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Spray Dried Rugose Lipid Particle Platform for Respiratory Drug Delivery

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Abstract

Purpose

To develop a new lipid-based particle formulation platform for respiratory drug delivery applications. To find processing conditions for high surface rugosity and manufacturability. To assess the applicability of the new formulation method to different lipids.

Methods

A new spray drying method with a simplified aqueous suspension feedstock preparation process was developed for the manufacture of rugose lipid particles of 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC). A study covering a wide range of feedstock temperatures and outlet temperatures was conducted to optimize the processing conditions. Aerosol performance was characterized in vitro and in silico to assess the feasibility of their use in respiratory drug delivery applications. The applicability of the new spray drying method to longer-chain phospholipids with adjusted spray drying temperatures was also evaluated.

Results

Highly rugose DSPC lipid particles were produced via spray drying with good manufacturability. A feedstock temperature close to, and an outlet temperature lower than, the main phase transition were identified as critical in producing particles with highly rugose surface features. High emitted dose and total lung dose showed promising aerosol performance of the produced particles for use as a drug loading platform for respiratory drug delivery. Two types of longer-chain lipid particles with higher main phase transition temperatures, 1,2-diarachidoyl-sn-glycero-3-phosphocholine (DAPC) and 1,2-dibehenoyl-sn-glycero-3-phosphocholine (22:0 PC), yielded similar rugose morphologies when spray dried at correspondingly higher processing temperatures.

Conclusions

Rugose lipid particles produced via spray drying from an aqueous suspension feedstock are promising as a formulation platform for respiratory drug delivery applications. The new technique can potentially produce rugose particles using various other lipids.

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Acknowledgments and Disclosures

The authors acknowledge the language editing provided by Luba Slabyj. PC, KL, NC, DLB are employees of AstraZeneca and may own stock or stock options. The authors declare no conflict of interest.

Funding

This work was supported by the Natural Sciences and Engineering Research Council of Canada through its Collaborative Research & Development program (Grant CRDPJ 543336–19).

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Authors and Affiliations

  1. Department of Mechanical Engineering, University of Alberta, Alberta, Canada

    Hui Wang, Mani Ordoubadi, Scott Tavernini, Andrew R. Martin, Warren H. Finlay & Reinhard Vehring

  2. Inhalation Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, South San Francisco, CA, USA

    Patrick Connaughton, Kellisa Lachacz, Nicholas Carrigy & David Lechuga-Ballesteros

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  1. Hui Wang
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Wang, H., Ordoubadi, M., Connaughton, P. et al. Spray Dried Rugose Lipid Particle Platform for Respiratory Drug Delivery. Pharm Res 39, 805–823 (2022). https://doi.org/10.1007/s11095-022-03242-w

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