Excipient Services for Lyophilized Formulation

Lyophilized formulation is designed around their API and in most cases include many excipients, such as buffers, fillers, tension regulators and stabilizers. CD Formulation can screen out suitable excipient formulation for customers, so that freeze-dried products with long shelf life and stable biological activity level can be prepared.

Our Services

The main objective of lyophilized formulation is to make the formulation as simple and stable as possible while achieving acceptable chemical, physical and microbial stability. CD Formulation can balance the buffers, fillers, tension regulators and stabilizers in the excipients of freeze-dried formulation to ensure beneficial interaction with API at each stage of the freeze-drying process. So as to ensure the efficacy, safety and sterility of lyophilized pharmaceutical formulation and avoid the possibility of a large amount of pollution. The specific service contents are as follows:

• Screening of appropriate excipients for customers.
• Provide the formulation scheme of auxiliary materials according to customer needs.
• Physical and chemical performance test of products.
• Product testing data and professional data analysis.

Why are excipients important?

Because each auxiliary ingredient plays a certain role in the formulation, it can help the lyophilized preparation maintain better quality and stability, which is conducive to the research and development and industrialization of drugs. The following are the functions of several excipients in lyophilized formulation:

• Buffers

Choosing the right buffer is particularly important in freeze-drying formulations, as some buffers undergo drastic pH changes during freezing. No matter what buffer is selected, the concentration of buffer used in freeze-drying shall be reduced to the minimum amount required to control pH, so as to prevent instability due to concentration area during freeze-drying.

• Fillers

In the formulation with low API concentration, the filler helps to form a larger and stronger cake structure, which is used in the freeze-dried formulation to provide structure for the freeze-dried cake and prevent collapse.

• Tension Regulators

The selected tension regulator can be determined by the stability requirements of the bulk solution or the route of administration. They can be contained in the diluent rather than in the preparation itself. At the same time, they are the main contributors to rapid dissolution and absorption, which has proved to be the main selling point of freeze-dried products.

• Stabilizers

The applicability of specific stabilizers varies from formulation to formulation and helps stabilize liposomes and proteins throughout the freeze-drying process.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

References

1. Costantino, H. R. , et al. Effect of excipients on the stability and structure of lyophilized recombinant human growth hormone. J Pharm, 2010, 87(11).
2. Roughton, B. C. , et al. Use of glass transitions in carbohydrate excipient design for lyophilized protein formulations. Computers & Chemical Engineering, 2012, 36(none):208-216.