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Bioavailability improvement by atomic layer coating: Fenofibrate a case study.

Balaji Ganapathy1, Vijayendra Redasani2, Sujit Debnath1

  • 1Applied Materials India Pvt. Ltd., IIT-Bombay, Powai, Maharashtra, India.

Journal of Pharmaceutical Sciences
|November 3, 2024
PubMed
Summary
This summary is machine-generated.

Atomic layer coating (ALC) significantly enhances the bioavailability of fenofibrate, a poorly soluble drug. Silicon oxide-coated fenofibrate showed a two-fold increase in bioavailability in animal models without toxicity.

Keywords:
Atomic layer depositionDispersibilityDissolution studiesSilicon oxide coatingWettabilityZinc oxide coating

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Biopharmaceutical Classification Systems (BCS) class II drugs exhibit poor solubility and high permeability.
  • Fenofibrate (FF), a BCS class II drug, is used to manage high cholesterol and triglyceride levels.
  • Atomic layer coating (ALC) is a surface engineering technique for modifying active pharmaceutical ingredient (API) particles.

Purpose of the Study:

  • To investigate the efficacy of ALC in enhancing the bioavailability of fenofibrate.
  • To compare the physical and performance characteristics of uncoated, zinc oxide-coated, and silicon oxide-coated fenofibrate.
  • To assess the in vivo safety and efficacy of ALC-modified fenofibrate.

Main Methods:

  • Fenofibrate particles were coated using ALC with silicon oxide and zinc oxide.
  • Physical properties (flow, wetting) and chemical/solid-state stability (1H NMR, powder X-ray diffraction) were analyzed.
  • In vivo studies in rodents and dogs evaluated bioavailability (AUC, Cmax).
  • Oral subacute toxicity studies were conducted on silicon oxide-coated fenofibrate.

Main Results:

  • ALC coatings (silicon oxide, zinc oxide) did not compromise the structural integrity of fenofibrate.
  • Silicon oxide coating improved wetting (contact angle near 0°) and hydrophilicity.
  • Zinc oxide coating improved flow characteristics and particle de-agglomeration.
  • ALC enhanced dissolution rates without altering equilibrium solubility.
  • In vivo studies showed a ~2-fold increase in AUC and ~3-fold increase in Cmax for silicon oxide-coated fenofibrate.
  • No toxicity was observed for ALC silicon-coated fenofibrate.

Conclusions:

  • ALC is a promising technology for improving the bioavailability of poorly water-soluble BCS class II drugs like fenofibrate.
  • Silicon oxide coating enhances fenofibrate bioavailability through improved wetting and hydrophilicity.
  • Zinc oxide coating offers benefits in particle processing and dispersion.
  • ALC-modified fenofibrate demonstrates a favorable safety profile.