PEARLITOL® SW-F 200
Wheat-Free Mannitol
Product Profile

PEARLITOL® SW-F 200
Wheat-Free Mannitol

 

Product Name PEARLITOL® SW-F 200
Generic Name Mannitol Directly Compressible
Physico-chemical properties
Compliance

FCC

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® SW-F200 wheat-free 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.

Water content (LOD)

Water Content (LOD) Maximum: 0.3 %

Morphology
Average mean particle diameter 200 µm
Particle Size Distribution by Laser Diffraction

dv10: 100 µm

dv50: 160 µm

dv90: 260 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: STYLONE EVO

Production Speed: 20% Pre-compression, 100 RPM (linear punch velocity: 140 mm/s; simulated KORSCH XL-400 rotary press speed: 210000 tablets/hour)

Tooling: Diameter 10 mm flat and diameter 10 mm R10 concave 

Formula: 98.8% PEARLITOL® SW-F200 / 1.2% magnesium stearate 

Tablet Mass: 400 mg

Powder Characteristics

Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 4

Bulk Density: 0.52 g/cm3

Tapped Density: 0.62 g/cm3

True Density: 1.514 g/cm3

Specific surface area: 0.86 m2/g

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