Specific requirements, development and application

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Specific requirements and development and application of Western medicine tablet packaging

western medicine tablet is one of the drug dosage forms with the largest variety and sales volume at present. The packaging materials used for drug tablets are directly in contact with 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 and 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. At present, the packaging of tablet drugs in China, such as plain tablets and sugar coated tablets, including capsules, has changed from simple paper bag packaging, simple plastic bag packaging, transparent and brown glass bottle packaging to high-quality plastic bottle packaging, blister packaging, aluminum plastic unit strip packaging. This kind of packaging materials are also constantly innovating, and the solid dosage form packaging of drugs is also becoming the product with the best benefit and the highest technical content in the packaging industry. 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 pharmaceutical plastic bottles, which are mainly made of non-toxic polymers such as PE, PP, PC and pet, Advanced plastic molding technology and equipment are used to produce various pharmaceutical plastic bottles, which mainly contain various kinds of drugs in solid dosage forms and liquid preparations such as oral tablets, capsules, capsules, etc

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, foreign countries developed blow molding bottles, which made the appearance and accuracy of printing molded parts very ideal. The new material polyethylene naphthalene dicarboxylate (pen) plastic bottle has better properties than pet. It has high strength, good heat resistance, UV 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

principle of bottle body selection

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, when selecting plastic bottles, it mainly grasps the following principles:

1. Select the main raw materials of plastic bottles and the formula of additives: the product standards of plastic bottles for solid use stipulate the applicable main raw materials respectively, and must meet the requirements of non-toxic, non odor and so on. Because there are many main raw materials available, it is necessary to select the comprehensive properties of raw materials, Generally, tablets are made of high-density polyethylene and polypropylene bottles. If transparency is required, PET bottles can be selected. If drugs need higher barrier performance, light blocking and opaque, brown PET bottles are selected. Pen bottles have better barrier performance. Polypropylene bottles or polyester bottles are generally used as the main raw materials for liquid dosage forms

2. Tightness of bottle body and cap, water vapor permeability. 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

3. Product quality standard of 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

4. 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

5. Charge stability and compatibility of plastic bottles. The frequency of selecting plastic bottles, especially new plastic bottles (or new materials, new processes) for new drugs should be tested first to investigate the stability of the charge. Finland has developed low-cost polylactic acid foaming materials and the compatibility between 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

1. 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

2. Basic principle of selecting medical plastic hard tablets or composite materials: common tablet drugs, PVC hard tablets can be selected if the requirements for moisture resistance are not high. There are moisture-proof and anti-oxidation requirements for; Or drugs with longer shelf life requirements can choose pet hard tablets and PP hard tablets. Composite hard tablets include: PVC/PVDC composite tablets or PVC/PE/PVDC composite tablets. 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 are packed with strip composite film, referred to as sp (strip packaging). 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 with 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 the inner layer of the strip packaging film, which has excellent heat sealing performance, chemical stability, safety and hygiene. It is generally made of low-density polyethylene

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 of drugs and the characteristics of composite products. The following are 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), which is characterized by good printing adaptability, It has 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. (text/Bai Bing)

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