Analysis of plastic packaging for the hottest oral

2022-10-15
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Analysis of plastic packaging for oral drugs (2)

III. common plastics for drug packaging

(1) polyethylene plastic

polyethylene is polymerized from ethylene monomer. It is the general name of ethylene polymer compounds. Polyethylene resin is generally colorless, odorless, non-toxic, small water absorption and strong cold resistance. It is the most commonly used plastic in the packaging of oral drugs. According to the density of polyethylene raw materials, there are three kinds of density: high, medium and low. Low density polyethylene is the phenomenon that the aluminum shovel breaks when cooking, the shovel breaks when digging, and the pickaxe is divided into two when digging. It is not uncommon for the first generation products, which are characterized by softness, good low temperature resistance, and good heat sealing. However, the strength is relatively low, and the needle resistance and oil resistance are poor. It is often used as the inner sealing layer in the composite film for SP packaging

high density polyethylene is the second generation polyethylene. Like LDPE, it has good chemical stability, cold resistance, wear resistance and moisture resistance. It has higher strength than low-density polyethylene and slightly better oil resistance. Medical plastic bottles are generally made of high-density polyethylene. Due to the poor odor resistance and oil resistance of polyethylene, plastic bottles made of HDPE are generally not suitable for storing aromatic and greasy drugs. It is also not easy to store drugs that are particularly sensitive to oxygen or water vapor

even if there is monomer migration in polyethylene, there is no safety problem. As long as the variety and quantity of additives used are controlled, there is no problem in safety

(2) polypropylene plastic

polypropylene is colorless, odorless and non-toxic. It has strong heat resistance and chemical stability, and its tensile strength is greater than that of polyethylene. It is the only plastic in common use that can be boiled in water and disinfected at 130 ℃. Its disadvantage is poor cold resistance and transparency. The medicine packaging can be made into plastic bottles of solid preparations, plastic bottles of oral liquids, and infusion bottles by the bidirectional stretching method. Polypropylene is often used as a single membrane in composite membranes. Polypropylene films used in composite films include stretch films and cast films. Biaxially stretched PP film has good transparency, bright and beautiful appearance. The disadvantage is that the tear strength is greatly reduced and the heat sealing property is not good. Therefore, biaxially stretched PP film is generally used as the outer surface of composite film. Cast PP film maintains the characteristics of good tear strength and heat sealing, and can generally be used as the inner seal of composite film

(3) PVC plastic PVC

PVC is polymerized from vinyl chloride monomer and is one of the earliest plastic varieties in the world to realize industrial production. The original form of PVC is transparent and hard. Only by adding enough plasticizers can it become soft. Polyvinyl chloride is an excellent barrier for oils, volatile and nonvolatile alcohols

most of the concerns about the safety of PVC are focused on the unpolymerized polyethylene monomer VCM (PVC infusion containers also have the migration of plasticizers, which will not be discussed here)

generally used as PVC packaging materials or containers for drugs or food, as well as the pellets used, the control of vinyl chloride monomer is relatively strict, generally ≤ 1ppm

(4) polyester

polyester is the general name of a kind of resin. The so-called "polyester" usually refers to one of them, namely polyethylene terephthalate (PET). Pet is transparent, with high strength, good heat resistance and low temperature resistance, non-toxic, light weight, excellent chemical stability, good barrier to water vapor and oxygen, good barrier to odor, and no pinholes. These are the advantages of pet. The amount of additives in pet plastics is less than that of PE and PP, and the chances of migration are also less, which will not pose a problem in terms of safety. Pet is a good plastic for manufacturing beverage and condiment packaging bottles, and it is also the best plastic variety for manufacturing syrup and other oral liquid plastic packaging bottles. The outer single film of solid oral preparation packaging bottles, blister packaging molding materials and composite films for strip packaging are often made of pet

(5) other

in addition to the above commonly used plastics, some plastics with special functions are also used for drug packaging, such as polyvinylidene chloride (in fact, the polymer of vinylidene chloride and% vinyl chloride is used in packaging materials). Its outstanding advantage is its excellent gas barrier performance. The barrier to water vapor is several times - dozens of times that of polyethylene, polypropylene and polyvinyl chloride, and the barrier to oxygen is hundreds of times that of these plastics

polyvinylidene chloride (PVDC) is generally used in drug packaging:

1 Composite PVC hard sheet (pvc/pvdc hard sheet) to improve the barrier property of PVC hard sheet

2. Single layer and coating in the composite film used for strip packaging

in addition, there are also reports that PVDC is coated in medical plastic bottles made of PE or PP to improve their barrier properties

IV. plastic packaging of oral preparations

before a large number of plastic packaging, almost all tablets, capsules and oral liquids were packed in brown glass bottles (large mouth bottles for tablets, capsules and small mouth bottles for oral liquids). The glass bottle should be cleaned and dried before charging. Wax scalding process with broken wood plug after charging. After packaging, the glass is easy to break during transportation. 5. For the test pieces with complex shapes, the cushion blocks with corresponding shapes should be adopted. There are many sequences, poor appearance, many consumption and many damages, so that the glass bottles are rare in the oral solid glass packaging at present (oral liquid can also be packaged in glass bottles)

at present, the packaging forms of direct contact with oral solid preparations are as follows:

(1) plastic bottle

plastic bottle is one of the packaging containers used more for oral preparations at present. It is reported that 70% of oral solid preparations abroad are packed in plastic bottles. Since the early 1980s, China began to introduce the injection and blowing three position bottle making equipment, the output and quality of pharmaceutical plastic bottles have been greatly improved

plastic bottles for solid preparation packaging are generally made of polyolefin (PE or PP), and titanium dioxide is added as a colorant to avoid light. There are also colorless transparent or brown transparent plastic bottles made of pet. Plastic bottles for liquid oral preparations are generally made of P carbon fiber composites, which have obvious advantages in automobiles, P or pet

in recent years, more and more medical plastic bottles use sealing films. The sealing film may be beneficial to the stability of drugs during transportation and storage. However, it is impossible to change the bottled drugs. Once a piece (tablet) is taken out of the bottle, the remaining drugs in the bottle will inevitably be affected by external gases

the bottle cap is generally equipped with a safety ring. Once the bottle cap is opened, the safety ring will fall off by itself, which is conducive to safe medication. There is another kind of bottle cap called safety cap. Ensure that children under the age of 5 cannot open and take it by themselves, which belongs to children's safety packaging. For the requirements and test methods of children's safety packaging, China is formulating national standards (equivalent to international standards)

(2) single dose blister packaging

blister packaging refers to a packaging form in which hard plastic tablets are first heated into small bubbles, in which 1 tablet or 1 capsule is filled, and then sealed with aluminum foil coated with adhesive as covering material. It is generally called PTP packaging

PTP packaging has been used for tablets and capsules for more than 30 years, and its main advantages are:

1 For single dose packaging, after taking out one tablet (tablet), other drugs are still packaged completely, with the function of single sealing

2. The contents of the package can be viewed for verification

3. Light package and convenient transportation

so far, the molding material of PTP packaging is mainly PVC hard sheet. PVC hard sheet is easy to form, with good transparency, but poor barrier to water vapor. For this reason, PP and pet hard films are now available. At the same time, there are pvc/pvdc, pvc/cfe (CFE polytetrafluoroethylene), pvc/pe/pvdc and other composite hard films that can retain the advantages of PVC hard films and overcome their shortcomings

pvdc and CFE have excellent gas barrier, with a thickness of 250 μ The moisture permeability of PVC hard sheet of M is 2.5g/m ﹤ 2 · 24h. Compound a layer 30 μ The moisture permeability of PVDC can be reduced to 0.3g/m 2 · 24h. As a single dose blister package, the other side is aluminum foil for drug packaging (commonly known as "PTP" aluminum foil). As the main material, metal aluminum should be completely isolated from light and gas. It is generally believed that the thicker the aluminum foil, the smaller the possibility of pinholes. Blister packaging is generally put into cartons. The function of cartons: 1 Protection; 2. Printing; 3. Light blocking

packaging

has the forms of single dose strip packaging and single dose or multi dose bag packaging

strip packaging is a kind of unit packaging, which uses two layers of strip SP film to place tablets, capsules or suppositories in the middle, heat seals the inner side of the two layers of SP film around the drug, and presses tooth marks between the tablets to form a unit packaging. When using, tear it gradually according to the tooth mark. The advantage of strip packaging is that it is easy to use, but the disadvantage is that it must be operated on a special SP packaging machine. Generally, cartons are also needed for packaging. Bag type packaging is generally a small flat bag sealed by hot pressing on three or four sides, which can be single dose or multi dose. Suitable for packing powder, granule, tablet and capsule

the packaging materials used for SP packaging are various composite films. Composite films can be divided into plastic/plastic composite films, paper/plastic composite films, plastic/aluminum/plastic composite films, etc. from the base material structure. From the perspective of composite method, it can be divided into dry composite film, coextrusion composite film and extrusion coating composite film. Requirements of composite membrane (1) hygiene, which must meet the hygiene requirements. (2) For protection, drugs must maintain their medicinal value within their validity period. To achieve this, we must have a certain physical strength, good moisture resistance and gas resistance. (3) Workability, good adaptability to filling and sealing machinery, good heat sealing performance, etc. (4) Simplicity, safety, portability, etc. (5) Good merchantability and printing performance. (6) Economy, low price, easy transportation, storage, etc. The main single types of composite membranes are as follows

(1) polyethylene film

polyethylene film is a film used in a considerable amount of pharmaceutical composite films. It is often used as the inner seal layer in direct contact with drugs in composite films. Generally, low-density polyethylene film is used. Corona treatment is required for single-layer polyethylene before printing and dry compounding. There is also a linear low-density polyethylene film, which is more and more used in composite films at present. It is characterized by excellent heat sealing performance, wide heat sealing temperature range and better mechanical strength than low-density polyethylene. Generally, some linear low-density polyethylene can be mixed into low-density polyethylene to make film/composite film to improve the heat sealing performance

(2) polypropylene film

among the polypropylene single films used in the composite film, there are two kinds of stretched polypropylene film and salivary polypropylene. The stretched polypropylene film is transparent and bright, which can be used as the outer layer of the composite film, and the salivary polypropylene film can be used as the inner seal of the composite film

(3) polyester film

polyester film is one of the main substrates for the production of various high-performance composite films. It is the main component of high-temperature steaming composite films and vacuum packaging composite films. It has the advantages of high strength, good toughness, good oil resistance, transparency and brightness. (4) Aluminum foil metal has an absolute barrier effect on gas and light. Using aluminum foil as an intermediate layer can greatly improve its barrier property

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