First purchase of high yield, ambient micronization system
LaminarPace, Inhalation Sciences’ spray drying micronization system, has successfully micronized over 160 compounds, and has just been purchased by one of Europe’s leading respiratory medication developers. Product Development Manager for Formulation Dr Fernando Acevedo explains why it is so valued by environmental and pharmaceutical researchers.
“For toxicologists working with small particles between 2-4 microns this is powerful technology,” says Dr Acevedo: ”Spray drying reproduces toxicants in their real state in nature. We run a lot of tests for environmental agency research on noxious environments, separating particles to see exactly how they behave in the lungs and how they are noxious in the environment. I’ve carried out inhalation screening work and toxicological studies around swine-house dust infections. 20% of pigs get ill in the lungs, and a large number of pork framers get lung symptoms. I’ve carried out particle and screening work too in the fish processing industry, where high numbers of workers report respiratory symptoms. Although our public profile has been about generating powders for inhalation drug development, a significant percentage of our work has always been toxicological, environmental research.”
Room temperature keeps powders active
LaminarPace has been specially tailored to turn extremely small amounts of candidate substance into micron sized powders; the system typically requires just 10 – 500 mg of test substance per batch. Uniquely, the system operates at room temperature, meaning even delicate substances remain active after being micronized – without having to be tested for activity: A significant advantage to toxicology researchers:
“Unlike any other spray dry system and all other freeze drying systems, LaminarPace operates at room temperature so that even sensitive substances like peptides, protein, and enzymes remain active after being micronized,” says Dr Acevedo. “The system removes >98% of solvent vapors before collecting the particles. It is excellent for drying unstable solutions. You can dry antibodies and enzymes and keep them active, whereas freeze drying may kill them. Spray drying is extremely useful for protein chemistry. Protein and peptide research are important, fast-moving areas right now. LaminarPace keeps these compounds active in a way other systems can’t.”
High yields, low waste, easy-to-collect filter
Another differentiating feature of LaminarPace is its filter collection, making it a high-yield system with little waste. Combined with the fact that the system is slow drying, using a countercurrent separated by a membrane, the yield of micronized powder from each batch is very high – typically >90%.
“The system consists of two columns,” says Dr Acevedo. “Uniquely to LaminarPace, in the drying column an inner and outer tube is separated by a membrane. The driving air flow pushes the cloud down the inner tube. The membrane keeps it in the inner tube. The micronization is slow and gentle, in the drying air solvent disappears through the membrane to the circulating countercurrent outside the membrane. The second column is filled with carbon and silica, the carbon takes away organics, the silicon water. The filter at the bottom of the first tube is where the micronized powder comes out, the filter and gentle flow makes the powder loose, fine and very easy to collect. The quality of the micronized powder achieved is exceptional. For drug developers this means faster and more cost effective pre-clinical results.”
|KEY BENEFITS: LaminarPace
LaminarPace has been highly valued for toxicological and environmental Contract Research. It has been used to successfully micronize over 160 compounds. For companies wishing to generate high volumes of powder, purchasing the system is a cost-effective alternative. The system is relatively simple to assemble and install, and onsite training is part of the rollout.
The whole LaminarPace system has recently been purchased by one of Europe’s leading respiratory medication developers. Final refinements are being completed to the prototype before installation and rollout in June 2014.
“The client initially gave us five test substances totaling 60 mg to carry out a series of complex experiments. The first test I trialed of one of the substances was with 20 mg, a third of the total substance – and it did not perform as expected. It was spoilt. I carried out the remaining experiments using just the remaining 40 mg of test substance – for complex experiments using 12 animals. The results were excellent. The client was really impressed. They just looked at the system and said ‘we want that.’ We explained it was just a prototype, but they wanted it directly. The results, the control, the benefits – they just all spoke for themselves.”
Dr Fernando Acevedo co-wrote the 2010 paper The LaminarPace Spray Dryer: Producing Small Portions of Fine Powders at Ambient Temperatures in High Yields, with system designer and inventor Dr Per Gerde and has worked with the system through its patent.