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Boulder, CO, United States

Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 296.00K | Year: 2006

Commercially available products rich in phytosterol may now be used to cut serum low-density lipoprotein by as much as 14 percent. Unfortunately, phytosterols are poorly soluble and therefore present unique problems concerning their ability to suppress cholesterol absorption in the gut. This impediment often leads to sub-optimal dosing and poor performance of phytosterol compounds and restricts their use in nutraceuticals and functional food products. One promising approach to enhancing the dissolution rate of such compounds is to formulate them as micro- and nano-size particles. The purpose of this Phase II SBIR is to produce amorphous phytosterol powders with rates of dissolution in water and body fluids that significantly exceed what is currently available in the commercial market. We will also demonstrate the physical stability of the amorphous particles over an 18 month shelf life. Finally, the Phase II work will provide an engineering design and analysis for integrating a CAN-BD process with an existing system for manufacturing phytosterol powders on a commercial scale.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.99K | Year: 2006

DESCRIPTION (provided by applicant): Aktiv-Dry LLC, in collaboration with Nabi Biopharmaceuticals, proposes to develop and evaluate in animal models the needle-free respiratory delivery of fine dry powder nicotine vaccine. While syringe and needle have been a common vaccine administration mechanism, international authorities recognize a growing requirement for alternative formulations and delivery systems, especially because of inadvertent disease from needle contamination, accidental needle-sticks, thermal instability of current formulations, and compliance with vaccination regimens. Nicotine is primarily responsible for the psychoactive and addictive effects of smoking. Immunotherapy has already been shown to be useful in prevention and/or treatment of addiction to nicotine and other drugs of abuse. Nicotine-specific antibodies can bind and sequester nicotine in the serum, thus preventing nicotine from reaching the brain as antibodies are too large to cross the blood-brain barrier. A number of studies have shown that, in animals, NicVAX(tm), a nicotine-carrier protein conjugate vaccine, reduces the distribution of nicotine to the brain, attenuates the locomotor and stimulus properties of nicotine and prevents nicotine from relieving nicotine abstinence syndrome. In humans, such a vaccine may be an effective aid in smoking cessation and reduce the rate/extend the time to relapse. Nabi has already demonstrated the safety and immunogenicity of NicVAX(tm) in humans and established its potential as a useful therapeutic and preventative agent to assist in smoking cessation/abstinence and prophylaxis. Aktiv-Dry has developed a technology to manufacture pharmaceutically active microparticles suitable in size and stability for delivery by inhalation. Delivery of NicVAX(tm) by a needle-free approach to the respiratory tract using the Aktiv-Dry technology may facilitate patient compliance, address potential issues with distribution and use on a world-wide basis, and possibly enhance the efficacy of a nicotine vaccine.

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.

Agency: Department of Agriculture | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 79.98K | Year: 2004

Phytosterols and lycopene are neutraceuticals that are known antioxidants and cancer inhibitors. Unfortunately, they do not dissolve readily in body fluids and therefore present unique problems concerning their uptake by the blood stream. This project explores the ability to enhance the rate of solubility of lycopene and phytosterols by formulating tham as nano- and micro-particles.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.60K | Year: 2004

DESCRIPTION (provided by applicant): This Phase I SBIR proposal is the first step in the development of inhalable IgG microparticles for immunoprophylaxis against Influenza A, a category C Priority Pathogen. In Phase I, Aktiv-Dry will simultaneously s

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