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Details for Patent: 5,997,904

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Details for Patent: 5,997,904

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. (Los Angeles, CA)
Filing Date:Sep 30, 1996
Application Number:08/723,805
Claims:1. A method for the stabilization of a previously prepared total nutrient admixture (TNA) composition, said method comprising subjecting a mixture comprising:

submicron oil droplets stabilized by coating with a biocompatible polymer(s), and

aqueous medium containing sugars, amino acids and 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,

to high shear and cavitation forces, thereby stabilizing said previously prepared TNA composition.

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

3. A method according to claim 1 wherein the diameter of said oil droplets is no greater than about 10 microns.

4. A method according to claim 1 further comprising sterile-filtering said stabilized TNA composition.

5. A method according to claim 1 further comprising diluting the stabilized TNA composition with a biocompatible liquid to a desired calorie uptake level.

6. A method according to claim 1 further comprising removing water from said stabilized TNA composition to produce a solid TNA composition.

7. A method according to claim 6 wherein said water is removed by lyophilization.

8. A method according to claim 1 wherein said mixture is subjected to high shear and cavitation forces in a high pressure homogenizer.

9. A method according to claim 1 wherein said mixture is subjected to high shear and cavitation forces by ultrasonic irradiation.

10. A method according to claim 1 wherein said oil droplets are formed from coconut oil, cotton seed oil, vegetable oil, aliphatic, cycloaliphatic or aromatic hydrocarbons having 4-30 carbon atoms, aliphatic or aromatic alcohols having 2-30 carbon atoms, aliphatic or aromatic esters having 2-30 carbon atoms, alkyl, aryl, or cyclic ethers having 2-30 carbon atoms, alkyl or aryl halides having 1-30 carbon atoms, optionally having more than one halogen substituent, ketones having 3-30 carbon atoms, polyalkylene glycol, or combinations of any two or more thereof.

11. A method according to claim 10 wherein said vegetable oil is soybean oil, olive oil or safflower oil.

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

13. A method according to claim 12 wherein said protein is albumin, insulin, hemoglobin, lysozyme, immunoglobulins, .alpha.-2-macroglobulin, fibronectin, vitronectin or fibrinogen.

14. A method according to claim 12 wherein said protein is albumin.

15. A method for the preparation of a stable TNA composition, said method comprising subjecting a mixture comprising:

submicron oil droplets stabilized by coating with a biocompatible polymer(s), and

aqueous medium containing sugars, amino acids and 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,

to high shear and cavitation forces, thereby producing a stabilized TNA composition.

16. A method according to claim 15 wherein the average diameter of said oil droplets is no greater than about 400 nm.

17. A method according to claim 15 wherein the diameter of said oil droplets is no greater than about 10 microns.

18. A stabilized TNA composition produced by the method of claim 1.

19. A stable TNA composition produced by the method of claim 15.

20. 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 prepared according to the method of claim 1.
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