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Biopharmaceutical characterization - BCS and more
Is bioavailability primarily a drug substance-related parameter, or is it determined more by the
drug formulation characteristics? This question cannot be answered in a generally valid manner,
but has to be considered case by case. In this context the biopharmaceutical properties of the
active ingredient as well as the dosage form are of equal importance.
Ultimately decisive is the process which is most relevant for the rate and extent of absorption
of the active ingredient from the gastro-intestinal tract into the general circulation:
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Are the physico-chemical properties of the compound, its solubility in physiologic
relevant media or the permeability through biologic membranes more crucial?
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Or is drug release from the solid oral dosage form in the gastro-intestinal tract
the rate-determining process?
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A rationale, state-of-the-art development of improved pharmaceutical preparations calls for a
systematic elucidation of these processes. For this purpose certain in-vitro investigations
should be performed in order to study
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the solubility in media, which represent the physiologic conditions in the
gastro-intestinal tract
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the compound's permeability through biological membranes, e.g. tested in CaCo-2 cell systems
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the drug release in "bio-relevant" dissolution media.
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We look forward to supporting your
justification of bio-waivers by reviewing existing experimental
results and, where necessary, designing additional investigations or convincing Expert Statements.
This can be equally useful for the development of therapy-optimized medicinal products containing
known active ingredients when the clinical package has to be composed for regulatory purposes.
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