High-tech mixer for pharma applications
patented High-Pressure Multiple Stream Mixer Reactor (MMR), claimed
to create uniform particles smaller than anything achieved using
current technologies.
Many pharmaceuticals are produced in powder form, and it is well-established that uniformity in particle size is a key component in ensuring that a product behaves in a predictable and reproducible way, both in production and in the patient.
"The MMR produces uniform nanoparticles with phase purity previously unachievable by conventional batch reaction technology," said MMR, which maintains that this degree of reaction chemistry control "can lead to cost-effective product improvements and the development and manufacture of new nanomaterials in scalable quantities."
The MMR is available for order in a lab-scale version that is currently being tested in new product development by a biopharmaceutical customer, as well as in an in-house program to develop nanosuspensions of polymer-encased active materials as drug delivery systems.
Irv Gruverman, Microfluidics' chief executive, said that most reaction chemistry is done in batch reactors, "which is a very high capital and high operating cost way to go."
In contrast, he added, MMR can do it on a continuous basis and make the structures far smaller, purer and more uniform than a batch reactor.
The MMR can mix two or more solution streams of fast-reacting molecules, with control over the process afforded by the high pressure and geometry of the reaction chamber.
Using the system, reactants are fed in streams into the chamber under pressures up to 40,000 psi. The individual reactant streams are fed into tiny channels, initially no wider than a human hair, which get progressively narrower.
This narrowing provides three mixing stages - referred to as macro-, meso- and micromixing - that result in the formation of ultrasmall particles. And by altering the conditions in the reactor, the size of the particles can be closely controlled.
"This process produces exceptionally high product yields with minimal unwanted by-products, and with uniform nanoparticle size," said Microfluidics.
The development-level system has a capacity of 10 gallons per hour, with scale-up to 200 gallons per hour and higher achievable with the firm's production-scale systems.
The lab-scale version costs in the region of $200-$250,000 (€160-€200,000), while the production systems due for introduction in late 2004 or early 2005, will be priced in the $750,000-$1,000,000-plus range.
