Formulation Guideline
PEARLITOL® 50 C Mannitol and LYCATAB® DSH Maltodextrin Placebo
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:
- In a 6-liter lab-scale high shear granulator, introduce PEARLITOL® 50 C mannitol and LYCATAB® DSH maltodextrin.
- Dissolve the coloring agent in the water (1.5 g/L).
- Mix the powders for 3 min (impeller 250 rpm and chopper at 1800 rpm).
- 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). - After spraying, continue mixing for 5 minutes.
- 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.