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.
The 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.
Amorphous materials
Crystalline materials
The challenge
Historically, amorphous drug compositions were found to degrade during storage due to chemical and physical instability. Orexo has developed a solution: AmorphOX.
The solution
AmorphOX is a powder-based technology providing the stability needed for amorphous materials. It is 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 unique strengths
AmorphOX is validated in multiple clinical trials
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 of allergic reactions, including anaphylaxis. Data has demonstrated qualities such as rapid absorption, excellent bioavailability and improved handling and storage properties.
Plasma concentration
Superior pharmacokinetic (PK) properties with more rapid onset, higher peak and overall exposure.
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AmorphOX’s unique properties ensure physical and chemical stability
When AmorphOX is tested with various APIs 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.
AmorphOX is a versatile platform
AmorphOX works with a broad spectrum of active chemical substances, including small molecules, peptides and biologics, and 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.
The unique strengths
AmorphOX is validated in multiple clinical trials
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 of allergic reactions, including anaphylaxis. Data has demonstrated qualities such as rapid absorption, excellent bioavailability and improved handling and storage properties.
Plasma concentration
Superior pharmacokinetic (PK) properties with more rapid onset, higher peak and overall exposure.
AmorphOX’s unique properties ensure physical and chemical stability
When AmorphOX is tested with various APIs 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.
AmorphOX is a versatile platform
AmorphOX works with a broad spectrum of active chemical substances, including small molecules, peptides and biologics, and 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.
Versatility of AmorphOX
Orexo has tested a wide range of APIs to be formulated with AmorphOX. The formulation of temperature-sensitive APIs such as apomorphine and cetrorelix have been successful in eliminating the cold chain requirements. Biomolecyles like a spike protein and a live attenuated virus have successfully retained activity after several months of storage at accelerated temperatures.
Chemical degradation after accelerated stability studies at 40°C/75% RH
Small molecules
Apomorphine
0.2% after 24 months
Eletriptan
0.5% after 12 months
Loxapine
0.3% after 24 months
Naloxone
≤0.1% after 24 months
Epinephrine
0.3% after 24 months
Zavegepant
<0.1% after 9 months
Peptides
Cetrorelix
0.6% after 12 months
Biologics
Enzyme
Retained activity after 1 month
Protein (spike protein)
Retained activity after 3 months
Vaccine (Attenuated virus)
Retained titer levels, resilient to freeze thaw cycles
