Packaging materials and containers for direct cont

2022-06-01
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Packaging materials and containers for direct contact with drugs (Part I)

packaging refers to the container containing and protecting products. It plays an important role in maintaining product quality, reducing loss, facilitating transportation, storage, sales, beautifying goods and improving service quality. The packaging mentioned in this paper refers to the packaging materials and containers in direct contact with drugs

drug packaging is different from the packaging of general goods. The packaging of drugs is restricted by the inherent nature of drugs, that is, it is necessary to maintain the efficiency of drugs, improve the stability of drugs, delay the deterioration of drugs, ensure safety and health, and prevent decomposition and deterioration caused by moisture absorption, air leakage and light. Therefore, drug packaging is the guarantee to maintain the nature of drugs and the correct use of drugs. The qualified drug packaging shall have the characteristics of sealing, stability, lightness, beauty, appropriate specification, standardized, reasonable and clear packaging identification, so as to meet the requirements of all links of drug circulation, storage and application. Drug packaging is also an important index for the evaluation of drug quality

1 the development process of drug packaging in China [1]

drug packaging in China has experienced three stages. The first stage is the 1950s and 1960s, such as brown glass bottles, straw board cartons, straight neck ampoules and other drug packaging, based on the principle of practicality

the second stage is the early 1970s and 1980s, which is in a state of adjustment and wandering

from 1980s to now, it is the third stage. After years of running in, the pharmaceutical packaging industry has developed healthily. In terms of packaging form, in addition to tablets, powders, pills, creams, water, needles and powders, packaging suitable for suppositories, oral liquids, aerosols, capsules, patches, chewing agents and other dosage forms have been developed. In terms of materials, aluminum plastic, paper plastic, laser anti-counterfeiting and other composite materials are becoming more and more popular

2 particularity of drug packaging materials

2.1 safety [2]

2.1.1 packaging materials in direct contact with safe drug use play an important role in ensuring drug stability, thus directly affecting drug use safety. Unsuitable materials can cause the migration, absorption, adsorption and even chemical reaction of active drug components, resulting in drug failure and sometimes serious toxic and side effects. Therefore, before selecting the container material for any drug, it must be tested and confirmed that it is suitable for the intended use, its impact on the stability of the drug must be fully evaluated, and the protective effect of the container on the drug under different environmental conditions (such as temperature, humidity, light, etc.) during long-term storage must be evaluated. When evaluating a drug, the China food and Drug Administration [3] and the US FDA require that the packaging used for the drug can ensure the stability of its efficacy throughout its service life. In the process of new drug research, the preparation should be placed in 19. On the experimental items, the stability should be investigated in the marketing package

2.1.2 selection of packaging materials it is a very important work in the pharmaceutical industry to select appropriate packaging materials to protect the integrity of drug quality. The container materials used for drug packaging are mostly glass, metal, plastic and rubber. These materials have different characteristics, and appropriate categories must be selected in combination with the physical and chemical properties of drugs, so as to protect drugs from the influence of environmental conditions, do not react with drugs, and do not make drugs have polluting taste and non-toxic

2.2 adaptability of packaging materials [4] the selection of the applicability of drug packaging materials and the design of packaging directly affect the overall quality of drugs

2.2.1 the packaging of solid preparations, tablets and capsules have now tended to be packaged in plastic aluminum foil or aluminum foil. The utility model has the advantages of light weight, convenient use, less pollution and easy deployment. However, aluminum plastic packaging has certain moisture permeability and air permeability, and drugs are easy to absorb moisture and deliquesce. Aluminum foil aluminum foil plate packaging can block light, and the storage time is relatively long. For example, for drugs that are easily deliquescent, weathered and oxidized and discolored when exposed in the air for a long time, such as compound licorice tablets, aminophylline tablets, ferrous sulfate tablets, etc., if the pharmacy distributes them to patients in paper bags, the drugs are easy to deteriorate. If the single dose packaging with aluminum foil plate is directly sent to patients, it can not only ensure the quality of drugs, but also reduce the pollution during sub packaging and facilitate the deployment. Some drugs packaged in plastic bottles are easy to absorb moisture and deteriorate. For example, antavisol tablets and vitamin B1 tablets, they should be filled in glass bottles. Drugs that need to be protected from light should not be packaged in aluminum-plastic, such as tinidazole tablets. How to choose the experimental machine in aluminum-plastic packaging is the concern of most users. It can be transparent. Once the outer packaging is removed, it is easy to change color, and it is better to package with aluminum foil. Granules and suspensions are mostly packaged in single dose aluminum plastic bags, that is, the inner layer is aluminum foil and the outer layer is composite film, such as xisumi, which has the advantages of not easy to absorb moisture, not easy to break and easy to tear

2.2.2 at present, the packaging of oral liquid preparations mostly adopts the single dose packaging of easy to pull cap vials, which is convenient to use and not easy to pollute. In addition, the use of oral liquid bottles with measuring cups is also very convenient. But it's different for children's antipyretics. If the loading capacity is 60 ml, some use it once or twice to reduce fever, and the remaining liquid medicine has to be discarded for a long time, so it is more suitable to make a single dose packaging

2.2.3 packaging of injection and large infusion [5] easy to break ampoules are fully used for injection, which greatly facilitates clinical application. However, the printing on the glass ampoule is unclear and easy to be erased. For example, the application of polyester self-adhesive label can solve this problem. Most imported and joint venture drugs (such as phentolamine and carnitine) use this label. From the original glass bottle packaging, large infusion is developing into disposable polypropylene plastic bottle packaging. The utility model has the advantages of convenience, lightness, not easy to break, convenient transportation and storage, no pollution, stable infusion quality and storage time of up to 5 years

2.2.4 other types of preparations contain mineral oil, vegetable oil, some oil-soluble solutions and external tinctures, which should not be contained in polyethylene plastic bottles. Due to the soluble ethylene monomer, it is potentially harmful to human body

(to be continued)

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