General Properties

F-MELT® is available in three grades, Type C, Type M, and F1.

Grades
Type C - Application: Pharmaceutical / Nutraceutical
Type M - Application: Pharmaceutical
F1 - Application: Nutraceutical/dietary supplement
CONTENTS

Features

Physical Properties of F-MELT®

Type Type C Type M F1
Appearance White to pale yellow powder
Loss on Drying (%) 1.3 1.8 5.9
Loose Bulk Density (g/ml) 0.54 0.56 -
Tapped Bulk Density (g/ml) 0.65 0.65 -
Mean Particle Size Distribution (μm) 120.8 122.3 139.0
Angle of Repose (°) 34 34 34
Ingredients D-Mannitol
Xylitol
MCC
Crospovidone
Fujicalin®
D-Mannitol
Xylitol
MCC
Crospovidone
Neusilin®
Waxy Rice Starch
MCC
Fujicalin®

Scanning Electron Micrographs

F-MELT co-spraydried powder (X 500)
F-MELT® co-spraydried powder (X 500)
F-MELT co-spraydried powder (X 10,000)
F-MELT® co-spray dried powder (X 10,000)

Performance of F-MELT® placebo tablets

F-MELT® Type C, Type M
Formulation: F-MELT® 99.5% + Mg-St 0.5% (Dry Blending)
Tablet Size: ø11.3 mm, 450 mg / Tab
Tablet Machine: Tabletting Tester SK-02 (Sankyo Piotech)
The tablet hardness shows a linear increment up to 1 ton compression force
Performance of F-MELT placebo tablets

Tablet Hardness vs Oral Disintegration time (Placebo)

Excipient: F-MELT® Type C, M
Formulation: F-MELT® 99.6% + Mg-St 0.4%
Conditions: 20 rpm, φ8 mm, 200 mg Tab
Tabletting after blending F-MELT® with Lubricant
Tablet Hardness vs Oral Disintegration time (Placebo)
Excipient: F-MELT® F1
Formulation: F-MELT® 99.5%
Lubricant: Sucrose Esters S-370F
Tablet Size: ø8 mm x 9R, 200 mg/Tab, 15 rpm
Achieve optimum tablet hardness at low compression forces
Achieve optimum tablet hardness at low compression forces
Maintain optimum disintegration time at higher tablet hardness
Maintain optimum disintegration time at higher tablet hardness
Friability decreases rapidly with increased tablet hardness
Friability decreases rapidly with increased tablet hardness

Moisture Sorption Isotherm (25°C, 7days)

F-MELT® Type M
F-MELT® Type M
F-MELT® Type C
F-MELT® Type C
up to 75% RH, F-MELT® powder is stable against moisture sorption.

Package Size

a) Commercial Size:
20 kg net in aluminum bag in carton box
Box dimension: 880 mm x 990 mm
b) Sample Size:
1 kg net in aluminum bag
Bag dimension: 220 mm x 334 mm x c.a 50 mm