Asahi Kasei have recently announced the release of their novel microcrystalline cellulose, Ceolus, to reduce the risk of carcinogenic nitrosamine impurities in pharmaceutical and nutrition supplements.
Nitrite levels in the product are 0.1 μg/g (ppm) or less.
In 2018, a potentially carcinogenic nitrosamine impurity was detected in several pharmaceuticals. Since then, public awareness of the potential health hazards of nitrosamine has increased significantly worldwide.
Guided by regional authorities such as the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA), the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of the impurities.
One risk factor for the formation of nitrosamine is nitrosation – a reaction of secondary or tertiary amines with nitrites during or after the manufacturing process of drug substances and drug products.
Reducing the concentration of nitrites in raw materials for pharmaceuticals is considered to be an effective way to lower the risk of nitrosamine formation.
Minimising nitrite level in various Ceolus grades
Asahi Kasei has been manufacturing CeolusTM microcrystalline cellulose (MCC) in Nobeoka, Miyazaki, Japan since 1970.
MCC is made from natural pulp, mainly used as an excipient for pharmaceuticals, nutritional supplements and foods.
Ceolus is primarily used as a tablet binder, an additive that provides shape and increases the volume of pharmaceutical tablets.
High-performance grades of Ceolus in particular enable pharmaceutical and nutritional supplement manufacturers to realise challenging formulations, solve tableting issues and produce unique and patient-friendly dosage forms.
“Controlling the nitrite concentration in our products is an important step to ensure the provision of safer pharmaceuticals and nutritional supplements. We will continue to work on further improvements, and emphasise the importance of reducing the risk of nitrosamine impurities,” says Hideyuki Kimura, Senior General Manager of Asahi Kasei’s Healthcare Materials Division.