Packaging and application of solid dosage forms of

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Pharmaceutical solid dosage form packaging and application

pharmaceutical packaging is becoming the most active branch in the field of packaging in China. With China's entry into WTO, more international pharmaceutical enterprises have entered China, intensifying the competition in China's pharmaceutical industry. At the same time, it has accelerated the technological transformation of the entire pharmaceutical manufacturing industry and the development of new products, which has also driven the pharmaceutical packaging industry. Obviously, the external packaging of solid dosage forms of drugs will continue to push through the old and bring forth the new, so that the pharmaceutical packaging industry is also becoming one of the products with the best benefits and high technical content in the whole packaging field. Of course, there is still a large overall gap between the packaging of Chinese pharmaceutical products and that of developed countries. The analysis of the main reasons for this gap can be summed up in two aspects: first, the overall level of China's pharmaceutical industry is relatively low. For a long time, China's western medicine products have been mainly imitation, and there are few self-developed products, while the technical methods of traditional Chinese medicine production enterprises are old, and similar products lack unified standards, which restricts the development. Second, the disadvantages of the drug circulation system. Drugs are mainly sold in hospitals for a long time, and there is no distinction between prescription and over-the-counter drugs. Drugs sold in pharmacies account for only a small part of the total. This sales system restricts the development and research and development of drug packaging, so that drug packaging remains old-fashioned for a long time. At present, almost all of the world's top 100 pharmaceutical enterprises have established joint ventures or wholly-owned pharmaceutical enterprises in China, which not only brings more new drug varieties to China, but also advanced pharmaceutical packaging concepts and new product packaging forms. Due to the wide variety of drugs, the packaging forms are also diversified. With the deepening of the reform of the medical system, gratifying changes are taking place in the packaging of drugs in China. At present, the packaging of solid dosage forms in China (such as plain tablets, sugar coated tablets, capsules, capsules, etc.) has been updated and developed rapidly in the past 10 years, which has basically changed the backward situation of drug packaging in China. Especially in recent years, from the perspective of development speed and wide application, high-quality high-density polyethylene bottles, polypropylene bottles, polyester bottles, blister packaging and SP composite film soft packaging are the fastest-growing drug packaging forms in the future. The following describes their respective processes and drug packaging characteristics

I. The Application of injection blow molding to produce high-quality plastic bottles in the packaging of solid dosage forms

the wax sealing process of low-quality Huangyuan glass bottles, which was first used in China, is one of the backward packaging officially eliminated by the State Food and drug administration. In the early 1980s, China began to introduce injection blow molding production equipment and technology to produce medicinal plastic bottles. When this one-time injection blow molding equipment produces medical plastic bottles, it must first inject the nozzle in a closed environment to shape the bottle mouth, so as to ensure the dimensional accuracy of the bottle mouth and thread parts, and then blow the bottle body. This molding method meets the special requirements of the packaging of solid dosage forms of drugs, can prevent the volatilization of the gas contained in the bottle and the pollution of the external air, and seal the bottle mouth with electromagnetic induction aluminum foil gasket, so as to ensure the sealing performance between the bottle cap and the bottle mouth, so that the drugs will not deteriorate within the validity period. For this reason, the production of plastic bottle equipment enterprises in China have changed from the original extrusion and blowing process to injection molding process. The annual output of plastic bottles has increased from the initial 700 million/year to the current 300 billion/year. The raw materials used in plastic bottles such as high-density polyethylene (HDPE), polypropylene (PP) and polyethylene terephthalate (PET) have been localized

at present, PET bottles are more and more used in drug packaging, which can be used not only for the packaging of solid dosage forms, but also for the outer packaging of liquid drugs. Its advantages are becoming increasingly obvious. First of all, PET bottles are light and firm, with high strength and elasticity, and can withstand considerable impact without damage. For glass bottles with the same volume, the weight of PET bottles is 1/10 of the weight of glass bottles, while for PET bottles with the same outer diameter, its capacity is 1.5 times that of glass bottles, and it should not be damaged, which can greatly improve efficiency and save a lot of costs in transportation. In addition, transparent and glossy PET bottles can improve the value of goods. The light transmittance and appearance gloss of PET bottles are close to those of glass bottles, but the processing is convenient, especially for bottles with complex shapes. Therefore, PET bottles can be designed and shaped in a variety of ways to improve the added value of goods. The recycling and reuse of PET bottles is higher than other plastics. When it is burned as waste, it is easy to burn because of its low combustion card value and does not produce harmful gases. It is a material conducive to environmental protection. Therefore, it has a broad application prospect in the packaging of pharmaceutical liquids, solids and health care products

second, blister packaging of drugs is one of the fastest-growing varieties of solid dosage form packaging in the future.

western medicine tablets are the largest variety of solid dosage forms of drugs with the largest sales volume. The large capacity brown glass bottles used early are rapidly withdrawing from this field, mainly because the cork wax sealing process used in the glass bottles does not meet the requirements of drug packaging, and the glass bottles are easy to break. Therefore, pharmaceutical tablets and capsules are packed in plastic bottles or aluminum-plastic blisters, which are becoming the most important form of tablet packaging. Its advantage is that it is obviously superior to bottled drugs in terms of convenient carrying and accurate dosage. However, there is still a large single dose of drugs, which makes the unit cost of blister packaging significantly higher than that of bottled drugs. On the other hand, from the analysis of drug efficacy, the application of slow-release technology of drugs can make the drug property of a tablet release continuously for 12 hours, or even longer. Its appearance will greatly reduce the dosage of drugs. The reduction of dose has greatly narrowed the gap in the packaging cost of drugs, which provides a broader space for the wide application of blister packaging. Blister packaging of drugs rose from Europe in the 1930s. The blister packaging materials used in China since the early 1970s mainly rely on imports. They were introduced by joint ventures in the 1980s. At that time, the annual output of imported raw materials required by China was about 400t. By the 1990s, China had been able to manufacture monochrome or multicolor aluminum foil printing and coating equipment, and all the materials used for blister packaging had been localized, which could meet the needs of domestic drug packaging. The blister packaging form is to place the used drugs in the pits (or blisters or blisters) of the plastic hard sheet formed by blistering. The fixture should not cause the sample to break at the fixture, and then use a printed aluminum foil coated with protective agent and adhesive to bond and seal with the plastic hard sheet, so that the drugs can be protected. The materials used for blister packaging include: printing, coating, protective layer and adhesive layer materials, which are called protective agents and adhesives. The materials used as capping materials are medicinal aluminum foil, Referred to as "PTP" aluminum foil, there are also ink materials that can form ei~u character patterns on the surface of aluminum foil and PVC (polyvinyl chloride) plastic hard sheet materials used to form pits. Blister packaging of drugs is one of the most widely used and fastest-growing flexible packaging materials in the pharmaceutical industry today, and it is also the main packaging form of solid dosage forms of drugs in China at present.

III. strip composite film (SP film) It is the main form of packaging of pharmaceutical granules and powders at present.

for some larger dosage forms of granules, powders and drugs with strong hygroscopicity and sensitivity to UV light, strip composite film packaging is more suitable. Strip packaging is called sp (strip packaging) film packaging. It uses two layers of medicinal strip packaging film (SP film) to clamp the drugs in the middle, and the unit drugs are separated by a certain distance. On the strip packaging machine, the drugs are heat sealed with the inner side of the two layers of SP film, and the tooth marks are pressed between the drugs to form a unit packaging form, which can be packaged in a single piece or in rows to form a small package. The plastic film used for drug packaging can ensure a certain mechanical strength, and will not be broken and damaged in the process of drug packaging and circulation. It is also required to have a good peel strength between the layers of the composite material to prevent delamination of each layer, and it is also required to have good high temperature resistance. Because high temperature disinfection or heat sealing, bag making and sealing are required in drug packaging. It is required that the permeability to gas and moisture is low and the barrier performance to gas and moisture is good, which is very important in the packaging of Chinese and Western medicine. If the outside air enters, it will provide a suitable environment for the growth and reproduction of mold and make the medicine go bad and invalid. Based on the above requirements, different material compounding methods are needed to produce flexible packaging materials for drugs. The composite films of materials mostly adopt two or more methods, such as: hood furnace annealing with nitrogen (or nitrogen hydrogen mixture) protection for raw materials and advanced, fast and automatic continuous rolling process for thickness measurement; The stamping of small and medium-sized chain pieces adopts multi piece, multi station high-speed progressive die; The heat treatment adopts the new technology of controllable atmosphere quenching, carbonitriding and propane gas carburizing; The pin shaft is composed of more than two kinds of films (sometimes including paper, aluminum foil and other materials) such as the new chromizing process. Each layer of film is connected by adhesive, and films with different packaging properties are selected for reasonable combination according to the packaging requirements of different drugs, which can concentrate the advantages of each layer of film and fundamentally overcome some shortcomings of a single film in terms of drug packaging performance. Because the composite film has a variety of different structures and compositions, in order to identify and distinguish different composite films, it is usually marked, such as polypropylene (PP) as the outer material, aluminum foil (AL) as the intermediate material, polyethylene (PE) as the inner material, and PP/Al/PE as the composite film, which is undoubtedly a huge business opportunity. Composite films can be divided into paper plastic composite films, plastic plastic composite films, aluminum plastic composite films, etc. according to the composition of their materials, they can be divided into coextrusion films, extrusion films, laminated films, etc. according to different composite process methods. Take the most commonly used lamination method for example, that is, the lamination method of coating the adhesive on the film and heating and pressing another film with it. However, according to different production processes, this method is also divided into dry compounding method and wet compounding method: dry compounding method refers to the composite film formed by evenly coating a layer of adhesive on the composite substrate (film), drying after removing the solvent through the drying channel, and bonding with other composite substrates (films) under hot pressing. Wet compounding method is a composite film formed by coating a layer of water-soluble adhesive on the surface of the composite substrate (film) without affecting the experiment, pressurizing when the adhesive is not dry, bonding with other composite substrates through the pressure roller, and then drying through the drying channel. Dry and wet compounding processes are basically similar. The main difference is that the drying process is different from the pressing process. Dry compounding is drying before pressing, while wet compounding is pressing before drying. The common characteristics of the two lamination methods are simple process, convenient operation and fast lamination speed. At present, most pharmaceutical composite films are compounded by this process, while the solid dosage forms of Chinese and Western medicines, granules, powders and powders are more and more used in strip composite packaging, which is the development direction of traditional Chinese medicine packaging in the future

Bai Bing

reprinted from: Guangdong Printing

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