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 °

The information contained in this document is to the best of our knowledge true and accurate, but all instructions, recommendations or suggestions are made without guarantee. Since the conditions of use are beyond our control, we disclaim any liability for loss and/or damage suffered from use of these data or suggestions. Furthermore, no liability is accepted if use of any product in accordance with these data or suggestions infringes any patent. No part of this document may be reproduced by any process without our prior written permission.

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