Taste-Masked Flucloxacillin Powder Part 2: Formulation Optimisation Using the Mixture Design Approach and Storage...

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Drug Delivery

Background:

• Flucloxacillin's bitter taste limits pediatric adherence.
• Taste-masking is crucial for improving oral medication acceptance in children.

Purpose of the Study:

• To optimize flucloxacillin microparticle formulation for taste-masking.
• To achieve controlled drug release for pediatric use.
• To ensure microparticle stability during storage.

Main Methods:

• D-optimal mixture experimental design was employed.
• Formulation involved flucloxacillin, Eudragit EPO, and palmitic acid.
• Dissolution studies evaluated drug release profiles.
• Storage stability was assessed under various conditions.

Main Results:

• An optimal component ratio was identified, close to equimolar.
• Ionic interactions formed a polyelectrolyte complex, enhancing taste-masking.
• Minimal drug release occurred in the oral cavity (2 min).
• Over 90% drug load was retained after 12 months under preferred storage conditions.

Conclusions:

• The developed microparticles effectively mask flucloxacillin's bitter taste.
• The formulation ensures targeted drug release in the lower gastrointestinal tract.
• Optimized storage conditions maintain microparticle stability and drug integrity.