Product Profile
PEARLITOL® 150 SD
Mannitol-Low Reducing Sugar Content
| Product Name | PEARLITOL® 150 SD |
| Generic Name | Mannitol Directly Compressible |
| 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® 150 SD mannitol is a direct compression excipient with low reducing sugar content (300 ppm max). 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: 0.5 % |
| Morphology |
|
| Average mean particle diameter | 150 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: 60 µm dv50: 115 µm dv90: 185 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: STYLCAM 200R 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 250000 tablets/hour) Tooling: Diameter 10 mm R9 concave Formula: 98.8% PEARLITOL® 150 SD / 1.2% magnesium stearate Tablet Mass: 400 mg |
| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 6 s Bulk Density: 0.46 g/cm3 Tapped Density: 0.55 g/cm3 True Density: 1.514 g/cm3 Specific surface area: 1.3 m2/g |