XSpray Microparticles AB |
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Project: Right Size Particle Manufacture Technology |
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The Challenge
Many promising drug candidates fail in the drug development process due to formulation issues. In addition, formulation challenges limit the use of some existing drug molecules. New technology is needed to improve and enhance drug formulation and reformulation and to increase efficiency throughout the drug development process.
XSpray's Solution
XSpray’s patented RightSize™ technology is able to formulate challenging drug substances including poorly water-soluble compounds, inhaled compounds and biopharmaceuticals, providing full control over particle properties in the nanometer to micrometer size range.
XSprays Right Size technology showed ~ 50 % better solubility of itraconazole, a poorly soluble drug, compared with formulations obtained with more conventional techniques, such as hot melt extrusion and spray drying.
The RightSize process employs supercritical fluid technology. The supercritical fluid is used as an antisolvent for controlled precipitation of an active pharmaceutical ingredient (API) with or without the addition of excipients. The process is scalable from mg quantities at lab scale to drug manufacturing volumes.
Competitive Advantages
XSpray’s RightSize technology is able to formulate challenging drug substances, offering significantly improved bioavailability and/or other critical pharmaceutical properties that translate into clear medical benefit.
When compared with more traditional technologies, dissolution improvement has been shown for a variety of compounds.
The Market
Over the next five years it is estimated that more than USD 267bn of branded pharmaceutical sales are at risk from generic competition1. The pharmaceutical industry is experiencing difficulties in developing new pharmaceuticals at the same rate as the expiration rate of patents on many important pharmaceuticals, increasing the demand on effective life cycle management of successful products and access to external projects, resulting in more licensing deals and acquisitions.
Status
First commercial agreement was signed in 2008
- Fully functional service laboratory is in place
- GMP production facility supporting Phase I and II clinical trials is validated and ready for production
- A candidate for a proprietary drug has been identified and development work is ongoing
Dissolution testing of itraconazole when compared with more traditional technologies, dissolution improvement has been shown for a variety of compounds.
Planned Milestones
- Initiate 1-2 additional strategic partner or customer projects
- Initiate development of own drug project to clinical Proof of Concept
Patent Status
XSpray has a strong patent portfolio across major territories in key areas, including production technology for nanoparticles, scale up of nanoparticle production, and a production method for adaptation of particle size distribution to a desired range.
Commercialization
XSpray entered into commercial agreements with customers in 2008. The company is seeking to build its revenue stream through new customer development projects, the sale of cGMP-produced particles, and technology licensing. Proprietary drug products based on the RightSize technology are being developed, and will be offered to pharmaceutical companies engaged in life cycle management, or to generic pharmaceutical companies.
- Source: PharmExec. Managing product lifecycle, 2011
| Contact: Per Andersson, CEO | +46 8 730 37 00| per.andersson@xspray.com | www.xspray.com |