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Purpose <p>The aqueous instability of liposomes presents a major hurdle in their successful translation into stable drug products. This study aimed to develop a robust, time- and energy-efficient lyophilization process to stabilize pazopanib-loaded liposomes while maintaining their critical quality attributes and improving manufacturing efficiency.</p> Methods <p>A systematic approach was employed to optimize key lyophilization parameters including cryoprotectant selection, freezing rate, and drying conditions. Various cryoprotectants- mannitol, trehalose, sucrose, hydroxypropyl-β-cyclodextrin (HPβCD), and polyvinylpyrrolidone K12 were screened individually and in combinations. Process parameters such as normal freezing, annealing, and faster primary drying were evaluated. The optimized lyophilized liposomes were then subjected to real-time (2–8&#xa0;°C) and accelerated (25&#xa0;°C/60% RH) stability studies.</p> Results <p>The combination of trehalose and HPβCD with a fast primary drying process yielded lyophilized liposomes with preserved particle size, zeta potential, entrapment efficiency, and drug content over the stability period. Notably, the optimized process achieved a ~ 3-fold reduction in total lyophilization time compared to conventional methods, without compromising product stability or quality.</p> Conclusion <p>The study demonstrates that a strategic selection of cryoprotectants and process optimization can significantly improve lyophilization efficiency. This approach offers a promising route for the scalable and cost-effective manufacturing of stable liposomal drug products suitable for commercial translation.</p>

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Exploring Novel Approaches to Develop an Efficient Lyophilization Process for the Stabilization of Drug-Loaded Colloidal Liposomes

  • 期刊论文

  • 发表日期：

    2025年10月30日

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  • Siddhant Padhi,
  • Kanan Panchal,
  • Yadu Pillai,
  • Akash Chaurasiya

摘要

Purpose

The aqueous instability of liposomes presents a major hurdle in their successful translation into stable drug products. This study aimed to develop a robust, time- and energy-efficient lyophilization process to stabilize pazopanib-loaded liposomes while maintaining their critical quality attributes and improving manufacturing efficiency.

Methods

A systematic approach was employed to optimize key lyophilization parameters including cryoprotectant selection, freezing rate, and drying conditions. Various cryoprotectants- mannitol, trehalose, sucrose, hydroxypropyl-β-cyclodextrin (HPβCD), and polyvinylpyrrolidone K12 were screened individually and in combinations. Process parameters such as normal freezing, annealing, and faster primary drying were evaluated. The optimized lyophilized liposomes were then subjected to real-time (2–8 °C) and accelerated (25 °C/60% RH) stability studies.

Results

The combination of trehalose and HPβCD with a fast primary drying process yielded lyophilized liposomes with preserved particle size, zeta potential, entrapment efficiency, and drug content over the stability period. Notably, the optimized process achieved a ~ 3-fold reduction in total lyophilization time compared to conventional methods, without compromising product stability or quality.

Conclusion

The study demonstrates that a strategic selection of cryoprotectants and process optimization can significantly improve lyophilization efficiency. This approach offers a promising route for the scalable and cost-effective manufacturing of stable liposomal drug products suitable for commercial translation.