f-melt

F-melt is a co-processed excipient for manufacturing orally disintegrating tablets that is processed. It is engineered by our spray-drying technology and enables easy manufacturing of fast disintegrating tablets with direct compression.

Features of F-MELT®

F-MELT® is a proprietary co-spray dried excipient launched by Fuji in 2005.
F-MELT® is designed not only for manufacturing orally disintegrating tablets (ODTs) and tablets that dissolve fast in the oral cavity without the need of water, but is also an excellent excipient for soft chewable tablets. It is suitable for manufacturing directly compressible ODTs simply by blending with active pharmaceutical ingredients (APIs) and lubricants.

  • Ready to use excipient system for ODTs
  • Oral disintegration time less than 30 seconds and directly compressible
  • Spherical particle with high flowability
  • Tablet hardness more than 50 N possible with no sticking/capping
  • Pleasant mouth feel
  • It can create ODTs that meet customers’ needs
  • It is composed of pharmaceutical additives that are in compliance with major pharmacopoeias
  • It can minimize the development time.
  • F-MELT Type C conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF, JP, and EP. US DMF Type IV filed.
    Type M: Conforms to Japanese Pharmaceutical Excipients. All components meet USP-NF and JP/JPC and EP.

 

F-MELT® grades and general properties

There are three grades in F-Melt® family. F-Melt® Type M, which uses magnesium aluminate aluminate (Neusilin,) has an excellent balance between disintegration and compressibility. F-Melt® Type C uses anhydrous calcium hydrogen phosphate (Fujicarin) to improve disintegration. There is another grade specifically designed for a nutraceutical use- F-Melt® F1.

 

Type Type C
For pharmaceutical and nutraceutical applications
Type M
For pharmaceutical applications
F1
For dietary supplement applications
Appearance White to pale yellow poder
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 33 31
Ingredients D-Mannitol
Xylitol
MCC
Crospovidone
Fujicalin®
D-Mannitol
Xylitol
MCC
Crpspovidone
Neusilin®
Waxy Rice Starch
MCC
Fujicalin®

 

Strategy for preparing high performance F-MELT® tablets

F-MELT® is a directly compressible excipient. Depending on the actives, ODTs can also be prepared through wet granulation with F-MELT® and suitable solvents. Furthermore, if ODT quality does not meet requirement, formulators can improve the quality by adding other excipients and/or changing the lubricant. This flow chart helps the formulator to choose the appropriate route for preparing high performance ODTs with F-MELT®

ODT Formulation Studies using F-Melt

F-Melt can be customized or co-spray dried in order to improve the compatibility with API or enhance its property as directly compressible excipient (homogeneity, compressibility, disintegration, and dissolution)