Pharmaceutical Technical Newsletter F-Melt® by Fuji Chemical Industries

See the second issue of Fuji Chemical Industries Technical Newsletter. This issue focuses on achieving higher tablet hardness with pleasant mouth feel at good oral disintegranting (OD) times by addition of other common excipients.

F-Melt® fast melt tablet made easy!

NEWSLETTER HIGHLIGHT

Effect of replacing Magnesium Stearate with Sodium Stearyl Fumarate on tableting of Fast Disintegrating Oral Tablets with F-MELT®

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.

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.

FORMULATION EXAMPLES

Although we achieved our objectives, the formulations were a bit complex for the formulators who want to keep the formulations simple.

Formulation Example 1) 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.

Formulation 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.

See the full Pharmaceutical Technical Newsletter on “Issue 02 – F-Melt®” here:

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If you missed Pharmaceutical Technical Newsletter “Issue 01 – Fujicalin®”, download it here:

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