IF Novartis Crusher and grinding line for pre-processing Metformin and other agglomerated active pharmaceutical ingredients Introduction Millions of people worldwide are affected with type 2 diabetes, also known as adult-onset diabetes. An increasing tendency to develop type 2 diabetes has been observed in recent years, particularly in industrialized countries. Physicians resort to prescribing blood sugar-lowering medications when dietary measures are no longer enough to treat the condition. Novartis, an innovative producer of pharmaceutical products, is taking a leading role in the manufacture of diabetes medications with the fixed combination of the DPP-4 inhibitor vildabliptin and Metformin, enabling a comprehensive control of hyperglycaemia. Owing to a worldwide increase in the demand for blood sugar-lowering medications; Novartis has been compelled to increase it's production capacities at various sites in Europe. FREWITT Sfl, Rte du Coteau 7, CH-1763 Granges-Paccot - Postal address: Box 615, CH-1701 Fribourg - P +41 26 460 74 00, F +41 26 460 74 01, [email protected], www.frewitt.com

IF Initial situation From it's contract manufacturers, Novartis acquires active pharmaceutical ingredients and adjuvants that are usually delivered to the production facility in 25 kg cartons with inliners. The active pharmaceutical ingredient is delivered in various particle sizes and sometimes in block form. It has poor flow properties and tends to form lumps, therefore requiring pre-processing before undergoing further processing (customer-specific process). Because the product cannot be used as delivered, it must undergo a suitable grinding and preprocessing, which is generally a complex...

IFFrewitt solution for a new productivity-increasing pre-processing line Frewitt participated in the evaluation of a new processing line for increasing capacity. The new preprocessing procedure could thus be validated based on preliminary experiments conducted with the newest generation of Frewitt equipment. Frewitt had since reengineered it's DelumpWitt crusher and grinding line. Hence this new development could be incorporated as the core of the process. Thanks to the DelumpWitt's compact construction and 2-in-1 process, only one, rather than two lines were required for the crushing and grinding...