Asahi Kasei Receives Prestigious Okochi Memorial Prize for its Microcrystalline Cellulose (MCC) Ceolus™ UF Grade Used for Excipient in Tablets – Solving Tableting Issues, Improving Content Uniformity, and Achieving Challenging Dosage Form

On March 25, Japanese technology company Asahi Kasei was awarded the prestigious Okochi Memorial Prize, which acknowledges significant contributions to the areas of production engineering, production technology R&D, and the implementation of high-level production methods in Japan. The Okochi Memorial Foundation recognized the contribution of Asahi Kasei’s MCC Ceolus™ UF grade to solving challenges with poor compactibility and flowability, two pressing formulation issues for pharmaceutical companies in the development and manufacturing of tablets.

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Asahi Kasei's Hideki AMAKAWA - Involved in development of Ceolus in early 2000s.

Made from natural pulp, MCC Ceolus™ is used as an excipient for pharmaceuticals and nutritional supplements. MCC is primarily applied as a tablet binder, an additive which provides a powder formulation for tablets' compactibility and flowability. High compactibility provides tablets a sufficient hardness to prevent issues such as capping and chipping, while high flowability will contribute to productivity by filling a powder evenly and quickly in the tableting machine. However, achieving the right balance between these two properties in MCC has been a long-term challenge.

Asahi Kasei has developed the Ceolus™ UF grade, which features high compactibility and flowability with a porous particle shape and fine space inside. This has achieved high tablet productivity and sufficient API uniformity even in low-dose API tablets. It also supports the development of challenging dosage forms such as small tablets, contributing to the supply of tablets that make pharmaceuticals and nutritional supplements easier to take for patients and customers. This achievement has been highly evaluated and led to recognition by the Okochi Memorial Foundation.

“We are very proud to achieve this reward and believe it emphasizes Ceolus™’ key role in the pharmaceutical industry and the value we bring to customers worldwide. This recognition adds to our dedication to innovating the tablet industry and continuing to improve end-user experience by solving our customer’s most difficult development challenges,” commented Hideyuki Kimura, Senior General Manager of Asahi Kasei Healthcare Materials Division.

Nitrosamine reduction solutions with low nitrite levels of 0.1 μg/g (ppm) and less

In addition to the UF grade, Asahi Kasei is also improving nitrosamine risk reduction by distributing low-nitrite level products.

In 2018, several pharmaceuticals were found to contain a nitrosamine impurity, which was later identified as potentially carcinogenic, resulting in a significant increase in public awareness of the potential health hazards of nitrosamine. Guided by regional authorities such as the European Medicines Agency (EMA) and the U.S. Food & Drug Administration (FDA), the pharmaceutical industry carries out extensive assessments and research to identify the cause of such 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 products. Reducing the concentration of nitrites in raw materials for pharmaceuticals is an effective way to lower the risk of nitrosamine formation. In order to reduce potential health hazards due to nitrosamine impurities, Asahi Kasei's MCC Ceolus™ provides nitrite concentrations of 0.1 ppm or less across our available primary product lines. Test results confirming these levels are provided in every Certificate of Analysis.

To learn more about Ceolus™ and view testing results, click here.

About the Okochi Memorial Foundation

Established in 1954, the Okochi Memorial Foundation commemorates Dr. Masatoshi Okochi's services to academic societies and industries and recognizes notable contributions in the areas of production engineering, production technology research and development, and the implementation of high-level production methods in Japan.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber business, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Healthcare. For more information, visit www.asahi-kasei.com.

Asahi Kasei is also dedicated to sustainability initiatives and is contributing to reaching a carbon neutral society by 2050. To learn more, visit https://www.asahi-kasei.com/sustainability/.

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