PEARLITOL® CR-H
Co-processed Mannitol-HPMC
Product Profile

PEARLITOL® CR-H
Co-processed Mannitol-HPMC

Product Name PEARLITOL® CR-H
Generic Name Co-processed Mannitol HPMC
Physico-chemical properties
Compliance

EP/USP-NF/JP/CHP 

Synonyms

D-Mannitol-Hydroxypropyl methylcellulose, HPMC

Composition

D-Mannitol 30%-HPMC K4M 70%

CAS Number

D-Mannitol 69-65-8 Hypromellose 9004-65-3 

Chemical Structure
Average Molecular Weight

Mannitol: 182.2 g/mol

Physical Form or Appearence

White to yellowish-white, powder or granules

Application

PEARLITOL® CR-H co-processed mannitol HPMC is a direct compression excipient providing functional properties of binder as well as controlled release to your tablet. PEARLITOL® CR-H can be used in both pharmaceutical and nutraceutical oral dosage forms.

Water content (LOD)

Water Content (LOD) Maximum: 4 %

Morphology
Average mean particle diameter 160 µm
Particle Size Distribution by Laser Diffraction

dv10: 60 µm

dv50: 140 µm

dv90: 290 µm

Solubility

Partially soluble in cold water.

Melting temperature

Minimum melting temperature : Mannitol: 165 °C

Maximum melting temperature: Mannitol: 170 °C

Water sorption isotherm at 20°C
Taste/Odor

Neutral taste, slightly sweet

Tablet hardness
Experimental Conditions for Compression Behavior

Tablet Press: STYL'ONE EVO

Production Speed:

30 and 65 RPM (linear punch velocity: 49 and 91 mm/s; simulated KORSCH XL-400 rotary press speed: 63,000 and 136,500 tablets/hour)

Tooling: Diameter 11.28 mm flat

Formula: PEARLITOL® CR-H / external lubrication with magnesium stearate 

Tablet Mass: 400 mg

Powder Characteristics

Powder Flowability (according to Ph.Eur. 2.9.16, 10mm outflow opening): 12 s

Bulk Density: 0.34 g/cm3

Tapped Density: 0.43 g/cm3

True Density: 1.456 g/cm3

Specific surface area: 0.8 m2/g

API release kinetics
Experimental conditions for sustained release behaviour

Tablet press: STYL'ONE EVO

Production speed: 30 RPM (linear punch velocity: 49 mm/s; simulated KORSCH XL-400 rotary press speed: 63,000 tablets/hour)

Tooling: Diameter 13 mm flat

Formula: 50% Metformin / 49% PEARLITOL® CR-H / 1% magnesium stearate 

Tablet mass: 1,000 mg

Tablet hardness: 109 N

Tablet thickness: 6.8 mm

Dissolution bath: USP II with helical sinker

Release media: pH transition method adapted from USP <711> Dissolution Method A

 

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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