IP Library › Granted Patent US 12,214,019
Granted Patent B2
US 12,214,019 · App. 17/694,507 · Granted Feb 4, 2025

Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins

Inventors: Mercedes Morales (San Francisco, CA); Mir Imran (Los Altos Hills, CA); Radhika Korupolu (Fremont, CA); Mir Hashim (Fremont, CA)
Assignee: Rani Therapeutics, LLC
A61K38/28A61K9/2018A61K9/2027A61K9/2031A61K9/2072A61K9/2077A61K38/26C07K16/00C07K16/241C07K16/244C07K2317/21C07K2317/24C07K2317/76
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Quick Facts
Patent No.
US 12,214,019
App. No.
17/694,507
Granted
Feb 4, 2025
Kind
B2
Abstract

Embodiments of the invention provide shaped masses comprising one or more drugs such as proteins or polypeptides and methods for forming such shaped masses. One embodiment provides a shaped mass comprising a drug such as a protein or polypeptide having a biological activity in the body of a mammal. The shaped mass is formed by compression of a precursor material comprising the drug wherein an amount of biologically active drug in the mass is a preserved above a minimum level. Drugs which may be incorporated into the shaped mass may include one or more glucose regulating proteins such as insulin, incretins; and immunoglobulins such as TNF-inhibiting antibodies or interleukin neutralizing antibodies. Embodiments of the shaped mass may be incorporated into a tissue penetrating member which is inserted into the intestinal wall allowing for the oral delivery of proteins and peptides which would otherwise be degraded in the intestinal tract.

Claims (19)

1. A shaped mass comprising a biologically active protein or polypeptide and a pharmaceutical excipient, the shaped mass formed by compression of a precursor material comprising the biologically active protein or polypeptide, wherein an amount of biologically active protein or polypeptide in the shaped mass is at least 70% of that in the precursor material, the shaped mass having a density in a range of about 0.80 mg/mm 3 to about 1.15 mg/mm 3 .

2. The shaped mass of claim 1 , wherein the density is in a range of about 0.86 mg/mm to about 1.05 mg/mm 3 .

3. The shaped mass of claim 1 , wherein the precursor material has a particle size in the range of about 50 μm to about 450 μm.

4. The shaped mass of claim 1 , wherein the shaped mass comprises a degradable material.

5. The shaped mass of claim 1 , wherein the precursor material is a powder comprising the protein or polypeptide.

6. The shaped mass of claim 1 , wherein the precursor material is a slurry comprising the protein or polypeptide.

7. The shaped mass of claim 1 , wherein the protein or polypeptide comprises an immunoglobulin.

8. The shaped mass of claim 7 , wherein the immunoglobulin comprises an antibody.

9. The shaped mass of claim 1 , wherein the protein or polypeptide has an affinity for an antigen.

10. The shaped mass of claim 1 , wherein the shaped mass has a pellet or cylindrical shape.

11. The shaped mass of claim 1 , wherein the shaped mass has a tablet shape.

12. The shaped mass of claim 1 , wherein the shaped mass has a tissue-penetrating shape.

13. The shaped mass of claim 1 , wherein the shaped mass is configured to degrade in a wall of a small intestine so as to release the protein or polypeptide.

14. The shaped mass of claim 1 , wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent, or a bulking agent.

15. The shaped mass of claim 1 , wherein the shaped mass comprises a TNF inhibiting antibody.

16. The shaped mass of claim 15 , wherein the TNF inhibiting antibody comprises adalimumab.

17. The shaped mass of claim 16 , wherein the shaped mass comprises from about 1 mg to about 4 mg of adalimumab.

18. A shaped mass comprising a biologically active protein or polypeptide and a pharmaceutical excipient, the shaped mass formed by compression of a precursor material comprising the biologically active protein or polypeptide, wherein a percentage by weight of biologically active protein or polypeptide in the shaped mass is at least 70% relative to that of the precursor material prior to formation of the shaped mass, the shaped mass having a density in a range of about 0.80 mg/mm 3 to about 1.15 mg/mm 3 .

19. A shaped mass comprising a biologically active protein or polypeptide and a pharmaceutical excipient, the shaped mass formed by compression of a precursor material comprising the biologically active protein or polypeptide, wherein an amount of biologically active protein or polypeptide in the shaped mass is at least 80% relative to that in the precursor material prior to formation of the shaped mass, the shaped mass having a density in a range of about 0.80 mg/mm 3 to about 1.15 mg/mm 3 .

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2022
From: MORALES, MERCEDES; IMRAN, MIR; KORUPOLU, RADHIKA; HASHIM, MIR
To: INCUBE LABS, LLC
Reel/Frame 059665/0405 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 21, 2022
From: INCUBE LABS, LLC
To: RANI THERAPEUTICS, LLC
Reel/Frame 059665/0476 →
Continuity (6)
Continuation 16112558 · Aug 24, 2018
Continuation 14714120 · May 15, 2015
Provisional Application 62159134 · May 8, 2015
Provisional Application 62156105 · May 1, 2015
Provisional Application 61993907 · May 15, 2014
Related Publication 20220202910A1 · Jun 30, 2022
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