Taste masked chewable tablet formulation of acetaminophen for direct compression
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
(total weight: 1500mg)

% 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

  1. In a mixer, mix the ingredients maltitol, acetaminophen and sucralose for 5 minutes.
  2. Add the magnesium stearate and mix for 5 minutes more.
  3. 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.
 

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