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PEARLITOL® 100 SD - MANNITOL

PEARLITOL®

®Registered Trademark(s) of Roquette Frères
  • Designed for direct compression
  • For small particle size

Particle size mean diameter - 100 µm approx

Applications

  • 1. Solid Forms - Tablets
  • Chewable Tablets
  • Swallowable Tablets
  • Orally Dispersible Tablets
  • Effervescent Tablets
  • 2. Solid Forms - Capsules
  • Hard Capsules Shell
  • 5. Other Solid Forms
  • Granules and Pellets
  • 3. Films and coatings
  • Film Coating

Functional properties

  • Formulations Aids
  • Fillers and Binders for Direct Compression
  • Fillers and Binders for Roller Compaction
  • Sensory Enhancers
  • Stabilizers and Adjusters
  • Stabilizers

Physical and chemical properties

  • General Properties
  • Label-friendly
  • Plant-based & non-GMO
  • Available with Food Grade for Nutraceuticals (some regions)
  • Health & Nutritional Benefits
  • Sugar-free

Documents

Product Specification Sheet

Region :

477,99 Ko

Region :

482,01 Ko

Region :

481,33 Ko

Safety Data Sheet

Region : Europe, BE

EN 519,61 Ko

Region : Americas, BR

EN 586,18 Ko

Region : Americas, CA

EN 288,00 Ko

Region : Europe, CH

EN 520,15 Ko

Region : Asia, CN

EN 339,11 Ko

Region : Europe, CY

EN 516,58 Ko

Region : Europe, DE

EN 522,94 Ko

Region : Europe, FI

EN 519,63 Ko

Region : Europe, BE

DE 532,42 Ko

Region : Europe, BE

FR 633,60 Ko

Region : Europe, BE

NL 528,33 Ko

Region : Europe, BG

BG 678,67 Ko

Region : Americas, BR

PT 538,65 Ko

Region : Americas, CA

FR 401,60 Ko

Region : Europe, CH

IT 621,86 Ko

Region : Europe, CH

DE 532,60 Ko

Region : Europe, CH

FR 634,11 Ko

Region : Asia, CN

ZH 560,15 Ko

Region : Europe, CY

EL 670,96 Ko

Region : Europe, CY

TR 671,04 Ko

Region : Europe, CZ

CS 651,80 Ko

Region : Europe, DE

DE 537,03 Ko

Region : Europe, DK

DA 528,47 Ko

Region : Europe, ES

ES 534,91 Ko

Region : Europe, FI

FI 535,59 Ko

Get in touch with our Technical Experts

Please feel free to contact our technical experts for support during the development process.

Technical data

Synonyms D-Mannitol
CAS number 69-65-8
Physical form or apperance White or almost white crystalline powder
Application PEARLITOL® 100 SD 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.
Teste/Odor Slightly sweet and cooling effect.
Morphology
MORPHOLOGY
Water sorption isotherm at 20°C
WATER_SORPTION
Chemical Structure
CHEMICAL_STRUCTURE
Average molecular weight 182.2 g/mol
Maximal Water content (LOD) 0.50
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
Minimum melting temperature 165 °C
Maximum melting temperature 170 °C
Average mean particle diameter 100
dv10 Particle size distribution 20
dv50 Particle size distribution 100
dv90 Particle size distribution 185
Tablet Hardness
COMPRESSION_BEHAVIOUR_TABLET_HARDNESS
Experimental Conditions for Compression Behavior_Tablet Press STYLCAM 200R
Experimental Conditions for Compression Behavior_Production Speed 25 tablets/min (linear punch velocity: 96 mm/s; simulated rotary press speed: approximately 150000 tablets/hour)
Experimental Conditions for Compression Behavior_Tooling Diameter 10 mm R9 concave
Experimental Conditions for Compression Behavior_Formuls 98.8% PEARLITOL® 100 SD / 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) 6
Bulk Density (g/ml) 0.47
Tapped Density (g/ml) 0.57
True Density (g/ml) 1.51
Specific Surface Area (m²/g) 1.05
Angle of Repose (°) 32