Device requirements
Figure 4: Comparison of Pulmicort Respule (AstraZeneca, London) and budesonide NanoCluster (Savara Pharmaceuticals, Austin,
TX) performance by the LC Plus nebulizer (PARI, Midlothian, VA). The authors used an Andersen cascade impactor with a rate
of 30 L/min at 25 °C and 45% relative humidity.
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The particle size, shape, and performance characteristics of NanoCluster powders enable effective drug delivery through various
inhalation devices. Several studies and evaluations have demonstrated that NanoCluster formulations provide emitted doses
with high fine-particle fractions, even when delivered with simple, nonproprietary dry-powder devices such as the Monodose
(Plastiape, Osnago, Italy), Turbuhaler (AstraZeneca, London), Easyhaler (Orion Pharma, Espoo, Finland), and Accuhaler (GlaxoSmithKline,
London). When suspended in water and administered by nebulization, these formulations exhibit excellent delivery performance
(see Figure 4). Studies with NanoCluster formulations delivered through pMDIs are currently ongoing to confirm the formulations'
performance in this device class. The NanoCluster technology reduces the need for complex, expensive delivery devices to achieve
repeatable aerosol delivery appropriate for deep lung deposition.
Conclusions
Savara's NanoCluster technology enables high-performance powder formulations that offer the opportunity to improve the performance
of inhalation products significantly for local and systemic therapy. NanoCluster manufacturing processes are not complex and
use common equipment and accepted pharmaceutical processes. NanoCluster formulations help companies optimize the aerodynamic
properties of drug products, reduce the need for complex delivery devices, and improve safety and, potentially, efficacy.
The relative simplicity and adaptability of the NanoCluster technology provides a cost-effective formulation platform that
can shorten the development timelines of inhalation products.
Cory Berkland* is an associate professor of chemical and petroleum engineering and of pharmaceutical chemistry at the University of Kansas,
4141B Learned Hall, 1530 W. 15th St., Lawrence, KS 66045, tel. 785.864.1455, fax 785.864.4967, berkland@ku.edu
Stephen Lermer is a partner at AlphaVektor Consulting. George Laurence is founder, Pravin Soni is head of chemistry, manufacturing, and controls, and Michael Crowley is president of Theridian Technologies, all at Savara Pharmaceuticals.
*To whom all correspondence should be addressed.
Submitted: Sept. 24, 2009. Accepted: Feb. 1, 2010.
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