Principles for the selection of packaging material

2022-08-10
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Principles for the selection of pharmaceutical tablet packaging materials

western medicine tablets are one of the pharmaceutical dosage forms with the largest variety and sales volume at present. The packaging materials used for drug tablets directly contact drugs, so they belong to a class of drug packaging. Drugs are a kind of special commodities, whose efficacy and quality are directly related to human health and safety. The packaging materials and structural forms used must ensure the efficacy, but also play a role in ensuring the reliability and convenience of drugs. Therefore, as a drug manufacturer, when selecting packaging materials, it is necessary to understand some properties and characteristics of packaging materials and containers, so as to be reasonable and convenient in combination with some special requirements of drugs Accurately select pharmaceutical packaging materials

-- plastic bottle packaging of pharmaceutical tablets in the 1980s, with China's continuous introduction of advanced pharmaceutical plastic bottle production lines from abroad, the prologue of "plastic" instead of "glass" began to open. From then on, large capacity glass bottles and brown bottles gradually withdrew from the field of pharmaceutical tablet packaging, and were replaced by plastic bottles for scanning electron microscope detection and analysis of drugs 3.4. It is mainly made of non-toxic high molecular polymers such as PE PP, PC and pet are the main raw materials, and advanced plastic molding technology and equipment are used to produce various pharmaceutical plastic bottles, which mainly contain all kinds of drugs in solid dosage forms and liquid preparations such as oral tablets, capsules and capsules

the biggest feature of pharmaceutical plastic bottles is that they are light in weight, not fragile, clean and beautiful. Pharmaceutical manufacturers can use them directly without cleaning and drying. Some of its technical indicators and a large number of data show that it has excellent chemical resistance, water vapor permeability resistance and sealing performance, and it can completely play a role of safety shielding and protection for the drugs contained within the period of validity. In the varieties of materials used, there are high-density polyethylene bottles (HDPE), polypropylene bottles (PP), polycarbonate bottles (PC) and polyester bottles (PET). In the early 1990s, a new material polyethylene naphthalene dicarbonate (pen) plastic bottle with blow molding bottle body was developed abroad. Its properties are better than pet. It has high strength, good heat resistance, ultraviolet radiation resistance It has excellent barrier performance against carbon dioxide and oxygen, good chemical resistance, and is more widely used than pet. Pen material is a new polyester resin actively developed at home and abroad in recent years, and it is also an excellent material for plastic bottle packaging of drugs

-- bottle body selection principle

due to the numerous specifications of medical plastic bottles, the small ones are more than ten milliliters, the large ones are thousands of milliliters, some are colorless, some are transparent, the colors are diverse, the shapes are different, and there are many categories. In the face of the wonderful plastic bottle market, as a pharmaceutical manufacturer, the following principles are mainly grasped when selecting plastic bottles:

first, choose the main raw materials and auxiliary formulas of plastic bottles. The product standards of plastic bottles for solid use stipulate the applicable main raw materials respectively, and must meet the requirements of non-toxic and non odor. Since there are many kinds of main raw materials available, it is necessary to select the comprehensive properties of raw materials. Generally, high-density polyethylene and polypropylene bottles are used for tablets. If transparency is required, PET bottles can be used. If drugs need higher barrier performance, light blocking and opacity, brown PET bottles are used, Pen bottle with better barrier performance. Polypropylene bottles or polyester bottles are generally used as the main raw materials for liquid dosage forms

II. Tightness and water vapor permeability of bottle body and cap. Sealing and water vapor permeability are two important technical indicators of pharmaceutical plastic bottles, which have a crucial impact on the stability of the charge

III. product quality standards for plastic bottles. The quality of products can be analyzed and judged from the product quality standards of the manufacturer. Pharmaceutical plastic bottle enterprises should formulate enterprise standards that are stricter than national standards and industrial standards

IV. quality assurance system. The audit of suppliers has become an essential part of the purchase of plastic bottles. Through the audit, the comprehensive level of software and hardware facilities, technical equipment and quality of the manufacturer can be comprehensively and correctly evaluated

v. charge stability and compatibility of plastic bottles. When selecting plastic bottles, especially new plastic bottles (or new materials, new processes) for new drugs, charge tests should be carried out first to investigate the stability of the charge and the compatibility between the plastic bottles and drugs. The penetration, dissolution, adsorption, chemical reaction and denaturation between drugs and plastic bottle materials must be determined through scientific testing

-- blister packaging of drug tablets

blister packaging of drugs is also called blister eye packaging. Compared with bottled tablet drugs, the biggest advantage of blister packaging is that it is easy to carry, and it can reduce the pollution in the process of carrying and taking drugs. However, as patients with regular medication, there is a large single dose, which makes the unit cost of blister packaging significantly higher than that of bottled drugs. Some pharmaceutical enterprises usually choose blister packaging for drugs with high price, high technical content and new varieties. The materials used for blister packaging are mainly "PTP" medicinal aluminum foil and plastic hard pieces. Medicinal aluminum foil is a sealing material sealed on plastic hard pieces. It takes hard industrial pure aluminum as the base material, and has the characteristics of non-toxic, corrosion-resistant, impermeable, heat resistant, moisture-proof, light resistant and high-temperature sterilization. PVC, PVDC or composite materials are usually used as hard plastic sheet materials. They have good barrier properties to water, steam and light

-- basic principles for the selection of pharmaceutical blister packaging materials

I. matters and principles for the selection of pharmaceutical aluminum foil materials: the Demander shall first sign a purchase contract with the supplier before using PTP aluminum foil. The technical requirements for products in the contract must specify: product name, specification (width and thickness requirements), printing color, text arrangement direction and position of aluminum foil roll; Aluminum foil structure, adhesive coating amount, coating color requirements, packaging requirements, etc

II. Basic principles for the selection of medicinal plastic hard tablets or composite materials: for ordinary tablet drugs, polyvinyl chloride (PVC) hard tablets can be selected if the requirements for moisture resistance are not high. For drugs with moisture-proof and antioxidant requirements, or with long shelf life requirements, pet hard tablets and PP hard tablets can be selected. Composite hard sheets include: PVC/PVDC composite sheet or PVC/PE/PVD composite sheet with polyvinylidene chloride (PVC/PE/PVD is injected with polyurethane cube structure c). Polyvinyl chloride and polyethylene composite tablets (PVC/PE) can be used as oral liquid and suppository drugs. The general procedure for selecting the hard film material for drug blister packaging: A. according to the nature of the drug and the requirements of shelf life, choose which polymer hard film to use. For details, consult the technical experts of the drug packaging material manufacturer, or conduct material tests, and fully consider the versatility of the equipment, the novelty of the appearance and the lowest cost. b. Conduct on-line tests to determine the applicability of drug packaging materials to the equipment and the satisfaction of product quality and appearance. c. To do a good job of stability and compatibility tests, each drug must be done, because the properties of various drugs are different. d. Go to the pharmaceutical packaging material production enterprise to review the environment, equipment, process, quality and other related management contents; Jointly determine the raw materials, formulas, material structures and product standards of drug packaging materials with drug packaging material manufacturers, and finally sign an agreement

-- drug tablets are packed with aluminum-plastic strip composite film

for the selection of some large dosage forms of drug tablets or drug tablets that are sensitive to ultraviolet light, have strong hygroscopicity, require heat and cold resistance, and require a long period of validity and improve the packaging grade, most of them use strip composite film packaging, referred to as sp (strippackaging). It is a form of unit packaging (single packaging or small packaging in rows) formed by clamping the tablets in the middle with two layers of pharmaceutical strip packaging film (SP) film, separating a certain distance between the unit drugs, sealing the inner side of the two layers of SP film around the drugs on the strip packaging machine, and pressing tooth marks between the drugs. Strip packaging is a continuous operation on the strip packaging machine, which is especially suitable for automatic packaging in large quantities. When taking medicine, tear the SP film along the tooth mark. The strip packaging film has a certain tensile strength and elongation, which is suitable for drugs of various shapes and sizes. After packaging, it is close to the drugs inside, and it is not easy to produce cracks and wrinkles. At present, aluminum-plastic composite films are widely used, such as cellophane and aluminum foil and polyethylene (Pt/Al/PE), polyester and aluminum foil and polyethylene (PET/Al/PE), that is, aluminum foil and plastic film are laminated or extruded by adhesive. They are composed of base layer, printing layer, high resistance barrier layer and sealing layer. The base layer is outside, the heat sealing layer is inside, and the high resistance barrier layer and printing layer are in the middle. It is required that the base material has excellent mechanical properties, gloss, good printability, good transparency, high barrier performance, safety, non-toxic, and no heat sealing. Typical materials are polyester (PET), cellophane (PT) and cellophane with PVDC coating. The high resistance barrier layer should have good gas barrier performance and moisture resistance, not through bacteria and microorganisms, good mechanical properties, a certain elongation, cold and heat resistance, safety and non-toxic. Its typical material is soft aluminum foil. However, this soft aluminum foil is opaque, does not rust itself, and has strong shading. If transparent strip packaging film is required, PVDC shall be used as high resistance barrier material. PVDC, as a high resistance barrier material, is characterized by its excellent barrier performance against gas and water vapor. The sealing layer is a strip packaging film. The biggest change is that the plastic bag that was not charged by the supermarket in the past ensures that the water and gas circuits are unblocked and leak free. Now it needs to spend money to buy the inner layer, which has excellent heat sealing performance, chemical stability, safety and hygiene. Generally, low-density polyethylene materials are used

the choice of composite film for drug packaging by pharmaceutical enterprises depends on the properties of drugs (moisture, oxidation, drug flavor retention, etc.) and shelf life. It is mainly selected according to the quality characteristics required by drugs and combined with the characteristics of composite products. The following provides several characteristics of pharmaceutical composite film for reference:

a, common composite film: the composite structure is composed of polyester, aluminum foil and polyethylene (PET/Al/PE), It is characterized by good printing adaptability and good gas and water barrier to drugs

b, medicinal strip easy to tear composite film: the composite structure is composed of cellophane, polyethylene and aluminum foil (Pt/PE/Al/PE). Features: it has good tear resistance and is convenient for consumers to access the product. Good gas and water vapor barrier ensures a long shelf life of the contents. It is suitable for the packaging of effervescent, coating, tablet, capsule and other drugs

c paper aluminum plastic composite film: the composite structure is composed of paper, polyethylene and aluminum foil (paper/PE/Al/PE), which is characterized by good printability and good stiffness. It has good barrier performance to gas or water, which can ensure a long shelf life of drugs

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