Taste-Masked Diclofenac Sodium Microparticles Prepared by Polyelectrolyte Complexation: Formulation Using Different...

Area of Science:

• Pharmaceutical Sciences
• Drug Delivery Systems
• Materials Science

Background:

• Paediatric patients often lack age-appropriate oral medications, leading to off-label adult drug use.
• Current formulations can compromise dosing accuracy and expose children to unpleasant bitterness.
• This study builds on prior work to improve paediatric drug formulations.

Purpose of the Study:

• To investigate the impact of fatty acid chain length on diclofenac sodium (DS)-Eudragit® EPO (EE) polyelectrolyte complex (PEC) properties.
• To assess the formation, stability, dissolution, and sensory acceptability of DS-EE-FA PECs.
• To identify optimal fatty acids for paediatric-friendly diclofenac formulations.

Main Methods:

• Polyelectrolyte complex (PEC) microparticles were prepared using solvent evaporation.
• Drug content and stability were assessed over 3 months using a validated RP-HPLC assay.
• In vitro dissolution studies were conducted at pH 5.5, and sensory acceptability was evaluated by adult volunteers.

Main Results:

• All PECs maintained over 90% drug content after 3 months.
• PECs significantly suppressed early drug release compared to neat DS, achieving >87% release within 60 minutes.
• Palmitic acid-based PECs (DS-EE-PA) demonstrated the highest taste acceptability (92% willingness to take again).

Conclusions:

• Fatty acid chain length influences PEC formation and taste acceptability, but not stability or dissolution.
• Palmitic acid (PA) is a promising candidate for developing palatable paediatric diclofenac formulations.
• The developed PECs offer a potential solution for improving paediatric drug adherence.