The number of drugs coming from synthesis and being poorly soluble is steadily increasing. At present about 40% of the drugs in the development pipelines and approximately 60% of the drugs coming directly from synthesis are poorly soluble. For many new chemical entities of very low solubility oral bioavailability enhancement by micronisation is not sufficient, the next step taken was nanonisation. The production of drug nanocrystals by bottom up techniques (precipitation) is briefly described, main focus is given on particle diminution by high pressure homogenisation. Homogenisation can be performed in water (DissoCubes) or alternatively in non-aqueous media or water-reduced media (Nanopure). There is also a combination process of precipitation followed by a second high energy step, e.g. homogenisation (NANOEDGE). The result is a suspension of drug nanocrystals in a liquid, the so-called nanosuspension. As an important point the transfer of the liquid nanosuspensions to patient convenient oral dosage form such as tablets is described.
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