Troubleshooting and FAQs for MICROCEL® Microcrystalline Cellulose
Frequently asked questions for MICROCEL® Microcrystalline Cellulose and its applications
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MICROCEL® range offers several solutions for moisture sensitive components depending on the process:
- MICROCEL® 103 SD has less than 3% water content and a mean particle size around 50 µm. It is optimized for roll compaction, dry granulation and filler for hard capsules.
- MICROCEL® 113 SD has less than 2% water content and a mean particle size around 50 µm. It is optimized for roll compaction, dry granulation and filler for hard capsules.
- MICROCEL® MC-112 has less than 1.5% water content and a mean particle size around 100 µm. It is optimized for direct compression.
- MICROCEL® 112 SD has less than 1.5% water content and a mean particle size around 100 µm. It is spray-dried and is optimized for direct compression.
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Product name Main application Specificity Maximum water content (LOD) (%) Average mean particle diameter (µm) Particle size distribution by laser diffraction (µm) Bulk density (g/cm3) dv10 dv50 dv90 MICROCEL® spray-dried grades (EXCiPACT™ certified plant) MICROCEL® 103 SD Dry granulation filler-binder and hard capsule filler For moisture sensitive components 3 50 20 57 129 0.29 MICROCEL® 113 SD 2 50 19 57 131 0.3 MICROCEL® 101 SD Wet granulation, dry granulation Optimized compactibility 5 50 17 59 139 0.29 MICROCEL® 102 SD Direct compression (dry granulation) Optimized compactibility 5 100 26 99 231 0.3 MICROCEL® 112 SD For moisture sensitive components 1.5 100 34 96 208 0.31 MICROCEL® 200 SD Improved flowability 5 180 84 198 386 0.32 MICROCEL® 302 SD Higher density 5 100 14 72 190 0.41 MICROCEL® 301 SD Wet granulation 5 50 16 55 135 0.4 MICROCEL® spin/flash dried grades MICROCEL® MC-12 Direct compression (dry granulation) Improved flowability 7 160 60 180 380 0.3 MICROCEL® MC-102 Optimized compactibility 7 100 37 120 260 0.3 MICROCEL® MC-112 For moisture sensitive components 1.5 100 38 100 235 0.3 MICROCEL® MC-200 Improved flowability 7 180 66 198 385 0.37 MICROCEL® MC-302 Higher density 7 100 33 98 240 0.39 MICROCEL® MC-101 Wet granulation, dry granulation Higher density 7 50 26 81 152 0.29 -
MICROCEL® MC and MICROCEL® SD are two different microcrystalline cellulose products offered by Roquette. They are produced in two different production sites and both have compliance to all stringent regulatory requirements of U.S. and Europe. Consequently, the physical properties and performance of both microcrystalline cellulose products are not the same.
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MICROCEL® SD range is produced by spray-drying process. MICROCEL® MC grades are obtained through spin/flash drying process.
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MICROCEL® is available in different particle sizes, densities and moisture content grades. Depending on your application and formulation, the most appropriate grade may be selected. For example, MICROCEL® MC-112 is a low moisture grade of microcrystalline cellulose suitable for formulations with moisture instability. For direct compression, MICROCEL® MC-102 is one of the most commonly used grades.
MC-101 MC-102 MC-12 MC-200 MC-302 MC-112 Average Particle Size (µm) 50 100 160 180 100 100 Loss on Drying (%) ≤ 7 ≤ 7 ≤ 7 ≤ 7 ≤ 7 ≤ 1.5 Bulk Density (g/cm3) 0.26 – 0.31 0.28 – 0.33 0.30 – 0.40 0.30 – 0.40 0.35 - 0.45 0.28 – 0.33 -
MICROCEL® is a common tablet filler-binder. When used in direct compression (e.g. MC-102, MC-200 and MC-302), it gives a high tablet strength even at low compression forces. MICROCEL® may also be used in wet granulation (e.g. MC-101) , dry granulation (e.g. MC-101 and MC-102), or in capsule filling (e.g. MC-102, MC-200 and MC-302).
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Microcrystalline cellulose is sensitive to over-lubrication due to the fact that it is a plastically deforming material. When this happens, the tablet hardness will be reduced or tablet mechanical failure may be observed. It is recommended to review and optimize your process/formulation to make sure that no over-lubrication is occurring in your blender, press hopper or feed frame.
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As MICROCEL® microcrystalline cellulose is a plastically deforming material, it is also strain rate sensitive. Hence, when scaling up the tableting process from lab to pilot/production scale, the higher press speed and consequent reduction in dwell time can cause a loss of tablet hardness. It is advisable to perform "realistic" studies at the R&D stage to avoid scale-up issues later on. At Roquette, we employ the use of compaction simulators in our application labs to mimic industrial tableting conditions, offering "realistic" data and higher chance of success during scale-up.