Flexible tube packaging has been used to package medicines for just over twenty years. Before this, the packaging materials used in pharmaceutical packaging, are some small manual workshop, with simple mechanical equipment production. Since the 1980s, flexible packaging has gradually entered the field of pharmaceutical packaging. With the gradual deepening of the reform and opening up, the pharmaceutical economy has been developing rapidly, leading to the rise of the pharmaceutical packaging industry. A variety of new pharmaceutical packaging materials continue to emerge, showing a full of vitality, especially the flexible packaging materials. Development is a continuous process. In this process, it is difficult to draw a clear line between the old and the new. This is especially true for flexible pharmaceutical packaging, a product that is quite new to start with.
Therefore, the term "new" in this article is a relative term. After filling the goods in the vacuum-sucking (blowing) or molded blister, the covering material is used to heat seal with the foam base material under certain time and temperature conditions. This packaging form is called blister packaging, or PTP for short. The commonly used materials are pharmaceutical blister packaging aluminum foil (PTP aluminum foil), PVC hard sheet or other material hard sheet, cold stamping molding materials. PTP packaging was used in Europe as early as the 1930s. In the late 1980s and early 1990s, it began to be widely used in China, and quickly changed from relying on imports to localization. With the continuous exuberant demand for drug packaging, blister packaging has also been innovated on the basis of the original, and many new varieties have appeared. PTP aluminum foil
■ Multicolor printing on patterns and text, in the early days only monochrome printing, now has developed to more than four colors;
■ Double-sided printing is generally printed only on the side of the protective agent, now has developed to print on both sides of the protective agent and adhesive;
■ Color foil Traditional PTP aluminum foil, the background color is the natural color of aluminum foil. Color foil is mainly the use of PTP aluminum foil in the production process of coating protective agent and adhesive characteristics, will be a variety of colors of pigments or dyes evenly dispersed into the protective agent or adhesive system, so that the PTP aluminum foil background color presents a variety of colors;
■ Other special requirements: such as iodine resistance, anti-counterfeiting, etc. PVC hard sheet or other material hard sheet
PVC/PVDC coating composite material now the most commonly used blister packaging material, is PVC (PVC) hard sheet. PVC material is used for packing the blister, because of its good compatibility, easy molding and sealing, and low price. However, its thermal stability is poor, and the barrier to water vapor and oxygen is low. PVC/PVDC coated composite material is the best barrier performance of a kind of material, it can be used in high temperature and high humidity conditions, and other properties and PVC similar. The existing blister packing equipment can be used without the need for any new equipment.
■ACLAR (trifluoroethylene chloride homopolymer) composite forming performance is similar to the performance of the receiving surface is used to composite, die surface can be used with or without coating. ACLAR barrier material does not melt or stick to the mold, but has a high coefficient of friction, which complicates mold design.
■COC material (cyclic olefin copolymer) COC has excellent thermal forming properties, but it is brittle, so it is often combined with PP to maintain its shape. It is an ideal substitute for hot cover and cold formed aluminum composite.
■PP sheet (polypropylene) with the concept of environmental protection deeply rooted in the hearts of the people, PP sheet has gradually become a new material popular in the field of international drug packaging. The modified PP sheet has excellent air tightness, transparency, insulation, high impact resistance strength and good processing performance, and non-toxic and harmless. Especially suitable for high-grade, new type, easy to decompose or chemical change of drugs, can effectively protect the quality of drugs. Cold stamping molding materials in the 1980s, cold stamping molding materials developed from the pharmaceutical packaging market in Europe, began to export to foreign countries in the 1990s. The greatest advantage of this material is that the barrier is particularly good, suitable for oxygen, moisture, light sensitive medicine packaging. At present, domestic enterprises have successfully developed and mass production.
Cold stamping molding materials according to different uses can be divided into the following 3 categories: tablet, capsule packaging materials, the main structure: NY/AL/PVC, NY/AL/PP, etc. ■ suppository packaging materials, main structure: BOPP/AL/PE, OP(protective agent)/AL/PE, etc.; ■ Coated VC agent (adhesive) series composite molding materials, main structure: NY/AL/VC, etc. Composite film Composite film is a multi-layer structure film formed by a variety of plastic and paper, metal or other materials through laminated extrusion veneer, co-extrusion and other technology will combine the substrate together. It has the functions of dust prevention, pollution prevention, gas blocking, fragrance prevention, ultraviolet protection, decoration, printing, cooking sterilization, anti-static and so on. It is suitable for mechanical processing or other various sealing methods, which can basically meet the various requirements of drug packaging, but any single material can not achieve these functions. New composite membrane, mainly in the composite membrane production, the use of new materials, new technology, new equipment, new technology, new methods, etc., to meet the specific needs of some medical users. At present, the main products are: Anti-counterfeiting Packing Most of the flexible packaging of drugs in China are very simple in appearance design, and the anti-counterfeiting technology of packaging is relatively backward, which provides an opportunity for counterfeiters. Some pharmaceutical related enterprises invest millions of yuan every year to adopt three-dimensional laser anti-counterfeiting, digital anti-counterfeiting and pressure film anti-counterfeiting technology, to enhance the anti-counterfeiting effect. There are seven kinds of technology that can be used in medicine anti-counterfeiting, including digital anti-counterfeiting, ink anti-counterfeiting, optical anti-counterfeiting, paper anti-counterfeiting, special printing anti-counterfeiting, nuclear track anti-counterfeiting, biological anti-counterfeiting and so on. ■ Application of water-based inks and adhesives The current application of mature inks and adhesives are solvent-based. Its advantages are self-evident, such as high adhesion, mature application, etc. The disadvantage is that there are certain hazards to the environment and workers' health. Excessive amounts of residual solvents can cause unpleasant odors that may pose a threat to the packaged drug and the person who takes it. The printing method of water-based ink and solvent-based ink, the unit price of ink is 10%-20% lower than the solvent ink, the printing speed reaches the speed of solvent ink, the diluent is mixed with tap water or ethanol and water in a certain proportion, the printing process is harmless to the human body, non-flammable, non-toxic, tasteless, in line with environmental protection requirements. The situation is similar for water-based adhesives. ■ Aluminum-plastic composite Tube was originally made from lead or tin. It wasn't until the 1940s that aluminum tubes appeared and quickly became popular because of their good barrier properties.
Plastic tube appeared in the 1950s, aluminum-plastic composite tube appeared in the 1960s, aluminum-plastic composite tube was applied to the packaging of toothpaste in the 1970s, and began to be applied to the packaging of ointment in the 1980s. The so-called aluminum-plastic composite tube is made of aluminum foil with high barrier and plastic with flexibility and drug resistance by co-extrusion, and then processed by pipe making machine. It is characterized by flexure resistance, cracking resistance, strong barrier, no residual solvent effect, and exquisite printing. Aluminum-plastic composite tube for pharmaceutical packaging is a key product supported in the Outline of the "Tenth Five-year Plan" for Pharmaceutical Packaging Industry in China, and many domestic enterprises are working on its application. ■ Fluorohalogenated hydrocarbon film Fluorohalogenated hydrocarbon film is a copolymer of chlorotrifluoroethylene (CTFE), which is non-combustible and has excellent barrier property. The film has a unique range of applications, such as CTFE and ethylene trifluoroethylene chloride copolymers. CTFE can withstand severe chemical attacks that metals, ceramics and other plastics cannot. In addition, the water vapor transmittance of CTFE film is lower than that of any plastic film, and its moisture absorption is virtually zero. And with a variety of substrate composite, such as polyethylene, polyvinyl chloride, polyester, nylon, aluminum foil, etc., is mainly used for packaging tablets, capsules need a high degree of moisture resistance. Although the clean environment of pharmaceutical production is designed in accordance with GMP requirements, no dosage form can be absolutely sterile during the production and packaging process. Therefore, in order to extend the shelf life of drugs and ensure the safety of drugs, according to the requirements of GMP, the use of antimicrobial polymer packaging materials for drug packaging to inhibit bacterial contamination will also become one of the directions of flexible drug packaging. The application and development of nanotechnology and nanomaterials in the field of medicine has provided a golden opportunity for pharmaceutical packaging in China. The development of nano polymer, nano composite material (PNMC), nano adhesive and nano antimicrobial packaging will open up a new field for pharmaceutical flexible packaging. Plastic infusion packaging is one of the hot topics in the field of infusion. At present, there are mainly polyvinyl chloride bags, non-PVC polyolefin multi-layer bags and other packaging forms. -- PVC bag has 40 years of use history, production technology is mature. But the safety of its softener, DEHP, has been debated. -- The infusion soft bag made of non-PVC polyolefin material is one of the future development directions of infusion packaging materials. At present, the main source depends on imports. Many domestic tube companies have invested heavily in research.
Its main advantages are: ■ Do not use adhesives and plasticizers, safe and non-toxic to human body; ■ Membrane material in ten thousand grade production conditions (local hundred grade), to ensure the use of membrane material clean requirements; ■ Good transparency ensures the foreign body inspection during the production and use of membrane materials; ■ Good heat sealing performance of membrane material, suitable for a variety of filling equipment and interface; ■ Good elasticity, anti-drop; ■ The membrane material is biological and chemical inert; ■ Good barrier performance for water vapor, oxygen and nitrogen; ■ Chloride-free, no pollution to the environment when used for post-treatment. Non-PVC polyolefin multi-layer bag can be used to fill a variety of electrolyte infusion, nutrition infusion and therapeutic infusion, has become the main stream of infusion packaging materials. Adjustable air packaging makes the state of the gas in the package change, to ensure the quality of the packaged products for a long time, such as packaging with desiccant (oxygen absorption agent), air replacement (filled with helium, etc.) packaging. Small dose packaging Small dose packaging requires that the inner packaging of the drug has the function of standard measurement, including the use of packaging materials with the function of measurement and disposable packaging, the latter is the common small dose packaging. With the development of composite materials and the development of sterilization packaging technology, China has been able to effectively ensure the accuracy of liquid and solid dosage packaging, but will continue to develop small measurement packaging, which is convenient and accurate flexible packaging form. ■ Suitable for OTC (OTC) packaging OTC drug designation originated in the United States. In 1951, the United States Congress passed an amendment to the Food, Drug and Cosmetic Act proposed by a pharmacist senator (Durham Amendment), prescribing the classification standard of prescription drugs and over-the-counter drugs, creating the first system of classified management of drugs by prescription drugs and over-the-counter drugs in the world. Since then, Japan, the United Kingdom, Germany and Canada have respectively passed relevant laws and established a drug classification management system.
China's Hong Kong, Macao and Taiwan have also implemented the drug classification management system. OTC is a special consumer goods that consumers choose by themselves in pharmacies and drug counters. Patients can purchase drugs directly from the drug terminal according to medical knowledge, introduction of relatives and friends, consultation of doctors and recommendation of shop assistants. However, patients also pay attention to the packaging and design of drugs when they purchase drugs, and subconsciously judge the quality and efficacy of drugs. As OTC has the dual properties of drugs and commodities, its appearance design not only reflects the image of the enterprise and brand, but also reflects the psychological recognition of consumers, and extends to the field of product communication in the market. Therefore, the OTC market should not appear packaging "blind spot" phenomenon (health care products exquisite packaging can be a good reference). The elderly like safe and convenient drug packaging, they pay attention to the health and safety of the packaging when buying medicine, the packaging is easy to open, there is no need to prepare another opening device. Therefore, packaging design must consider the physiological characteristics of the elderly, such as slow reaction, poor memory and vision, as well as the habit of testing the packaging is not opened preference psychology. The text of the drug instructions and small manuals can be easily read with naked eyes in the form of sections or frames, and the main information should be fully emphasized, supplemented by special graphic signs to give necessary hints to the elderly patients. Research shows that up to 40% of children around the age of three have a "hobby" of stealing drugs.
The so-called child-safe packaging, also known as preventing children from opening the packaging, is a kind of packaging used to protect the safety of children. That is, certain toxic drugs and chemicals are packaged in special ways that make it difficult for children under five years of age to open or remove a significant amount within a certain period of time to avoid serious poisoning accidents by children who touch, use or swallow them. In terms of flexible packaging, there are no new products of child-safe packaging, which shows the huge market potential. The Outline of the "Tenth Five-Year Plan" for the Pharmaceutical Packaging Industry indicates that it supports the research and development of child-safe packaging and promotes the formulation of relevant laws and regulations. China pharmaceutical packaging association secretary-general hung tsai is introduced, the production of pharmaceutical packaging industry of our country has accounted for the national packaging industry output value of more than 10%, higher than that of the pharmaceutical industry output value accounts for the proportion of the total industrial output value, while the pharmaceutical packaging production with developed countries still have some gap in 30% of the total output value of pharmaceutical industry, but it is shows that in today's new drug dosage form emerge in endlessly, There is still plenty of room for tailoring "new clothes" to drugs.
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