In June, Roquette celebrated the build of a new GMP facility for the production of an API that is used worldwide for large volume parenteral preparations. Susan Birks went to the opening of the automated plant in France.
Dextrose (also known as glucose) monohydrate is a soluble, sweet-tasting powder that is used in the body as the main source of energy for cells. While most body cells can use fats for energy if necessary, brain cells and red blood cells rely almost entirely on glucose to fulfil their energy needs. The ingredient can, therefore, be a life-saving molecule when used as a first-line treatment in emergency situations that could lead to dehydration and acute hypoglycaemia.
Roquette has been producing pyrogen-free dextrose monohydrate for almost 40 years. In fact, it pioneered the development of powdered glucose grades for the preparation of parenteral solutions. Today the dextrose monohydrate, marketed by Roquette as Lycadex PF, is used worldwide by a large number of companies for making parenteral nutrition or dialysis preparations, as well as for injectables employed solely as nutrient or as a vehicle for medicinal drugs.
The use of such glucose-based parenteral preparations for injection into the body requires the API to be highly controlled and purified. Parenteral preparations must be sterile and pyrogen-free and their manufacturing conditions are subject to strict requirements and standards, including a high level of microbial and physiochemical quality for the API and raw materials.
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