Hunan Novol Pharmaceutical Packaging Technology Co., Ltd.

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Selection and Development Direction of Pharmaceutical Packaging Materials

2023-07-04

In daily life, we are very familiar with medicines. Many people are very concerned about the health of themselves and their families, as well as the safety of their medication. As a special commodity, the safety, sterility, quality and efficacy of drugs are closely related to people's safety and health. Packaging materials closely related to the efficacy of drugs should not only ensure the reliability of drugs, but also have convenience. Therefore, when pharmaceutical manufacturers choose pharmaceutical packaging materials, they must understand the characteristics and properties of packaging materials in order to accurately and reasonably select pharmaceutical packaging materials according to some special requirements of drugs. Because the drug packaging is accompanied by the entire production, circulation and use of the drug, the packaging material is an important factor in the quality of the drug. For the quality of drugs, people's requirements are getting higher and higher, and also for the packaging of drugs. Therefore, exploring the packaging materials of drugs is an important issue that can not be ignored by pharmaceutical packaging enterprises.

1. common pharmaceutical packaging materials

1 and plastic packaging materials

accompany the rapid development of the medical contract industry. in the pharmaceutical packaging field, plastic packaging is the current leading product and has great development prospects.

Plastic packaging consists of polyvinyl chloride and polyolefin. Some of the substances contained therein are non-toxic, heat-resistant, impermeable, and can block light, moisture, and autoclaving. In addition, the plastic packaging of liquid medicine does not need additional air during transportation, which can well prevent the liquid medicine from being polluted by air. Widely used in granules, pills, capsules and tablets.

From the perspective of the formula and materials of plastic packaging containers, it is not only closely related to the quality of medicines, but also directly affects the health of patients. Therefore, plastic packaging materials must have good safety, chemical stability, knowledge, sterilization resistance, convenient storage and transportation, good sealing, and convenient for clinical use.

However, at present, plastic packaging materials cannot be compared with glass packaging in terms of heat resistance and insulation. At the same time, polymer plastic containers also have a certain impact on the stability of drugs, such as air permeability, product degradation, and additive leaching.

2, glass packaging material

glass container, as a packaging material widely used in infusion, injection, powder injection and blood products, can adjust its radiation resistance and chemical properties with the group due to its heat resistance, chemical stability, good mechanical strength and good isolation, and not easily affected by the atmosphere. At the same time, they are cheap, beautiful, transparent, and can be recycled, so they have been widely used.

At present, there are two common types of glass materials used in China. Type I glass is borosilicate glass with a content of more than 8%. It has good thermal and chemical stability. It is commonly used in test vials, pre-filled syringes, pre-vaccination, and blood product packaging. Because type II glass is soda-lime glass, there will be a thin layer of rich silicic acid in pharmaceutical packaging materials. Therefore, before using a glass-packed infusion bottle for infusion, not only the appearance of the bottle mouth, stones, material points and cracks of the infusion bottle should be carefully checked, but also the silicon-rich layer should be specially checked to check whether the white film on the inner wall of the infusion bottle is complete and uniform. If the neutral treatment is incomplete and uneven, it should not be used to avoid the impact of the bottle wall falling off during storage.

From the performance of the two glass packages, neutral and weak acid infusions are suitable for soda-lime glass infusion bottles, while borosilicate glass bottles are more suitable for alkaline solutions. For example, if sodium bicarbonate injection is stored in a soda-lime monthly glass package, the glass bottle wall will fall off or fall off during long-term storage, causing the solution to be turbid and affecting product quality. In addition, glass containers will interact with certain drugs, thereby affecting the quality of the drugs. Therefore, during the use and storage of drugs, it is necessary to ensure that they will not fail or deteriorate due to changes in chemical properties. Before use, carefully check whether the value of the substance in the glass bottle has changed, whether there is any substance falling off, whether the medicine is clear, etc.

3, rubber packaging material

At present, the pharmaceutical rubber packaging used in our country mainly includes butyl rubber stopper and natural rubber stopper. From the composition point of view, the natural rubber plug has poor chemical stability, complex composition, poor sealing and shielding, and aging solution. If the liquid preparation is in contact with the rubber stopper, some substances in the rubber stopper may dissolve out and enter the liquid medicine at the same time, causing turbidity or foreign matter in the liquid medicine. Some of them will react with the components in the rubber stopper to produce impurities and cause harm to the patient's health. For example, latex allergens can cause skin allergies. At the same time, the rubber control plug can also absorb the antibacterial agent and the main drug in the solution, especially the antibacterial agent, which will greatly reduce the efficiency of the antibacterial agent. Therefore, we should rely on the concerns of other parties.

Butyl rubber stopper has stable quality, acid and alkali resistance, heat resistance, and high cleanliness. Especially compared with natural rubber in terms of biological safety and air tightness, it is a good substitute for natural rubber stopper. In order to better meet the packaging needs of various drugs, butyl rubber plugs have been improved and a variety of formulations have been developed. For example, halogenated butyl rubber is to improve the activity, mutual adhesion, self-adhesion and vulcanization crosslinking ability of butyl rubber, so that it is compatible with unsaturated rubber and maintains its original characteristics.

However, due to the complex composition of butyl rubber plugs, it is difficult to grasp its dilution conditions. If there is no reliable process and reasonable formula, it is easy to escape foreign proteins, impurities and vulcanizing agents, and insoluble particles appear in the solution, which affects the clarity of the injection and leads to unqualified. In addition, if more small particles are released from the butyl rubber, it will cause scattered light caused by the small particles, which will affect the clarity inspection. Therefore, for rubber plug production enterprises, the management level and technical level should be strengthened. Production shall be carried out in strict accordance with the legal production standards for pharmaceutical packaging materials, and quality improvement shall be strengthened from the source.

Water and gas are often used as catalysts for oxidation reactions. After inhaling water vapor, the drug is easy to cause agglomeration, deliquescence, oxidation and other changes, resulting in the weakening of the effect of some drugs, and even produce toxicity. Therefore, the moisture permeability and air permeability of drug packaging materials will directly affect the preservation and use of drugs.

packaging and testing instrument

drug packaging should ensure the safety of drugs as the premise, improve the overall sealing performance and increase the barrier performance. the production of pharmaceutical packaging needs to strengthen the further optimization of design and technology, strengthen the research and development of new materials, and further improve the packaging quality to meet higher standards. At present, the rapid development of science and technology, the market through nanotechnology preparation of nano-antibacterial packaging, nano-composite materials and nano-adhesive technology applications, the field of packaging materials to provide a direction of guidance.

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