Barrier blister materials in the field of gunpowde

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Barrier blister materials in the pharmaceutical field

the growth rate of the non trademark industry is about four times faster than that of the original pharmaceutical industry. In 2001, the turnover of the top 12 non trademark companies alone reached US $10billion. In addition, in the next few years, fewer and fewer new large companies will enter the market. On the contrary, more good drugs will no longer apply for patents and will be provided as non patented drugs. In this industry, there is a trend of rapid internationalization and enterprise alliance. I believe this trend will continue to develop. The drivers of this process expect to reduce costs in the registration process, optimize the use of production equipment, reduce overhead costs, and improve the process of quickly reaching the market. The result of its development is to promote the development of more professional and reasonable packaging, processes and strategies

not only must every manufacturer of non trademark drugs prepare a registration document to prove that his products have the same efficacy and safety as the original patented drugs; And we must also choose the right raw packaging materials to prove that the special packaging is enough to protect the product. These packaging materials may not be the same as the original drug packaging materials, because during the service life of these drugs, the materials may not be fully utilized by prescription companies. This is the only opportunity for non trademark drug companies to configure the correct packaging for non trademark drugs from the beginning

when determining the blister film of a drug, the most important criterion is that the initial packaging can meet the barrier function. There are three aspects to consider:

the most important parameter is water vapor transmission rate (WVTR), because most solid oral drugs will fail after inhalation of moisture. The stability study at the International Conference on Harmonization of technical requirements for drug registration for human use (ICH) showed that the critical state of humidity can be reflected in the rigorous control of relative humidity

the second most critical parameter is lightfastness. Its requirements are also specified in the ICH light fastness guidelines

the third parameter is oxygen impermeability; Oral solid drugs are rarely oxygen sensitive. When the drugs are not particularly sensitive to humidity, polyvinyl chloride (PVC) is usually the material of choice for blister packaging. If the drug is sensitive to humidity, adding a layer of PVDC coating on the PVC film or pressing a thin layer of PCTFE film can greatly improve the barrier property. However, in some extreme cases, aluminum blisters may also be required. If the pigment is added to the PVC layer of the initial blister package, the damage of light to the drug can be avoided. The choice of pigments depends on the photostability of drugs: transparent (for photostability drugs); UV blocked; Translucent amber or opaque white (light barrier is the best). A few oxygen sensitive products can choose several barrier materials, such as barex taro B ethylene/vinyl alcohol or PVDC. This paper assumes the need for moderate moisture resistance, and evaluates the barrier and cost of PVDC and PCTFE equivalent structures. Comparison between PCTFE and PVDC Aclar is the famous PCTFE brand of ohoneywell. In 2002, tekni plex, a company producing PCTFE film, whose brand is vaposhield taro apctfe, was the traditional preferred material for rapidly launching patented drugs to the market. The high barrier property of PCTFE film combined with thick thickness helps to accelerate the stability conditions. PCTFE materials are expensive, and the traditional thickness is thicker

pvdc is often used as a cost-effective barrier coating. But it becomes unstable when exposed to light. PVDC blisters will turn yellow after a long time, so they must be wrapped in thick black plastic bags. Comparison of barrier properties of molded blisters

not all blister materials can maintain barrier properties well after hot forming. Facts have proved that we cannot judge the moisture resistance of thermoformed blisters from the vapor transmission rate (WVTR) of flat films. Recent studies have shown that PVDC loses more barrier than PCTFE after hot forming. In order to measure the WVTR after hot forming, the Institute also participated in the optimization and improvement of the key parts of the car body by using a 0-size capsule blister at 40 ℃ and 75%; In the high-end pure electric car jointly produced with great wall Huaguan, the acceleration of humidity was tested under ICH stability conditions. The results show that PCTFE film maintains good barrier property (high barrier = low WVTR value) after hot forming. fifteen μ PCTFE shaped blister has better barrier performance than PVDC blister of 90g/m2. After hot forming, 10 μ The barrier property of PCTFE is equivalent to that of 90g/m2 PVDC, but the cost is reduced by about 15%. At the same cost, 15 μ The barrier property of PCTFE is 20% higher than that of 90g/M2 PVDC. The film cost of 60g/m2 PVDC blister is the lowest, but its barrier property is much lower than other films

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