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PEARLITOL® PRO-TEC - MANNITOL-MAIZE STARCH

PEARLITOL®

®Registered Trademark(s) of Roquette Frères
  • Designed for the direct compression of moisture sensitive ingredients.

Low water activity
Low moisture

Applications

  • 1. Solid Forms - Tablets
  • Swallowable Tablets
  • Orally Dispersible Tablets
  • Effervescent Tablets
  • 5. Other Solid Forms
  • Granules and Pellets

Functional properties

  • Formulations Aids
  • Disintegrants & Super Disintegrants
  • Fillers and Binders for Direct Compression

Documents

Product Specification Sheet

Region :

473,84 Ko

Safety Data Sheet

Region : Americas, US

EN 269,21 Ko

Region : Asia, ID

EN 276,31 Ko

Region : Europe, IT

EN 309,84 Ko

Region : Europe, GB

EN 308,91 Ko

Region : Asia, TW

EN 283,64 Ko

Region : Asia, VN

EN 280,92 Ko

Region : Oceania, AU

EN 275,61 Ko

Region : Europe, FR

EN 307,68 Ko

Region : Europe, DE

EN 310,22 Ko

Region : Europe, CH

EN 307,66 Ko

Region : Asia, MY

EN 276,50 Ko

Region : Asia, VN

EN 382,42 Ko

Region : Asia, KR

KO 374,09 Ko

Region : Europe, CH

FR 351,58 Ko

Region : Asia, ID

ID 297,56 Ko

Region : Asia, MY

MS 297,68 Ko

Region : Europe, FR

FR 351,07 Ko

Region : Europe, CH

DE 347,30 Ko

Region : Europe, ES

ES 345,55 Ko

Region : Europe, DE

DE 350,87 Ko

Region : Americas, BR

PT 348,60 Ko

Region : Europe, CH

IT 340,94 Ko

Region : Asia, TH

TH 367,21 Ko

Region : Europe, IT

IT 343,12 Ko

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Technical data

Synonyms D-Mannitol-Starch
Composition Approximately D-Mannitol 80%-Dehydrated Extra White Maize Starch 20%
CAS number D-Mannitol 69-65-8Maize Starch 9005-25-8
Physical form or apperance White powder
Application PEARLITOL® ProTec co-processed mannitol-starch is designed for the direct compression of moisture\nsensitive ingredients such as probiotics and vitamins. PEARLITOL® ProTec provides protection from\ntableting 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.
Teste/Odor Slightly sweet
Morphology
MORPHOLOGY
Water sorption isotherm at 20°C
WATER_SORPTION
Chemical Structure
CHEMICAL_STRUCTURE
Average molecular weight Mannitol: 182.2 g/mol
Maximal Water content (LOD) 1.00
Solubility Partially soluble in cold water, practically insoluble in ethanol (96%)
Minimum melting temperature Mannitol: 165 °C
Maximum melting temperature Mannitol: 170 °C
Water Activity 0.20
Average mean particle diameter 120
dv10 Particle size distribution 50
dv50 Particle size distribution 120
dv90 Particle size distribution 200
Tablet Hardness
COMPRESSION_BEHAVIOUR_TABLET_HARDNESS
Experimental Conditions for Compression Behavior_Tablet Press STYL'ONE EVO
Experimental Conditions for Compression Behavior_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)
Experimental Conditions for Compression Behavior_Tooling Diameter 10 mm R10 concave
Experimental Conditions for Compression Behavior_Formuls 98.8% PEARLITOL® ProTec / 1.2% magnesium stearate
Experimental Conditions for Compression Behavior_Tablet Mass 400 mg
Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening) 5
Bulk Density (g/ml) 0.48
Tapped Density (g/ml) 0.56
True Density (g/ml) 1.44
Specific Surface Area (m²/g) 1.60
Angle of Repose (°) 30