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Kisich K.O.,National Jewish Medical and Research Center | Higgins M.P.,National Jewish Medical and Research Center | Park I.,National Jewish Medical and Research Center | Cape S.P.,Cooperative Institute for Research in Environmental science CIRES | And 7 more authors.
Vaccine | Year: 2011

A stable and high potency dry powder measles vaccine with a particle size distribution suitable for inhalation was manufactured by CO2-Assisted Nebulization with a Bubble Dryer® (CAN-BD) process from bulk liquid Edmonston-Zagreb live attenuated measles virus vaccine supplied by the Serum Institute of India. A novel dry powder inhaler, the PuffHaler® was adapted for use in evaluating the utility of cotton rats to study the vaccine deposition, vaccine virus replication, and immune response following inhalation of the dry powder measles vaccine. Vaccine deposition in the lungs of cotton rats and subsequent viral replication was detected by measles-specific RT-PCR, and viral replication was confined to the lungs. Inhalation delivery resulted in an immune response comparable to that following injection. The cotton rat model is useful for evaluating new measles vaccine formulations and delivery devices. © 2010 Elsevier Ltd.


Manion J.R.,University of Colorado at Boulder | Cape S.P.,University of Colorado at Boulder | McAdams D.H.,University of Colorado at Boulder | Rebits L.G.,Aktiv-Dry | And 3 more authors.
Aerosol Science and Technology | Year: 2012

The development of unit-dose, inhalable, antibiotic microparticles for use in primary and combined therapy approaches to treating tuberculosis (TB), multi-drug-resistant (MDR-TB), and extensively drug-resistant TB is explored using the gentle drying process of Carbon-dioxide Assisted Nebulization with a Bubble Dryer (CAN-BD). The microparticles produced using this method contain capreomycin, kanamycin, and isoniazid, respectively, imbedded in L-leucine. Antibiotics were developed into inhalable antibiotic formulations for their utility in both first line and second line antibiotic treatment regimens. Capreomycin and kanamycin are typically administered by injection making them desirable candidates for the development of a needle-free delivery system that addresses the Grand Challenges in Global Health Initiative #3. In response to this challenge, unit-dose packaging that preserves powder properties by protecting them from moisture, oxidants, and UV exposure, and a low cost active dry powder inhaler, the PuffHaler, were developed and used as a prototype device, in addition to the Aerolizer, to disperse the microparticle antibiotic formulations. Antibiotic formulations show yields above 50% in small-scale powder production by CAN-BD. Capreomycin and kanamycin show improved powder yields in scale up experiments. The particle properties were characterized using scanning electron microscopy, Karl Fischer moisture analysis, Anderson Cascade Impaction studies, and X-ray diffraction. The inhalable antibiotic formulations are within a respirable size range (1-5 μm), and have less than 3% residual moisture. Unit-dose dry powder antibiotics have the potential to provide easy-to-use, stable products with improved safety profiles. © 2012 Copyright Taylor and Francis Group, LLC.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.00K | Year: 2013

"Measles is a highly contagious, human disease that is spread by the respiratory route, and, in the developing world, remains a leading cause of death due to vaccine-preventable infectious diseases in children younger than 5 years. The most recent estimates are that there were 139,300 deaths worldwide in 2010 due to measles. Research priorities to help achieve the goals of controlling, and eventually eradicating, measles worldwide should include the development of thermostable alternative delivery methods to improve vaccine safety, effectiveness, and coverage. In this Phase I SBIR project, we aim to develop dry wafer formulations for sublingual administration that are thermally stable (Aim 1) and immunogenic (Aim 2). We will use Aktiv-Dryʼs patented CO2-Assisted Nebulization with a Bubble Dryer® (CAN-BD) technology to prepare dry powders of measles vaccine formulations containing novel excipients to enhance stability. These powders will then be processed into wafers. We anticipate the outcome of the proposed research will be the development of a dry wafer formulation that exhibits less than one log loss in measles vaccine virus titer after 6 months of storage at 37 °C. Furthermore, the sublingual vaccine wafers will clearly induce an immune response in cotton rats, an accepted model for measles research.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 939.92K | Year: 2012

DESCRIPTION (provided by applicant): The overarching goal of this project is to move a new, dry powder formulation of Hepatitis-B vaccine on its path to commercialization. In the Phase I SBIR we tested in vitro three Hep-B dry powder formulations of commercially available Shanvac-B and demonstrated powder stability and immunogenicity at temperatures ranging from -20 ?C through 65 oC. At these temperature extremes the currently marketed liquid Hepatis B vaccine is inactivated as the HBsAg antigen separates from the alum adjuvant. Our studies also showed that the dry micro-scale powders dissolved very rapidly, suggesting their utility in single dose auto-reconstitution devices aimed at parenteral administration. These results have far-reaching implications inregard to vaccine storage, transport and administration, especially in developing countries where limited refrigeration and electric power and high ambient temperatures restrict the useful life and potency of liquid vaccines. In the proposed Phase II SBIRstudy, we will choose the optimum formulation from the three that we developed earlier and pair this powder with a single dose auto-reconstitution device being developed by Becton Dickinson (BD). The drug- device combination will be used to assess potency in a mouse model compared to a control group of animals that will be administered Shanvac-B by needle and syringe. Potency will be assessed from ELISA analysis of animal sera. . The outcome of the Phase II work will be judged based on the potency of the Hep-B dry powder formulation and the functionality and performance of the BD device as compared with the potency of the needle and syringe administration. PUBLIC HEALTH RELEVANCE: This project seeks to accelerate a new Hepatitis-B vaccineformulation on its path to commercialization. A commercially available thimerosal-free liquid vaccine, Shanvac-B, was formulated as a dry, rapidly dissolving micro-powder with stability over an 18-month period at temperatures ranging from -20 oC through 65oC. When considered in the context of combining Aktiv-Dry's vaccine powders with single dose auto-reconstitution devices, these results have far-reaching implications in regard to vaccine storage, transport and administration, especially in developing countries where limited refrigeration and electric power and high ambient temperatures restrict the useful life and potency of liquid vaccines.


Methods and products for treating and/or delaying onset of dysplastic lesions, and wafers for oral administration employ dry powder compositions including myo-inositol. Methods for administering a vaccine for a virus or bacteria to an individual comprising administering a first portion of the vaccine to the individual via one route and administering a second portion via a second, different route. In a specific embodiment, the first route is sublingually. Vaccines are provided in the form of dry powder compositions comprising a combination of nanoparticles and microparticles, or in the form of a wafer which dissolves in water at room temperature in less than about one minute. Storage stable unit dosages of a vaccine are provided by individually packaging individual unit dosages of a dry powder composition comprising the vaccine and a carrier in blister compartments formed of gas and moisture resistant material.


News Article | March 1, 2017
Site: www.prweb.com

Aktiv Solutions, the industry leader in functional fitness facility design and supply, today unveiled its pioneering Aktiv Virtual guided-training platform. Aktiv Virtual represents the first AI (artificial intelligence) personal trainer for the commercial fitness industry and will provide club members with the guidance, education and motivation of a personal training experience. The single and multi-user systems offer efficiencies to facility operators that significantly reduce many of the barriers associated with successful implementation of functional training within health clubs of all types. The immersive workout experience will also help facilities that compete with today’s high-demand studio-based offerings, largely structured around functional training modalities. Aktiv Virtual combines expert level audible and visual coaching with complete control of the physical environment in a manner not previously realized within the health club space. The system provides members a robust selection of on-demand and customizable functional training workouts without the staffing requirement associated with a personal trainer. Users access exactly the workouts they want based on their daily preferences and conditioning level from H.I.I.T. programs to Power Yoga. The system can also be co-branded to help reinforce a facility’s larger umbrella of programming and services. “Aktiv Virtual delivers a shockingly immersive user experience designed to thrill members and reinforce why they make the trip to their club or facility of choice. We’ve solved the problem of delivering safe and inspirational functional training workouts for members that seek more than spending 30 minutes on a treadmill or hunting for various equipment around the entire gym,” said Bryan Green, president and CEO of Aktiv. “Mobile fitness experiences are all the rage and attempt to compete at little or no cost against health clubs. The challenge is, they’re not optimized to work in concert with the physical training environment or deliver the convenience, safety and fun factor that Virtual Aktiv clients will now provide.” Movement coaching delivered via the system’s 24-inch HD display interacts seamlessly with the audible guidance provided by a virtual master trainer. Master Trainers will ultimately be selected by gender, style, and language type. The system is optionally embedded into the company’s proprietary Gym Rax® bay structure and includes the entire kit of functional training tools to support a library of over 500 movements leading to endless combinations of new workouts each day. Aktiv Virtual is a connected system designed to seamlessly pair with a full array of popular wearables, including Fitbit®, Apple® Watch, Polar®, Garmin® and more. The interface allows users to set up profiles where usage and results are tracked and members can tag and save favorite workouts. The platform offers facilities an ideal complement to, or expansion of, a traditional cardio equipment offering with Aktiv Virtual’s results-driven fun factory of strength and movement based training. Operators can choose from tailoring Aktiv Virtual to generate a robust new revenue stream, or simply wow their members with the significant added value of the most comprehensive self-guided training experiences available. “Helping clubs integrate a meaningful, technology driven solution that marries well with the physicality required to deliver safe and scalable training experiences for their customers is our passion,” said Larry Domingo, vice president of human performance for Aktiv. “Aktiv Virtual serves to control the chaos required to properly support functional training workouts by pre-defining the space, environment, and tools required to get the most out of one’s time in the gym. We believe that’s a game-changer for today’s clubs struggling to make this critical transition.” For more information on Aktiv Solutions, visit http://www.aktivsolutions.com or email info(at)aktivsolutions(dot)com. About Aktiv: At Aktiv we amplify dynamic training areas for health clubs and specialty studios alike. Our mission is to establish safe, functional, and revenue-generating space while our clients deliver inspirational exercise experiences. Integrating the principles of functional fitness with the technical expertise of functional design is our calling. We craft energizing and balanced operational solutions to accommodate today’s explosive dynamic training trends. Visit http://www.aktivsolutions.com.

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