Application development of pharmaceutical packaging materials

Abstract: This paper introduces the requirements of pharmaceutical materials for packaging materials, summarizes the current status of pharmaceutical packaging materials, and discusses the development trend of pharmaceutical packaging materials: new materials with high barrier properties, anti-bacterial self-cleaning materials, environmentally friendly new materials, and “smart materials”. It is the development focus of pharmaceutical packaging materials in the future.

Keywords: medicines; packaging materials; development trend

Drugs are a special kind of commodity. They are easily decomposed and degraded during the circulation process due to the influence of the surrounding environment such as light, moisture, and microbial contamination. After the drug is processed, it is necessary to select appropriate packaging to maintain the efficacy of the drug and improve the drug. Stability, delaying the deterioration of drugs, and ensuring the safety of the people's medication, so the packaging of medicines is called medicines: Second life'. Qualified pharmaceutical packaging should be characterized by sealing, stability, lightness, aesthetics, appropriate specifications, packaging labeling specifications, reasonable and clear, and should also meet the requirements of all aspects of drug circulation, storage and application. To meet the above-mentioned functions of pharmaceutical packaging, pharmaceutical packaging materials are the foundation and the key. With the improvement of China's pharmaceutical market, the classification management of prescription drugs and non-prescription drugs puts higher requirements on the packaging materials of drugs. To strengthen the management of pharmaceutical packaging materials, the State Food and Drug Administration passed the June 18th, 2004. And issued. Management of packaging materials and containers for direct contact with pharmaceuticals. Therefore, understanding and mastering the current status and development trend of pharmaceutical packaging materials is of great significance for the correct selection and development of pharmaceutical packaging materials.

1 Requirements for packaging materials

Unlike the requirements of ordinary packaging materials, the ideal pharmaceutical packaging materials should be able to meet the requirements.

1.1 Ensure the stability of the quality characteristics and composition of the drug

The main function of the packaging material zui is to ensure the quality characteristics of the drug and the stability of various components. During the shelf life, no change, loss or contamination of any form of chemical components will occur. Therefore, different packaging materials should be selected according to the characteristics of the drug and the preparation. First of all, pharmaceutical packaging materials must be safe, non-toxic, non-polluting, etc. Secondly, pharmaceutical packaging materials must have good physical and chemical and microbiological stability, do not decompose and age during the shelf life, do not adsorb drugs, do not with drugs Material migration or chemical reaction occurs between them without changing the drug properties.

1.2 Adapt to various requirements in circulation

After the drug is produced, it needs to go through the various circulation links such as storage and transportation to reach the patient's hands. The climatic conditions, circulation period, transportation mode, loading and unloading conditions, etc. of each link are different or even different. Therefore, the packaging materials of the medicines must be compatible with the circulation environment. It must have certain physical properties such as heat resistance, cold resistance and barrier properties to meet the requirements of temperature and humidity changes in the circulation area; it must also have certain resistance to tearing, pressure, puncture and fall prevention. Performance to prevent various forms of damage and damage during handling, transportation, and stacking.

1.3 has certain anti-counterfeiting features and aesthetics

In order to prevent counterfeit and inferior drugs and ensure the purity of the drugs, the drug packaging materials should have certain anti-counterfeiting ability, and the patients can easily distinguish the authenticity of the drugs through the packaging materials. The aesthetics of the packaging materials will promote the sales of medicines to a certain extent, and at the same time make the patients feel happy and help the health and improvement of the health, so the pharmaceutical packaging materials need better printing and decorative properties.

1.4 Low cost, convenient for clinical use and does not affect the environment

Pharmaceutical packaging materials should select materials with a wide range of raw materials, low prices and good processing properties, and the cost of packaging the drug, thereby reducing the price of the drug; it should also be convenient for clinical use, in order to improve the efficiency of medical staff; It will not affect the environment, it will be naturally decomposed and easy to recycle.

2 Status of pharmaceutical packaging materials

2.1 Plastic

The plastic has the advantages of light weight, transparency, toughness, easy processing, low cost, collision resistance, and not easy to be broken. It can be made into plastic bottles and plastic bags of various specifications and shapes, and can be combined with various packaging materials to make high. The performance of composite packaging materials is thus widely used to package medicines.

1) Polyethylene. It has the characteristics of non-toxic, hygienic and low-cost, has good flexibility, transparency varies with molecular weight, has good moisture resistance, is easy to process, has excellent heat sealing and thermal adhesion. , strong cold resistance; but poor air tightness, poor printing performance, low strength and heat resistance, easy to be degraded by the action of light and heat, generally need to add antioxidants, the commonly used antioxidant is butyl hydroxytoluene or Dilaurate thiodipropionate.

2) Polypropylene. The appearance is similar to that of polyethylene, but it is lighter and more transparent than polyethylene. It is odorless, non-toxic, and has good moisture resistance. It can prevent odor from passing through and has high heat resistance. It will not be destroyed after being sterilized in steam at 135~C for 100 hours. Disadvantages are poor aging resistance, poor printing performance, unsuitable use at low temperatures, and poor air tightness.

3) Polyester. Because of its good transparency, high strength, excellent dimensional stability, good air tightness, odorless and non-toxic, it is commonly used to replace the packaging of solid containers such as glass containers and metal containers and tablets and capsules; PET is formed by biaxial stretching. BOPET is commonly used to package traditional Chinese medicine decoction pieces. In addition, it has excellent barrier to odor permeability and moisture resistance, and can be used as a barrier layer in a multi-layer composite film to ensure that the drug does not deteriorate during the effective period and is not cracked by light irradiation. Such as PET / PE composite film. The disadvantage of PET is that it is easily degraded by boiling in hot water, can not withstand high temperature steam sterilization, and is easy to carry static electricity and cannot be heat sealed.

4) Polyvinylidene chloride. PVDC has good transparency. Excellent printability and heat sealing performance, extremely low transmittance to water vapor, gas and odor, excellent moisture resistance, air tightness and aroma retention, and it is a high barrier property with excellent performance. Its shortcomings are poor aging resistance, easy to be decomposed by hydrogen and hydrogen by the influence of heat and ultraviolet rays, and its residual monomers are also toxic. Therefore, the quality of the packaging materials should be strictly controlled; in addition, because of its high price, in medicine The packaging is mainly made of a composite film made of PE, PP or the like as a packaging bag for powders and powders, so as to give full play to the advantages of good barrier properties.

5) Polyethylene naphthalate (PEN). PEN has good transparency and barrier properties. Excellent mechanical properties, glass transition temperature up to 121 ° C, slow crystallization rate, easy to make transparent thick-wall heat-resistant bottles. Due to the high price of PEN, PEN is usually blended with PET to reduce costs, and its airtightness and shelf life are comparable to those of glass bottles. PEN has strong UV-resistant characteristics, so the composition of the drug does not change due to light irradiation, and is often used for thermal encapsulation of oral liquids, syrups, and the like.

6) Polyvinyl chloride. PVC has good moisture resistance, water resistance and air tightness, can be heat-sealed, and has excellent printing performance. In pharmaceutical packaging, rigid PVC is mainly used to make turnover boxes and bottles; soft PVC is mainly used for making films and bags. Wait. In recent years, with the improvement of the quality and grade of pharmaceutical packaging, a new application space has been opened for semi-rigid PVC sheets. At present, a large number of PVC sheets are used as blister materials for aluminum-plastic blister packaging of tablets and capsules. j. It should be pointed out that the PVC used for pharmaceutical packaging should be non-toxic and the content of vinyl chloride monomer should not exceed 1×10.

7) Polystyrene. It is a non-toxic, tasteless, glass-like, colorless and transparent material with good coloring and printing properties, low water absorption, good dimensional stability, rigidity and no ductility. It is mainly used for making small drugs. Packaging container. The disadvantages are low impact strength, poor moisture resistance and heat resistance.

Plastics used for pharmaceutical packaging are ethylene-vinyl acetate copolymers, polyamides, polytetrafluoroethylene, polycarbonates, cellulose acetate, polyurethanes, and the like.

2.2 Glass

Due to its stable chemical properties, good barrier properties, low cost, good appearance and easy disinfection, it can protect the drug. Glass is widely used in the packaging of pharmaceutical products, mainly used in infusion bottles, antibiotic powder injection bottles, oral liquids. Bottles, water injection packaging, etc. The main disadvantage of glass is that it is easily broken and has a large specific gravity. It is not portable. Long-term contact with water or alkaline substances or brushing and heat sterilization will reduce the surface of the inner wall or reduce the transparency, and can hydrolyze the glass and directly release the substances. Affect the stability, pH and transparency of the drug.

2.3 Metal

The metal material used in the pharmaceutical packaging is aluminum. The material is beautiful in appearance, has excellent metallic luster, has excellent moisture resistance and gas barrier property, good printability, no magnetism, no resilience, easy to open, High thermal conductivity, good heat and cold resistance, not easy to rust, oxide non-toxic, shading, excellent processing performance, treated aluminum foil has good ductility, easy to be combined with paper, plastic, etc. material. Its main application forms are: aluminum-plastic blister packaging, double-aluminum foil packaging, aluminum foil and plastic composite bag-making packaging I, cold-stamped packaging and aluminum cover for powder injection packaging. There are also metal hoses made of tin, plastic coated tin, tin-plated lead and other metals.

2.4 Rubber

The rubber has good elasticity and can be quickly recovered after deformation by external force, and is easy to clean. Therefore, rubber gaskets, rubber gaskets or rubber stoppers are mostly used in pharmaceutical packaging bottles. The rubbers used mainly include natural rubber and butyl rubber, of which natural rubber has been basically eliminated. At present, China is vigorously promoting the use of butyl rubber uo1"j. Base rubber has excellent air tightness, heat resistance and ozone oxidation resistance. It can be exposed to sunlight and air for a long time without damage. The high temperature can reach 200~C, good chemical resistance, acid and alkali resistance. And polar solvents have been increasingly used in the packaging of antibiotic powders. It should be noted that the compatibility of the drugs should be noted in the process of using butyl rubber.

3 Trends in pharmaceutical packaging materials

3.1 high barrier new materials

The high barrier properties of pharmaceutical packaging are the criteria that Zui needs to consider, effectively preventing gas, water vapor, odor, light, etc. from entering the package, which can fully guarantee the effectiveness of the drug. The application of high-barrier packaging materials has become very common in Europe and Japan. Since the introduction of high-barrier packaging materials such as PVDC in the 1980s, China has also attached great importance to the development and use of high-barrier packaging materials. However, the current comprehensive performance of barrier materials still needs to be improved and there are problems such as high price. Therefore, the development of new, low-cost, high-barrier materials is a major trend in the development of pharmaceutical packaging materials.

3.2 Antibacterial self-cleaning materials

Although the clean environment for pharmaceutical production is designed in accordance with GMP requirements, it is impossible to absolutely sterilize any one of the dosage form production and packaging processes. In addition, some medicines (such as bottled pills, bagged pills, etc.) are not used up after opening. However, it is used many times. Since the sealing performance of the package is greatly reduced after unsealing, it is likely to be contaminated by microorganisms. Therefore, in order to extend the shelf life of the drug and ensure the safety of the drug, the development and use of the drug packaging material with antibacterial self-cleaning function has profound advantages. The meaning. By compounding nano-titanium dioxide, nano-silver and other antibacterial agents in a matrix such as plastic, a material with antibacterial self-cleaning function is obtained, but these studies have just started, and it is necessary to further study its compatibility and wide application in pharmaceutical packaging. Problems such as generality and long-term effectiveness, therefore, this will be a hotspot and main direction for the development and application of pharmaceutical packaging materials in the future.

3.3 Environmentally friendly new materials

With the strengthening of people's environmental awareness, development. Green packaging has reached a consensus, and most of the plastics in pharmaceutical packaging materials are not degradable after recycling and are difficult to recycle, causing serious environmental damage. White pollution' has developed some degradable polymer materials. However, most of them are still in the experimental research stage, and the comprehensive performance needs to be improved. Therefore, it is a long-term and arduous way to develop environmentally-friendly pharmaceutical packaging materials that are degradable, easy to recycle, environmentally friendly, and compatible with drugs. jobs.

3.4 “Smart Materials”

Smart materials, known as new materials in the 21st century, refer to new materials that are sensitive, responsive, and functionally discoverable to the environment. Their emergence has aroused great interest among scientists and technicians. A hot spot in research and development. Combining advanced technologies such as biotechnology, information technology, electronic technology, and nanotechnology with pharmaceutical packaging materials, it is expected to develop a variety of functions such as self-testing of drugs, anti-counterfeiting, timely reminding patients to take medicine, and self-repairing when broken. Intelligent pharmaceutical packaging materials are undoubtedly of great significance for extending the shelf life of drugs and facilitating drug use for patients. Therefore, smart drug packaging materials will definitely be the focus and hotspot of long-term research and development in the field of materials.

4 Conclusion

With the deepening of scientific research on pharmaceutical packaging materials and the application of new materials, new technologies and new processes in the field of packaging materials, pharmaceutical packaging materials will be more convenient, safer and more environmentally friendly, thus better People serve.

Author brief introduction <br>Yang Kangli, Yuan Zhiqing, Chen Hong (1. Zhuzhou City First Hospital, Zhuzhou 412000; 2. Hunan University of Technology, Zhuzhou 412008; 3. Central South University of Forestry and Technology, Changsha 410004, China)