Multivitamin Suckable Tablet formulation for direct compression
Directly compressible formulation of multivitamin suckable tablets using NEOSORB® P 300 C sorbitol as filler-binder
Objective
Develop a prototype formulation for a suckable multivitamin tablet demonstrating the excellent tabletability of NEOSORB® P 300 C as a filler-binder for direct compression of tablets with high hardness.
Formula
|
Ingredient |
Functionality of the ingredient |
mg/tablet |
% by weight |
|
Vitamin A (retinol acetate) |
Active ingredient |
3.00 (5000 IU) |
0.600 |
|
Vitamin D2 (ergocalciferol) |
Active ingredient |
0.01 (400 IU) |
0.002 |
|
Vitamin E (DL.α.tocopherol acetate) |
Active ingredient |
1.34 (2 IU) |
0.268 |
|
Vitamin C (L(+) ascorbic acid) |
Active ingredient |
60.00 |
12.000 |
|
Vitamin PP (nicotinamide) |
Active ingredient |
10.00 |
2.000 |
|
Vitamin B2 (riboflavine) |
Active ingredient |
1.50 |
0.300 |
|
Vitamin B1 (thiamin mononitrate) |
Active ingredient |
1.20 |
0.240 |
|
Vitamin B6 (pyridoxine hydrochloride) |
Active ingredient |
1.20 |
0.240 |
|
Vitamin H (D(+) Biotin) |
Active ingredient |
0.04 |
0.008 |
|
Vitamin B12 (cyanocobalamin) |
Active ingredient |
0.03 |
0.006 |
|
Orange powder flavor |
Flavor |
5.00 |
1.000 |
|
NEOSORB® P 300 C sorbitol |
Direct compression filler-binder |
411.28 |
82.256 |
|
Silica |
Glidant |
1.50 |
0.300 |
|
Sodium saccharinate |
Sweetener |
0.40 |
0.080 |
|
Magnesium stearate |
Lubricant |
3.5 |
0.700 |
Method
1. Solubilize the vitamins A, B12, D2 and E in a sufficient amount of ethanol.
2. Spray the solution on the NEOSORB® P 300 C sorbitol using a fluidized air bed dryer.
3. Evaporate the solvent.
4. In a mixer, mix all the ingredients except the magnesium stearate for 20 minutes.
5. Add the magnesium stearate and mix for 5 minutes more.
6. Compress the powder with a 13 mm diameter round flat punch.
Additional comments
|
Tablet hardness |
103 N |
|
Tablet density |
1.394 g/cm3 |
|
Tablet thickness |
2.7 mm |
|
Tablet mass |
500 mg |
Comment on Roquette product benefits
NEOSORB® sorbitol provides key functional properties of a filler and filler/binder as well as a bulk sweetener. Our sorbitol range has excellent tableting properties, as well as being non-cariogenic, non-acidogenic and sugar-free. These properties make it suitable to be used in formulation of several oral dosage forms including suckable tablets or lozenges.
NEOSORB® is EP/USP-NF/JP compliant (varies by grade).
® Registered trademark(s) of Roquette Frères.
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.