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

Formula:

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.