In the February issue technical newsletter, we introduced F-MELT®, a proprietary excipient system for oral disintegrating tablets (ODT). ODT is a rapidly developing market and more and more technologies are coming to the fore front with distinct advantages. However, direct compression is still the preferred choice because it uses conventional equipment and materials while maintaining lower manufacturing costs.

F-MELT® is ideally suited for direct compression and in this newsletter; we demonstrate F-MELT® formulations with a focus on three important characters of ODT, viz. tablet hardness, mouth feel and acceptable oral disintegration times. In some cases, the desired tablet cannot be achieved with F-MELT® alone. However, a higher tablet hardness and pleasant mouth feel can be maintained by incorporating additional organic or inorganic excipients with F-MELT® as illustrated in the following examples.
*Patented in Japan and patent pending in U.S, EU and India

In case of acetaminophen and aspirin as API, a combination of CMC or Kollidon CL with F-MELT®Type C provided hard tablets with very good mouth feel and satisfactory oral disintegration times.

In case of acetaminophen, a combination of corn starch with F-MELT®Type M provided hard tablets with good mouth feel and excellent oral disintegration time.

Ascorbic acid is a difficult API for tabletting due to its sticky nature. F-MELT® could be successfully used in formulations to achieve ODT of ascorbic acid. An external lubrication system provided harder tablets with excellent ODT at 30% API load. 

F-MELT® from Fuji Chemical offers the formulator with multiple choices as the final formulation certainly depends on the type and characteristics of API. In the examples cited above, A tablet hardness of above 40N and an oral disintegration time of less than 30 seconds was achieved by effectively utilizing other excipients and lubricants.

F-MELT® is a spray-dried powder of five pharmaceutical excipients consisting of carbohydrates, inorganic ingredients and disintegrants. It is available in two grades, F-MELT® Type C and F-MELT® Type M.

 F-MELT® Type C conforms to USP-NF, EP and JP and Type M conforms to USP-NF and JP An U.S. Drug Master file is available for Type C.

To obtain a sample or to find your local distributor, please contact us at pharma@fujichemical.co.jp.  For more technical information, please visit www.fujichemical.co.jp/english/F-MELT.html
F-MELT, Fujicalin and Neusilin are trademarks or registered trademarks of Fuji Chemical Industry Co., Ltd. in Japan, United States of America, Europe and/or other countries.

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Information found is presented in good faith and no guarantee or obligation as to accuracy and no assumption of liability. The information herein does not imply a performance warranty. Purchasers should decide the suitability of the product with respect to their desired application and purpose.