Compatibility test between pharmaceutical packaging materials and pharmaceutical products

Pharmaceutical packaging here refers to packaging that is in direct contact with drugs, such as glass bottles, plastic bottles, aluminum foil, butyl gaskets, rubber stoppers, aluminum caps, etc. Direct contact with the quality of pharmaceutical packaging like these has a direct impact on the drug. Compatibility basically encompasses any mutual exchange that occurs between products and packaging. Incompatibilities can be related to reactions, migration, leakage, adsorption, absorption, and extraction, resulting in component gains and losses, as well as physical or chemical changes. These exchanges can manifest as changes in organ sensation, increased toxicity or irritation, gains and losses in microbial effects, precipitation, turbidity, color changes, pH shifts, and degradation. On the other hand, other external influences can catalyze, induce, or eliminate chemical changes. Chemical changes can be accompanied by further chemical reactions. Chemical reactions or contamination can also be caused by impurities in the components, accidental components from the production process, or abrasion between contact interfaces.

At present, China's pharmaceutical packaging has more than 60 packaging materials and container varieties in direct contact with drugs in five categories, including pharmaceutical glass, metal, pharmaceutical gelatin products, rubber, plastic (containers, sheets, films) and their composite sheets (films). Although in recent years, under the influence of internationalization, the promotion of market demand and the support and guidance of China's relevant policies, pharmaceutical packaging materials have developed greatly, but China's pharmaceutical packaging material manufacturers and pharmaceutical packaging materials products are still relatively backward, the overall level of drug packaging is low, and the contribution rate of packaging materials to the development of the pharmaceutical economy is low. The overall level of pharmaceutical packaging, including packaging quality, packaging material quality and the contribution rate of packaging to the pharmaceutical economy, is significantly lower than that of developed countries.

Although there are large enterprises in China's existing pharmaceutical packaging material production enterprises, most of them are township collective enterprises, with small scale, low personnel quality, equipment, technology and management level, and unstable product quality. At present, many pharmaceutical packaging material manufacturers have backward packaging material technology and market chaos, especially in the face of new products and new dosage forms developed by pharmaceutical companies in an endless stream, and the follow-up speed of drug packaging materials that match their physical and chemical characteristics is too slow to be solved. Less innovation, more imitation of existing packaging materials is now the way of survival of pharmaceutical packaging materials manufacturers, a drug packaging materials packaging different drugs phenomenon has always existed.

For a long time, when pharmaceutical companies pay attention to the safety of drugs in the research and development of new drugs, they often only consider the safety of drugs (active ingredients) in the traditional sense of the new drugs they develop, that is, the safety of the drugs themselves, mainly the relevant characteristics of drug toxicology and the adverse reactions (serious adverse reactions, unexpected adverse reactions, side effects) generated in clinical use. However, the potential factors that can affect the quality of drugs - the packaging materials of APIs and pharmaceutical preparations have not attracted everyone's attention. This concept exists not only in pharmaceutical packaging material manufacturers, but also in pharmaceutical packaging material use enterprises. Improper drug packaging form, improper selection of packaging materials, and the impact of storage environment will have a negative impact on the quality of drugs.

The packaging materials and containers that are in direct contact with drugs are an inseparable part of drugs, which accompany the whole process of drug production, circulation, storage and use. Due to the different composition and formulation, selected raw materials and excipients and production processes of pharmaceutical packaging materials and containers, some components may be dissolved by the drugs they come into contact with, migrate to the drugs, and release toxic and harmful substances. Or interact with drugs, adsorb the active ingredients in the drug, reduce the content of the active ingredient and affect the efficacy of the drug. or be soaked in the drug for a long time, corroded and detached, which directly affects the quality of the drug. Some substances will even lead to accelerated degradation of drugs, not only because the reduction of active ingredients affects the clinical efficacy of drugs, but also because of the toxic side effects of some degraded ingredients, which will also bring serious safety risks to the public.

For example, if the retort infusion bottle (bag) is not used for different drugs with different formulas and production processes, there will often be components dissolved and glass delamination, which can not be found in routine drug testing. The anisotropic protein dissolved in the natural rubber plug has a sensitizing effect on the human body, and the dissolved pyridine compounds are carcinogenic, teratogenic and mutagenic. Some additives in the butyl gum cold can produce serious hemolysis phenomenon when tested alone, and some additives are very toxic in the separate test, and if the JuN addition ratio is not appropriate in the finished butyl gum cold, the results can be imagined. The subtle glass delamination in the glass infusion bottle is a hidden danger of blocking blood vessels to form thrombosis or pulmonary granulomas, and iodine preparations can seriously corrode the aluminum foil that packages it, causing iodine volatilization and so on. On the other hand, due to the wide variety of pharmaceutical products and the complexity of the effective bracket groups, the requirements for packaging materials and containers that come into direct contact with them are much higher than those of other products.