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Nanos from the bottom up
BETHLEHEM, Pa.—Particle Sciences Inc.—a self-described boutique contract research organization—has formed a strategic alliance with Microfluidics to share formulation and nanotechnology expertise for drug development, analysis and commercialization.
Particle Sciences was founded in 1991 with a specialization in formulation and delivery, analytic services and clinical trial material production. With more than 35 scientists holding more than 100 patents, a comprehensive formulations laboratory, cGMP production suites and cGMP analytical/bioanalytical capabilities, Particle Sciences claims a solid track record of developing commercializable technologies for companies ranging from start-ups to large pharma.
"Clients come to us with tough formulation problems," says Dr. Robert W. Lee, vice president of pharmaceutical development at Particle Sciences. "We like to tinker, come up with new process twists. Our model is to offer our clients a number of state-of-the-art approaches using best-of-breed, reproducible and scalable technologies. For high-shear fluid processing, we chose the Microfluidizer after a thorough evaluation of the competing alternatives. One area of interest to us is adding the Microfluidizer processor to our existing approaches for particle size reduction to the submicron range of poorly water-soluble APIs, which is an increasingly important formulation approach for pharmaceutical API development."
As part of the non-exclusive agreement, Particle Sciences has installed an M-110EH-30 Basic BioPharma Microfluidizer processor to produce nanoemulsions and nanosuspensions, and for cell disruption and nanoencapsulation in pilot and production volumes.
"We believe Microfluidizer processors are the undisputed gold standard in the pharmaceutical industry, from the lab to clinical research and production," says Bill Kober, vice president of Americas sales at Microfluidics. "Through this relationship, our users now have access to our technology combined with the scientific ingenuity and experience of Particle Sciences."
Microfluidics, a wholly owned subsidiary of Microfluidics International Corp., has been a worldwide supplier of Microfluidizer high shear fluid processing systems to the biotechnology, pharmaceutical, chemical and cosmetics industries since 1984.
Microfluidics Reaction Technology (MRT) is a continuous and scalable microreactor system used for efficient, large-scale production of nanoparticles with high purity at low cost. MRT is particularly well-suited to pharmaceutical applications where the trend is to go to very small particles that have precise polymorph control. Microfluidics has demonstrated MRT by creating nanosuspensions of a variety of injectable or inhalable drugs, including cancer therapies, antibiotics, antihistamines and nonsteroidal anti-inflammatories.
MRT solves an issue that conventional mixers/reactors have been unable to overcome. Conventional processes utilize a "top-down" method to grind particle sizes to the nano-level through a process of wet-milling, homogenization, micronization and other techniques. This top-down process does not allow for optimal and consistent sizing of the particles and is often unable to produce particles sizes small enough to be effective. MRT utilizes a "bottom-up" proprietary approach whereby the particle is built up molecule by molecule in seconds, allowing not only for optimal and consistent sizing of the particles, but also for the creation of smaller particle sizes not previously achievable. The process is both continuous and results in extreme phase purity of products.
MRT was presented during a poster presentation at the Nano Science and Technology Institute (NSTI) Nanotech 2007 Conference and won a Nano50 Award as one of the most innovative ideas in nanotechnology. The core of this technology is a continuous microreactor (reaction chamber) based on impinging jet design. Two opposing jets form as fluids flow through two microchannels within the chamber. The jets collide inside a microliter volume where the fluids mix at the nanometer scale. Average fluid velocities inside the channels may exceed 400 m/s, which is orders of magnitude higher than existing impinging jet reactors. A planar array of opposed pairs of such channels ensures effective scaling up of the technology.