Analysis of the principle of drug packaging material selection

[China Packaging Network News] The packaging materials used for pharmaceutical tablets are directly exposed to drugs, and therefore are a type of pharmaceutical packaging. Drugs are a special commodity whose efficacy and quality are directly related to human health and safety. The packaging materials and structural forms used must also ensure the efficacy of drugs while also ensuring the reliability and convenience of drug use. Therefore, as a drug manufacturer in the selection of packaging materials, it is necessary to understand some properties and characteristics of the packaging materials and containers so as to combine the specific requirements of the drugs and to select rational and accurate pharmaceutical packaging materials.

Plastic bottle packaging

The biggest characteristic of medicinal plastic bottles is light weight, non-broken, clean, and beautiful. Pharmaceutical manufacturers do not need to clean and dry and can use them directly. And some of its technical indicators and a large number of data show that its chemical resistance, water vapor permeability and sealing performance is excellent, it can completely protect the loaded drugs in the effective period of the security shield.

There are high-density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC), and polyester bottles (PET) in the materials used. In the early 1990s, foreign countries developed blow molded bottles. The new material, polyethylene naphthalate (PEN) plastic bottle, is superior to PET in terms of its high strength, good heat resistance, ultraviolet radiation resistance, excellent carbon dioxide gas and oxygen barrier properties, and chemical resistance. Well, more widely used than PET, PEN material is a new type of polyester resin actively developed at home and abroad in recent years, and it is also an excellent material for pharmaceutical plastic bottle packaging.

Because of the many specifications of medicinal plastic bottles, small dozens of milliliters, large thousands of milliliters, some colorless, some transparent, various colors, different shapes, a wide range of categories. Faced with the brilliant market of plastic bottles, as a drug manufacturer, the following principles are mainly taken into consideration when selecting plastic bottles:

1 Select the plastic bottle main raw materials, additives formula

The product standards for plastic bottles for solids stipulate the applicable main raw materials, respectively, and must meet the requirements of non-toxicity, no odor, etc. Since there are many kinds of main raw materials available for selection, it is necessary to select the comprehensive properties of the raw materials. General tablets use high-density polyethylene, polypropylene bottles, such as the need for transparency can use PET bottles, such as drugs need to block higher performance, and block light, opaque, the choice of brown PET bottles, barrier performance is better for the PEN bottle. Liquid formulations of drugs generally use polypropylene bottles or polyester bottles as the main raw material.

2 bottle body and cap sealing, water vapor permeability

Sealability and water vapor permeability are two important technical indicators of medicinal plastic bottles, and they play an important role in the stability of charge.

3 Plastic Bottle Product Quality Standard

From the production plant's product quality standards can be analyzed and judged the pros and cons of product quality. Pharmaceutical plastic bottle companies should establish corporate standards that are stricter than national standards and industry standards.

4 Quality Assurance System

Auditing suppliers has become an essential part of purchasing plastic bottles. Through the audit, a comprehensive and correct assessment of the integrated level of the software and hardware facilities, technical equipment, and quality of the production plant can be made.

5 Plastic bottle charge stability and compatibility

The use of plastic bottles, especially new drug selection of new plastic bottles (or new materials, new processes) should be carried out to test drug loading in order to investigate the stability of the charge and the compatibility between the plastic bottle and the drug. The penetration, dissolution, adsorption, chemical reaction, and denaturation of drugs and plastic bottles must be determined through scientific tests.

Pharmaceutical tablet blister pack

Pharmaceutical blister packs are also called blisters packs. Compared with bottled tablet medicines, blister packs have the greatest advantage of being easy to carry, and can reduce the pollution during the carrying and taking of medicines. However, as a regular drug patient, there is a large dose of single dose, making the unit cost of blister packaging significantly higher than bottled drugs, some pharmaceutical companies, usually higher prices, high technical content and new varieties of drugs use blister Most of the packaging.

The materials used for blister packs are mainly PTP pharmaceutical aluminum foils and plastic hard sheets. Medicinal aluminum foil is a sealing material that is sealed on a plastic hard film. It is based on hard industrial pure aluminum. It is non-toxic, corrosion-resistant, non-permeable, heat-resistant, moisture-proof, light-blocking, and high-temperature sterilization. Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite materials are commonly used for hard plastic sheet materials. They have good barrier properties to water, steam and light.

1 Pharmaceutical Foil Materials Selection and Principles

The acquirer first signs the purchase contract with the supplier before using PTP aluminum foil. In the contract, the technical requirements of the product must be stated: product name, specification (width and thickness requirements), printing color, direction and position of the aluminum foil roll text; whether the aluminum foil structure, adhesive coating amount, coating color are required, Packaging requirements, etc.

2Selection of basic principles for plastic hard plastic or composite materials

Ordinary tablet medicines, optional polyvinyl chloride (PVC) hard sheets with low requirements for moisture resistance. For the drugs that have moisture-proof and anti-oxidation requirements, or have a longer shelf life, PET hard sheets and PP hard sheets can be used. Composite hard sheets are: polyvinyl chloride and polyvinylidene chloride composite sheet (PVC/PVDC) or polyvinyl chloride and polyethylene and polyvinylidene chloride (PVC/PE/PVDC) composite sheet. Oral liquid, suppository drugs can choose PVC and polyethylene composite sheet (PVC/PE).

General procedure for selecting blister packaging hard sheet materials:

a. According to the nature of the drug and its shelf life requirements, select which kind of polymer hard film to use. Specifically, consult the technical experts of the drug packaging material manufacturer or conduct material tests. Full consideration should be given to the versatility of the device, the novelty of appearance, and the lowest cost. Sex.

b. Conduct an on-board test to determine the applicability of the pharmaceutical packaging materials to the suitability of the equipment and the appearance of the product quality.

c. Do a good job of stability and compatibility tests. Each drug must be done because of the different nature of the drugs.

d. To examine the environmental, equipment, process, quality, and other related management contents of drug packaging material manufacturing enterprises; and jointly determine the structure of raw materials, formulation and materials, and packaging material product standards of drug packaging materials with drug packaging material manufacturing enterprises, and The final signing of the agreement.

Tablets for plastic tablets

For some larger formulations of pharmaceutical tablets or for UV sensitive, strong hygroscopicity, requiring heat and cold resistance, and requires a long period of validity and improve the packaging of pharmaceutical tablets, most of the use of strip composite film packaging, referred to as SP (strip packaging).

It is the use of two layers of pharmaceutical packaging film (SP) film sandwiched between the drugs, a certain distance between the units of drugs, in the strip packaging machine on the inside of the two layers of SP film heat sealing and sealing between drugs Upper teeth marks, formed in a unit package form (single packs or rows of small packs).

Bar-shaped packaging is continuous operation on the bar-shaped packaging machine, especially suitable for large-volume automatic packaging. When taking the medicine, tear the SP film along the tooth mark. Bar-shaped packaging film, has a certain tensile strength and elongation, suitable for a variety of shapes and sizes of drugs, and packaging close to the drug, not easy to produce cracks and wrinkles.

Currently widely used are aluminum-plastic composite films, such as glass paper and aluminum foil and polyethylene composite (PT/AL/PE), polyester and aluminum foil and polyethylene composite (PET/AL/PE), that is, aluminum foil and plastic film to stick The mixture is laminated or compounded by extrusion and consists of a base layer, a printing layer, a high barrier layer, and a sealing layer. The base layer is outside, the heat sealing layer is included, and the high barrier layer and the printing layer are located in the middle. The base material is required to have excellent mechanical properties, good gloss printability, good transparency, high barrier properties, safety, non-toxicity, and no heat sealability. Typical materials are polyester (PET), cellophane (PT) and cellophane with PVDC coating. The high barrier layer is good for gas barrier properties and moisture-proof, does not penetrate bacteria and microorganisms, has good mechanical properties, has a certain elongation, is resistant to cold and heat, is safe and non-toxic, and its typical material is a soft aluminum foil. However, this soft aluminum foil is opaque, does not rust itself, and has strong light shielding properties. If a transparent strip packaging film is required, PVDC should be used as a high barrier material. PVDC is used as a high barrier layer material, and its greatest feature is its excellent barrier properties against gases and water vapor. The sealing layer is the inner layer of the strip packaging film, has excellent heat sealing properties, and has chemical stability and safety and hygienic properties. Generally, low density polyethylene material is used.

The choice of pharmaceutical membranes for pharmaceutical companies is determined by the nature of the drug (wetness, oxidation, taste retention, etc.) and shelf life. It is mainly selected based on the quality characteristics of the drug requirements and the characteristics of the composite product. Medicinal compound film features for reference:
a. Ordinary composite membrane: The composite structure is composed of polyester, aluminum foil and polyethylene (PET/AL/PE). It is characterized by good printing adaptability and has good gas and moisture barrier properties to drugs.

b. Medical strip-like tearable composite film: The composite structure is composed of cellophane, polyethylene and aluminum foil (PT/PE/AL/PE). Features are: good tearability, convenient for consumers to access the product. Good gas and vapor barrier properties ensure long shelf life of the contents. Suitable for packaging of effervescent agents, paints, tablets and capsules.

c. Paper aluminum-plastic composite film: The composite structure is composed of paper, polyethylene and aluminum foil (paper/PE/AL/PE). The characteristics are: good printing property and good stiffness. Good barrier properties to gases or water can ensure long shelf life of drugs.