Selection of Solvent (or) Excipients to get appropriate portion of granules

To get appropriate portion of granules, the solubility of API and major excipients in the granulating solvent is critical.

  • All components (API and Excipients present in the dry mix) are highly soluble in the granulating solvent, during granulation process may lead dough like mass and quickly resulting in over granulation.
  • All components (API and Excipients present in the dry mix) are insoluble in the granulating solvent, the resulting granules will be soft due to poor binding. 
  • A powder mass containing a mixture of soluble and insoluble components in appropriate portions provide excellent granulation.

E.g.:1

IF, Solvent is fixed (Purified water) and dry mix components are insoluble in water, the resulting granules form very soft granules.

In this case, Water insoluble excipients replaced with water soluble excipients (like lactose), to get desired granules and vice versa.

E.g.:2

IF, Excipients is fixed in dry mix components, which are highly soluble in water, the resulting dough like mass and quickly resulting in over granulation.

In this case, Water has to be replaced with other granulating solvents, to get desired granules.

Solvents include water, ethanol, Isopropyl alcohol and methylene chloride either alone and combination.

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Your comments and suggestions will be greatly appreciated….

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