Improving solubility: MilliporeSigma opens dedicated meglumine site

By Dan Stanton contact

- Last updated on GMT

Merck's site is in Mollet des Valles, Spain. Image: Wikimedia/Rafael Ferran
Merck's site is in Mollet des Valles, Spain. Image: Wikimedia/Rafael Ferran

Related tags: Active ingredient

MilliporeSigma has opened a facility in Spain dedicated to the manufacture of the solubility-enhancing excipient meglumine.

The site in Mollet des Vallès – about 20km north of Barcelona – has received US Food and Drug Administration (FDA) validation and will solely manufacture the excipient for customers of MilliporeSigma, the life science business of Merck KGaA.

Meglumine, an amino sugar derived from glucose, is used to make active pharmaceutical ingredients (APIs) into more soluble salt forms, and is also a component of medical imaging contrast media.

“As a functional component in pharmaceuticals, meglumine interacts directly with active pharmaceutical ingredients (APIs) to increase solubility. One example is its function as a counter ion for eligible APIs, forming a new salt with improved solubility,”​ MilliporeSigma spokeswoman Karen Tiano told in-Pharmatechnologist.com.

“Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs.”

Meglumine is present as a non-active ingredient in a number of marketed products, including Novo Nordisk’s glycemic control drug PrandiMet​ (repaglinide and metformin HCl), Lupin’s heart generic Ramipril​, and Glenmark’s lipid-altering agent Pravastin​.

“We sell Meglumine as an FDA-approved pharmaceutical raw material, suitable for pharmaceuticals and as a component of medical imaging contrast media,”​ said Tiano, without divulging the firm’s customers.

She also did not reveal the firm’s worldwide meglumine capacity. However, it increased its production network after buying Sigma-Aldrich for $17bn​ in 2015, adding facilities including the API, excipient and antibody-drug conjugate site in St Louis, Missouri.

The Mollet des Vallès site has been subject to a number of investments, and last May​ Merck said it was spending €6.2m on the construction of a new building to optimize its operations for weighing and dispensing raw materials and excipients.

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