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Dosing considerations for inhaled biologics.

Silvia Ferrati1, Tian Wu2, Sekhar R Kanapuram2

  • 1The University of Texas in Austin, Division of Molecular Pharmaceutics and Drug Delivery, Austin, TX, USA.

International Journal of Pharmaceutics
|July 28, 2018
PubMed
Summary

Biologic drugs delivered via inhalation are growing. This review covers biologic powder formulations and dry powder inhalers for effective drug loading and clinical dosing.

Keywords:
BiologicsDevicesDry powder inhalersFormulation drug loading

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Drug Delivery

Background:

  • The pipeline for biologic therapeutics, including inhaled formulations, is expanding.
  • Biologics are complex macromolecules with unique properties influencing their action, stability, and delivery.
  • Effective delivery of biologics requires careful consideration of formulation and device characteristics.

Purpose of the Study:

  • To systematically review critical factors in biologic powder formulations for dry powder inhalers (DPIs).
  • To guide the establishment of optimal drug loading and payload for desired clinical doses.
  • To address the unique challenges associated with delivering complex biologics via inhalation.

Main Methods:

  • Systematic literature review of biologic powder formulations.
  • Analysis of physicochemical characteristics of biologics relevant to inhalation.
  • Examination of dry powder inhaler design and performance parameters.

Main Results:

  • Key formulation aspects influencing biologic powder properties (e.g., particle size, morphology, stability) were identified.
  • The impact of formulation on drug loading efficiency and aerosol performance in DPIs was analyzed.
  • Critical parameters for achieving consistent and effective delivery of biologics were highlighted.

Conclusions:

  • Optimizing biologic powder formulations is essential for successful dry powder inhaler development.
  • Understanding the interplay between biologic characteristics, formulation, and inhaler device is crucial for therapeutic success.
  • This review provides a framework for developing inhaled biologic therapies to meet clinical dose requirements.