Fuji gets DMF for fast dissolving excipient

By Anna Lewcock

- Last updated on GMT

Related tags New drug Food and drug administration

Japanese firm Fuji Chemical has been assigned a drug master file
(DMF) number for its new excipient for fast-dissolving oral

F-Melt type C, an excipient which results in tablets with a disintegration time of less than 30 seconds, is a blend of carbohydrates, disintegrants and inorganic ingredients. Combined with spray-drying, the formulation has resulted in a fast-dissolving excipient system. F-Melt was designed as a directly compressible excipient, and has a very porous structure to facilitate rapid water adsorption and oral disintegration. The excipient, which can be used for tablets containing active pharmaceutical ingredients (APIs) and lubricants, has the advantage that it can be used in the manufacture of orally disintegrating tablets (ODTs) with standard tabletting equipment. This could prove a distinct selling point for some manufacturers hoping to avoid the cost pricey third party technologies. DMFs, while not expressly required by the US Food and Drug Administration (FDA) which issues the DMF allocations, could offer added value to the product for Fuji customers. As the DMF holder, Fuji can authorise the FDA to release the information to support customers' investigational new drug applications (INDs), new drug applications (NDA)s, or an abbreviated new drug application (ANDA). "We have received tremendous interest in F-Melt from both the pharmaceutical and dietary supplement industries,"​ said Fuji Health Science president, Charles DePrince. "[It gives] the opportunity to the formulator for an alternative delivery system and…the advantage for a company to produce in house."​ In November 2006, the company announced the first commercial application of the new excipient. The functional supplemental tablets formulated with F-Melt type C were launched in Italy by healthcare company Biosline, for the treatment of colds and throat inflammation. An alternative form of F-Melt is also available, type M, for higher flowability and improved tablet quality. The F-Melt products add to the company's other existing tabletting excipients, Neusilin and Fujicalin. Neusilin is a synthetic magnesium aluminometasilicate and Fujicalin a dibasic calcium phosphate anhydrous.

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