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Lactulose - From milk sugar to Lactulose

LactuloseFresenius Kabi Austria distributes the Active Pharmaceutical Ingredient (API) Lactulose Liquid and Crystals produced in the plant in Linz, Austria, and in the Italian facility Società Chimica Mugello in Vicchio del Mugello.

Lactulose structureLactulose API is manufactured according to the recent guidelines of Good Manufacturing Practices (GMP/cGMP) and meets the current specifications of the European Pharmacopoeia (Ph.Eur./EP), Japanese Pharma-copoeia (JP), or the U.S. Pharmacopoeia (USP). Our customers as well as various regulatory authorities constantly approve the strict adherence to EU GMP and US cGMP regulations, persistent from raw material to the finished product.

The disaccharide Lactulose (galacto-fructose) does not occur in nature but is an isomerisation product from lactose (galacto-glucose), a natural component of milk. Lactulose is orally applied but cannot be split by human or animal enzymes present in the gut. Therefore it passes the stomach and small intestine unchanged and reaches the colon undigested. There it is fermented by bacteria into short chain fatty acids (SCFA) and supports the growth of Lactobacilli and Bifidobacteria. Therefore Lactulose is also known as a prebiotioc agent.

The main consequences of oral Lactulose intake are a drop of pH in the colon and a favourable change in composition as well as metabolic activity of the intestinal flora.
Depending on the dosage the pharmacologically simple mode of action provokes diverse effects, yielding in different application areas in human medicine.

Lactulose acts as a mild relaxant in the treatment of constipation. Degradation of Lactulose by colonic bacteria yields in an increase of osmotic pressure, which in turn results in increased stool volume and enhancement of peristalsis. As a result Lactulose alleviates bowel movement.

Moreover the decomposition products of Lactulose enhance the transformation of ammonia into ammonium, thereby reducing ammonia blood levels. This detoxifying property of Lactulose is used to treat portal systemic encephalopathy, a brain impairment cause by liver cirrhosis.

Lactulose is an experienced and important product in human medicine with a well known and good safety profile applicable to all age groups. Lactulose intake is even possible for sensitive patients and over longer periods of time.

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