Formulation Studies

Our pharmaceutical Development services include formulation development for a wide range of molecules, including controlled substances, small chemical, and large protein molecules. Our analytical and development services include pre-formulation and formulation studies, lyophilization, drug product dissolution, and Stability studies, to determine the shelf life of the medicinal product.

We are committed to providing our customers with the highest quality services and support. Be sure to visit our Analytical Development page for more information on the services we offer.

At Synergy Bioscience, we can support your product development activities by offering the following studies:

Stress-degradation

Protein is subjected to stress conditions (e.g. oxidation, extreme pH, elevated temperature, freeze-thaw cycling, agitation) in order to identify product sensitivity to various stress conditions and to confirm that the selected assays are stability-indicating.

Preformulation

A variety of excipients and parameters are examined under accelerated conditions to identify those providing the greatest product stability

Formulation Selection

Several candidate formulations are examined under real-time and accelerated conditions, typically over a period of three months, to provide an optimized final formulation together with preliminary stability data

In-use Stability

Product stability is assessed in configurations to be used in a toxicology dose-ranging study or in the clinic

Material Compatibility

Product compatibility is assessed with materials used in candidate container closure systems or with materials used during manufacturing.