subject: Pharmaceutical Development As A Means For Ensuring Financial Success [print this page] Developing a new pharmaceutical active ingredient isn't just about developing a molecule with the best biological activity. The physical form has to be optimised to ensure the top possible performance and that no one can find a superior form and usurp your hard won patent position.
Pharmaceutical development is the progression of a new chemical entity found in early screening through to the later stages of clinical development. Pharmaceutical development includes the construction of a scaleable manufacturing process as well as refinement of the optimum physical form of the Active Pharmaceutical Ingredient (API).
Pharmaceutical development starts with an active compound that displays the desired response in an assay. However, in vivo (in the organism), the compound might not get to the point of action as it so easily did in vitro (lit. in glass). Pharmaceutical development is needed to turn the compound into a form that is stable, is biologically available and can be made into the most favourable formulation. A balance is needed between the water solubility and lipophilicity (ability to dissolve in fats) characteristics of the drug. Skilled scientists will be able to turn a compound with poor physical properties into one that can be crystallised and processed effectively. A Salt screen will lead to candidate compounds that can subsequently be selected and further optimised. A balance will need to be made between optimal drug performance and manufacturability.
It is essential to integrate manufacturing expertise with solid-state expertise using a diverse range of state-of-the-art equipment and facilities operating to current Good Manufacturing standards. Scale up and production of kilo quantities of the drug under GMP conditions completes the early pharmaceutical development phase. If properly conducted, the optimal physical form will be taken forward coupled with the means to manufacture. Ultimately your intellectual property will be secured and long term financial success guaranteed.
