of the primary packaging material. The detailed characterization of primary packaging materials was crucial for understanding the behavior of captopril 25 mg tablets when packed in each material. The practice of using complementary techniques, beyond the traditionalphysical tests, should be a routine in the pharmaceutical industries, to check the specifications informed by suppliers and to ensure the stability of the product in the packaging material that was studied and in which prooved its quality, efficacy and safety for drug product registration in the regulatory agency.