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Sunett approved for Pharmaceuticals in Japan

15 Feb 2002 - In Japan, the high-intensity sweetener Sunett® (acesulfame K) marketed by Nutrinova has recently been registered in the first pharmaceutical product, an OTC drug for nasal catarrh. Issued by the Ministry of Health, Labour and Welfare (MHLW), the approval authorizes the use of Sunett for ethical, OTC and "quasi" drugs. The pharmaceutical manufacturers now have the opportunity of optimizing their formulations with a safe and stable sweetener, offering a clean, sweet taste.
 
"The importance of this registration goes well beyond Japan. Homogenization of markets, as well as stringent regulations, mean it is important to multinational manufacturers that the ingredients they use are accepted internationally in order to ensure the success of their product on a global scale", comments Peter Brown, Head of Global Marketing of Nutrinova.
 
The pharmaceutical grades of Sunett are listed under acesulfame K in the European Pharmacopoeia (1998:1282) and the Drug Master File of the FDA. Sunett also conforms to the Japanese purity requirements. The high intensity sweetener is explicitly approved for use in drugs in over 50 countries worldwide.
 
Sunett exhibits a number of properties that render it ideal for masking unpleasant taste and bitter notes in tablet, powder, capsule and liquid applications. With its impact sweetness, it not only remains stable over long storage periods at a wide range of temperatures and pH values, it also demonstrates excellent solubility and requires no additional mixing.