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Mitigating Shear Stress in Spray Drying for RNA-Loaded Lipid Nanoparticles through Process and Formulation
Susana Farinha1,2,3, Rute Mota1,2,4,5, Carolina Lopes1
1R&D Inhalation and Advanced Drug Delivery, Hovione Farmaciência S.A, Estrada Do Lumiar, Campus Do Lumiar, Edifício R, Lisbon, 1649-038, Portugal.
AAPS Pharmscitech
|May 28, 2025
Summary
Spray drying enhances the stability of lipid nanoparticles (LNPs) for nucleic acid therapies. Optimizing spray drying with Poloxamer 188 protects RNA-loaded LNPs, overcoming cold chain limitations.
Area of Science:
- Biotechnology
- Materials Science
- Pharmaceutical Sciences
Background:
- Lipid nanoparticles (LNPs) are crucial for nucleic acid therapies, including mRNA vaccines.
- Current LNP therapies face stability challenges, necessitating cold chain storage.
- Improving LNP stability is vital for broader therapeutic accessibility.
Purpose of the Study:
- To optimize spray drying (SD) for enhanced stability of ribonucleic acid (RNA)-loaded LNPs.
- To investigate formulation and process parameters for maintaining LNP integrity post-drying.
- To evaluate the protective role of Poloxamer 188 (P188) during spray drying.
Main Methods:
- Microfluidics used for high-efficiency encapsulation (>95%) of RNA into LNPs.
- Systematic optimization of spray drying (SD) process and formulation.
- Benchmarking SD against freeze drying (FD) for LNP stability.
- Analysis of colloidal stability and RNA encapsulation efficiency post-drying.
Main Results:
- Optimized SD process successfully maintained LNP colloidal stability and RNA encapsulation.
- Poloxamer 188 (P188) demonstrated significant protective effects against shear stress during SD.
- Spray drying proved effective in enhancing LNP stability compared to traditional methods.
- Microfluidic production yielded highly efficient RNA encapsulation in LNPs.
Conclusions:
- Spray drying is a viable technology for stabilizing RNA-loaded LNPs.
- Formulation and process optimization, particularly with P188, are key to successful SD of LNPs.
- Enhanced LNP stability through drying technologies can reduce reliance on cold chains.
- This study highlights potential for improved delivery and accessibility of nucleic acid therapies.
