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Biopharmaceutics: how drug formulations contribute to efficacy
The therapeutic efficacy of medicinal products is not determined by the properties of the drug
substance alone - a generally accepted paradigm. But the rate of onset of efficacy or the duration
of clinical effects is also determined by the biopharmaceutical properties of the pharmaceutical
form, e.g. the rate and extent of drug release from a dosage form and the resulting absorption
kinetics.
A greater challenge is the realistic and reliable characterization of the properties of a drug
formulation by use of in-vitro dissolution tests. This is an issue that our scientists have
been working on intensively for decades. However, new findings on the physiology of the gastro-
intestinal tract have significantly modified our current understanding. The consistent
consideration of these findings is essential to ensure that results from laboratory tests may be
used to predict the in-vivo performance of solid oral dosage forms. Otherwise such
investigations remain a material test without in-vivo relevance.
For those interested in compiling effective information on the treatment of patients by
biopharmaceutical in-vitro investigations, we are your reliable and competent partner.
Very often our input gives rise to new solutions and strategies. Reasons for a waiver
of in-vivo studies or, often even more important, the rationale for the systematic
optimization of an oral preparation are valuable consequences. Our know-how can help you to
benefit from all opportunities.
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