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Details for Patent: 6,528,067

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Details for Patent: 6,528,067

Title: Total nutrient admixtures as stable multicomponent liquids or dry powders and methods for the preparation thereof
Abstract:In accordance with the present invention, there are provided stabilized total nutrient admixture (TNA) compositions which are useful for the in vivo parenteral delivery of pharmacologically acceptable lipids or fats, as well as methods for the preparation thereof. In particular, the pharmacologically acceptable lipid or fat is contained within a protein walled shell. In a particular embodiment of the invention, a TNA composition using human serum albumin (HSA) as a stabilizer has been prepared as a convenient three-in-one formulation (i.e., containing a fat emulsion, dextrose, and amino acids plus electrolytes). This "three-in-one" formulation can be prepared in liquid form or in dry form (comprising submicron-sized nanoparticles). The dried material is stable, even under long term storage, and is easily reconstituted immediately before use by simply adding sterile water (with or without vitamin supplementation) This serves to rehydrate the powder into a TNA suitable for injection. The long shelf life, ease of reconstitution, and single-component injectability of invention compositions provide significant cost savings, as such compositions can be reconstituted and administered safely, even in the home. In addition, HSA, the stabilizing agent of choice for use in the practice of the present invention, has been shown to improve survival and wellness when given as a supplement to patients receiving conventional forms of total nutrient admixtures.
Inventor(s): Magdassi; Shlomo (Jerusalem, IL), Yang; Andrew (Rosemead, CA), Tao; Chunlin (Beverly Hills, CA), Desai; Neil P. (Los Angeles, CA), Yao; Zhiwen (Culver City, CA), Soon-Shiong; Patrick (Los Angeles, CA)
Assignee: American Bioscience, Inc. (Santa Monica, CA)
Filing Date:Dec 07, 1999
Application Number:09/457,085
Claims:1. A stabilized total nutrient admixture (TNA) composition useful for in vivo parenteral delivery of a pharmacologically acceptable lipid or fat, said composition comprising: submicron droplets of lipid or fat stabilized by intimate association with a biocompatible polymer, wherein said lipid or fat is a solid or liquid, and wherein the diameter of said stabilized droplets is no greater than about 10 microns, sugars, amino acids, electrolytes, and optionally, one or more additives selected from the group consisting of calcium sequestering agents, water, water-soluble vitamins, water-soluble trace elements, stabilizers, agents of therapeutic value and oil-soluble vitamins.

2. A composition according to claim 1 wherein the average diameter of said oil droplets is no greater than about 400 nm.

3. A stabilized TNA composition according to claim 1 wherein said stabilized droplets containing lipid or fat therein is suspended in biocompatible aqueous medium.

4. A composition according to claim 1 wherein said biocompatible polymer is a natural or synthetic protein, oligopeptide, polynucleic acid or polysaccharide.

5. A composition according to claim 4 wherein said protein is albumin, insulin, hemoglobin, lysozyme, immunoglobulins, .alpha.-2-macroglobulin, fibronectin, vitronectin or fibrinogen.

6. A composition according to claim 4 wherein said protein is albumin.

7. A method for the delivery of a total nutrient admixture (TNA) composition to a subject, said method comprising administering to said subject an effective amount of composition according to claim 1.
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