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Evaluation of Uniform-Sized Microcapsules Using a Vibration-Nozzle Method.

K Shimano1, O Kondo1, A Miwa1

  • 1Research Center, Taisho Pharmaceutical Co., Ltd., 1-403, Yoshino-cho, Ohmiya, 330, Japan.

Drug Development and Industrial Pharmacy
|January 5, 2023
PubMed
Summary
This summary is machine-generated.

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New microcapsules (MC) effectively mask the bitter taste of clarithromycin (CAM) in a water-free syrup. This formulation ensures taste masking and maintains therapeutic drug levels for 14 hours, demonstrating its clinical utility.

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Materials Science

Background:

  • Polyvinylacetal diethyl-aminoacetate (AEA) gel exhibits unique thermal gelation properties.
  • Clarithromycin (CAM) is an antibiotic with a notably unpleasant taste.
  • Effective taste-masking and controlled drug release are crucial for pediatric and sensitive patient populations.

Purpose of the Study:

  • To develop and evaluate microcapsules (MC) using AEA gel for taste-masking clarithromycin (CAM).
  • To assess the dissolution profile, taste masking efficacy, and bioavailability of CAM from AEA gel microcapsules in a syrup formulation.
  • To demonstrate the clinical utility of the developed CAM microcapsule syrup.

Main Methods:

  • Fabrication of uniform-sized microcapsules using a specialized vibration nozzle machine.

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  • Dissolution testing of CAM from microcapsules across a range of pH values (Japanese Pharmacopoeia 12th edition).
  • Organoleptic testing (bitter taste assessment) and pharmacokinetic studies (bioavailability in human subjects) of the syrup formulation.

    • Main Results:

    • Complete dissolution of CAM from microcapsules occurred within 5 minutes at pH below 4.0, with minimal dissolution at pH 6.8.
    • Syrup formulations completely masked the bitter taste of CAM for 60 minutes in human volunteers.
    • Pharmacokinetic analysis showed a mean AUC0-24 of 5.66 ± 0.73 µg·hr/ml and Cmax of 0.66 ± 0.13 µg/ml, with therapeutic levels maintained for approximately 14 hours.

    Conclusions:

    • AEA gel microcapsules provide effective taste masking for clarithromycin in a water-free syrup.
    • The microencapsulation technique ensures controlled release and maintains therapeutic drug concentrations.
    • The developed syrup formulation demonstrates significant potential for improving patient compliance and therapeutic outcomes.