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
Features
- Ready-to-use excipient for oral disintegrating tablets
- Directly compressible
- Oral disintegrating time less than 30 seconds
- Tablet hardness more than 50 Newtons
- API loading more than 50% possible
- Highly flowable with minimum or no sticking/capping
- Suitable with conventional tabletting machines
- No Royalty or license fee required
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-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
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
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
Maintain optimum disintegration time at higher tablet hardness
Friability decreases rapidly with increased tablet hardness
Moisture Sorption Isotherm (25°C, 7days)
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