Vitamin C Chewable Tablets using PEARLITOL® 160 C Mannitol (Wet Granulation)
Formulation Guideline

Vitamin C Chewable Tablets using PEARLITOL® 160 C Mannitol (Wet Granulation)

Chewable Vitamin C tablets produced via wet granulation containing PEARLITOL® 160 C Mannitol as filler and LYCATAB® DSH Maltodextrin as binder solution

Formula:

 

% (By weight)

mg / tablet

PEARLITOL® 160 C mannitol

60.90

456.70

Sodium ascorbate (granulated)

21.35

160.00

Ascorbic acid (coated)

12.00

90.00

LYCATAB® DSH maltodextrin (in aqueous solution 10%, w/w)

3.14

23.50

Magnesium stearate

2.00

15.00

Orange powder flavor

0.30

2.25

AEROSIL® R 972 silica*

0.30

2.25

Sodium saccharinate

0.04

0.30

Method:

  1. Introduce in the planetary mixer the PEARLITOL® 160 C mannitol.
  2. Slowly add the binder solution (LYCATAB® DSH maltodextrin).
  3. Total time of mixing: 20 minutes.
  4. Introduce this wet mix in the granulator, equipped with a wire mesh of 1250 µm.
  5. Dry the granules in a fluidized air bed dryer at 60-70 oC for 30 minutes.
  6. Introduce in the mixer the granules of mannitol and all the other ingredients except the lubricant.
  7. Mix for 10 minutes.
  8. Add the magnesium stearate and mix again for 5 minutes.
  9. Compress the powder on a single stroke press equipped with round punches of 13 mm diameter.

Additional comments:

  • Target Tablet Properties

    • Weight:                            750 mg
    • Thickness:                       4.38 mm +/- 0.02
    • Tablet density:                1.293 g/cm3
    • Tablet hardness:             70 N
    • Dosage:                            250 mg of vitamin C / 750 mg tablet
  • 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.

*AEROSIL® is registered trademark of Evonik Industries or its subsidiaries.