PEARLITOL® SW-F 200 - MANNITOL - USP/NF

1 of 13 products in this brand

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

Chemical Name: Mannitol

Functions: Binder, Filler

CAS Number: 87-78-5

Dosage Form: Granules, Lozenges, Pellets, Tablets

Labeling Claims: Halal, Kosher, Natural, Naturally Derived, Non-Carcinogenic, Plant-Based, Sugar-free, Vegan

Certifications & Compliance: FCC Compliant, FSSC 22000, Generally Recognized As Safe (GRAS), Halal, Hazard Analysis Critical Control Point (HACCP), ISO 9001, Japan Pharmacopeia (JP), Kosher, National Formulary (NF), United States Pharmacopeia (USP), Vegan

Synonyms: 1,2,3,4,5,6-Hexanehexol, Cordycepic Acid, Manicol, Manitol

Safety Data Sheet

Knowde Enhanced TDS

Identification & Functionality

Chemical Name
Pharma & Nutraceuticals Functions
EINECS-No.
200-711-8
Chemical Structure

PEARLITOL® SW-F 200 - MANNITOL - USP/NF - Chemical Structure

Features & Benefits

Key Attributes
  • Direct Compression
  • High stability with no hygroscopicity
  • Natural Sweetness
  • Designed for direct compression
  • Applications: Swallowable tablet
  • Chewable tablets
  • Effervescent tablets
  • Orally Dispersible tablet
  • Coating
  • Functional properties: Excipient
  • Filler or Filler/Binder
     

Applications & Uses

Manufacturing Technology
Manufacturing Process

PEARLITOL® SW-F 200 - MANNITOL - USP/NF - Manufacturing Process

Process type: Continuous process

Packaging, Labeling: Packaging is done directly after production. Labeling is directly printed on package unit after Packaging filling.

Water: Potable water in compliance with national and european regulations and controlled by French national inspection agency.

Warehousing:

  • A written instruction is available concerning the cleaning and hygiene in the warehouse.
  • Computerized quarantine for products, confirms that product can be delivered to customers.
  • FIFO principle is performed.
  • Temperature and humidity are monitored in the warehouse.
Recommended Uses & Known Applications

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.

Properties

Physical Form
Appearance
White or almost white crystalline powder
Odor
Slightly sweet and cooling effect.
Soluble in
Water
Insoluble in
Ether
Sparingly soluble in
Ethanol (95%)
Typical Properties
ValueUnitsTest Method / Conditions
Water Contentmax. 3%LOD
Particle Diameter200µm
Particle Size Distribution (dv10) 100µmLaser Diffraction
Particle Size Distribution (dv50) 160µmLaser Diffraction
Particle Size Distribution (dv90) 260µmLaser Diffraction
Melting Temperature165 - 170°C
Bulk Density0.52g/cm3
Tapped Density0.62g/cm3
True Density1.514g/cm3
Specific Surface Area0.86m2/g
Molecular Weight182.2g/mol

Regulatory & Compliance

Technical Details & Test Data

Tablet Hardness

PEARLITOL® SW-F 200 - MANNITOL - USP/NF - Tablet Hardness

Water Sorption Isotherm at 20°C

PEARLITOL® SW-F 200 - MANNITOL - USP/NF - Water Sorption Isotherm At 20°C

Morphology

PEARLITOL® SW-F 200 - MANNITOL - USP/NF - Morphology

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

Packaging & Availability

Packaging Type
Packaging Information

Availabale in 25 Kg bag.
Detailed packaging specifications are available on request.

The type of packaging: used is suitable for use in contact with foodstuffs (food contact certificate is available upon request). In case of bulk deliveries, the road tanker is dedicated to foodstuffs.

Packaging specification: Detailed packaging specifications are available on request.

Storage & Handling

Storage Conditions

Preserve in well-closed original containers, preferably protected from wide variations in temperature and humidity.