A well designed formulation will enable efficient 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 lyophilization 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 Our 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.
- Our team of scientists has extensive knowledge in the different qualities of different excipients and the best way to combine them for optimum effect.
- We are capable of developing a formulation from scratch for a specific product (API), as well as assessing and modifying existing formulation for optimization.
- Biopharma Technology has worked on over 1000 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.
- Separate dedicated facility for cytotoxic products read more
You may also be interested to read:
>>Reformulation: The Future of Formulation Development by Dr. Roberto Castangia as published as a guest article in IPT57 – July 2016
(This article is taken from Innovations in Pharmaceutical Technology July 2016, pages 6-11. © Samedan Ltd)