Silicified Microcrystalline Cellulose
History
Excipients play a major role in the development of tablets and capsules for the health science industry. As API and manufacturing processes evolve, the need for excipients with greater functionality increases.
Over 20 years ago, JRS PHARMA developed a new and innovative excipient, (silicified microcrystalline cellulose), to alleviate some of the known deficiencies of conventional binders including: low bulk density, poor flow, loss of compatibility, stickiness issues, and sensitivity to lubricants not only addresses these challenges, but also offers enhanced performance.
Physical Properties of PROSOLV SMCC®
- White, free flowing powder
- High degree of brightness
- Practically insoluble in water, acetone, and anhydrous ethanol
- Chemically inert
- Excellent compatibility
- High intrinsic flow
- Enhanced lubrication efficiency
- Improved blending properties
- Exhibits both brittle fracture and plastic deformation, leading to superior binding properties
- Five times greater specific surface area than MCC alone
Effects of Silicification
The specific production process of PROSOLV SMCC® leads to a homogenous distribution of the colloidal silicon dioxide particles throughout the product and on the particle surfaces.
At low magnification, traditional and silicified MCC look very similar in terms of their particle size and shape. At high magnification, however, electron microscopy reveals the differentiation in the microstructures of silicified MCC and traditional MCC.
Silicification reduces the cohesiveness of the powder bed. Consequently, PROSOLV SMCC® shows much better powder flowability than traditional MCC grades of the same particle size.
Compared to traditional MCC, the unique surface structure of PROSOLV SMCC® enables excellent blend homogeneity and content uniformity, even for low-dosed, micronized active ingredients.
Lastly, silicification further increases the surface area by a factor of five thus improving the outstanding binding properties of microcrystalline cellulose. This makes PROSOLV SMCC® an ideal choice for high dose, direct compression formulations.
PROSOLV SMCC® 90
Traditional MCC
High magnification SEMs show CSD particles on the SMCC surface and in the SMCC pores.
Benefits
PROSOLV SMCC® provides tremendous technical and manufacturing benefits through the product lifecycle including:
- Rapid formulation development
- Dust-free handling during production
- Superior flow
- Improved compatibility, leading to more robust tablets
- Fewer excipients needed at lower use levels
- Smaller tablet size
- Optimized content uniformity
- Shorter disintegration time
Typical Reduction of Excipient Usage with PROSOLV SMCC®
Formulations including PROSOLV SMCC® typically require lower excipient use levels including:
- 30 - 50 % less MCC/binders
- 25 - 50 % less lubricants
- 25 - 50 % less disintegrants
- No DCP
- No CSD/glidants
Grades of PROSOLV SMCC®
The wide variety of PROSOLV SMCC® grades available ensures the perfect solution for a range of different formulation challenges.
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Silicified Microcrystalline Cellulose, NF
(Microcrystalline Cellulose, Ph.Eur., NF, JP, E 460(i) and Silica, Colloidal Anhydrous, Ph.Eur., E 551 ) |
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|---|---|---|---|
| Grade | Average Particle Size by Laser Diffraction (μm) |
Bulk Density (g/mL) |
Grade Main Application |
| PROSOLV® SMCC 50 | 65 | 0.25 - 0.37 | Formulas in which optimal compaction and decent flow are required. |
| PROSOLV® SMCC 50 LD | 50 | 0.20 - 0.30 | Best in class binder |
| PROSOLV® SMCC 90 | 125 | 0.25 - 0.37 | Formulas in which a balance of flow and compaction are required. |
| PROSOLV SMCC HD 90 | 125 | 0.38 - 0.50 | Formulas in which optimal flow and consolidation are required. This grade shows the best disintegration times. *Low moisture grade available on request. |
| PROSOLV SMCC 90 LM | 125 | 0.27 - 0.39 | Equivalent to quality of PROSOLV® SMCC 90, but with lower moisture content (< 3 %) |
Direct Compression
PROSOLV® SMCC is 30-50 % more compactible than MCC. It accommodates poorly compactible APIs, delivers superior compactibility in high drug-loading applications, and excels in roller compaction processes.
Volume Flow
PROSOLV® SMCC offers a balance of best in class compaction and flow for tablet formulations. Silicification provides flow that is comparable to doubling the particle size of MCC in addition to superior compaction.
Surface Area
PROSOLV® SMCC shows a five-fold specific surface area increase compared to MCC. The increased specific surface area enables PROSOLV® SMCC to impart enhanced compactibility to formulations.
