amorphOX® - a novel and inventive drug delivery platform 

Orexo has successfully developed a drug delivery platform, amorphOX®, which is a novel and inventive powder-based technology, that is very rapidly dissolving and stable. As amorphOX® works with different APIs, dosage forms and administration routes it is a versatile platform with significant potential.

Amorphous solids are non-crystalline solids, and possess no long-range order, giving them unique and highly sought-after properties, such as very rapid dissolution in water. These properties enable formulation of drugs in a manner that allows for a faster onset and a higher bioavailability. Historically however, amorphous drug compositions were found to be both chemically and physically unstable and therefore to degrade during storage. Orexo has a solution to this problem with the development of a drug delivery platform. The platform, named amorphOX®, is a powder-based technology that is both chemically and physically stable when stored in even elevated temperatures, while still being rapidly dissolving.

A versatile drug delivery platform

The powder-based technology is made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other excipients such as a permeability enhancer. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability. The surface structure can be tuned for optimal process ability, and the size of the particle can be tailored to suite different administration routes.

Orexo is in the process of developing an aspect of the amorphOX® platform to formulate and administer naloxone (OX124) and nalmefene (OX125) to reverse opioid overdoses. The number of deaths from opioid overdoses have grown in recent years, particularly in the US, creating a need for new and improved rescue medications, particularly for overdoses caused by synthetic opioids such as fentanyl.

Validated in humans

Den pulverbaserade teknologin består av partiklar som byggs upp med hjälp av en unik kombination av ett läkemedel, bärarmaterial och, när så är lämpligt, andra hjälpsubstanser som en permeabilitetsförbättrare. Partiklarna presenteras som en amorf sammansättning av de olika ingredienserna som ger utmärkt kemisk och fysikalisk stabilitet. Ytstrukturen kan justeras för optimal processförmåga och storleken på partikeln kan skräddarsys för att passa olika administrationsvägar.

Orexo håller på att utveckla en aspekt av amorphOX®-plattformen för att formulera och administrera naloxon (OX124) och nalmefen (OX125) för att motverka opioidöverdoser. Antalet dödsfall till följd av opioidöverdoser har ökat de senaste åren, särskilt i USA, vilket skapat ett behov av nya och förbättrade akutläkemedel, särskilt för överdoser orsakade av syntetiska opioider som fentanyl.

Wide applicability

The amorphOX® platform has also shown good results in accelerated stability studies when used with numerous other APIs with very different chemical structures. The technology also supports various dosage forms and administration routes and the properties of the powder can be tailored to meet specific needs such as particle size, dissolution, and mucosal retention. This makes it a versatile technology with broad applicability in pharmaceutical development across multiple therapeutic areas.