Abstract:
The present invention discloses a method to continuously manufacture micro- and/or nanoparticles of single component particles or multi-component particles such as particulate amorphous solid dispersions or particulate co-crystals. The continuous method comprises the steps of 1. preparing a first solution comprising at least one component and at least one solvent and a second solution comprising at least one anti-solvent of the at least one component comprised in the first solution, 2. mixing said first solution and said second solution by means of microfluidization to produce a suspension by precipitation or co-precipitation, 3. feeding said suspension to a filtration system to obtain a concentrate stream, 4. feeding said concentrate stream to a spray dryer, 5. atomizing said concentrate stream using at least one atomization nozzle, 6. drying said atomized concentrate stream to obtain particles, and 7. collecting said particles. Single component particles or multi-component particles, particulate amorphous solid dispersions, particulate co-crystals and pharmaceutical compositions are also disclosed.
Abstract:
The present invention discloses a method for producing amorphous solid dispersions in a nanoparticulate form, through solvent controlled co-precipitation, using microfluidization/microreaction technology to promote high energy mixing/interaction at a micro and/or molecular level between the streams involved in the process. Feed streams, solvent and anti-solvent, are fed to an intensifier pump at individually controlled rates and forced to interact to micro-and/or nano-scale within a microreactor. The present invention also discloses amorphous solid dispersions obtained by the method of the invention as well as pharmaceutical compositions containing the same.