The packaging container system in medical packaging refers to the sum of all packaging components that contain and protect the active substance or preparation. It includes a direct packaging component and a secondary packaging component, the latter being used for additional protection of the active substance or preparation. This article mainly discusses direct packaging components, that is, packaging container systems that directly contact drugs. On the one hand, the packaging container system that directly contacts the drug provides protection for the active substance or preparation to meet its intended safety and effectiveness; on the other hand, it should have good compatibility with the active substance or preparation, that is, it cannot be introduced to cause safety The problematic leachables (substances that migrated from the packaging container system or generated as a result and entered the drug product), or their level of leachables meet safety requirements.
The compatibility of drugs and packaging container systems has always been a matter of great concern to drug regulatory authorities, and is also an urgent need for drug research and production companies to understand and need to conduct research, especially high-risk preparations, such as inhalation preparations (aerosol, inhalation solution Agents, suspensions, sprays and nasal sprays, etc.), injections (solution type, suspension type) and eye drops (solution type, suspension type), etc. The research on the safety of extract is an important part of the review. How to conduct the compatibility study of medicine and packaging container system has no practical guiding principles at present.
The European Union EMA issued the Chinese Journal of New Drugs 2012, 21(19) 2227, Chinese Pharmaceutical Journal 2012, Volume 21, Issue 19, Guidelines for Sexual Research [2], which mainly describes plastics The application requirements for packaging materials and the study of the compatibility of plastic packaging materials with pharmaceuticals are only general descriptions, and there are no specific technical requirements.
The US FDA published industrial guidelines for metered dose inhalers (MDIs) and dry powder inhalers (DPIs) in 1998 [4], which provides general guidance and recommendations for the research on extractables and extracts of inhaled formulations, and there is no specific skills requirement. Selection of components and materials for packaging container systems that are in direct contact with pharmaceuticals; identification of key components of packaging and container systems; rational design of extraction tests, including calculation of the amount of extracted test materials, determination of extraction solvents and extraction conditions, establishment of sensitive and exclusive analysis methods, and extraction tests Analysis of results, etc.; reasonable design of migration test and adsorption test, evaluation of migration test results, etc. are all contents that need to be considered for the compatibility study of drug and packaging container systems.
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