PEARLITOL® SW-F 200
Wheat-Free Mannitol
| Product Name | PEARLITOL® SW-F 200 |
| Generic Name | PEARLITOL® Mannitol powder for Direct Compression |
| Physico-chemical properties | |
| Compliance | FCC |
| Synonyms | D-Mannitol |
| CAS Number | 69-65-8 |
| Chemical Structure |
|
| Average Molecular Weight | 182.2 g/mol |
| Physical Form or Appearence | White or almost white crystalline powder |
| Application | PEARLITOL® SW-F200 wheat-free mannitol is a direct compression excipient. It is a spray-dried form of mannitol with exceptional physical and chemical stability. It offers high API compatibility and no hygroscopicity. It is also a non-cariogenic and non-acidogenic sugar-free sweetener. It is suitable in formulations addressing all types of patient populations including pediatric and diabetic. It can be used in lozenges, swallowable tablets, orally dispersible tablets, chewable tablets, and effervescent tablets. |
| Water content (LOD) |
Water Content (LOD) Maximum: 0.3 % |
| Morphology |
|
| Average mean particle diameter | 160 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: 100 µm dv50: 160 µm dv90: 260 µm |
| Solubility | Freely soluble in water (1 part in 5.5 part of water at 20°C), sparingly soluble in 95% ethanol (1 part in 83), practically insoluble in ether |
| Melting temperature |
Minimum melting temperature : 165 °C Maximum melting temperature: 170 °C |
| Water sorption isotherm at 20°C |
|
| Taste/Odor | Slightly sweet and cooling effect. |
| Tablet hardness |
|
| Experimental Conditions for Compression Behavior |
Tablet Press: STYLONE EVO Production Speed: 20% Pre-compression, 100 RPM (linear punch velocity: 140 mm/s; simulated KORSCH XL-400 rotary press speed: 210000 tablets/hour) Tooling: Diameter 10 mm flat and diameter 10 mm R10 concave Formula: 98.8% PEARLITOL® SW-F200 / 1.2% magnesium stearate Tablet Mass: 400 mg |
| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 4 Bulk Density: 0.52 g/cm3 Tapped Density: 0.62 g/cm3 True Density: 1.514 g/cm3 Specific surface area: 0.86 m2/g |
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