I. Introduction
Drugs are a special commodity whose efficacy and quality are directly related to human health and safety. The materials and structural forms of pharmaceutical packaging play a key role in ensuring drug efficacy and convenience while ensuring efficacy, and are an important indicator for the evaluation of drug quality. China's packaging of solid dosage forms (pharmaceutical tablets, sugar-coated tablets, capsules, capsules, injections, and stickers for external use) has undergone rapid development in recent years. It has experienced simple paper bag packaging, polyester bottle packaging, aluminum-plastic blister packaging, and unit bars. Improvements such as packaging and packaging have greatly improved the quality of pharmaceutical packaging. The following is a description of the principle of new packaging materials and packaging technology for solid dosage forms of pharmaceuticals.
Second, solid dosage form of new drug packaging technology and materials
1. High-quality medicinal plastic bottle packaging and materials
In 1995, the State Drug Administration had explicitly eliminated the glass bottle and wax seal process, and promoted the use of high-quality plastic bottle packaging produced by the injection blow molding process. The main materials used for high-quality pharmaceutical plastic bottles include high-density polyethylene (HDPE), polypropylene (PP), and polyethylene terephthalate (PETP). Although these three materials have their own characteristics, they are all crystalline plastics. They have good impact strength, environmental stress resistance, chemical resistance and good gas barrier properties, moisture barrier properties and are nontoxic, and are widely used for the packaging of tablets, capsules, and capsules. Since the drug is most sensitive to light in the range of 290-450 nm, it is necessary to consider the addition of opacifying agents in the application of plastic raw material formulations to ensure that the bottle is not transparent. In the early 1990s, a new material for blow-molded bottles, polyethylene naphthalate (PEN), was developed in foreign countries. PEN has high strength, good heat resistance, ultraviolet radiation resistance, excellent gas barrier performance against carbon dioxide gas and oxygen, and good chemical resistance. It is more widely used than PETP. PEN is a new type of polyester resin that has been actively developed in foreign countries in recent years. It is also an excellent material for pharmaceutical plastic bottle packaging.
The drug is contained in the bottle, and its moisture resistance and tightness are largely determined by the cooperation between the bottle mouth and the bottle cap, that is, the tightness after applying the torque. In order to improve the sealing moisture resistance and ensure safety, in recent years, the use of aluminum foil gasket seals at the plastic bottle mouth, the bottle cap uses a security anti-theft ring structure, can provide obvious traces of seal damage. The opening and re-sealing of this type of bottle packaging is very convenient, but the storage conditions of other drugs are also affected when each dose is taken. For drugs that cannot be consumed within a short period of time and require high barrier properties to air, they are prone to adhesion and even deterioration.
2. Pharmaceutical blister packaging technology and materials
Pharmaceutical blister packaging, also known as blister packaging. That is PTP (Press Through Package) packaging technology. It provides patients with a dose package that is economical and convenient. PTP technology is to first send the plastic sheet under the heater to soften it, then place the sheet in the mold, and then fill the mold with compressed air from above. The sheet is attached to the mold wall to form a blister or cavity. If the blister or cavity is not deep and the thin film is thin, vacuum is drawn from the bottom of the mold to form a plastic part. After molding, cooling is taken out, the medicine is put into the eyes of a plastic sheet blisters, and the side of the medicine aluminum foil coated with the adhesive is heat-sealed with a plastic film already containing the medicine under a certain temperature, pressure, and time conditions to form a blister pack. It has good drug resistance, good chemical stability, tearing by hand, good drug resistance and easy access and carrying.
Medicinal blister packaging materials include medicinal aluminum foil, plastic harder films, and sealing materials, also known as cover materials. It is based on hard industrial pure aluminum. It has the advantages of non-toxic, corrosion-resistant, non-permeable, heat-resisting, moisture-proof, light-blocking, and high-temperature sterilization. Medicinal aluminum foil is usually 0.02 mm thick and consists of a protective layer, an ink layer, its material, and an adhesive layer. Because drugs are very sensitive to moisture, moisture, and light penetration, they require high barrier properties to water, vapor, and light. Use polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite material PVC/PVDC, PVC/PE, PVC/PVDC/PE, PVDC/OPP/PE and so on. Due to the poor performance of PVC in moisture barrier and other aspects, cash has been used PVDC and its composite materials. Comparing materials of the same thickness, PVDC and its composite materials. Compared with the same thickness of material, PVDC has 1500 times more oxygen barrier performance than PVC, 100 times that of PP and 100 times that of PET. Its water-blocking vapor and odor properties are also superior to PVC. For example, some vitamin E capsules packed in PVC or PET have been adhered to the wall when they have not been used. There are also proprietary Chinese medicines that require high barrier packaging, especially oxygen-blocking packaging medicines, such as analgesic and anti-inflammatory creams. The use of PVDC membranes will not dissipate the odor and will not affect the efficacy.
In addition, pharmaceutical aluminum foil printing ink should have good adhesion to aluminum foil, fast solvent release, good heat and wear resistance, good gloss, and non-toxic. Mainly include alcohol-soluble polyamide inks and aluminum foil special inks based on polyethylene vinyl acetate copolymer resin acrylic. Medicinal aluminum foil adhesive material is mainly a solvent adhesive composed of polyvinyl acetate and nitrocellulose. Its solution solid content is generally about 18-22%, which can meet the heat sealing of aluminum foil and blister material after hot pressing. strength.
3. Pharmaceutical strip packaging technology and materials
For some larger dosage forms, strong hygroscopicity, sensitive to ultraviolet light, requiring heat and cold resistance, and requiring a long effective period of the drug is more suitable for strip packaging. Strip Packaging SP (Strip Packaging) uses two layers of medical strip packaging film (SP film) to sandwich drugs with a certain distance between each drug. In the strip packaging machine, two layers of SP film around the drug are placed on the inside. Sealed by heat sealing and pressed with a tooth mark between medicines to form a kind of unit packaging form (single pack or grouped into small packs.) Strip packer is continuous operation on strip packer, especially suitable for large batch automatic packer. When taking drugs, tear the SP film along the tooth marks. Taking a dose of medicine like this does not affect the packaging of other medicines.
Strip packaging film (SP film) is a composite film, has a certain tensile strength and elongation, suitable for a variety of shapes and sizes of drugs, and packaging close to the drug, not easy to produce cracks and wrinkles. At present, aluminum-plastic composite films, such as PT/AL/PE, PET/AL/PE, etc., are widely used. That is, aluminum foil and plastic film are laminated or compounded with an adhesive, and are composed of a base layer and a printing layer. High barrier layer and sealing layer. On the outside of the base layer, the heat seal layer and the high barrier layer and the print layer are in the middle. The base material is required to have excellent mechanical properties, gloss, good printability, good transparency, good barrier properties, safety and non-toxicity, but no heat sealability. Typical materials are PET, cellophane PT and cellophane with PVDC coating. The high barrier layer is good for gas barrier and moisture proof, does not penetrate bacteria and microorganisms, has good mechanical properties, has a certain elongation, is resistant to cold and heat, is safe and nontoxic, and its typical material is a soft aluminum foil. However, this soft aluminum foil is opaque, itself stainless, and strong in light blocking. If a transparent strip packaging film is required, PVDC should be used as a high barrier material. PVDC is used as a high barrier layer material, and its greatest feature is its excellent barrier properties against gases and water vapor, and it maintains the original flavor of the drug well. The sealing layer is the inner layer of the strip-shaped packaging film, and has excellent heat-sealing properties. At the same time, it has chemical stability, safety and hygienic properties, and generally uses LDPE material. At present, foreign pharmaceutical strip packaging films have been developed from double-layer composites to multi-layer composites, and some have reached seven layers. Some domestic manufacturers are also trying to produce and promote the development of strip packaging technology in China.
Since the bar-shaped packaging is a unit package, the outer surface of each unit package must have an independent and complete single-sided or double-sided graphic printing. The ink used should have heat resistance and be suitable for heat sealing requirements.
Third, the conclusion
The above-mentioned packaging technologies and materials have been adopted in different degrees in domestic and foreign pharmaceutical packaging. Among them, PTP technology and SP technology are suitable for tablet medicines, capsules (pills) dosage forms, injection packaging, and even solid food packaging, with broad development prospects. . In particular, SP packaging technology is very suitable for special requirements of brand-name or high-grade solid dosage forms of pharmaceutical packaging. With the continuous improvement of packaging materials and the performance of packaging equipment, PTP technology and SP technology will become the leading technology for solid dosage form pharmaceutical packaging in China, and will be widely used in the domestic pharmaceutical and food industry.
Drugs are a special commodity whose efficacy and quality are directly related to human health and safety. The materials and structural forms of pharmaceutical packaging play a key role in ensuring drug efficacy and convenience while ensuring efficacy, and are an important indicator for the evaluation of drug quality. China's packaging of solid dosage forms (pharmaceutical tablets, sugar-coated tablets, capsules, capsules, injections, and stickers for external use) has undergone rapid development in recent years. It has experienced simple paper bag packaging, polyester bottle packaging, aluminum-plastic blister packaging, and unit bars. Improvements such as packaging and packaging have greatly improved the quality of pharmaceutical packaging. The following is a description of the principle of new packaging materials and packaging technology for solid dosage forms of pharmaceuticals.
Second, solid dosage form of new drug packaging technology and materials
1. High-quality medicinal plastic bottle packaging and materials
In 1995, the State Drug Administration had explicitly eliminated the glass bottle and wax seal process, and promoted the use of high-quality plastic bottle packaging produced by the injection blow molding process. The main materials used for high-quality pharmaceutical plastic bottles include high-density polyethylene (HDPE), polypropylene (PP), and polyethylene terephthalate (PETP). Although these three materials have their own characteristics, they are all crystalline plastics. They have good impact strength, environmental stress resistance, chemical resistance and good gas barrier properties, moisture barrier properties and are nontoxic, and are widely used for the packaging of tablets, capsules, and capsules. Since the drug is most sensitive to light in the range of 290-450 nm, it is necessary to consider the addition of opacifying agents in the application of plastic raw material formulations to ensure that the bottle is not transparent. In the early 1990s, a new material for blow-molded bottles, polyethylene naphthalate (PEN), was developed in foreign countries. PEN has high strength, good heat resistance, ultraviolet radiation resistance, excellent gas barrier performance against carbon dioxide gas and oxygen, and good chemical resistance. It is more widely used than PETP. PEN is a new type of polyester resin that has been actively developed in foreign countries in recent years. It is also an excellent material for pharmaceutical plastic bottle packaging.
The drug is contained in the bottle, and its moisture resistance and tightness are largely determined by the cooperation between the bottle mouth and the bottle cap, that is, the tightness after applying the torque. In order to improve the sealing moisture resistance and ensure safety, in recent years, the use of aluminum foil gasket seals at the plastic bottle mouth, the bottle cap uses a security anti-theft ring structure, can provide obvious traces of seal damage. The opening and re-sealing of this type of bottle packaging is very convenient, but the storage conditions of other drugs are also affected when each dose is taken. For drugs that cannot be consumed within a short period of time and require high barrier properties to air, they are prone to adhesion and even deterioration.
2. Pharmaceutical blister packaging technology and materials
Pharmaceutical blister packaging, also known as blister packaging. That is PTP (Press Through Package) packaging technology. It provides patients with a dose package that is economical and convenient. PTP technology is to first send the plastic sheet under the heater to soften it, then place the sheet in the mold, and then fill the mold with compressed air from above. The sheet is attached to the mold wall to form a blister or cavity. If the blister or cavity is not deep and the thin film is thin, vacuum is drawn from the bottom of the mold to form a plastic part. After molding, cooling is taken out, the medicine is put into the eyes of a plastic sheet blisters, and the side of the medicine aluminum foil coated with the adhesive is heat-sealed with a plastic film already containing the medicine under a certain temperature, pressure, and time conditions to form a blister pack. It has good drug resistance, good chemical stability, tearing by hand, good drug resistance and easy access and carrying.
Medicinal blister packaging materials include medicinal aluminum foil, plastic harder films, and sealing materials, also known as cover materials. It is based on hard industrial pure aluminum. It has the advantages of non-toxic, corrosion-resistant, non-permeable, heat-resisting, moisture-proof, light-blocking, and high-temperature sterilization. Medicinal aluminum foil is usually 0.02 mm thick and consists of a protective layer, an ink layer, its material, and an adhesive layer. Because drugs are very sensitive to moisture, moisture, and light penetration, they require high barrier properties to water, vapor, and light. Use polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite material PVC/PVDC, PVC/PE, PVC/PVDC/PE, PVDC/OPP/PE and so on. Due to the poor performance of PVC in moisture barrier and other aspects, cash has been used PVDC and its composite materials. Comparing materials of the same thickness, PVDC and its composite materials. Compared with the same thickness of material, PVDC has 1500 times more oxygen barrier performance than PVC, 100 times that of PP and 100 times that of PET. Its water-blocking vapor and odor properties are also superior to PVC. For example, some vitamin E capsules packed in PVC or PET have been adhered to the wall when they have not been used. There are also proprietary Chinese medicines that require high barrier packaging, especially oxygen-blocking packaging medicines, such as analgesic and anti-inflammatory creams. The use of PVDC membranes will not dissipate the odor and will not affect the efficacy.
In addition, pharmaceutical aluminum foil printing ink should have good adhesion to aluminum foil, fast solvent release, good heat and wear resistance, good gloss, and non-toxic. Mainly include alcohol-soluble polyamide inks and aluminum foil special inks based on polyethylene vinyl acetate copolymer resin acrylic. Medicinal aluminum foil adhesive material is mainly a solvent adhesive composed of polyvinyl acetate and nitrocellulose. Its solution solid content is generally about 18-22%, which can meet the heat sealing of aluminum foil and blister material after hot pressing. strength.
3. Pharmaceutical strip packaging technology and materials
For some larger dosage forms, strong hygroscopicity, sensitive to ultraviolet light, requiring heat and cold resistance, and requiring a long effective period of the drug is more suitable for strip packaging. Strip Packaging SP (Strip Packaging) uses two layers of medical strip packaging film (SP film) to sandwich drugs with a certain distance between each drug. In the strip packaging machine, two layers of SP film around the drug are placed on the inside. Sealed by heat sealing and pressed with a tooth mark between medicines to form a kind of unit packaging form (single pack or grouped into small packs.) Strip packer is continuous operation on strip packer, especially suitable for large batch automatic packer. When taking drugs, tear the SP film along the tooth marks. Taking a dose of medicine like this does not affect the packaging of other medicines.
Strip packaging film (SP film) is a composite film, has a certain tensile strength and elongation, suitable for a variety of shapes and sizes of drugs, and packaging close to the drug, not easy to produce cracks and wrinkles. At present, aluminum-plastic composite films, such as PT/AL/PE, PET/AL/PE, etc., are widely used. That is, aluminum foil and plastic film are laminated or compounded with an adhesive, and are composed of a base layer and a printing layer. High barrier layer and sealing layer. On the outside of the base layer, the heat seal layer and the high barrier layer and the print layer are in the middle. The base material is required to have excellent mechanical properties, gloss, good printability, good transparency, good barrier properties, safety and non-toxicity, but no heat sealability. Typical materials are PET, cellophane PT and cellophane with PVDC coating. The high barrier layer is good for gas barrier and moisture proof, does not penetrate bacteria and microorganisms, has good mechanical properties, has a certain elongation, is resistant to cold and heat, is safe and nontoxic, and its typical material is a soft aluminum foil. However, this soft aluminum foil is opaque, itself stainless, and strong in light blocking. If a transparent strip packaging film is required, PVDC should be used as a high barrier material. PVDC is used as a high barrier layer material, and its greatest feature is its excellent barrier properties against gases and water vapor, and it maintains the original flavor of the drug well. The sealing layer is the inner layer of the strip-shaped packaging film, and has excellent heat-sealing properties. At the same time, it has chemical stability, safety and hygienic properties, and generally uses LDPE material. At present, foreign pharmaceutical strip packaging films have been developed from double-layer composites to multi-layer composites, and some have reached seven layers. Some domestic manufacturers are also trying to produce and promote the development of strip packaging technology in China.
Since the bar-shaped packaging is a unit package, the outer surface of each unit package must have an independent and complete single-sided or double-sided graphic printing. The ink used should have heat resistance and be suitable for heat sealing requirements.
Third, the conclusion
The above-mentioned packaging technologies and materials have been adopted in different degrees in domestic and foreign pharmaceutical packaging. Among them, PTP technology and SP technology are suitable for tablet medicines, capsules (pills) dosage forms, injection packaging, and even solid food packaging, with broad development prospects. . In particular, SP packaging technology is very suitable for special requirements of brand-name or high-grade solid dosage forms of pharmaceutical packaging. With the continuous improvement of packaging materials and the performance of packaging equipment, PTP technology and SP technology will become the leading technology for solid dosage form pharmaceutical packaging in China, and will be widely used in the domestic pharmaceutical and food industry.
Ningbo Smile tools Co.,ltd , https://www.nbsmiletools.com