Amoxicillin chewable tablets intended for pediatric use: formulation development, stability evaluation and taste...

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Formulation Science

Background:

• Amoxicillin's unpleasant taste poses a challenge for patient compliance, particularly in pediatric populations.
• Effective taste masking is crucial for improving the palatability of oral medications.

Purpose of the Study:

• To develop and characterize a taste-masked formulation of amoxicillin (250 mg) using maize starch and milk chocolate.
• To evaluate the physicochemical properties, stability, and *in vitro* performance of the developed formulation.

Main Methods:

• Co-formulation of amoxicillin with maize starch and milk chocolate.
• Characterization using Dynamic Light Scattering (DLS), Differential Scanning Calorimetry (DSC), and Fourier-Transform Infrared (FT-FTIR) spectroscopy.
• Taste evaluation by volunteer groups, HPLC analysis for amoxicillin content, and assessment of tablet physicochemical properties, dissolution, and *in vitro* digestion.

Main Results:

• The co-formulation successfully masked the bitter taste of amoxicillin.
• The developed formulation exhibited satisfactory physicochemical characteristics, including hardness, disintegration time, and low mass loss.
• Validated HPLC method confirmed amoxicillin stability in the formulation for at least one year, with high recovery rates in dissolution and *in vitro* digestion tests.

Conclusions:

• Maize starch and milk chocolate are effective excipients for taste-masking amoxicillin.
• The developed taste-masked amoxicillin formulation is stable, possesses desirable quality attributes, and demonstrates good *in vitro* performance.
• This formulation offers a promising approach to improve amoxicillin palatability and enhance patient adherence.