PEARLITOL® ProTec
Co-processed Mannitol-Starch
| Product Name | PEARLITOL® ProTec |
| Generic Name | PEARLITOL® Flash - filler/binder & disintegrant for ODT |
| Physico-chemical properties | |
| Compliance | EP/USP-NF/JP for pharma and USP-NF/FCC for nutra |
| Synonyms | D-Mannitol-Starch |
| Composition | Approximately D-Mannitol 80%-Dehydrated Extra White Maize Starch 20% |
| CAS Number | D-Mannitol 69-65-8 |
| Chemical Structure |
|
| Average Molecular Weight | Mannitol: 182.2 g/mol |
| Physical Form or Appearence | White powder |
| Application | PEARLITOL® PROTEC co-processed mannitol starch is designed for the direct compression of moisture sensitive ingredients such as probiotics and vitamins. PEARLITOL® ProTec provides protection from tableting process, including compression and improves stability due to low-water activity. PEARLITOL® ProTec may also be used in free-flowing powder formulations such as stick packs and sachets. |
| Water content (LOD) |
Water Content (LOD) Maximum: 1 % |
| Water activity | Maximum water activity: 0.2 |
| Morphology |
|
| Average mean particle diameter | 120 µm |
| Particle Size Distribution by Laser Diffraction |
dv10: 50 µm dv50: 120 µm dv90: 200 µm |
| Solubility | Partially soluble in cold water, practically insoluble in ethanol (96%) |
| Melting temperature |
Minimum melting temperature : Mannitol: 165 °C Maximum melting temperature: Mannitol: 170 °C |
| Water sorption isotherm at 20°C |
|
| Taste/Odor | Slightly sweet |
| Tablet hardness |
|
| Experimental Conditions for Compression Behavior |
Tablet Press: STYL'ONE EVO Production Speed: 25, 40 and 60 RPM (linear punch velocity: 35, 56 and 84 mm/s; simulated KORSCH XL-400 rotary press speed: 52,500, 84,000 and 126,000 tablets/hour) Tooling: Diameter 10 mm R10 concave Formula: 98.8% PEARLITOL® ProTec / 1.2% magnesium stearate Tablet Mass: 400 mg |
| Powder Characteristics |
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 5 s Bulk Density: 0.48 g/cm3 Tapped Density: 0.56 g/cm3 True Density: 1.443 g/cm3 Specific surface area: 1.6 m2/g Angle of Repose: 30 ° |
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