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:
- Introduce in the planetary mixer the PEARLITOL® 160 C mannitol.
- Slowly add the binder solution (LYCATAB® DSH maltodextrin).
- Total time of mixing: 20 minutes.
- Introduce this wet mix in the granulator, equipped with a wire mesh of 1250 µm.
- Dry the granules in a fluidized air bed dryer at 60-70 oC for 30 minutes.
- Introduce in the mixer the granules of mannitol and all the other ingredients except the lubricant.
- Mix for 10 minutes.
- Add the magnesium stearate and mix again for 5 minutes.
- 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.