|
Critical Pharmaceuticals has developed two proprietary platform technologies for advanced drug delivery - CriticalMix™ and CriticalSorb™.
CriticalMix™ Injectable Sustained Release Technology
CriticalMix™ uses supercritical CO2 to encapsulate drugs into biodegradable, biocompatible polymers for sustained release applications. In a single step, and in the absence of solvents, injectable microparticles are produced able to control the release of the drug over periods of days to weeks. Other product morphologies such as implants and fibrous packing materials can be manufactured by changing the process variables to control the release of the drug over days to weeks. To see an animation of our process click here.
The advantages of the CriticalMix™ process are:
 The drug is not chemically modified. The drug activity, stability, safety and distribution in the body are unchanged.
The CriticalMix™ process operates at ambient temperatures, allowing temperature sensitive molecules such as proteins and peptides to be encapsulated without any degradation.
A wide range of regulatory approved polymers may be used.
A one-step process where 100% of the drug is encapsulated.
The CriticalMix™ process is entirely solvent free .
No solvent residue concerns
Savings on financial and environmental costs associated with solvent disposal.
The therapeutic plasma levels can be maintained for days to weeks following a single injection.
The CriticalMix™ process is protected by a family of patents.
CriticalSorb™ Absorption Promoter Technology
CriticalSorb™ is a novel delivery system that it is highly effective in promoting the absorption of challenging molecules including proteins and peptides across biological membranes such as the nasal mucosa. CriticalSorb™ has a low systemic toxicity and is well tolerated on the nasal mucosa. CriticalSorbTM has the potential to provide a viable alternative to injection for a wide variety of drugs.
Key properties of CriticalSorb™ are:
A pharmaceutically acceptable excipient (GRAS) used in marketed products for intravenous and oral administration
A Drug Master File is available.
Preclinical tox studies have shown CriticalSorb™ to be non-toxic, with no irritation to the skin or eyes or nasal mucosa.
Available as liquid or powder formulations.
Promotes absorption of peptides and proteins such as insulin (~6kDa) and human growth hormone (22kDa) across the nasal mucosa in preclinical studies with exceptionally high bioavailabilities.
Generally applicable to all drugs e.g. small molecules, proteins, peptides, DNA.
|
