| 20080229609 | Preservation by Vaporization - Significant research is being done to develop and improve delivery mechanisms for biopharmaceuticals and vaccines, including pulmonary (inhalation), nasal, transdermal, and oral alternatives. Market projections indicate that the delivery of proteins and vaccines by inhalation and oral formulation has become and will continue to be increasingly important. These delivery mechanisms, to be effective, will require better stabilization of the biologicals so that they can maintain potency and effectiveness at ambient temperatures for extended periods of time. The novel Preservation by Vaporization (PBV) Technology described herein provides cost-effective and efficient industrial scale stabilization of proteins, viruses, bacteria, and other sensitive biologicals, thereby allowing a production of products that are not possible to be produced by existing methods. The suggested new PBV process comprises primary drying under vacuum from a partially frozen state (i.e. slush) at near subzero temperatures followed by stability drying at elevated temperatures (i.e., above 40 degrees Celsius). The new suggested method can be performed aseptically in unit doze format (in vials) and/or in bulk format (in trays, bags, or other containers). The drying can be performed as a continuous load process in a manifold vacuum dryer comprising a plurality (e.g., 30) of vacuum chambers attached to a condenser during the drying. | 09-25-2008 |
| 20100120014 | Stability Drying - A method of formulating high ambient temperature (room temperature and above) stable biologics (biologically active macromolecules, enzymes, serums, vaccines, viruses, pesticides, drug delivery systems, liposomes, cells suspensions, sperm, erythrocytes, other blood cells, stem cells, multicellular tissues, skin, heart valves) including secondary drying comprising at least two steps of stability drying at elevated temperature: 35° C., 40° C., 45° C., 50° C., and higher temperatures. The method could be applied to stabilize biologics encapsulated in alginate gel microspheres for better oral delivery. The method encompasses the following: microspheres are formulated using a cryo-encapsulation procedure comprised of mixing drops of frozen preservation mixture (To form the preservation mixture, biologics are mixed with preservation solutions containing sodium alginate.) with frozen drops of a calcium solution (i.e. calcium gluconate) and subsequent warming to form the gel particles. | 05-13-2010 |
