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Celphere™
A 100% MCC sphere, Celphere™ facilitates precise dissolution profiles of controlled release formulations by its
high sphericity and narrow particle size distribution.
Functional benefits
- Facilitates precise dissolution profile of controlled release formulation
- Yield improvement
Reduces agglomeration, tolerance with high stress and coating machine varieties
Function & features
- High sphericity
- Narrow particle size distribution
- High mechanical strength
Experimental
example
Example 1:
Film coating in aqueous coating system
* Percentage of particles with particle size larger than 500μm
Base granules : Vitamin B2 (2%) layered on Celphere™ or sugar sphere
Film coating : Ethylcellulose aqueous dispersion/Triethyl citrate/HPMC/
Water=10.9/2.7/1.4/85 (up to 10% against base granules)
Equipment : Wurster fluid bed coater
Example 2:
Dissolution profile affected by shear stress
Drug layering : Theophylline/Corn starch/Sucrose=10/10/20 + HPC-L aq. (3 wt%)
Film coating : Ethylcellulose aqueous dispersion/Acetylated monoglycerides/Talc=100/33/57
Equipment : CF-Granulator
Grade lineup
CP-102
CP-203
CP-305
CP-507
CP-708
General properties
| Grade | Particle size range (μｍ) | Sphericity | Bulk density (g/cm3) | Water absorption (%) |
|---|---|---|---|---|
| CP-102 | 106-212 | 1.2 | 0.83 | 100 |
| CP-203 | 150-300 | 1.1 | 0.87 | 100 |
| CP-305 | 300-500 | 1.1 | 0.97 | 110 |
| CP-507 | 500-710 | 1.2 | 0.97 | 70 |
| CP-708 | 710-850 | 1.2 | 0.93 | 65 |
All values presented here are solely for the purpose of basic reference and should not be regarded as specifications.
Pharmacopoeia listings
JPE : Microcrystalline Cellulose Spheres
USP/NF : Microcrystalline Cellulose
Ph. Eur. : CELLULOSE, MICROCRYSTALLINE
Packaging information
| Net weight | Packaging type |
|---|---|
| 20 kg | Polyethylene bag in carton box |
Formulation examples
* You can download PDF files after log in Member page.
MCC sphere for controlled release formulations
Celphere™
Film coating with MCC spheres causes less agglomeration than with sugar spheres regardless of the film coating conditions such as spray rate because of their moderate water absorption capacity without dissolving. Also, film coating with MCC spheres causes less damage to core particles than with sugar spheres because of their high mechanical strength. These results suggest MCC spheres facilitates precise dissolution profile of controlled release formulations.
Challenges
Key words
MCC sphere for controlled release formulations
Celphere™
In the case of film coating with sugar spheres, core particles dissolve in water and the granules become unstable. It indicates negative impact on dissolution profile would be assumed due to external shear stress such as the gastrointestinal tract. On the other hand, film coated granules with MCC spheres are more robust against external shear stress, and maintain stable dissolution profile because of insoluble property of MCC.
Challenges
Key words
Reduction of agglomeration in coating process
Celphere™
Drug layering with MCC spheres causes less agglomeration than with sugar spheres regardless of the drug layering conditions such as spray rate because of their moderate water absorption capacity without dissolving. This result suggests that the use of MCC sphere improves productivity.
Challenges
Key words