Published online by Cambridge University Press: 30 August 2011
Many manufacturing techniques to produce nano-materials via a “bottom-up” approach are currently being developed and evaluated. The PureNanoTM platform technology developed by Microfluidics International Corporation (MFIC) has proven to be both an effective and energy efficient method to produce nano-scale entities including emulsions in addition to suspensions. This nano-manufacturing platform utilizes crystallization, precipitation and chemical reaction methods that produce nano-particles with specified size distributions and a desired morphology. The solids formed can be either amorphous or crystalline, which may exist in numerous polymorphs. In many cases the ability to obtain a specific composition (single species or mixture) is possible via careful selection and implementation of key processing conditions. The methods are based on controlling the local degree of super-saturation (SS) and/or stoichiometry during their formation and subsequent configuration and growth, when appropriate. To accomplish this, operational strategies and innovative processing techniques are coupled with qualitative insight into the basic mechanisms involved with these processes. Validation of the technology at the bench scale for crystallization, emulsions/cargo loading, and multi-phase reactions (interfacial and homogeneous) provided the justification to develop commercial scale systems. Examples are given here for crystallization of drugs for the pharmaceutical industry, a catalyst formed by deposition of metallic crystals on a carbon substrate, production of fine chemicals via emulsion formation for multi-phase reactions, and a homogeneous substitution reaction forming an insoluble product. Nano-materials with median particle size as low as 50 nm were produced. With respect to the drug particles, they were highly crystalline, of a single polymorph and pure. In all cases, results indicate both process performance enhancement and product quality/functionality improvements compared to materials produced with conventional methods, with at least 1-2 order of magnitude increases in surface/interfacial area and reduced energy needs. Furthermore, the technology is suitable for current Good Manufacturing Practices (cGMP) manufacturing.