Abstract: When it comes to protecting the efficacy of ultra-sensitive drugs, the packaging must strengthen and provide the necessary oxygen and moisture barriers. Some components of the drug are prone to oxidation and deterioration problems when they encounter oxygen or water, so they should have good and good oxygen barrier properties.

Keywords: pharmaceuticals, aluminum-plastic composite film, oxidative deterioration, oxygen transmission properties, oxygen transmission rate, barrier, gas permeability meter.

Current status
The safety of drugs is of paramount importance, so the performance requirements of their packaging materials are also high, especially the barrier performance of the packaging to external oxygen, a lower oxygen transmission rate can effectively prevent oxidation and deterioration of drugs. The packaging materials of powder drugs commonly include plastic composite film, aluminized composite film, aluminum composite film, etc. Among them, aluminum composite film packaging not only has high barrier performance, but also can make the drug packaging with exquisite appearance, but the aluminum foil layer in the aluminum composite film is easy to appear in the packaging molding, drug filling, heat sealing and transportation and sales process to a certain extent of the crease, so that the barrier properties of the composite film deterioration, the finished packaging The overall tightness of the finished package is greatly affected.

In this paper, we introduce the monitoring scheme of oxygen barrier property of aluminum-plastic composite film packaging for powder pharmaceuticals, and explain that oxygen barrier property is an important factor affecting the shelf life quality of pharmaceuticals. If the packaging oxygen barrier is poor, the oxygen transmission rate of the packaging will be too large in the long-term circulation and storage process after leaving the factory, which will lead to oxidation and deterioration of the drug and reduce the efficacy of the drug. Therefore, pharmaceutical companies should strengthen the regular monitoring of the packaging oxygen barrier performance

Test sample
Aluminum-plastic composite film packaging of powder drugs provided by a pharmaceutical company.
Test equipment
GBPI self-developed and designed N530L differential pressure method gas permeation tester
4.1 Testing Principle
The N530L gas permeation instrument adopts the principle of differential pressure method, in which the pre-treated specimen is placed between the upper and lower test chambers and clamped. First, the low-pressure chamber (lower chamber) is vacuumed, and then the whole system is evacuated; when the specified vacuum is reached, the lower chamber is closed and the high-pressure chamber (upper chamber) is filled with a certain pressure of test gas, and a constant pressure difference (adjustable) is formed on both sides of the specimen; thus the gas will permeate from the high-pressure side to the low-pressure side under the action of the pressure difference gradient, and through the monitoring and processing of the pressure on the low-pressure side, thus By monitoring the pressure on the low pressure side, the barrier parameters of the test sample can be obtained.
4.2 Scope of application
(1) This equipment is suitable for testing the gas permeability of plastic films, sheets, paper, cardboard and their composites, cosmetic hose sheets, various rubber sheets and other packaging.
Film: gas permeability testing of various plastic films, plastic composite films, paper-plastic composite films, co-extruded films, aluminized films, aluminum foil, aluminum foil composite films and other film-like materials.
Sheet category: gas permeability testing of various engineering plastics, rubber, building materials and other sheet materials, such as PP sheet, PVC sheet, PVDC sheet, etc.
(2) This equipment is suitable for the gas permeability test of various gases, such as oxygen, carbon dioxide, nitrogen, air, helium, etc. and the barrier performance test of various films against flammable and explosive gases.
Test procedure
(1) Cut 3 pieces of Φ50mm samples with the sampler.
(2) Clamp the 3 pieces of specimens on the 3 test chambers of the equipment.
(3) Set the sample name, sample thickness, test temperature, test humidity and other parameters.
(4) Start the vacuum pump, click "Start Test" option, the test starts, the instrument automatically calculates and displays the test results.
6、Test results
The oxygen transmission rates of the three samples tested in this paper were 0.0842 cm3/(m2-24h-0.1MPa), 0.0628 cm3/(m2-24h-0.1MPa) and 0.0484 cm3/(m2-24h-0.1MPa).
7. Conclusion
GBPI's N530L gas permeability analyzer by differential pressure method is a professional oxygen permeability testing instrument for packaging of pharmaceuticals, foodstuffs, daily chemical products, etc. The equipment is easy to operate, has high testing accuracy and good repeatability, and can reflect the barrier performance of powder pharmaceutical aluminum-plastic composite film packaging to external oxygen. In addition, it should also strengthen the overall sealing performance of the packaging, heat sealing strength and other key items testing.