Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Ingredient Origin
- EINECS-No.
- 200-711-8
- Technologies
- Product Families
- 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
- Markets
- Manufacturing Technology
- 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
Value | Units | Test Method / Conditions | |
Water Content | max. 3 | % | LOD |
Particle Diameter | 200 | µm | — |
Particle Size Distribution (dv10) | 100 | µm | Laser Diffraction |
Particle Size Distribution (dv50) | 160 | µm | Laser Diffraction |
Particle Size Distribution (dv90) | 260 | µm | Laser Diffraction |
Melting Temperature | 165 - 170 | °C | — |
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 | — |
Molecular Weight | 182.2 | g/mol | — |
Regulatory & Compliance
- Certifications & Compliance
- Chemical Inventories
- Grade
Technical Details & Test Data
- Tablet Hardness
- Water Sorption Isotherm at 20°C
- 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.