PEARLITOL® 200 GT Mannitol

Physico-chemical properties

Compliance

EP/USP-NF/JP/CHP

Synonyms

D-Mannitol

CAS Number

69-65-8

Average Molecular Weight

182.2 g/mol

Physical Form or Appearence

White or almost white crystalline powder

Application

PEARLITOL® 200 GT mannitol is a direct compression excipient, specially designed to avoid capping, improve flowability and tabletability. It is a granulated 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 tablets (lozenges, swallowable tablets, orally dispersible tablets, chewable tablets, and effervescent tablets) and in powder blends (sachets, oral stick pack and hard gelatin capsules filling).

Water content (LOD)

Water Content (LOD) Maximum: 0.5 %

Average mean particle diameter

160 µm

Particle Size Distribution by Laser Diffraction

dv10: 90 µm

dv50: 150 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

Taste/Odor

Slightly sweet and cooling effect.

Experimental Conditions for Compression Behavior

Tablet Press: STYLONE EVO

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 240000 tablets/hour)

Tooling: Diameter 10 mm R9 concave

Formula: 98.8% PEARLITOL® 200 GT / 1.2% magnesium stearate

Tablet Mass: 400 mg

Powder Characteristics

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

Bulk Density: 0.63 g/cm3

Tapped Density: 0.75 g/cm3

True Density: 1.514 g/cm3

Specific surface area: 1.3 m2/g

Angle of Repose: 27 °