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Sheffield Bio-Science

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LubriTose MCC Case Study

CASE STUDIES
By Sheffield Bio-Science

LubriTose MCC is a co-processed excipient that combines Microcrystalline Cellulose (MCC) with a tablet lubricant. The lubricant is integrated into the MCC, resulting in a directly compressible excipient system that eliminates the necessity to use Magnesium Stearate.

The product is used in direct compression tablet formulations as a replacement for the compression aid and lubricant. The API and other materials are added in a typical fashion but the need for adding a lubricant in the final blending step is eliminated.The product consists of the following ingredients:

  • NF/EP/JP compliant Microcrystalline Cellulose (MCC)
  • NF compliant Glyceryl Monostearate (GMS)
  • The chemical attributes of both products are preserved

Benefits

Eliminates the necessity of using magnesium stearate

  • No overblending issues
  • Does not leave residue on equipment
  • Maintains tablet hardness and dissolution over using Magnesium Stearate

Self-lubricating

  • Low ejection forces result in extended tooling life

Excipients are integrated together

  • Enhanced flowability and less dust

MCC based

  • Excellent tablet hardness and dissolution

Ability to run at high speeds

  • Acceptable ejection forces even at high press speeds

High dilution potential for adding API and functional excipients to formulation

  • Ability to add API and functional excipients
  • Excellent lubrication even at low use level in formula

Study objective

To show that LubriTose MCC can be used in typical Acetaminophen tablet formulations that result in acceptable tablet hardness, fast dissolution values, and low ejection forces at various press speeds.

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