Fuji Chemical offers a simple alternative to the current fast-disintegrating technologies by offering a direct compression excipient that can be made into oral disintegrating tablets with standard tabletting equipment. F-MELT® is a proprietary spray–dried powder of 5 pharmaceutical excipients consisting of carbohydrates, inorganic ingredients and disintegrants.

 

 

 *Patented in Japan and patent pending in U.S, EU and India
 US Drug Master filed for F-MELT®-Type C

Pharmacopoeias:
F-MELT® Type C- conforms to USP-NF, EP and JP
F-MELT® Type M – conforms to USP-NF and JP

 

F-MELT® consists of free flowing porous particles which are directly compressible.

F-MELT® is available in two grades, F-MELT® Type C and F-MELT® Type M. Type C has dibasic calcium phosphate anhydrous (Fujicalin®) and Type M has magnesium aluminometasilicate (Neusilin®) in its composition. Type C is for faster disintegration needs, while Type M has better flow properties and improves the overall quality of tablets.  Although both types do not differ significantly in their physical properties, formulators are advised to test the suitability of their specific API’s with both types.

 

Physical properties*

Physical parameters

Type M

Type C

Appearance

White to pale yellow powder

Loss on Drying (%)

1.80

1.30

Loose Bulk Density (g/mL)

0.56

0.54

Tapped Bulk Density (g/mL)

0.65

0.65

Angle of Repose (°)

32.9

34.2

Mean particle size distribution (µm)

122.3

120.8

*Reference data


Tablet compaction vs oral disintegration time
An API formulation to test the tablet hardness and oral disintegration time was carried out using Acetaminophen, a poorly water soluble API and F-MELT® Type C and Type M. 10 to 40 % of Acetaminophen was compounded with 89.6 to 59.6 % of F-MELT® and 0.4 % Magnesium stearate as lubricant. Tablets of 200 mg with 8 mm diameter were made on a rotary tabletting machine (Hata Iron Works).

Ex.

Weight Ratio (%)

F-MELT®

Acetaminophen

Mg-St

1

89.6

10.0

0.4

2

79.6

20.0

0.4

3

59.6

40.0

0.4

 

 

In both cases, an oral disintegration time of 20 seconds was achieved after loading 40% Acetaminophen at reasonable compression pressure demonstrating the effectiveness of F-MELT® technology. Fast oral disintegrating tablets are becoming increasingly popular due to its versatility in drug delivery and we hope F-MELT® will help pharmaceutical companies to develop oral disintegrating tablets with short development times.



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.