Gelatin is a biomaterial designed by nature. It is extracted from collagen, a natural protein found in animal bones and skin – generally beef and pork. Gelatin has been used in food applications since ancient history.
Most gelatins nowadays are purified. But on today’s markets, demand for higher purity levels is increasing. High purity, in gelatin, means low-endotoxin levels. Endotoxins are bacterial toxins that can cause strong, sometimes fatal, immune response in humans. Reduced endotoxin levels, therefore, increase the physical safety of patients, especially in-body. Low-endotoxin gelatins also create new manufacturing and research possibilities.
The body has a high acceptance for gelatin, as it can be fully metabolized and is naturally present in human tissue in the form of collagen. This explains why pharma and medical developers are finding more and more new uses for gelatin – both human and veterinary – in addition to the many applications already in existence.
As the world leader in the production of pharmaceutical gelatins, Rousselot has developed the X-Pure range consisting of a comprehensive assortment of highly purified gelatins for in-body pharmaceutical and medical applications, such as hemostatics, parenteral formulations and regenerative medicine.
The US FDA has placed the endotoxin limit for medical devices in contact with the cardiovascular system and lymphatic system at 20 EU/device (or 0.5 EU/ml). The only exceptions are devices that are in contact with cerebrospinal fluid, for which the limit has been set at 2.15 EU/device (or 0.06 EU/ml). With an endotoxin level below 10 EU/g, X-Pure 10 HGP for example enables manufacturers to create totally safe medical injectables that comply with FDA requirements.
All Rousselot X-Pure gelatins comply with the US, European and Japanese pharmacopeia.
The X-Pure range is the result of years of research by Rousselot experts. Further complementing Rousselot's comprehensive range of gelatin products, X-Pure represents an exciting step forward in patient safety and research possibilities on the pharma and medical markets.
The X-Pure manufacturing process is designed to produce gelatins of the highest purity. The multistage process includes purification, filtering and drying steps, performed under controlled clean room conditions and through a validated process. The end product is tested to ensure maximum quality and safety.