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GMP-compliant manufacture of nanoparticles

Process Skid For GMP-Compliant Manufacture of Nanoparticles

| Author / Editor: Ann-Kathrin Hoffmann* / Anke Geipel-Kern

The commercial plant with a microjet reactor enables for the first time the mobile, continuous and large-scale GMP production of nanoparticles of active pharmaceutical ingredients.
The commercial plant with a microjet reactor enables for the first time the mobile, continuous and large-scale GMP production of nanoparticles of active pharmaceutical ingredients. (Source: © Stephan Gawlik, Mannheim/Germany, Stephan Gawlik Fotodesign)

A microjet reactor transforms pharmaceuticals into nanoparticles that are easily absorbed by the body. Now the patentee has scaled the process from the laboratory process to a GMP plant. The pharmaceutical company got support from a competent plant manufacturer.

For some time now nanoparticles have been used in pharmaceutical medicine, and the benefits of doing so speak for themselves: Taken in this form, medicines are absorbed much more rapidly by the body and therefore reach full effect faster and at a lower dose. Using conventional techniques, nanoparticles for pharmaceutical use can only be produced slowly and laboriously through a process of iterative grinding.

Fast and Continuous Production of Nanoparticles

However, a technology already established in inorganic chemistry now permits the faster, continuous production of nanoparticles using simple physical precipitation in a Micro Jet Reactor (MJR). Under laboratory conditions this process had been used successfully for the production of nanoparticles of active medical ingredients, but to produce them commercially a full-scale technological facility was needed.

The patent for physical precipitation in MJRs is held by the pharmaceutical company Leon-Nanodrugs. Use of this key technology now permits the simple, faster, and therefore more economical manufacture of nanoparticles. However, the laboratory equipment used to develop the technology was not designed for commercial production, and only has a maximum capacity of two to three liters. The idea was to build a commercial-scale facility with a capacity of 100 liters per batch, and for this purpose Leon-Nanodrugs needed a partner with expertise in plant construction.

Additional Information
 
How the Nanoparticles are Created

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