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    Home > Active Ingredient News > Drugs Articles > Non resealed drug packaging increased in Europe and America

    Non resealed drug packaging increased in Europe and America

    • Last Update: 2007-01-10
    • Source: Internet
    • Author: User
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    In Germany, about 140000-160000 children are poisoned every year due to improper use of drugs, and about 20000 of them need to be treated in hospitals Unfortunately, 30 to 50 children die every year, which could have been avoided According to the survey data of family injury accidents conducted by the British Medical Association (pagb) from 1982 to 1998, the incidence of poisoning accidents in children has continued to decline with the increasing proportion of drugs that are not used to re cover protective packages, of which 50% of children are younger than 5 years old According to foreign investigation and research, the substances that are easily poisoned or contain toxic ingredients due to children's ingestion include household cleaning agents, drugs, poisonous plants, cosmetics and oils, while the proportion of drug poisoning is as high as 37% Another U.S study showed that the use of prescription drugs to prevent children from eating by mistake significantly reduced the death rate of poisoning caused by improper use, and the incidence of children's eating accidents in the United States decreased by 45% In addition to the United States and other countries, more and more countries have also introduced standards and decrees to prevent children from eating drugs by mistake The British BS & 8404 standard and the European Union standard * times define the packaging for children and the elderly to take (CR / SF) as: it is a kind of packaging that is difficult for children to open in a certain period of time and easy for adults to open However, there are significant differences between European and American regulations on pharmaceutical packaging In Europe, 80% of solid drugs use blister packaging; in the United States, traditional drugs are bottled, but the proportion of blister packaging has continued to grow in recent years In the United States, in order to attract patients, the shape and color of drugs is one of the important factors in marketing If the aluminum blister is not used for packaging, the bottom film material can be transparent In this way, there is a risk of children mistaking drugs for candy However, in Europe, opaque colored thermoforming materials or formed aluminum are usually used for blister packaging Therefore, all medicines that may cause children to eat by mistake should be packed with Cr / SF However, whether or not the pharmaceutical companies are using CR / SF packaging, for each new drug or API with different doses, it is necessary to pass the test before it is put on the market, and it is also necessary to understand the specific provisions of countries on pharmaceutical packaging The United States: the PPPA has clear regulations and requirements for the following drugs, such as aspirin, acetaminophen and other antipyretic and analgesic drugs, methyl salicylate, benzacylimide and various controlled anesthetics The blister packaging of Cr / SF has the following forms: open tear packaging; peel open packaging; peel push open packaging; rely on the hidden tear packaging when opening All drug packaging requires two actions to remove the drug Usually, when children take medicine, when they take the blister plate to the mouth, there will always be a plastic film wrapped on the outer layer, which makes it difficult for children to break the packaging The new Cr / SF packaging uses the packaging form combined with the blister paper, so when they take medicine, they can take the medicine out of the aluminum foil cover only by pushing up and stripping EU: the EU standard en14375 has come into force since the end of 2003, which is approved by the member states of the EU standards committee When the standard comes into force, it is also converted into the national standard of each member state Peel push open packaging is mainly found in the U.S market Peel or peel push open packaging makes the space of blister plate larger (split line + peel split part = non sealing area), which increases the consumption of packaging materials, indirectly reduces the efficiency of the machine, and makes its cost greater than that of touch break packaging Germany: the drug law also regulates the packaging of some drugs to prevent children from eating by mistake According to the "drug law" issued on February 12, 1982 and September 17, 1984, the following varieties can only be sold in the following packaging containers: 1 Single dose push-break packaging (blister packaging) can only use opaque or dark packaging materials 2 Only opaque or dark packaging materials can be used for single dose sealed packaging 3 Containers with safety cover (combined cover system) should increase the difficulty for children to open 4 Single dose packaging of powder or granule drugs is enough 5 The packaging container of liquid medicine must meet the following standards: children can't take out the medicine without damaging the container; after the package is opened or shaken, the overflow amount each time shall not be more than 0.5ml And the liquid is dripped out, and other spillage is not more than 2 ml (containers mentioned in 1, 2 and 3 must conform to DIN 55559 German industrial standard) the pharmaceutical industry has been looking for better Cr / SF packaging solutions, because some materials have been used for more than 20 years, and the development of the market is constantly promoting new technologies, which are all aimed at maintaining the same or even better processing performance while reducing the production cost of materials.
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