Meeting the highest standards - Cognis achieves GMP certification for Delios MCT oils
Cognis' Delios VF and VL MCT oils, manufactured at the Cognis site in Illertissen, are now officially certified as complying with the principles and guidelines of the ICH Q7 GMP standard, and therefore stand in line for use as active ingredient (API) in pharmaceutical products. Cognis is one of two companies worldwide that offer GMP certificated MCT oils for application in parenteral pharmaceutical formulations - for example in intravenous lipid nutrition. GMP compliance guarantees that APIs meet the highest standards in terms of traceability, documentation, composition, quality and purity.
Medium chain triglycerides, also known as MCT oils, are oils based on medium chain fatty acids from renewable raw materials with unique technological and nutritional properties. They are consisting mainly of totally saturated fatty acids such as caprylic (C8) and capric (C10) acid. As excipients in pharmaceutical formulations, Cognis' Delios MCT oils are used as emollients, solvents for hydrophobic actives or as penetration enhancers. They can also be used as an energy source in parenteral lipid nutrition including intravenous feeding. Therefore, they need to be certified as active pharmaceutical ingredients produced under ICH Q7 GMP standards. Lipid emulsions with different compositions are used for parenteral nutrition: soybean oil as well as combinations of it with olive oil and synthetic MCT oils for example. Due to their special metabolic pathway, MCTs are claimed to be oxidized more extensively. They are not metabolized by the lymphatic system, but through the blood stream in the liver (portal system). This is possible due to their small molecular size.
Comments Bertram Fuchs, Quality & Food Safety Manager: "The GMP Certification adds further value to our Delios MCT oils, and allows us to offer them as active pharmaceutical ingredients." Thomas Rosen, Global Product Line Manager Pharmaceuticals & Healthcare adds: "This is another example of how we are helping our customers to meet the challenging requirements of today's pharmaceutical and consumer healthcare markets."
BASF Personal Care and Nutrition GmbH
Cognis is a worldwide supplier of innovative specialty chemicals and nutritional ingredients, with a particular focus on the areas of wellness and sustainability. The company employs about 7,600 people, and it operates production sites and service centers in 30 countries. Cognis has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Another main focus is on products for a number of other industries, such as coatings and inks, lubricants, as well as agriculture and mining.
Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and SV Life Sciences. In 2007, Cognis recorded sales of about 3.52 billion euros and an Adjusted EBITDA (operating result) of 410 million euros.