In the March issue technical newsletter, we focused on achieving higher tablet hardness with pleasant mouth feel at good oral disintegrating (OD) times by addition of other common excipients. Although we achieved our objectives, the formulations were a bit complex for the formulators who want to keep the formulations simple.

In this issue, we demonstrate that higher tablet hardness with pleasant mouth feel and good OD times can be achieved with F-MELT® alone or by adding minimum amount of Talc. Also, the lubricant was changed from magnesium stearate to sodium stearyl fumarate in order to take advantage of the superior qualities of this lubricant. PRUV is relatively inert and it overcomes problem associated with magnesium stearate like film formation and over lubrication.
*Patented in Japan and patent pending in U.S. , Europe and India

Formulation examples:

Example1. F-MELT® Type C –Acetaminophen ODT formulations with focus on tablet hardness, mouth feel and acceptable oral disintegration times

ODT with optimum hardness, a pleasant mouth feel and satisfactory oral disintegration times were achieved with acetaminophen and F-MELT® Type C when sodium stearyl fumarate was used as lubricant. The hardness improved either by adding 0.5% talc or by increasing the compression pressures.

Example 2. F-MELT®Type M –Acetaminophen ODT formulations with focus on tablet hardness, mouth feel and acceptable oral disintegration times

ODT with optimum hardness, a pleasant mouth feel and satisfactory oral disintegration times were achieved with acetaminophen and F-MELT® Type M when sodium stearyl fumarate was used as lubricant. The hardness improved either by adding 0.5% talc or by increasing the compression pressures.

Example 3. F-MELT®Type C –Ascorbic acid ODT formulations with focus on tablet hardness, mouth feel and acceptable oral disintegration times

ODT with optimum hardness, a pleasant mouth feel and satisfactory oral disintegration times were achieved with Ascorbic acid and F-MELT® Type C when sodium stearyl fumarate was used as lubricant.

Example 4. F-MELT®Type M –Ascorbic acid ODT formulations with focus on tablet hardness, mouth feel and acceptable oral disintegration times

ODT with optimum hardness, a pleasant mouth feel and satisfactory oral disintegration times were achieved with acetaminophen and F-MELT® Type M when sodium stearyl fumarate was used as lubricant. Ascorbic acid is a difficult to tablet API and occasionally slight adhesion to the punches were observed while tableting. If problem of stickiness persist, an external lubrication system or addition of other common excipients as described in the previous newsletter could overcome the problem.

Physical properties*

*Reference data

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 is implied. 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.