PEARLITOL® 200 GT
Mannitol
| Product Name | PEARLITOL® 200 GT |
| Generic Name | PEARLITOL® Mannitol powder for high intensity Direct Compression |
| Physico-chemical properties | |
| Compliance | EP/USP-NF/JP/CHP |
| 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® 200 GT mannitol is a direct compression excipient, specially designed to avoid capping, improve flowability and tabletability. It is a granulated 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 tablets (lozenges, swallowable tablets, orally dispersible tablets, chewable tablets, and effervescent tablets) and in powder blends (sachets, oral stick pack and hard gelatin capsules filling). |
| Water content (LOD) |
Water Content (LOD) Maximum: 0.5 % |
| Morphology |
|
| Average mean particle diameter | 160 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: 90 µm dv50: 150 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: 10, 25 and 40 tablets/min (respective linear punch velocity: 38, 96 and 152 mm/s ; respective simulated rotary press speed: 60000, 150000 and 240000 tablets/hour) Tooling: Diameter 10 mm R9 concave Formula: 98.8% PEARLITOL® 200 GT / 1.2% magnesium stearate Tablet Mass: 400 mg |
| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 4s Bulk Density: 0.63 g/cm3 Tapped Density: 0.75 g/cm3 True Density: 1.514 g/cm3 Specific surface area: 1.3 m2/g Angle of Repose: 27 ° |
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