Enhancing pharmaceutical safety: Microcrystalline cellulose with ultra-low nitrite concentration

Asahi Kasei is advancing pharmaceutical safety by presenting Ceolus™ microcrystalline cellulose (MCC) with nitrite levels reduced to 0.1 μg/g (ppm) or less. This initiative aims to contribute to minimising the potential risk of carcinogenic nitrosamine impurities in pharmaceuticals and nutritional supplements.

In response to the detection of potentially carcinogenic nitrosamine impurities in pharmaceuticals in 2018, there has been a global increase in awareness regarding the health risks associated with nitrosamine. Aligning with guidelines from authoritative bodies such as the European Medicines Agency (EMA) and the US Food & Drug Administration (FDA), the pharmaceutical industry has been actively investigating and addressing the factors contributing to nitrosamine impurities. Nitrosation, a reaction involving secondary or tertiary amines with nitrites during or post the drug manufacturing process, is identified as a key risk factor. Reducing nitrite concentrations in pharmaceutical raw materials stands out as a crucial strategy for mitigating the risk of nitrosamine formation.

Ceolus™, Asahi Kasei's MCC produced in Nobeoka, Miyazaki, Japan since 1970, primarily serves as an excipient in pharmaceuticals, nutritional supplements, and foods. Recognised for its application as a tablet binder, especially in high-performance formulations, Ceolus™ contributes to overcoming tableting challenges and creating distinctive and patient-friendly dosage forms. Asahi Kasei has succeeded in maintaining the nitrite concentration in various grades of Ceolus™ at 0.1 ppm or less, underscoring its commitment to delivering safer pharmaceuticals and nutritional supplements.

Hideyuki Kimura, Senior General Manager of Asahi Kasei’s Healthcare Materials Division overseeing Ceolus™, emphasised: "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."

Additionally, in January 2024, Asahi Kasei commenced full commercial operations of its second Ceolus™ manufacturing facility at Mizushima Works in Okayama Prefecture, Japan. This strategic move not only increases supply capacity but also enhances supply chain stability through dual-site production.

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