The VRx2 Delivery Platform
Vaccine formulations typically require cold-chain storage and transport to ensure their continued stability. However, a cold-chain
requirement is difficult to impractical in applications involving large populations situated in geographic regions or nations
that lack an established healthcare infrastructure, in clinical settings where refrigeration of vaccine doses may not always
be accessible or reliable, and in crisis situations. Lyophilized or spray-dried vaccine powders are used to reduce the need
for cold-chain management because they can ultimately be reconstituted to their original formulations by the addition of a
diluent at point of use.
Development of a lyophilized or spray-dried intranasal vaccine powder that could be easily reconstituted in situ with a liquid diluent in a sterile environment in a delivery device could represent an ideal solution. Such a capability
would also eliminate the current use of sterile vials for mixing and the associated risk for vaccine contamination during
The VRx2 intranasal delivery platform under development by Mystic Pharmaceuticals has the potential to reduce the risks and
costs currently encountered with vaccine or drugs that require reconstitution. Reconstitution just before intranasal administration
eliminates the need for cold-chain storage and distribution. VRx2 delivery systems provide an auto-reconstitution capability
in each delivery device. Each VRx2 blister contains the sterile freeze-dried vaccine and the sterile diluent solution in separate
reservoirs. On activation at the point of use, the vaccine powder is mixed with the diluent to accomplish in situ reconstitution in the delivery system, followed by intranasal delivery. Intranasal delivery enables self-administration and
reduces the dependency on a trained healthcare provider.
Dry powder vaccine technology, the VersiDoser, and VRx2 delivery platforms provide convenient and easy dispensing approaches
to needle-free administration of a wide range of vaccine products. The delivery devices based on these technologies are modular,
compact, disposable after use, and can be used for self-administration. The production methods are very amenable to scale-up
and to rapid production and distribution in the event of a significant disease outbreak.
The VRx2 reconstitution technology platform further eases the storage space and cold-chain requirements for maintaining vaccine
stockpiles by federal and local governments and their respective agencies. It is suggested that these technologies may prove
useful to applications in the development of global vaccine products, to assist a transition to noninvasive needle-free inoculations
in pandemic planning and response, and potentially to reduce present cold-chain management requirements.
TIMOTHY SULLIVAN is the president and CEO, IRACH TARAPOREWALA, PhD, is the vice president of regulatory affairs and clinical research, and WALTER ZIELINSKI, PhD is senior scientist, program development, all at Mystic Pharmaceuticals, Inc., Austin, TX, 512.918.2900, firstname.lastname@example.org
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