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 150 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 13,6500 tablets/hour)

Tooling: Diameter 13 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

These typical values are provided for information only and we believe them to be reliable. Methods available upon request.

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