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New packaging materials and technology development of solid dosage forms of medicines

New packaging materials and technology development of solid dosage forms of medicines

(Summary description)Medicine is a special commodity, and its efficacy and quality are directly related to personal health and safety.

New packaging materials and technology development of solid dosage forms of medicines

(Summary description)Medicine is a special commodity, and its efficacy and quality are directly related to personal health and safety.

Information

Medicine is a special commodity, and its efficacy and quality are directly related to personal health and safety. The material and structure of drug packaging not only ensure the efficacy of the drug, but also play a key role in ensuring the reliability and convenience of drug use. It is an important indicator for evaluating drug quality. The packaging of solid dosage forms of medicines (plain tablets, sugar-coated tablets, capsules, capsules, injections, topical drugs, etc.) in China has been updated and developed rapidly in recent years. Shape packaging and other improvements, the quality of pharmaceutical packaging has been greatly improved. The following is an elaboration on the new packaging materials and packaging process principles of solid dosage drugs.  

In 1995, the National Medical Products Administration had banned the glass bottle and wax sealing 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 medical plastic bottles are 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 non-toxic. They are currently widely used in the packaging of tablets, capsules, and capsules. Since medicines are most sensitive to light in the range of 290-450 nanometers, it is necessary to consider adding sunscreens in the application of plastic raw material formulations to ensure that the medicine bottles are opaque. In the early 1990s, polyethylene naphthalate (PEN), a new material for blow molding bottles, was developed abroad, with better properties. PEN has high strength, good heat resistance, UV resistance, excellent barrier properties to carbon dioxide gas and oxygen, and good chemical resistance. It has more uses than PETP. PEN is a new type of polyester resin that has been actively developed abroad in recent years, and it is also an excellent material for pharmaceutical plastic bottle packaging.  The drug is contained in a bottle, and its moisture resistance and sealing performance largely depend on the fit between the bottle mouth and the bottle cap, that is, the tightness after torque is applied. In order to improve the moisture resistance of the seal and ensure safety, aluminum foil gaskets have been used to seal the mouth of the plastic bottle in recent years, and the bottle cap adopts an anti-theft safety ring structure, which can provide obvious traces of seal damage. This kind of bottle packaging is very convenient to open and reseal, but the storage conditions of other medicines are also affected every time the medicine is taken. For medicines that cannot be taken in a short time and require high air barrier properties, they are prone to adhesions and even deterioration and failure.  

Pharmaceutical blister packaging is also called blister packaging. Namely PTP (Press Through Package) packaging technology. It provides patients with one-dose packaging, which is economical and convenient. PTP technology is to first convey the plastic sheet to the electric 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 film is thin, use a vacuum method to draw air from the bottom of the mold to form a plastic. After molding, take it out and cool, put the medicine into the blister of the plastic sheet, and heat-seal the side coated with the adhesive with the medicinal aluminum foil with the plastic film containing the medicine under certain temperature, pressure and time conditions to form a blister package. It has good drug resistance, good chemical stability, can be torn by hand, can maintain drug properties well and is easy to take and carry.   medicinal blister packaging materials include medicinal aluminum foil, plastic harder sheets, sealing materials, also called lidding materials. It uses hard industrial pure aluminum as the base material, and has the advantages of non-toxic, corrosion-resistant, impermeable, heat-resistant, moisture-proof, light-blocking, and high-temperature sterilization. The thickness of medicinal aluminum foil is usually 0.02 mm, and it is composed of a protective layer, an ink layer, its material and an adhesive layer. Because drugs are very sensitive to moisture, moisture, and light penetration, the blister material used is required to have high barrier properties to water, vapor, and light. Polyvinyl chloride (PVC), polyvinylidene chloride (PVDC) or composite materials PVC/PVDC, PVC/PE, PVC/PVDC/PE, PVDC/OPP/PE, etc. are mostly used. Due to the unsatisfactory performance of PVC in terms of moisture and vapor resistance, PVDC and its composite materials have been adopted. Compare with the material of the same thickness, PVDC and its composite materials. Compared with materials of the same thickness, the barrier performance of PVDC to oxygen in the air is 1500 times that of PVC, 100 times that of PP, and 100 times that of PET, and its water vapor and odor barrier properties are also better than PVC. For example, some vitamin E capsules packed in PVC or PET may stick to the wall before taking it. There are also some proprietary Chinese medicines that require high-barrier packaging, especially those that are packaged in oxygen barriers, such as Shangshi Pain Ointment. When using PVDC film, the smell will not be lost and the efficacy will not be affected.  

In addition, medicinal aluminum foil printing inks should have good adhesion to aluminum foil, fast solvent release, good heat and wear resistance, good gloss, and non-toxicity. There are mainly alcohol-soluble polyamide inks and special inks for aluminum foil with polyethylene vinyl acetate copolymer resin acrylic as the main component. The medical aluminum foil adhesive material is mainly a solvent-based adhesive mixed with polyvinyl acetate and nitrocellulose. The solid content of the solution is generally about 18-22%, which can meet the thermal bonding of aluminum foil and blister material after hot pressing. strength.   It is more suitable for some drugs with larger dosage forms, strong hygroscopicity, sensitivity to ultraviolet light, heat and cold resistance, and long validity period, to use strip packaging. Strip packaging SP (Strip Packaging) uses two layers of medicinal strip packaging film (SP film) to sandwich the medicines. The unit medicines are separated by a certain distance. The inside of the two layers of SP film around the medicines is placed on the strip packaging machine. Heat sealing is a unit packaging form (single piece packaging or small packages formed in rows) formed by pressing tooth marks between medicines. Strip packaging is a continuous operation on a strip packaging machine, which is especially suitable for automatic packaging in large quantities. When taking the medicine, you can tear the SP film along the tooth marks. In this way, taking a single dose of medicine does not affect the packaging of other medicines.  

Strip packaging film (SP film) is a composite film with certain tensile strength and elongation. It is suitable for medicines of various shapes and sizes. After packaging, it is close to the medicine inside, and it is not easy to break and wrinkle. At present, the more commonly used aluminum-plastic composite film, such as PT/AL/PE, PET/AL/PE, etc., that is, aluminum foil and plastic film are laminated or extruded with an adhesive. It consists of a base layer, a printing layer, It is composed of high barrier layer and sealing layer. The base layer is outside, the heat sealing layer is inside, and the high barrier layer and the printing 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 must have good gas barrier properties and moisture resistance, no bacteria and microorganisms, good mechanical properties, a certain degree of elongation, cold and heat resistance, safe and non-toxic. Its typical material is soft aluminum foil. However, this kind of soft aluminum foil is opaque, is not rusty, and has strong shading properties. If a transparent strip packaging film is required, PVDC should be used as the high barrier layer material. PVDC is used as a high-barrier layer material, and its biggest feature is its excellent barrier properties to gas and water vapor, and it maintains the original effect of the original flavor of the medicine. The sealing layer is the inner layer of the strip-shaped packaging film, which has excellent heat-sealability, chemical stability, safety and hygiene, and generally uses LDPE materials. At present, foreign medicinal strip packaging films have developed from double-layer composite to multilayer composite, and some have reached seven layers. Some domestic manufacturers are also trying to produce, which has promoted the development of strip packaging technology in China.  

Since the strip packaging is a unit packaging, the outer surface of each unit packaging must have independent and complete single-sided or double-sided graphic printing. The ink used should have heat resistance and be suitable for heat sealing requirements.  

The above-mentioned packaging technology and materials have been adopted to varying degrees in domestic and foreign pharmaceutical packaging. Among them, PTP technology and SP technology are suitable for the packaging of tablet medicines, capsule (pill) dosage forms, injections, and even solid food packaging. They have broad development prospects. . In particular, SP packaging technology is very suitable for the packaging of famous brand or high-end solid dosage forms with special requirements. With the renewal of packaging materials and the continuous improvement of the performance of packaging equipment, PTP technology and SP technology will become the leading technology for solid dosage form pharmaceutical packaging in my country, and will be widely used in the domestic pharmaceutical and food industries.

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As a supplier of pharmaceutical packaging materials that has always been export-oriented and supplemented by domestic sales, today we will talk to you about the differences in the procurement of pharmaceutical packaging materials for domestic and foreign customers!

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