Body fluid compartments dunnet8/15/2023 The present invention relates to a method of preparing a dried protein product such that when the dried product is placed in a delivery device which is inserted or implanted into the body of a living being, or added to a solution which is administered by means of an intravenous injection or an infusion pump, the protein will retain its bioactivity and will not significantly suffer from insolubility problems. This invention also relates to the administration of the novel dried protein products to enhance a biological process in a living being. It surprisingly has been found that when an ionic detergent which will bind strongly with a protein is mixed with an aqueous solution of the protein, and the protein-detergent mixture is dried to form a dried product, the bioactivity and potential for solubility of the protein when it subsequently is contacted with an aqueous-based fluid are substantially maintained, provided the amount of detergent mixed with the protein is sufficient to substantially coat the protein. In accordance with the present invention there is disclosed a novel dried protein product and a method for making it. 4,306,553, issued to Dorman, teaches adding specific detergents in low concentrations to an insulin solution to maintain the solution's fluidity.Īlthough the teachings of these two patents may be helpful in certain situations, further methods for stabilizing polypeptides are sought. Specifically, Blackshear discloses stabilizing the insulin by adding an effective amount of a polyol, such as glycerol, to the solution. 4,439,181, issued to Blackshear, discloses a method for preventing the precipitation of solubilized insulin within an infusion pump-type of delivery system that depends on the fluidity of the insulin solution for proper function. ![]() As a result, when they are placed in a slow release delivery device and come into contact with body fluids or they are added to a solution for purposes of intravenous administration, they have a tendency to transform into insoluble aggregates.Īttempts have been made to solve this problem. One problem is that certain beneficial agents, especially high molecular weight agents, such as some proteins, are unstable, insoluble or cannot be solubilized in body fluids or other aqueous-based solvents. That solution is dispensed through the passageway at a rate controlled by the permeability of the wall and the osmotic pressure gradient across the wall of the device.ĭespite these and various other systems and devices for releasing beneficial agents, certain problems have remained. To release the agent, fluid is imbibed through the wall into the compartment to produce a solution of the agent. The wall is permeable to an external body fluid but impermeable to the agent and has a passageway for delivering the agent to the body. 3,845,770, issued to Theeuwes et al., is directed to an osmotic device for the controlled release of an agent which comprises a semi-permeable membrane that surrounds a compartment which contains the agent. 3,279,996, issued to Long et al., discloses a method and means for the controlled release of a therapeutic agent into a living organism by implanting within the body of that organism a capsule formed of silicone rubber and containing a therapeutic agent soluble in and capable of diffusing through the rubber to its outer surface at a constant rate. The pump can be refilled by injecting infusate through the skin of the patient, through a pump septum and into the chamber inside the apparatus.Īlso well known are a number of devices which can be implanted inside the body of the living being and are constructed such that the beneficial agent can diffuse out of the device. 4,190,048, which discloses an apparatus having a reservoir which is implanted in the body of a living being and a pump which also is implanted. There are a number of patents which teach various types of infusion pumps. Alternatively, the agent in solution may be administered by means of an infusion pump. For example, the agent may be dissolved in a fluid which is compatible with body tissues and body fluids and then administered to the living being by means of an intravenous tube. ![]() In recent years, a variety of methods and devices have been disclosed for the administration of various beneficial agents, such as drugs or medicaments, to the body of a living being. The invention also relates to a method for preparing this novel product and to the administration of the product to a living being. ![]() This invention relates to a novel dried protein product wherein the potential for solubility and bioactivity of the protein are substantially maintained.
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