Spray-dried human plasma

Patent metadata

Field	Value
Publication number	US-12208121-B2
Application number	US-202318176797-A
Country	US
Kind code	B2
Filing date	Mar 1, 2023
Priority date	Sep 16, 2009
Publication date	Jan 28, 2025
Grant date	Jan 28, 2025

Abstract

The technology relates to spray dried plasma and methods of making the same. The method includes providing plasma to a spray drying apparatus, spray drying the plasma, at the spray drying apparatus, to form physiologically active plasma powder, the spray drying apparatus configured utilizing one or more parameters, and storing the physiologically active plasma powder.

First claim

What is claimed is:

1. A method for spray-drying plasma derived from blood, the method comprising:
providing plasma derived from blood to a spray-drying apparatus;
spray-drying the plasma with the spray-drying apparatus to form physiologically-active plasma powder, the spray-drying apparatus configured utilizing one or more parameters; wherein during spray drying, the spray-drying apparatus determines an outlet temperature; and adjusts a pump setting and/or an inlet temperature of the spray-drying apparatus based on the outlet temperature; and
storing the physiologically-active plasma powder.

2. The method of claim 1 , wherein the one or more parameters comprise an inlet temperature, a pump setting, an aspiration setting, a spray flow rate, an outlet temperature, or any combination thereof.

3. The method of claim 1 , wherein the one or more parameters comprise an inlet temperature of substantially 107° C., a pump setting of substantially 24%, an aspiration setting of substantially 100%, a spray flow rate of substantially 35 mm Hg, an outlet temperature of substantially between 40° to 44° C., or any combination thereof.

4. The method of claim 3 , wherein the spray flow rate is nitrogen flow rate.

5. The method of claim 1 , wherein the one or more parameters comprise an inlet temperature of substantially between 100° to 114° C., a pump setting of substantially between 18 to 28%, an aspiration setting of substantially between 80% to 100%, a spray flow rate of substantially between 30 to 40 mm Hg, an outlet temperature of substantially between 40° to 44° C., or any combination thereof.

6. The method of claim 1 , further comprising reconstituting the physiologically-active plasma powder utilizing a reconstitution fluid to form physiologically-active reconstituted plasma.

7. The method of claim 6 , further comprising transfusing the physiologically-active reconstituted plasma into a human.

8. The method of claim 6 , wherein a recovery rate of physiologically-active functional proteins in the reconstituted plasma ranges from 50% to 90%, as compared to physiologically functional plasma proteins in plasma prior to spray drying.

9. The method of claim 6 , wherein the reconstitution fluid comprises distilled water, glycine, or any combination thereof.

10. The method of claim 1 , wherein the plasma comprises human plasma.

11. The method of claim 1 , wherein the adjusting a pump setting and/or an inlet temperature based on the outlet temperature further comprises adjusting a pump setting and/or an inlet temperature if the outlet temperature is not between substantially 40° to 44° C.

12. The method of claim 1 , further comprising applying the physiologically-active plasma powder directly to a human via application of the physiologically-active plasma powder directly to a wound on the human.

13. A spray-dried physiologically-active plasma powder-prepared by made from the steps of:
providing plasma derived from blood to a spray-drying apparatus;
spray-drying the plasma with the spray-drying apparatus to form the physiologically-active plasma powder, the spray-drying apparatus configured utilizing one or more parameters, wherein during spray drying, the spray-drying apparatus determines an outlet temperature; and adjusts a pump setting and/or an inlet temperature of the spray-drying apparatus based on the outlet temperature.

14. The spray-dried physiologically-active plasma powder of claim 13 , wherein the one or more parameters comprise an inlet temperature, a pump setting, an aspiration setting, a spray flow rate, an outlet temperature, or any combination thereof.

15. The spray-dried physiologically-active plasma powder of claim 13 , wherein the one or more parameters comprise an inlet temperature of substantially 107° C., a pump setting of substantially 24%, an aspiration setting of substantially 100%, a spray flow rate of substantially 35 mm Hg, an outlet temperature of substantially between 40° to 44° C., or any combination thereof.

16. The spray-dried physiologically-active plasma powder of claim 15 , wherein the spray flow rate is nitrogen flow rate.

17. The spray-dried physiologically-active plasma powder of claim 13 , wherein the one or more parameters comprise an inlet temperature of substantially between 100° to 114° C., a pump setting of substantially between 18 to 28%, an aspiration setting of substantially between 80% to 100%, a spray flow rate of substantially between 30 to 40 mm Hg, an outlet temperature of substantially between 40° to 44° C., or any combination thereof.

18. A physiologically-active reconstituted plasma derived from blood made from the steps of prepared by:
providing plasma derived from blood to a spray-drying apparatus;
spray-drying the plasma with the spray-drying apparatus to form physiologically-active plasma powder, the spray-drying apparatus configured utilizing one or more parameters, wherein during spray drying, the spray-drying apparatus determines an outlet temperature; and adjusts a pump setting and/or an inlet temperature of the spray-drying apparatus based on the outlet temperature; and
reconstituting the physiologically-active plasma powder utilizing a reconstitution fluid to form the physiologically-active reconstituted plasma.

Assignees

• Velico Medical Inc

Inventors

• Dacorta Joseph
• Rosiello Keith

Classifications

• A61K9/1682

  Processes · CPC title

• A61K9/14

  Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} · CPC title

• B01D1/18

  to obtain dry solids (B01D1/24 takes precedence) · CPC title

• B01D1/20

  Sprayers (in general B05B) · CPC title

• A61K9/16

  Agglomerates; Granulates; Microbeadlets {; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction (A61K9/20 takes precedence if the final form is a tablet; microspheres with drug-free outer coating, microcapsules A61K9/50; mixture of different granules, microcapsules, (coated) microparticles A61K9/5084; nanoparticles A61K9/51)} · CPC title