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Peer-reviewedCC BYAAPS PharmSciTech

Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles

  • Kinnari Santosh Arte1
  • Rachana Sapkota1
  • Chanakya Patil1
  • Yijing Huang1
  • Eric J Munson1
  • Sajal Patel2
  • Nicole Payton2
  • Rushit Lodaya3
  • Qi (Tony) Zhou1
  • Li (Lily) Qu1
  1. 1Department of Industrial and Molecular Pharmaceutics, College of Pharmacy, Purdue University, West Lafayette, IN 47907, USA
  2. 2Dosage Form Design & Development, Biopharmaceutical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD 20878, USA
  3. 3mRNA Platform, Discovery Technologies; GSK – 200 Cambridge Park Drive, Cambridge MA 02420
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Abstract

Spray-freeze drying (SFD) is a promising drying technique for stabilizing RNA lipid nanoparticles (RNA-LNPs) by converting them into solid-state formulations. This study examined the impact of the SFD process and the widely utilized stabilizing disaccharides, such as sucrose and trehalose, on the major properties (e.g. particle size, encapsulation efficiency) of RNA-LNPs post drying. Various process parameters, such as atomization, freezing, and drying temperature, were systematically evaluated, along with the impact of incorporating annealing post freezing step. Surface area measurements, solid-state particle size analysis, scanning electron microscopy, powder X-ray diffraction and solid-state NMR spectroscopy were employed to gain deeper insights into powder characteristics and matrix mobility. Our findings demonstrated that sucrose provided superior stabilization as compared to trehalose in our tested formulations and processes. Moreover, incorporation of the annealing process enhanced LNP stability. Results from the stability study revealed that the annealed 10% and 20% sucrose formulations maintained their stability, highlighting the potential of optimized SFD processing for producing solid formulations of RNA-LNPs.

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Cite

BibTeXRIS
BibTeX
@article{arte2026spray,
  title = {{Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles}},
  author = {Kinnari Santosh Arte and Rachana Sapkota and Chanakya Patil and Yijing Huang and Eric J Munson and Sajal Patel and Nicole Payton and Rushit Lodaya and Qi (Tony) Zhou and Li (Lily) Qu},
  journal = {AAPS PharmSciTech},
  year = {2026},
  month = sep,
  doi = {10.1208/s12249-026-03516-1},
  url = {https://doi.org/10.1208/s12249-026-03516-1},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Spray Freeze Drying for Solid Formulations of RNA Lipid Nanoparticles
AU  - Kinnari Santosh Arte
AU  - Rachana Sapkota
AU  - Chanakya Patil
AU  - Yijing Huang
AU  - Eric J Munson
AU  - Sajal Patel
AU  - Nicole Payton
AU  - Rushit Lodaya
AU  - Qi (Tony) Zhou
AU  - Li (Lily) Qu
PY  - 2026
DA  - 2026/09/09
JO  - AAPS PharmSciTech
DO  - 10.1208/s12249-026-03516-1
UR  - https://doi.org/10.1208/s12249-026-03516-1
AB  - Spray-freeze drying (SFD) is a promising drying technique for stabilizing RNA lipid nanoparticles (RNA-LNPs) by converting them into solid-state formulations. This study examined the impact of the SFD process and the widely utilized stabilizing disaccharides, such as sucrose and trehalose, on the major properties (e.g. particle size, encapsulation efficiency) of RNA-LNPs post drying. Various process parameters, such as atomization, freezing, and drying temperature, were systematically evaluated, along with the impact of incorporating annealing post freezing step. Surface area measurements, solid-state particle size analysis, scanning electron microscopy, powder X-ray diffraction and solid-state NMR spectroscopy were employed to gain deeper insights into powder characteristics and matrix mobility. Our findings demonstrated that sucrose provided superior stabilization as compared to trehalose in our tested formulations and processes. Moreover, incorporation of the annealing process enhanced LNP stability. Results from the stability study revealed that the annealed 10% and 20% sucrose formulations maintained their stability, highlighting the potential of optimized SFD processing for producing solid formulations of RNA-LNPs.
SN  - 1530-9932
ER  -