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The experience and knowledge-based pharmaceutical dissolution development platform within Biogenes focuses primarily on supporting formulation development and problem solving.

For us, dissolution testing is never a routine test, but an essential tool in pharmaceutical formulation development to:

- evaluate the physico-chemical properties of drug candidates to select the most appropriate solid form for further development (pre-formulation)

- perform biorelevant in-vitro tests to mimic fed and fasted state conditions

- compare prototype formulations (preclinical selection)

- elucidate drug release mechanism (diffusion, erosion, etc.)

- as an indicator of stability (e.g., temperature, humidity)

- as an indicator of the robustness of the manufacturing and

- assure safe release and reproducibility of the products to the market.

Dissolution testing should be a discriminatory method that is sensitive to variables affecting release rate and ideally has a predictive value for bio-performance.

It takes a lot of skills, knowledge and experience to design dissolution methods that contribute to the development of safe, robust and successful pharmaceutical dosage forms.