Hydrochlorothiazide Tablets using PEARLITOL® 50 C Mannitol, LYCATAB® DSH Maltodextrin and Maize Starch Extra White (Wet Granulation)
Formulation Guideline

Hydrochlorothiazide Tablets using PEARLITOL® 50 C Mannitol, LYCATAB® DSH Maltodextrin and Maize Starch Extra White (Wet Granulation)

Hydrochlorothiazide tablets produced via wet granulation containing PEARLITOL® 50 C Mannitol as filler and LYCATAB® DSH Maltodextrin as binder solution

Formula:

  

% (By weight)

mg / tablet

PEARLITOL® 50 C mannitol

67.5

459.0

Maize Starch Extra White

17.5

119.0

Hydrochlorothiazide

10.0

68.0

LYCATAB® DSH maltodextrin

4.0

27.2

Magnesium stearate

1.0

6.8

Method:

  1. Mix all the ingredients except the binder and the lubricant in a planetary mixer for 5 minutes at low speed. 
  2. Disperse the binder in water and add the solution (23.5%, w/w) to the powders and mix for 10 minutes.
  3. Pass the wet blend through the 1000 µm sieve of an oscillatory granulator.
  4. Dry the granules for 20 minutes at 60 oC in a fluidized bed dryer.
  5. Sieve the granules through a 1000 µm sieve.
  6. Lubricate with magnesium stearate in a mixer for 5 minutes.
  7. Compress using a single-punch press fitted with flat 11.25 mm diameter punches.


Additional comments:

  • Target Tablet Properties
          - Tablet hardness: 120 N
          - Disintegration time: 490 s
  • 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.