Pari has conducted laboratory testing to evaluate the performance of various particle reduction methods for the formulation of inhalation medicine.
The Microfluidizer M-110EH high shear fluid processor was compared with a conventional homogeniser.
In the first set of tests, both sets of equipment created a suspension formulation of budesonide, a glucocorticoid steroid for treating asthma, non-infectious rhinitis (including hay fever and other allergies) and for treating and preventing nasal polyposis.
The drug also has efficacy for bowel and colon disease, but has a high first pass metabolism, making it suitable for systemic inhalation delivery.
In the test of the budesonide suspension formulation, the Pari laboratory found no difference in the average size of the particles between the Microfluidizer processor and the conventional homogeniser.
However, the Microfluidizer processor produced a polydispersity index of 0.8 compared with 1.0 for the homogeniser after one cycle.
The next test was to produce emulsions used to deliver budesonide.
With one cycle of processing, the Microfluidizer processor produced a smaller z-average particle size (250nm) compared with 475nm for the conventional homogeniser.
The conventional homogeniser also required five cycles to come close to the results achieved by the Microfluidizer processor in a single cycle.
The Microfluidizer processor also produced a narrower particle size distribution with a polydispersity index of only 1.3 after one cycle, compared with 4.0 for the conventional homogeniser.
