Aphios
Awarded United States Patent for Polymer Drug Delivery Nanotechnology
Platform
Woburn,
MA —
June
23, 2010
— Aphios Corporation today announced that it
was awarded United States Patent No. 7,708,915 B2 for “Polymer
Microspheres/Nanospheres and Encapsulating Therapeutic Proteins
Therein,” granted May 04, 2010. This invention is
an improved process to formulate polymeric microspheres
and nanospheres, and encapsulate therapeutic proteins or
other useful substances, and a polymer microspheres/nanospheres
apparatus. This invention also entails methods of purifying
protein-containing polymeric microspheres/nanospheres from
unused polymer and an apparatus therefore.
Conventional large-scale production of polymeric microspheres
utilizing numerous processing steps and large quantities
of organic solvents is very time consuming, costly and inefficient.
In addition, the exposure of therapeutic agents to organic
solvent adversely effects protein integrity and bioactivity.
The uniformity and integrity as well as processing time
and the cost associated with preparation of biodegradable
polymer microspheres containing therapeutic products are
greatly reduced by using supercritical fluids, critical
or near-critical fluids with or without polar cosolvents
[SuperFluids™].
In our process, a biodegradable polymer such as PLGA is
dissolved in SuperFluids™ and mixed with the target
therapeutic in solution or as a slurry of nanoparticles
at operating pressures. The mixture is then decompressed
through a nozzle into an aqueous solution, liquid nitrogen
or an empty vessel (spray dryer). Polymer nanospheres are
formed encapsulating the protein therapeutics. Alternatively,
the polymer-enriched SuperFluids™ stream can be decompressed
into an aqueous solution containing the target therapeutic
agent. In addition to reduction or elimination of organic
solvent usage, use of SuperFluids™ for making nanospheres
imparts advantages of no residual toxic organic solvent
and pathogen safety.
SuperFluids™ polymer nanospheres (PNS) process can
be utilized to encapsulate therapeutic proteins and other
molecules without utilizing organic solvents as is traditionally
done. By changing nozzle design and process parameters,
the process can also be utilized to manufacture polymer
microspheres. SuperFluids™ PNS is a single-step process
that is readily scalable. SuperFluids™ PNS can be
utilized for improving the oral bioavailability of peptides
and proteins, depot delivery of peptides and proteins for
sustained, controlled release and the subcutaneous and/or
oral delivery of sensitive vaccine antigens.
Aphios® Corporation ,
Woburn, MA is a “green” biotechnology company
developing enabling technology platforms for improved drug
discovery and manufacturing, nanotechnology drug delivery
and pathogenic drug safety. Using these enabling technology
platforms, Aphios and its collaborators are developing enhanced
therapeutics for health maintenance, disease prevention
and the treatment of certain cancers, infectious diseases
and Central Nervous System (CNS) disorders.
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