Application and selection of medicinal plastic packaging materials
Category: Industry Dynamics
2023-07-04
1, brief introduction of medicinal plastic packaging materials
1.1 what is medicinal plastic packaging materials
plastic is short for plastic polymer materials, mainly composed of resin and chemical additives, and is one of the main materials of medicinal packaging materials. Compared with glass packaging materials, plastic packaging materials have the characteristics of light texture, high mechanical properties, corrosion resistance, convenient sealing, and low cost. In recent years, they have been widely used in pharmaceutical packaging.
Features of 1.2 medicinal plastic packaging material
(1) Good mechanical properties. It has good strength and elasticity, can resist bending, impact resistance, compression resistance, friction resistance, and is not easy to break;(2) good chemical stability. Compared with the easy hydrolysis of glass packaging materials and the easy corrosion of metal packaging materials, plastic packaging materials have good chemical stability, good tolerance to general acids, alkalis and salts, and good resistance to oxygen, moisture, carbon dioxide and other series of chemical media in the external environment of packaging;(3) light texture. The plastic packaging material is lighter as a whole, which is related to its lower density, which is about the 1/2 of glass and the 1/5 of metal;(4) it has good processing performance. Plastics are sensitive to heat, have high plasticity, are convenient for molding, heat sealing, compounding, etc., and are convenient for printing and decoration;(5) have good optical properties. It can be made into transparent or opaque packaging materials according to drug light sensitivity;(6) low cost. Plastic packaging materials are cheaper, lighter in texture and lower in transportation costs.
2, Types and Advantages and Disadvantages of Pharmaceutical Plastic Encapsulating Materials
2.1 Polyethylene (PE)
Polyethylene Material is abbreviated as PE. According to its density and structural differences, it can be divided into linear low density polyethylene (LLDPE), low density polyethylene (LDPE), medium density polyethylene (MDPE), high density polyethylene (HDPE), etc. Different density polyethylene materials have different properties:
high density polyethylene (HDPE) is a relatively hard and tough material, has strong resistance to various chemicals, relatively low transparency, and good barrier properties;
low density polyethylene (LDPE) is soft, transparent, and has good heat sealing properties, but has poor barrier properties to gas or odor;
Linear low-density polyethylene (LLDPE) is superior to LDPE in toughness, elasticity, and barrier properties. It is thinner and 20% thinner than low-density polyethylene. It can be made into softer and thinner films and has good heat sealing properties.
2.2 Polypropylene (PP)
Polypropylene is a high molecular polymer of propylene. Its appearance is similar to polyethylene, but its density is smaller and lighter than polyethylene. It is currently the lightest plastic packaging material.
polypropylene material has high chemical resistance; Excellent mechanical properties, mechanical properties are better than PE, especially good bending resistance and rigidity; High transparency than PE; Good moisture resistance and better air resistance than PE, which can well prevent peculiar smell from passing through. Good heat resistance, boiling water resistance, can be used as packaging materials for products requiring high-temperature disinfection and sterilization; Non-toxic and tasteless.
But this material also has some disadvantages. Polypropylene is very brittle at low temperature, cold resistance is far less than PE, not suitable for use at low temperatures; aging resistance is relatively weak, worse than PE, often need to add some antioxidants; printing performance is not good.
2.3 Polyvinyl chloride (PVC)
Polyvinyl chloride is polymerized from polyvinyl chloride monomers. The material is widely used in the packaging of solid preparations. At present, a large number of aluminum-plastic blister packaging materials for tablets and capsules on the market are made of PVC.
PVC material products have good transparency, high strength and excellent printing performance, which can well meet the needs of tablets, capsules and traditional Chinese medicine preparations for moisture-proof, bacteria-proof and anti-atomization.
PVC material itself is non-toxic, but polyethylene monomer has the effect of causing liver cancer, so attention should be paid to the PVC monomer content of PVC sheet used for drug packaging should be controlled within one part per million. On the other hand, polyvinyl chloride material has poor heat resistance and is easy to deform when heated. It is often necessary to add stabilizers and plasticizers to reduce the processing temperature and adjust the softness and hardness of PVC. Non-toxic additives should be selected for medicinal PVC sheets.
2.4 Polyvinylidene Chloride (PVDC)
Polyvinylidene chloride is formed by polymerizing vinylidene chloride (VDC) and polyethylene (VC). Polyvinylidene chloride material has better printing performance, good transparency, excellent heat sealing and chemical resistance; the most prominent feature of the material is that it has very low water and oxygen permeability, and is an excellent high barrier material.
However, this material also has some shortcomings, and its thermal stability is worse than PVC. Poor aging resistance; The residual sheet polyethylene monomer is toxic and has the risk of teratogenic and carcinogenic if exposed for a long time. Therefore, it should be strictly controlled when used as a medical packaging material, and the sheet polyethylene monomer content should not exceed 3 parts per million.
Compared with PE and PP,PVDC is more expensive. In pharmaceutical packaging, it is mainly made of composite film materials with PE and PP to improve the air tightness and barrier properties of the film materials, so as to improve the moisture resistance, oxygen barrier, sealing and other properties of the packaging.
2.5 Polyester (PET)
Polyester is a polymer containing ester linkages. Polyethylene terephthalate is commonly used in pharmaceutical plastic packaging materials. The material has excellent mechanical properties, and its toughness is the largest among the commonly used thermoplastics. It has strong tensile and impact strength. The tensile strength of the film is similar to that of aluminum foil. The impact strength is 3-5 times that of ordinary films. It has good folding resistance but poor Ness strength. Cold resistance and heat resistance are both good. Chemical resistance is good, but it is not resistant to concentrated acid and alkali. The gas barrier property is excellent and belongs to medium barrier material. Non-toxic, tasteless and safe. High transparency, good gloss, and the ultraviolet has good shielding.
But the material has poor heat resistance and is easy to degrade in hot water; it cannot accept high temperature steam sterilization; it has static electricity; it has poor heat sealing properties.
3, Application and Precautions of Pharmaceutical Plastic Packaging Materials
Plastic is easy to process, can be made into plastic bottles and plastic bags of various specifications and shapes, and can also be compounded with various packaging materials to make high-performance composite packaging materials. Medicinal plastic has the characteristics of light texture, high strength, not easy to break, good sealing, moisture, health, can not be washed, dried directly for pharmaceutical packaging, is an excellent pharmaceutical packaging container, widely used in oral solid preparations (such as tablets, granules, capsules, etc.) and liquid preparations (such as syrups, etc.) packaging. Although
plastic has many advantages, it may be selected according to the formulation when used. For example, when solid drug plastic bottles are produced, titanium dioxide or white masterbatch is usually added to make the bottle white and opaque, while for liquid drugs or drugs that need to be transparent, brown or other color masterbatch should be added to make the bottle meet the demand of transparency and have a certain color on the surface of the bottle to block sunlight. Due to the characteristics of the plastic packaging material itself, its barrier is relatively weak, if the product contains volatile components, may be through the container wall and cause loss. On the other hand, plastic packaging materials in the production process may be added to a series of additives, such as plasticizers, light stabilizers, heat stabilizers, lubricants, antioxidants, colorants, antistatic agents, etc., the use of the relevant additives need to pay attention to whether compatible with drugs, whether toxic, irritating and so on.
4, Summary
A variety of plastic packaging materials can be selected and applied according to the characteristics of drugs. For some soft packaging, low density polyethylene can be selected. For drugs with waterproof requirements, high density polyethylene and polypropylene can be selected. For drugs that are more sensitive to oxygen, polyvinylidene chloride with high barrier properties can be selected. For oral liquid preparations, if glass bottles are not selected, polyester packaging is a good substitute. The plastic bag for infusion can rely on its own tension to press the liquid drops without forming an air circuit, which can avoid the secondary pollution caused by the use of glass bottles and is a good substitute for glass infusion bottles.