PEARLITOL® ProTec
Co-processed Mannitol-Starch
Product Profile

PEARLITOL® ProTec
Co-processed Mannitol-Starch

 

Product Name PEARLITOL® ProTec
Generic Name Co-Processed Mannitol Starch
Physico-chemical properties
Compliance

EP/USP-NF/JP for pharma and USP-NF/FCC for nutra

Synonyms

D-Mannitol-Starch

Composition

Approximately D-Mannitol 80%-Dehydrated Extra White Maize Starch 20%

CAS Number

D-Mannitol 69-65-8
Maize Starch 9005-25-8 

Chemical Structure
Average Molecular Weight

Mannitol: 182.2 g/mol

Physical Form or Appearence

White powder

Application

PEARLITOL® PROTEC co-processed mannitol starch is designed for the direct compression of moisture sensitive ingredients such as probiotics and vitamins. PEARLITOL® ProTec provides protection from tableting process, including compression and improves stability due to low-water activity. PEARLITOL® ProTec may also be used in free-flowing powder formulations such as stick packs and sachets.

Water content (LOD)

Water Content (LOD) Maximum: 1 %

Water activity

Maximum water activity: 0.2

Morphology
Average mean particle diameter 120 µm
Particle Size Distribution by Laser Diffraction

dv10: 50 µm

dv50: 120 µm

dv90: 200 µm

Solubility

Partially soluble in cold water, practically insoluble in ethanol (96%)

Melting temperature

Minimum melting temperature : Mannitol: 165 °C

Maximum melting temperature: Mannitol: 170 °C

Water sorption isotherm at 20°C
Taste/Odor

Slightly sweet

Tablet hardness
Experimental Conditions for Compression Behavior

Tablet Press: STYL'ONE EVO

Production Speed: 25, 40 and 60 RPM (linear punch velocity: 35, 56 and 84 mm/s; simulated KORSCH XL-400 rotary press speed: 52,500, 84,000 and 126,000 tablets/hour)

Tooling: Diameter 10 mm R10 concave 

Formula: 98.8% PEARLITOL® ProTec / 1.2% magnesium stearate 

Tablet Mass: 400 mg

Powder Characteristics

Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 5 s

Bulk Density: 0.48 g/cm3

Tapped Density: 0.56 g/cm3

True Density: 1.443 g/cm3

Specific surface area: 1.6 m2/g

Angle of Repose: 30 °

Disclaimer

® Registered trademark(s) of Roquette Frères. Any information provided herein is intended for healthcare and food industry professionals for internal use only and not to be delivered as such to final consumers. Information is based on our current state of knowledge and made available on an informational basis; products described may have restrictions with respect to their use, communication, and/or usage levels, and such may vary on a country-by-country basis. Manufacturers of dietary supplements should evaluate the intended use of the particular ingredient in their finished dietary supplement to confirm compliance with the applicable laws and regulations of authorities regulating such products, because the suitability and regulatory status of a product may be dependent on its specific intended use. As the use of these products is beyond our control, Roquette makes no express or implied warranties regarding the use of the product and no guarantee of product properties, and in particular no express or implied warranties regarding the use of the product in dietary supplements, including without limitation the implied warranties of merchantability and fitness for a particular purpose, and Roquette disclaims liability for any loss and/or damage related to such use. Roquette, further, does not warrant that the information or its use will not infringe any patent or other proprietary rights of any third party. Roquette providing this information is not a commitment to sell any product encompassing any of such information in the future.

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