SocraTec R&D Biopharmaceutics - Drug substance - driving force of a medicinal product

Drug substance - driving force of a medicinal product

The properties of the active drug ingredient are most relevant for efficacy and therapeutic benefit of a medicinal product. In this context not only is its pharmacodynamic activity of importance, but also the pharmacokinetic properties, in particular the absorption from the gastro-intestinal tract, the distribution throughout the organism and finally the elimination.

Basis for the development of innovative drugs or the improvement of existing products is the detailed knowledge of these pharmacokinetic and pharmacodynamic characteristics of the compounds. This is paramount for attuning the product quality accordingly:

	Are the physico-chemical properties of the drug substance, e.g. its poor solubility, of that type that bioavailability problems may have to be expected?
	Does absorption of the compound occur rapidly and almost quantitatively from all parts of the gastro-intestinal tract?
	Does the drug substance exhibit favourable pharmacokinetic properties to achieve suitable plasma profiles, e.g. with consistent levels over a 24-hour period?

These are essential questions, which must be answered systematically in rationale drug development. In general an "experienced reflection" on the compound's chemical structure does not seem sufficient in this context. In most cases a definitive assessment will only be possible based on experimental findings from specifically designed investigations.

Our scientists have been active in this field for decades and have gathered invaluable experience. We look forward to sharing this experience with your experts in the development of innovative concepts for new medicinal products.