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Regulatory & Marketplace

Magnesium Alloys: Revolutionising the Pharmaceutical Industry The pharmaceutical industry has been growing by 7.8% year on year, and its worth is estimated to be $1.6 trillion by 2020 (PWC, 2012). In Europe alone, pharmaceutical production has grown exponentially since the turn of the century, increasing from €125,316 billion in the year 2000 to €225,000 billion in 2015 (EFPIA, 2016).

However, the pharmaceutical industry is facing a range of challenges, including rising customer expectations as well as declining R&D productivity. Therefore, it is increasingly important to get the best possible products to market by improving existing product lines and introducing new ones. This can often be difficult, with innovative solutions hard to come by. A recent development may offer potential new, ground-breaking solutions to the pharmaceutical industry. Magnesium alloys have been used in veterinary auto wormers to allow a drug to be delivered over specified, set intervals in the body, rather than at one single time. They have also been successfully developed for use in CE Marked cardiovascular scaffold implants. So, what are magnesium’s properties and how can it be used in pharmaceutical applications? A Bespoke Pharmaceutical Solution Bioresorbable materials are now being used increasingly in the medical device and healthcare industry to help address major challenges. Bioresorbable materials are advantageous for use in the body, as they achieve optimum healing by resorbing at a steady rate. Polymer materials are one example, but they do have their limitations because they have comparatively low strength, can cause foreign body reactions and can take a long time to resorb relative to other bioresorbable materials. 30 INTERNATIONAL PHARMACEUTICAL INDUSTRY

Magnesium alloys offer an exciting alternative to polymers. Whilst it is a material which is already strongly associated with the aerospace and nuclear industries, it is also biocompatible and naturallyoccurring in the body. As a result, it is starting to be used with success in medical devices. As research continues into the therapeutic properties of magnesium alloys, it is becoming clear that they demonstrate not only biocompatibility, but also biosafety. Therefore, the uses and outcomes of magnesium as a biomaterial are more widely understood, as well as the potential for it to be used in a greater range of applications within the body. Magnesium’s biocompatibility means that the body has the ability to remove magnesium degradation products. Studies of blood, following the placement of magnesium within the body, revealed resorption caused little change to the composition, with no disorder to the liver or kidneys (Zhang et al., 2009). Furthermore, magnesium is needed for effective heart, muscle, nerve, bone and kidney function (Institute of Medicine, 1997) and the World Health Organization (WHO) recommends adults need 280-300mg of magnesium per day. The one main challenge magnesium faced was its potential to degrade too quickly under physiological conditions. However, magnesium alloys can now be designed to take advantage of the degradation process, creating tailored degradation rates. Magnesium can, therefore, be used in the body for a wide range of applications.

has begun to be used for healing within the body, however they have typically been produced from titanium and stainless steel, which are permanent materials that often require secondary operations should they need to be removed. In contrast, bioresorbable materials made from magnesium alloys allow optimal healing and tissue regeneration before resorbing into the body as the surrounding tissue replaces the implant. Bioresorbable implants also degrade within the human body, with matching resorption kinetics to the healing period. This avoids the need for secondary surgical procedures, which are costly and stressful for patients. The advantage of the degradation or resorption process of a magnesium implant is that it allows for new bone to grow inwards. This is in contrast to other bioresorbable materials such as polymers, which, as well as taking longer to degrade, have the potential to intake water during degradation, leading to a loss in structural integrity, as well as size (Hofmann et al., 2009). A good example of successful use of magnesium is in Magmaris, a bioresorbable cardiovascular scaffold from BIOTRONIK that received CE Mark in 2016.

How Magnesium Compares with Other Materials for use in Different Applications in the Body? Im plants are an example of an application where magnesium Spring 2017 Volume 9 Issue 1

IPI - Spring 2017  
IPI - Spring 2017  
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