Formulation Guideline
Taste masked chewable tablet formulation of acetaminophen for direct compression
SweetPearl® P300 DC maltitol–sucralose formulation for masking the bitterness of acetaminophen.
Objective
Realize a formulation for chewable tablets of acetaminophen with a high capability to mask the bitterness of the API.Formula
|
Ingredient |
Functionality of the ingredient |
mg/tablet |
% by weight |
|
Acetaminophen powder |
Active Pharmaceutical Ingredient |
250 |
16.7 |
|
SweetPearl® P300 DC maltitol |
Direct compression filler-binder |
1231 |
82 |
|
Sucralose |
High intensity sweetener |
9 |
0.6 |
|
Magnesium stearate |
Lubricant |
10 |
0.7 |
Method
- In a mixer, mix the ingredients maltitol, acetaminophen and sucralose for 5 minutes.
- Add the magnesium stearate and mix for 5 minutes more.
- Compress the powder with a 16 mm flat punch.
Additional comments
|
Hardness |
100 N |
| Friability test | Passed |
|
Tablet thickness |
5.7 mm |
|
Tablet mass |
1500 mg |
Comment on Roquette product benefits
SweetPearl® P300 DC maltitol is a direct compression excipient with high chemical stability and low hygroscopicity that is suitable for chewable tablets. Having good flow and compressibility properties, SweetPearl® P300 DC allows simple, easy to produce and cost-effective formulation. It is a non-cariogenic and non-acidogenic sugar-free sweetener. Combined with sucralose, it offers a synergistic bitterness-masking effect for acetaminophen that could be extended to other pediatric formulations.
SweetPearl® P300 DC is EP/USP-NF compliant.
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.
These details are for information only, and we believe them to be reliable.