Lyophilization Cycle Design and Optimization

Online Inquiry Or by Phone:

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.

Mechanism of bilayer conformation during lyophilization and rehydration, with and without lyoprotectant 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.

The principle of QbD in pharmaceutical formulationFigure 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

  1. Franzé, Silvia, et al. "Lyophilization of liposomal formulations: still necessary, still challenging." Pharmaceutics 10.3 (2018): 139.
  2. Chen, Chengjun, et al. "An overview of liposome lyophilization and its future potential." Journal of controlled release 142.3 (2010): 299-311.
  3. Roehl, Holger, Philippe Lam, and Dominique Ditter. "Fogging." Challenges in Protein Product Development. Springer, Cham, 2018. 305-309.
※ Only for research. Not suitable for any diagnostic or therapeutic use.

Online Inquiry

Verification code