07/25/2012 | Editor: Dominik Stephan
The deagglomeration and grinding of raw materials are decisive factors as far as quality is concerned in the preparation of medications. This is illustrated by a practical example: metformin, an active substance used by Novartis for manufacturing medications for adult-onset diabetes. A necessary treatment for millions — but with a tendency for lump formation.
Millions of people around the world suffer from type 2 diabetes, also known as adult-onset diabetes, with constantly rising numbers — particularly in developed countries. When dietary measures are not sufficient for treating this disease, the excessively high blood sugar must be lowered with medications.
Novartis is a trend setter in the manufacture of diabetes medications with the fixed combination of metformin and the DPP-4 inhibitor vildagliptin. A comprehensive control of glycemia is possible with this medication. Owing to a strongly increasing demand worldwide for diabetes medications, Novartis felt compelled to increase the production capacity at various European sites.
Novartis obtains the active substances and processing agents for manufacturing the blood sugar-lowering medication from its contract manufacturers. They are delivered in powder form in cartons with 25 kg inliner bags, in which agglomerates or lumps can form due to the hygroscopic properties, the bearing pressure or the ambient temperature. The product as delivered can therefore not be processed directly but must first undergo a two step deagglomeration and grinding process. The properties of the active substance (which has poor flow properties and tends to form lumps) further complicates preparation. In its search for a better way to process products containing agglomerates and lumps, Novartis came across an innovative solution by Frewitt during the evaluation phase of a new processing system.
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