Stockholm, Sweden – November 04, 2010. XSpray Microparticles today announced that the US Patent and Trademark Office has granted a patent relating to the company’s particle production technology. XSpray’s RightSize™ technology provides complete control over particle production, enhancing drug formulation options and optimizing the performance of challenging drug substances, such as poorly soluble compounds, inhaled compounds, and biomolecules.
The technology uses supercritical fluid (SCF) as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The new patent approval covers both design and method patents relating to XSpray’s unique nozzle head, where precipitation of the drug substance takes place.
The breakthrough design enables reproducible production of small particles of specific sizes, required for the development of inhalable drugs. It also enables nanoparticles to be produced with a consistent particle size below 200 nm. The technology is compatible with a wide range of excipients. These can, for example, be added to increase stability and/or wettability in amounts from >50% down to trace amounts.
The dimensions of the actual fluid mixing and spray forming regions are kept constant at all scales. This means the technology can be effectively scaled up to drug manufacturing volumes. Consistent high-quality particles are produced, with full control over particle size, size distribution and polymorph, irrespective of production scale.
XSpray’s CEO, Per Andersson, commented, “RightSize™ production offers significant advantages over traditional micronization technology. It provides an easy-to-operate, single-step process that gives the user full control over particle properties. As well as being used for developing new chemical entities, it is also ideally suited to drug reformulation and life cycle management.”
“As a fully scalable SCF-based technology, RightSize™ production represents a significant breakthrough in drug particle manufacturing. Today, we already offer GMP production of clinical trial materials to support our growing customer base. As such, the patent is an important step that further strengthens the company’s intellectual property rights in the US,” added Dr. Andersson.
For more information, contact:
Per Andersson, CEO, XSpray Microparticles AB
Tel: +46 (0)8 730 37 00
XSpray Microparticles AB is a Swedish life science technology company with in-depth knowledge of supercritical fluid technology, solid state properties, formulation science and the drug development process. The Company’s cutting-edge platform technology – RightSize™ manufacturing – uses supercritical fluid as an antisolvent for controlled precipitation of an active pharmaceutical ingredient/drug substance. The technology not only provides a superior process to traditional methods but also delivers better quality pharmaceutical particles, from discovery to production.
The process yields consistent powder particles in terms of size, shape and morphology that simplify formulation and can be incorporated into a variety of dosage forms, such as tablets, capsules and inhalation systems. RightSize™ technology addresses unmet therapeutic needs by enabling the development of drugs with enhanced delivery options, such as faster onset of action, and by adding innovative properties that truly benefit patients.
A key advantage of RightSize™ technology is that it can be effectively scaled up to production volumes, making it an important breakthrough in the manufacture of pharmaceutical particles.
XSpray Microparticles has its headquarters and development laboratories in Stockholm, Sweden, and offers GMP production at a state-of-the-art manufacturing facility in Malmö, Sweden.