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PEARLITOL® 200 GT

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Description

Mannitol Directly Compressible

PEARLITOL® Mannitol pharma range is used as a filler and filler/binder. The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity. Using different texturizing technologies we have designed a crystalline range of directly compressible PEARLITOL® with various particle size allowing you to find the right product. With great organoleptic, non-cariogenic and sugar-free properties PEARLITOL® is suitable to be used in formulation addressing all type of patient population including pediatric and diabetic.

PEARLITOL® can be used in in various oral dosage forms in both pharmaceutical and nutraceutical applications including swallowable tablets, orally dispersible tablets, chewable tablets, effervescent tablets, lozenges, blends, granules, pellets premix and medicated confectionary.

  • Direct Compression
  • Natural Sweetness
  • High stability with no hygroscopicity

Applications

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).

 

  • Oral Dosage for Pharmaceuticals and/or Nutraceuticals
    • Swallowable tablet
    • Chewable tablets
    • Effervescent tablets
    • Coating
    • Orally Dispersible tablet

Functional Properties

  • Excipient
    • Filler or Filler/Binder

Other Properties and Benefits

  • DMF Available

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 °

 

If you have any questions, please contact Roquette directly here

Additional information

Manufacturer

Roquette
Quality

EP/USP-NF/JP/CHP
Composition

Mannitol
Dosage Form

White or almost white crystalline powder
Function

direct compression excipient, avoid capping, improve flowability and tabletability, high API compatibility and no hygroscopicity, sweetener

Documents and Links

PEARLITOL 200 GT_Quality Specification Sheet

Download

PEARLITOL 200 GT_SDS

Download

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