ACTILLETS™ Microcrystalline Cellulose Spheres
ACTILLETS™ MCC are neutral cores of microcrystalline cellulose that are highly engineered, highly spherical, and high quality. These materials have become essential tools in drug development for the important, growing advanced controlled release doses needed for modern medicines.
PARTICLE ENGINEERING
ACTILLETS™ Microcrystalline cellulose pellets are manufactured for SPI using Cellets® processes from Advanced Drug delivery Technology, ltd. This ensures robust mechanical stability, the highest consistency and sphericity, and the lowest friability to enable effective loading and coating of the particles.
ACTILLETS™ ADVANTAGE
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Product Features |
Formulation Benefits |
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Micropellets (100 - 200 µm) for highly active low dose API |
Simplified and homogeneous drug coating and control |
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Wide range of particle size fractions |
Easy taste-masking of the final drug |
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Narrow particle size distribution within each fraction |
Application in multiple unit pellet systems (MUPS) |
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Uniform spherical shape and structure |
Application in drug formulations for paediatrics |
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Made under GMP conditions with MCC from certified suppliers |
Better customer acceptance and safety |
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Quality analyzed according to Ph.Eur., USP/NF and JPE |
Reduced food effect, variability and dose dumping |
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Almost in-soluble in water |
High control on time and place of drug delivery |
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High abrasion resistance |
Perfect tool for combinatory and controlled release products |
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Ideal for capsules |
Formulation of sensitive actives due to the inertness of MCC |
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Excellent compactibility due to the high plasticity |
Higher payload permits smaller capsule sizes |
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Unique carrier system for API in jelly formulations |
Product Properties
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ACTILLETS 100 MCC |
ACTILLETS 200 MCC |
ACTILLETS 350 MCC |
ACTILLETS 500 MCC |
ACTILLETS 700 MCC |
ACTILLETS 1000 MCC |
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Particle size distribution (≥ 85 %) |
100-200 µm |
200-355 µm |
350-500 µm |
500-710 µm |
700-1000 µm |
1000-1400 µm |
Additional Properties
| Loss on drying Ph.Eur., USP/NF, JP, JPE | ≤ 7.0 % |
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Bulk density (g/m3) Ph.Eur., USP/NF, JP |
0.80 g/m3 ± 5 % (for information only) |
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Sphericity degree Cellets Standard (average) |
≥ 0.90 |
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Friability, Cellets Standard |
0 % |
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Swelling index, Cellets Standard |
≤ 2 mL/g |
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Identification infrared absorption Ph.Eur., USP/NF, JP |
passed |
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Identification zinc chloride test Ph.Eur., USP/NF, JP, JPE |
passed |
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Degree of polymerization Ph.Eur., USP/NF, JP |
≤ 350 |
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pH value Ph.Eur., USP/NF, JP, JPE |
5.0 – 7.5 |
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Conductivity Ph.Eur., USP/NF, JP, JPE |
≤ 75 µS/cm |
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Ether soluble substances Ph.Eur., USP/NF, JP, JPE |
≤ 0.05 % |
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Water soluble substances Ph.Eur., USP/NF, JP, JPE |
≤ 0.25 % |
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Heavy metals JP, JPE |
≤ 10 ppm |
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Sulfated ash / Residue on ignition Ph.Eur., USP/NF (determined on 1g) |
≤ 0.1 % |
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Sulfated ash / Residue on ignition JP, JPE (determined on 2g) |
≤ 0.1 % |
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Total aerobic microbial count Ph.Eur., USP/NF, JP, JPE |
≤ 1,000 CFU/g |
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Fungi / moulds and yeasts Ph.Eur., USP/NF, JP, JPE |
≤ 100 CFU/g |
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E. coli Ps. aerugin. St. aureus Ph.Eur., USP/NF, JP, JPE |
absence in 1 g sample |
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Salmonella species Ph.Eur., USP/NF, JP, JPE |
absence in 10 g sample |