New product – Kleptose F 7% – BETA CYCLODEXTRIN

Roquette presents a new product:

KLEPTOSE® F 7% – EXP β-cyclodextrin for oral dosage forms contains less than 7% of water. It is well suited for dry processing techniques, such as direct compression, where its low water content benefits moisture-sensitive APIs and formulations (e.g., ODTs, chewables, effervescent tablets) while offering enhanced stability, solubility, and taste masking through molecular encapsulation.

Kleptose F 7% – BETA CYCLODEXTRIN

  • Excellent tabletability across a range of compression forces and speed
  • Moisture protection, reducing degredation in moisture sensitive formulations
  • Consistent particle size distribution to enhance processability

Product information

Product Name KLEPTOSE® F 7% – BETA CYCLODEXTRIN
Generic Name Betacyclodextrin

 

Physico-chemical properties
Compliance EP/USP-NF/IP
Synonyms Beta-cyclodextrin
CAS Number 7585-39-9
KLEPTOSE F 7% - Structure
KLEPTOSE F 7% – Chemical Structure
Physical Form or Appearence White or almost white crystalline powder
Water content (LOD) Water Content (LOD) Maximum: 7 %
KLEPTOSE F 7% - Morphology
KLEPTOSE F 7% – Morphology
Average mean particle diameter 40 µm
Particle Size Distribution by Laser Diffraction dv10: 10 µm

dv50: 40 µm

dv90: 96 µm

Solubility Solubility in water: 18.5 g/l. Practically insoluble in ethanol (95 %).

 

Water sorption isotherm at 20°C

Water sorption isotherm at 20°C
KLEPTOSE F 7% – Water sorption isotherm at 20°C

Tablet hardness

Tablet hardness
KLEPTOSE F 7% – Tablet hardness
Experimental Conditions for Compression Behavior Tablet Press: STYL’ONE EVO

Production Speed: 50 RPM (linear punch velocity: 70 mm/s; simulated KORSCH XL-400 rotary press speed: 105,000 tablets/hour); 20% pre-compression force

Tooling: Diameter 10 mm R10 concave

Formula: 5% API / 25% KLEPTOSE® F 7% – EXP beta-cyclodextrin / 69% PEARLITOL® 100 SD mannitol / 1% Roquette Magnesium Stearate

Tablet Mass: 400 mg

Powder Characteristics Bulk Density: 0.53 g/cm3

Tapped Density: 0.76 g/cm3

True Density: 1.48 g/cm3

Read more here

Source: Roquette, website KLEPTOSE® F 7% – EXP β-cyclodextrin


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