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Nanosuspensionen - Formulierungen für schwerlösliche Arzneistoffe mit geringer Bioverfügbarkeit

1. Mitteilung: Herstellung und Eigenschaften

Rainer H. Müller, Bernhard H. L. Böhm und Mathias J. Grau

Freie Universität Berlin, Institut für Pharmazeutische Technologie, Berlin

Nanosuspensions - Formulations for Poorly Soluble Drugs with Poor Bioavailability / Ist Communication: Production and properties

The poor solubility of drugs is generally accompanied by a poor bioavailability and represents a major problem in drug formulation, especially in case the drugs are poorly soluble in aqueous and simultaneously in organic media. Nanosuspensions are an alternative novel formulation for such poorly soluble and bioavailable drugs. The first communication of this publication series deals with the production of nanosuspensions and their special properties -increased Saturation solubility cs and increased dissolution velocity dc/dt. Nanosuspensions are produced by high-pressure homogenisation of aqueous drug suspensions, the resulting particle size can be controlled by varying the production Parameters. The theoretical background of the increased solubility is discussed with regard to an increased dissolution pressure according to the Kelvin equation, creation of new high-energetic interfaces based on the Ostwald-Freundlich equation and a reduction in the diffusional distance according to the Prandtl equation. This section covers also the Sterilisation of nanosuspensions. The second communication will deal with physical stability, bioavailability aspects, creation of various nanosuspension-based drug formulations and also regulatory and registration aspects.

Key words Bioverfügbarkeit · Nanosuspensionen, Eigenschaften, Herstellung · Schwerlösliche Arzneistoffe