Nanosuspensions of poorly soluble drugs--reproducibility of small scale production.
The major problem of many newly developed pharmaceutical drugs is their poor solubility in water and simultaneously in organic media. To solve these problems formulation as nanosuspensions is an attractive alternative. During the drug development process screening for an optimal formulation by homogenisation is essential. Time and cost effective production in an initial phase of R&D can be conducted on lab scale by using the Micron Lab 40 in its discontinuous version. In this report reproducibility of small scale production parameters (particle size, size distribution, content of microparticles) was exemplary studied for the drug RMKP22.
Grau
M J
MJ
Department of Pharmaceutics, Biopharmaceutics and Biotechnology, Free University of Berlin, Kelchstr. 31, D-12196, Berlin, Germany.
Kayser
O
O
Müller
R H
RH
D009025:Morpholines / Q000737:chemistry; D010316:Particle Size; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D011621:Pteridines / Q000737:chemistry; D015203:Reproducibility of Results; D012995:Solubility; D013053:Spectrophotometry / Q000379:methods; D013535:Suspensions / Q000737:chemistry*
D009025:Morpholines; D004364:Pharmaceutical Preparations; D011621:Pteridines; C407563:RMKP 22; D013535:Suspensions