Development and Application of Pharmaceutical Aluminum Tubes

Medicinal aluminum tubes can be divided into soft aluminum tubes and rigid aluminum cans. Soft aluminum tubes, also known as “hooks”, are softened and used to package creams, ointments, ophthalmic ointments and other dosage forms, while hard aluminum cans are not softened and used for packaging. Effervescent tablets, tablets, capsules, sprays and other dosage forms of containers. The two types of containers are made of pure aluminum and aluminum products (aluminum content not less than 99.5%), and the aluminum has a wide range of sources and has the unique characteristics of metal: good shading and air tightness, and can fully meet the special requirements of pharmaceuticals: Easy to recycle, no pollution to the environment, in line with the concept of environmental protection. Therefore, today's material science is highly developed and still has an irreplaceable advantage. Among the many pharmaceutical packaging materials at home and abroad, there is a wide range of applications and good development prospects. The history of production, application and development of hoses has been long and has been replaced by three generations. The former generation product is a lead-tin hose (strictly speaking, it should be the predecessor of the aluminum tube). Lead will cause serious harm to the human body, and tin resources will be less, so it has long been eliminated by the market. The second generation is an aluminum hose. Because of the poor sealing ability of such products, it is impossible to isolate the contact between drugs and air. The exposed aluminum and the drugs are prone to chemical reactions and directly involve the safety of drugs. Therefore, these products have long been eliminated in foreign countries, and the domestic market is rapidly decreasing. Third-generation products replaced. The State Food and Drug Administration has already stipulated that aluminum tubes must have inner coating, thin top sealing film, printing and tail coating, that is, the third-generation products that are upgraded. The technical level of the third-generation aluminum tubes is fundamentally different from that of the second-generation products. It has a thin top seal and a seal coating at the end to ensure that the drug does not come into contact with air during the storage period and does not There will be any leakage and drying phenomenon. The inner wall coating can effectively isolate the direct contact between the drug and metal aluminum, and provide reliable guarantee for the efficacy and safety of the drug within the effective period; Multi-color printing technology (up to 8 colors available abroad) , domestic generally 4-8 colors) make the appearance more beautiful. In recent years, aluminum tubes with plastic cleaning heads and tip-to-eye ointment tubes with cleaning heads have also been developed to avoid blackening of aluminum products due to thread friction, effectively improving the cleanliness of medicines and the safety of medications. With the entry of WTO and the listing of over-the-counter drugs (OTCs), the excellent performance of the third-generation aluminum tube products is closer to and in line with the needs of consumers and the development of the market, with broad application prospects. Hard aluminum cans are also used in a large number of applications abroad due to their excellent characteristics similar to those of hoses. Domestically, the production and application of hard cans are basically blank, generally replaced by glass or plastic. In recent years, due to the development of Sino-foreign joint-venture pharmaceutical companies, aluminum tablets and spray cans have also been produced using imported equipment and started to be used in large quantities. Therefore, the safety and aesthetics of medicines have been improved, and the grades of medicines have also been upgraded. The bulk products have already entered foreign markets. With the expansion of market demand and dosage forms, as the level of consumer demand increases, the market prospects for hard aluminum cans are also very optimistic. Medicinal packaging is an integral part of medicines. The more basic and important principle is that it must meet the quality requirements of the medicines that are packaged. In particular, it should ensure its safety and convenience and reliability for consumers. Regardless of hoses or hard cans, packaging materials that are in direct contact with the drug and used without cleansing are classified in the drug management specification as a category of products. Therefore, when selecting an application, in addition to the appearance quality, the intrinsic technological level and quality level of the product are also important factors that must be examined and verified. There are various combinations of inner coating materials, all of which are thermosetting resins. Among them, epoxy resins, epoxy resins, epoxy-amino resins, epoxy-ethylene resins, etc., which have good performance and high quality, are sometimes added with an appropriate amount of titanium dioxide. The main function of the coating is an epoxy resin, and a linear bisphenol A type resin having a high molecular weight is generally used. For example, the E-03 grade epoxy resin has an average molecular weight of 3750. This resin has more polar genes in the molecule and has a strong binding force with the polarity of the metal molecules. It can resist the erosion of some strong polar solvents and moisture, thus enhancing the physical stability of the coating to the drug; due to the fact that the original covalent chain is not destroyed in the curing process, the material has a low shrinkage (less than 2%) and a low internal stress. , Stable performance, extended compatibility with various drugs and chemical stability; no ester chain in the molecule after curing, enhanced alkali resistance (usually coatings are usually unstable for alkaline substances); longer molecules The chain facilitates internal rotation, making the coating flexible so that it does not break or fall off during use. The tail seal refers to the sealing layer at the end of the hose (hard cans without this process), and its tightness is also an important means to meet the special requirements of drugs, which can effectively prevent the leakage of drugs, especially for isotonic oil formulations or gel formulations Strong leakage of the matrix, such as eye ointment, etc., and now the general cream also use a tail seal to improve its sealing. The material of the tail seal layer is generally an acrylate copolymer, and the water-based paint is more. The coating has a certain degree of flexibility and can fill the tiny gaps in the aluminum tube seal to block all the possible "leakage" of the leak. After a comparative experiment, kerosene was contained in an aluminum tube sample with a tail seal. Then it was suspended, and no leakage occurred in all the samples within a year. However, more than half of the aluminum tubes without tail seal leaked in less than one month. As the third generation product has applied many new technologies, new processes and new materials, its external quality level has also been greatly improved compared to previous products, such as the application of polyester resin (or polyurethane) coatings and new printing inks, making aluminum The outer wall of the pipe is decorated with better brightness, wear resistance and weather resistance, and is adapted to the characteristics of wide geographical area and large climate difference in China. The multicolored printing technology expands the product's ability to adapt to complex pattern texts and increases the aesthetic effect. , And improve product quality, but also to a certain extent, reducing the possibility of counterfeiting. The aluminum plastic composite pipe that is widely used in the market is widely used in the daily chemical industry due to its beautiful appearance. Regarding whether it is applicable to the packaging of drugs, people in the industry generally believe that the special requirements of composite pipes in relation to drugs have obvious defects, because in addition to environmental protection reasons, composite pipes have not yet effectively solved the “rebound” and the outside world has taken advantage. Into. As we all know, the whole process of production of pharmaceutical packaging materials and drugs and can sealing is completed in a clean environment, with its health and safety considerations. However, it is obviously inappropriate for a large number of unpurified air outside the compound pipe to directly enter the pipe to come into direct contact with the drug, and it is inevitable that there will be a possibility of secondary pollution caused by drug jealousy. Regardless of high-quality pharmaceutical aluminum tubes or aluminum cans, to achieve high-efficiency, high-quality, and stable production levels, its equipment currently has to rely on imported high-speed automatic production lines, and corresponding production elements such as raw materials, processes, and quality management are also proposed. As a result of higher requirements, in the process of selecting suppliers, we should fully examine the comprehensive capabilities of the production companies. We must have a stable, reliable and continuous production line, a clean workshop that meets the requirements of pharmaceuticals, advanced production processes, and good quality. The raw and auxiliary materials and standard quality management, etc., believe that companies with these conditions will have the ability to produce high-quality products. Good medicines must have good packaging. These good companies and their products should be the priority targets for selection. Source: Shanghai Packaging