PEARLITOL® 150 SD
Mannitol-Low Reducing Sugar Content
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

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