AmorphOX® is a world-class powder technology for innovative drug delivery
With the introduction of Orexo’s latest drug delivery technology, AmorphOX, we are meeting the challenges of delivering large and small molecules previously thought to be impossible to formulate for alternative routes of administration.
Identified need
Amorphous materials are more and more common in drug development and can be of great importance for the properties of the drug product. These materials are non-crystalline and possess no long-range order, providing them with unique and highly attractive properties, such as very rapid dissolution in aqueous solutions. Historically however, amorphous drug compositions were found to degrade during storage due to chemical and physical instability. Orexo has a developed a solution to this problem: AmorphOX.
The solution
Orexo’s proprietary drug delivery platform, AmorphOX, is a powder-based technology made up of particles that are built using the 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 resulting in excellent chemical and physical stability in both low and high temperatures, meanwhile the rapidly dissolving property is maintained. The platform is protected by patents and patent applications until 2039-2044.
Clinically validated
AmorphOX has successfully been validated in multiple clinical studies during the development of nasal rescue medications for opioid overdoses, one including naloxone (OX124) and one with nalmefene (OX125). In addition, it has also been clinically proven with epinephrine (OX640), a product for acute treatment for allergic reactions (anaphylaxis). Data has demonstrated qualities such as rapid absorption, excellent bioavailability and improved handling and storage properties.
Wide applicability
AmorphOX works with a broad spectrum of active chemicals, including:
1. Small molecules
As proven for OX124 and OX640 enabling superior stability combined with a rapid onset. In addition, AmorphOX has the ability to improve both variability and bioavailability compared to traditional liquid based products.
2. Peptides
Enabling alternative routes of administration and/or improved stability, produced by a cost-efficient manufacturing and an already establish commercial supply chain.
3. Biologics
- Enzymes
Providing new opportunities utilizing cost-efficient manufacturing and excellent stability under ambient conditions.
- Proteins
Successful feasibility study of a sensitive 17 kDa protein by formulation into a stable powder with retained activity. AmorphOX has shown its potential to open the opportunity for life cycle management, elimination of cold chain distribution and improved patient convenience thanks to improved storage conditions and offering alternative ways of administration.
The properties of the powder can be tailored to meet specific needs such as particle size, dissolution properties, and mucosal retention. This makes it a versatile technology with broad applicability in pharmaceutical development across multiple therapeutic areas.
- Vaccines
Ongoing external collaborations have generated strong data using AmorphOX as a vaccine delivery platform. Various vaccine types (protein, enveloped virus, VLP) have been successfully formulated into a stable powder with retained activity, even under accelerated conditions (40oC / 75% RH).
The properties of the powder can be tailored to meet specific needs such as particle size, dissolution properties, and mucosal retention. This makes it a versatile technology with broad applicability in pharmaceutical development across multiple therapeutic areas.
