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Drug Delivery Technologies Q&A

  •   Do you see a discernable increase in demand for formulation development services, particularly in active preclinical formulations where it is often more difficult due to higher dosage levels?

    Answered January 19th, 2010 by Expert: David M. Oakley, R.Ph., Ph.D.

    Yes. Inquiries to our organization which involve preclinical programs where dosing levels have reached and, perhaps, exceeded limits for reasonable administration have increased. A reasonable explanation may be the increased percentage of new drugs with challenging biopharmaceutical properties. In a recent scientific forum, it was estimated that only 10% of new drugs meet the criteria for high solubility, with the majority of new drugs displaying low solubility, low permeability, or both. In addition, strained budgets and accelerated project timing pressures seem to encourage more risky development strategies. This situation can reach a crisis point where a formulation solution is sought as a quick fix. Unfortunately, it is common that critical biopharmaceutical data (e.g., permeability, solubility, Log P/D) are not available to serve as a guide for the formulation effort. The early acquisition of data that identifies bioavailability limitations (e.g., solubility, permeability) can be critical to the development of optimized formulations with potential benefits for lower API demand and cost, increased bioavailability, and more rapid drug product development.

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