Biopharma Technology Ltd

Pharmaceutical Formulation Development Service

A well-designed pharmaceutical formulation development services will protect the product from the stresses of freeze drying. It will also ensure a thermal profile that is favorable for freeze drying. BTL has decades of experience designing formulations for all types of products and an extensive knowledge of excipient. Freeze drying cycles should be efficient, reliable and safe for product and personnel. The development of a cycle should be undertaken rationally, using detailing information about the product’s thermal profile and the production equipment. After analyzing your product BTL can design a cycle that meets all these criteria in typically just 3 runs.

Freeze drying is a potentially damaging process, especially to labile materials such as proteins or living organisms. Depending on the drug formulation development process 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.