Lyophilization Cycle Design and Optimization

Online Inquiry

The lyophilization of liposome formulation could ensure the long-term stability of liposomes and provide a solid dosage form for administration. BOC Sciences could address the complexity of the lyophilization process to overcome the instability issue.

How we do?

Drying Steps

Temperature and freezing rates have critical influence on the liposome structure preserving. We will design the lyophilization cycle to stabilize bilayer structures.

Stabilization by Excipients

Protectants included in aqueous phase of liposomal dispersions could stabilize biological syetem during lyophilization. We will select appropriate lyoprotectant to achieve a matrix that could inhibit the conformational changes after frez-drying.

Figure 1. Mechanism of bilayer conformation during lyophilization and rehydration, with and without lyoprotectant (Chen, C. 2010)

Quality by Design

The application of Quality by Design (QbD) paradigm could be applied to obtain a well-design lyophilization process. We will investigate a control strategy to improve the quality of final products.

Figure 2. The principle of QbD in pharmaceutical formulation (Roehl, H. 2018)

Limitations of the lyophilized liposomes

The residual water, batch consistency, mechanical properties, morphology after reconstitution of freeze-dried structure will be evaluated.

References

Franzé, Silvia, et al. "Lyophilization of liposomal formulations: still necessary, still challenging." Pharmaceutics 10.3 (2018): 139.
Chen, Chengjun, et al. "An overview of liposome lyophilization and its future potential." Journal of controlled release 142.3 (2010): 299-311.
Roehl, Holger, Philippe Lam, and Dominique Ditter. "Fogging." Challenges in Protein Product Development. Springer, Cham, 2018. 305-309.