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A Novel Method for Preparing Uniform Micro-Sized Dry Powder Formulations, Including Aggregation-Controlled VHH.

Tatsuru Moritani1, Hidekazu Masaki2, Ryo Yonehara2

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Summary
This summary is machine-generated.

Fine droplet drying (FDD) can create stable variable domain of heavy-chain antibodies (VHHs) powders. While some VHHs lost function, others remained stable for years, showing potential for new drug delivery systems.

Keywords:
fine droplet drying processinhalable powderinkjet technologyintratracheal administrationmicroparticlenanobodysingle-domain antibody

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Antibody powderization is key for novel drug delivery and non-refrigerated storage.
  • Variable domain of heavy-chain antibodies (VHHs) offer superior thermal stability and refolding capabilities compared to conventional antibodies.

Purpose of the Study:

  • To evaluate the feasibility of using fine droplet drying (FDD) for VHH powder preparation.
  • To assess the physicochemical properties, including aggregation, binding activity, particle characteristics, and inhalation properties of VHH powders (VHHps).

Main Methods:

  • The fine droplet drying (FDD) process was employed for VHH powderization due to its mild conditions and uniform particle generation.
  • Evaluated VHHps for aggregation, binding activity, particle size, and in vitro inhalation properties.

Main Results:

  • VHH aggregation increased with higher FDD flow temperatures; however, binding activity remained comparable to native VHHs.
  • Approximately 30% of VHHs lost function post-FDD, but non-degraded VHHs showed sustained functionality for over two years at room temperature.
  • Generated VHHps were uniformly spherical, micron-sized particles with favorable inhalation properties.

Conclusions:

  • FDD is a viable technique for producing diverse VHH powder formulations.
  • The study demonstrates the potential of FDD-derived VHH powders for pharmaceutical applications, including drug delivery systems.