PEARLITOL® 50 C Mannitol and LYCATAB® DSH Maltodextrin Placebo Granules
Formulation Guideline

PEARLITOL® 50 C Mannitol and LYCATAB® DSH Maltodextrin Placebo Granules

Placebo formulation demonstrating processability of PEARLITOL® 50 C Mannitol as filler/binder and LYCATAB® DSH Maltodextrin as binder in high shear wet granulation process

Formula:

 

% (By weight)

Quantity Used (g)

PEARLITOL® 50 C mannitol

82.95

630.0

LYCATAB® DSH maltodextrin

9.22

70.0

Water

7.83

59.5

Blue coloring agent

qs

qs

Method:

  1. In a 6-liter lab-scale high shear granulator, introduce PEARLITOL® 50 C mannitol and LYCATAB® DSH maltodextrin.
  2. Dissolve the coloring agent in the water (1.5 g/L).
  3. Mix the powders for 3 min (impeller 250 rpm and chopper at 1800 rpm).
  4. Spray the solution on the powder for 1 min 43 seconds while mixing
    (spraying conditions: 3 bars pressure, 0.4 mm spraying nozzle diameter, 75 g of solution per minute).
  5. After spraying, continue mixing for 5 minutes.
  6. Dry the granules in a fluidized bed dryer at 60 oC until 1-2% moisture content.

Additional comments:

  • PEARLITOL® mannitol is used as a filler and filler/binder as well as a bulk sweetener. The PEARLITOL® range offers a unique blend of exceptional physical and chemical stability and no hygroscopicity. With great organoleptic, non-cariogenic and sugar-free properties, PEARLITOL® is suitable to be used in formulations addressing various patient populations including pediatric and diabetic.
  • LYCATAB® DSH maltodextrin is a high-performance wet granulation binder. It is completely soluble in cold water and has excellent wettability. These characteristics make it a versatile excipient for most granulation equipment and for binder incorporation (in the dry mix or as a binder solution).

Disclaimer:

This formula is a guideline for recommended use of our products; it does not imply consent to their use in violation of existing patent(s). 
These details are for information only, and we believe them to be reliable.