Freeze Drying Formulation Development Services
Freeze drying is a potentially damaging process, especially to labile materials such as proteins or living organisms. Depending on the product type damage can occur at various stages of the process including freezing, drying and heating.
A well designed formulation is the key to successful freeze drying.
An Ideal Formulation
Formulating a product for freeze drying is a precise process.
Freeze drying is a potentially damaging process, especially to labile materials such as proteins or living organisms. Depending on the product type damage can occur at various stages of the process including freezing, drying and heating. Excipients must be selected and combined so as to protect the active ingredient from these stresses without damaging it in any other way, and without lowering the critical temperatures of the formulation overall to make freeze drying unviable. Every component used will have an impact on the final acceptability of the product.
The success of a formulation is measured on many criteria, including final moisture content, stability, activity and rehydration characteristics.
The Benefits of BTL’s Approach
- Product characterization is the starting point of formulation development, providing a detailed map of the product’s thermal characteristics before any reformulation has taken place.
- BTL has extensive knowledge in the different qualities of different excipients and the best way to combine them for optimum effect.
- BTL is capable of developing a formulation from scratch for a specific product (API or else), as well as assessing and modifying existing formulation for optimization.
- BTL has worked on hundreds of different products from small drug molecules to large complex biomolecules, foods, tissues and cells, and has experience of the individual processing challenges of all these types