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, Markskill 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 MARK 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 MARK 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, MARK SMCC shows much better powder flowability than traditional MCC grades of the same particle size.
Compared to traditional MCC, the unique surface structure of MARK 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 MARK SMCC an ideal choice for high dose, direct compression formulations.
Benefits
MARK 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 MARK SMCC
Formulations including MARK 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 MARK SMCC
The wide variety of MARK SMCC grades available ensures the perfect solution for a range of different formulation challenge