PEARLITOL® CR-H
Co-processed Mannitol-HPMC
| Product Name | PEARLITOL® CR-H |
| Generic Name | PEARLITOL® CR-H Controlled Relase for OSDF cores |
| 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 |
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| 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 |
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| 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 |
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