Kleptose F 7%
β-cyclodextrin
| 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 |
| Chemical Structure |
|
| Average Molecular Weight | 1135 g/mol |
| Physical Form or Appearence | White or almost white crystalline powder |
| Application | 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. |
| Water content (LOD) |
Water Content (LOD) Maximum: 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 %). |
| Melting temperature |
Minimum melting temperature : 280 °C
Maximum melting temperature: 300 °C
|
| Water sorption isotherm at 20°C |
|
| Taste/Odor | Tasteless and odorless |
| 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 |
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