Selection of PTP packaging materials for the most

The choice of pharmaceutical PTP packaging materials (Part 1)

has also entered the transformation period of innovation driven development. The aluminum plastic blister packaging of drugs is also known as water through package, which is called "press through package" in English and "PTP" packaging for short. PTP packaging is to first transport the plastic sheet to the electric heater to soften it, then place the sheet in the mold, then fill the sheet with compressed air from the upper mold or vacuum it in the lower mold to form a blister or cavity, cool it after forming, and put the medicine into the blister. The side of the medicinal aluminum foil coated with adhesive is heat sealed with the plastic sheet containing the medicine under the given temperature, pressure and time to form a blister packaging. PTP packaging materials include medicinal aluminum foil, plastic hard pieces, etc. this chapter mainly introduces the plastic hard pieces used for PTP packaging

ptp packaging was jointly developed by German Lawson mardon Singen company and Bosch Company in the mid-1950s. The application of PTP packaging makes the single package of drugs on the road to success

ptp packaging has great advantages: first, it provides patients with a single dose of drug packaging, which is convenient and economical; Secondly, PTP packaging protects drugs with good performance, high production efficiency, low cost, small storage space, light weight and convenient transportation; Thirdly, it has good safety. Because the PTP package can be printed with text instructions, both the sender and the receiver can avoid the occurrence of wrong drugs. In China, the development of PTP aluminum plastic packaging can be traced back to the 1980s. 85 years ago, the pharmaceutical tablets and capsules produced in China were packed in glass bottles or simple plastic bags, which brought many problems in use, drug shelf life and drug safety. After 84 years, the rigid PVC pharmaceutical packaging tablets were successfully developed by Hangzhou plastic factory (the predecessor of Hangzhou Plastic Industry Co., Ltd.), which made PTP aluminum plastic packaging, a novel packaging, widely welcomed by pharmaceutical factories, and rapidly developed into the main packaging form of tablets and capsules. The most common surface materials used in PTP aluminum-plastic blister packaging are PVC medical tablets and a series of composite materials coated with PVC medical tablets or compounded with other functional polymer materials made of metal materials. These materials are mainly polyvinylidene chloride (PVDC), polytrifluoroethylene (PCTFE), nylon (PA), polyethylene (PE), aluminum foil (AL), etc. Composite materials combine the properties of a variety of materials. It not only has the basic properties of PVC medicinal tablets, but also has excellent properties that a single material does not have, such as excellent barrier to water vapor and oxygen, good light repellency, heat sealing, excellent thermal stability and processability. It is gradually replacing PVC pharmaceutical tablets and becoming one of the development directions of pharmaceutical packaging in the future

in recent years, PTP aluminum plastic packaging surface materials such as polypropylene (PP) and polyethylene terephthalate (PET) have been successively developed abroad. Although they have advantages over PVC hard films in some aspects, they are far inferior to PVC hard films in processing performance and production efficiency. In addition, new equipment needs to be purchased and the production cost is high. Therefore, they are not widely used, but only used for the packaging of a small number of special drugs, accounting for a small proportion. PVC hard sheet is the most important PTP packaging material. The choice of these material varieties can be finally determined by the pharmaceutical factory according to the suggestions of packaging material experts, combined with the properties of built-in drugs and relevant stability tests (see Table 1 omitted)

1.1 medicinal polyvinyl chloride (PVC) hard tablets

PVC medicinal tablets are mainly made of polyvinyl chloride (PVC) resin with certain processing aids. Through extrusion, calendering and other processing methods, they produce a new packaging material that meets the pharmaceutical requirements. It separates each tablet, pill and capsule independently, making it the smallest packaging unit. The accuracy and safety of using drugs have been greatly improved. Because the processing method is simple, the investment is small, and it is easy to form and process, the production cost of pharmaceutical factories has been greatly reduced, and the production efficiency has been greatly improved. In the early 1990s, almost all pharmaceutical factories are willing to use this packaging to produce tablets, pills and capsules, This development trend continues to this day. PTP aluminum plastic packaging has become the first packaging method when more and more pharmaceutical companies and new pharmaceutical companies launch new tablets, pills and capsules. PVC pharmaceutical tablets account for more than 95% of domestic PTP packaging materials. At present, the development trend of PTP aluminum plastic packaging abroad is also dominated by PVC materials, but now there are packaging materials such as PP, pet, PS, etc., but there is a gap between the comprehensive performance and PVC. The main thing is that there is no new image of the packaging appearance of drugs. Therefore, the packaging materials used for PTP aluminum-plastic packaging are mainly PVC materials abroad, accounting for about 60%, the rest are mostly composite packaging materials, and other single packaging materials account for a small proportion. In terms of growth rate, the growth rate of composite packaging materials is 3-4 times that of single packaging materials. Therefore, composite packaging materials will soon become the mainstream of PTP packaging

1.2 PVC series composite materials for pharmaceutical packaging

PVC series composite sheets for pharmaceutical packaging are mainly composed of PVC pharmaceutical sheets and another or several new polymer films and sheets. Through extrusion, compounding, coating and other processing methods, another new composite material that meets the requirements of pharmaceutical packaging is produced. In the 1990s, the safety of medication has been paid more and more attention. Because the ingredients of some drugs are easily deliquescent and oxidized, the original PVC aluminum-plastic packaging can no longer meet the packaging requirements of these drugs. According to the development trend of foreign drug packaging materials, the pharmaceutical packaging material manufacturer led by Hangzhou Plastic Industry Co., Ltd. has successfully developed PVC pharmaceutical tablets as the base material and added some high barrier polymer materials (such as PVDC from Solvay company). It integrates the rigidity and good molding of PVC and the effect of PVDC on water vapor, oxygen, such as the working surface of support holes, bushings, and axle holes The excellent barrier property of various odors of CO 2, such as reducer, has become a new composite material, which can meet the packaging requirements of drugs that are easy to deliquescence and oxidize, and some traditional Chinese medicine retain fragrance. At the same time, it still uses the PTP aluminum-plastic packaging type, and the packaging equipment and process are exactly the same as PVC drug packaging materials. This series of composite materials can customize the packaging materials for pharmaceutical companies according to the degree of moisture and oxidation of drugs, and become a higher-level PTP packaging type. In addition, pvc/pe packaging materials replace glass bottles to fill liquid and suppository drugs, which greatly improves the drug safety of this kind of drugs. Since PVC and PVC series composite materials used in PTP packaging are in direct contact with drugs, pharmaceutical manufacturers should pay great attention to the sanitary conditions and environment of PVC manufacturers after determining to use PVC series materials to package drugs, and must have a production environment of drug packaging materials that is consistent with the production environment of drugs

2 raw materials, formula

2.1 PVC medicinal tablets

pvc medicinal tablets are mainly made of PVC resin, stabilizer, processing aids, reinforcing agents, lubricants, plasticizers, etc. The selection of raw materials should not only consider the processability and secondary processability (PTP packaging), but also consider the hygiene of drug production, both of which are indispensable. In fact, PVC hard chips contain about 90% PVC resin, and additives account for only a small part. The specific components are as follows:

PVC resin: 88-92% stabilizer: 1.5% enhancer: 4.5% processing additives: 1-1.5% plasticizer: 0-1% lubricant: 1.5-2%

therefore, packaging material factories should first pay attention to the selected PVC resin during production, which must meet the requirements of pharmaceutical packaging, Control procedures must be established to control each batch of raw materials in strict accordance with pharmaceutical requirements. At the same time, the improper selection of additives will also affect the internal quality of PVC medicinal tablets, and eventually harm the drugs themselves. Therefore, the selection of additives should also meet the requirements of medicine. Therefore, the pharmaceutical factory must conduct stability and compatibility tests before determining that the packaging material factory provides PVC medicinal tablets. Once it is determined, it should agree with the packaging material factory that the raw materials and formula of PVC medicinal tablets cannot be changed at will

2.2 raw materials and formulas of PVC series pharmaceutical composite hard tablets

2.2.1 raw materials of PVC series pharmaceutical composite hard tablets:

raw materials of PVC series pharmaceutical composite hard tablets. How can the main concrete pressure testing machine be maintained and used correctly to make the test results more accurate? There are PVC medicinal tablets, PVDC lotion or resin, PE film, adhesives, etc. The selection of raw materials should not only consider the processability and secondary processability (PTP packaging), but also consider the hygiene of drug production, both of which are indispensable. Once the composition and structure of the material are determined, the packaging material factory cannot easily change it, which will eventually affect the quality of drugs

2.2.1.1 PVC medicinal tablets

must be produced in a clean workshop that meets the production requirements of pharmaceutical packaging materials, and the products approved and registered by SDA can be used in the static testing machine for the production of composite hard tablets

2.2.1.2 PVDC

PVDC is a high barrier polymer material. Its structural formula is － [h 2-ccl2 -] M-N -, X represents the copolymerization group. Pure PVDC is a very difficult polymer to process, so it must be copolymerized with other groups to be used for processing. Different copolymerization groups produce PVDC with different properties and processing technologies. Usually, the copolymerization groups include methacrylates and vinyl chloride

as a special commodity, drugs have increasingly stringent requirements for packaging. The special physical properties of PVDC have attracted more and more attention, and are increasingly used in drug packaging. These special physical properties include excellent barrier performance and chemical stability to oxygen, water vapor, carbon dioxide and organic compounds. When more and more polymer materials are processed for drug packaging, only PVDC has high barrier performance to water vapor and oxygen at the same time. In fact, many polymer materials have their own barrier properties against water vapor. Coating a thin layer of PVDC on them will greatly enhance this performance. In addition, PVDC coating can block oxygen and other substances and keep fragrance. PVDC also has the properties of acid resistance, alkali resistance, grease resistance, solvent resistance and drug resistance, which makes it more suitable for various types of drug packaging, especially some drug packaging that is easy to deliquescence, easy to oxidize or contains chemical active substances, as well as those that need to preserve fragrance or block odor adsorption

at present, all PVDC used in the production of pharmaceutical packaging materials in China are imported from abroad. These products have been approved by FDA and can be used in the packaging of drugs and food. Domestic manufacturers have produced PVDC lotion, but there is still a big gap in quality compared with imported ones, mainly in barrier property, coating uniformity, stability, hygiene and so on. As the PVC series pharmaceutical composite tablets have health requirements, the vdcm (vinylidene chloride monomer) content of the selected PVDC lotion must be less than 3ppm. See Table 2 for the comparison between PVDC and other polymers

2.2.1.3 PE film

the selection of PE film is the same as that of PVC medicinal tablets. It must be produced in a clean workshop that meets the production requirements of pharmaceutical packaging materials, and the products approved and registered by SDA can be used in the production of composite hard films

2.2.1.4 adhesives

at present, the adhesives used in composite hard films are two-component polyurethane adhesives, which are composed of main agent and curing agent. The main agent, curing agent and solvent are mixed evenly in a certain proportion and then used for production. The quality of adhesives directly affects the quality of products. At present, imported adhesives are mainly used in China. Foreign students