Claims for Patent: 10,058,595

Summary for Patent: 10,058,595

Title:	Pharmaceutical compositions and methods for fabrication of solid masses comprising TNF-inhibiting antibodies
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.
Inventor(s):	Morales; Mercedes (San Jose, CA), Imran; Mir (Los Altos Hills, CA), Korupolu; Radhika (San Jose, CA), Hashim; Mir (Fremont, CA)
Assignee:	InCube Labs, LLC (San Jose, CA)
Application Number:	14/714,126
Patent Claims:	1. A shaped mass comprising a TNF inhibiting antibody, the shaped mass formed by compression of a precursor material comprising the TNF inhibiting antibody, wherein at least about 75% of the TNF inhibiting antibody in the shaped mass has affinity for an epitope on a TNF molecule, the shaped mass having a density in a range of about 0.80 to about 1.10 mg/ mm.sup.3. 2. The shaped mass of claim 1, wherein the density is in a range of about 0.85 to about 1.05 mg/ mm.sup.3. 3. The shaped mass of claim 1, wherein the density is in a range of about 1.00 to about 1.01 mg/ mm.sup.3. 4. The shaped mass of claim 1, wherein the precursor material has a particle size in a range of about 100 to 400 .mu.m. 5. The shaped mass of claim 1, wherein at least about 80% of TNF inhibiting antibody in the shaped mass has affinity for an epitope on a TNF molecule. 6. The shaped mass of claim 1, wherein the TNF inhibiting antibody comprises adalimumab. 7. The shaped mass of claim 6, wherein the shaped mass comprises a therapeutically effective dose of adalimumab for treatment of an autoimmune disorder. 8. The shaped mass of claim 6, wherein the shaped mass comprises between about 1 to 4 mg of adalimumab. 9. The shaped mass of claim 7, wherein the autoimmune disorder is rheumatoid arthritis. 10. The shaped mass of claim 1, wherein the compression is performed in a mold. 11. The shaped mass of claim 1, wherein the shaped mass is formed by compression of a powder comprising the TNF inhibiting antibody. 12. The shaped mass of claim 1, wherein the shaped mass is formed by compression of a slurry comprising the TNF inhibiting antibody. 13. The shaped mass of claim 1, wherein the shaped mass has a pellet or cylindrical shape. 14. The shaped mass of claim 1, wherein the shaped mass has a tablet shape. 15. The shaped mass of claim 1, wherein the shaped mass has a tissue penetrating shape. 16. The shaped mass of claim 1, wherein the shaped mass comprises a biodegradable material which breaks down in a wall of a small intestine so as to release the TNF inhibiting antibody. 17. The shaped mass of claim 1, wherein the shaped mass comprises a pharmaceutical excipient. 18. The shaped mass of claim 17, wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent or a bulking agent. 19. A shaped mass comprising a TNF inhibiting antibody, the shaped mass formed by compression of a precursor material comprising the TNF inhibiting antibody, wherein at least about 75% of the TNF inhibiting antibody in the shaped mass has affinity for an epitope on a TNF molecule, and wherein the precursor material has a particle size in a range of about 50 to 450 .mu.m. 20. The shaped mass of claim 19, wherein the precursor material has a particle size in the range of 100 to 400 .mu.m. 21. The shaped mass of claim 19, wherein the shaped mass has a density in a range of about 0.80 to about 1.10 mg/ mm.sup.3. 22. The shaped mass of claim 19, wherein the TNF inhibiting antibody comprises adalimumab. 23. The shaped mass of claim 22, wherein the shaped mass comprises a therapeutically effective dose of adalimumab for treatment of an autoimmune disorder. 24. The shaped mass of claim 23, wherein the shaped mass comprises between about 1 to 4 mg of adalimumab. 25. The shaped mass of claim 23, wherein the autoimmune disorder is rheumatoid arthritis. 26. A shaped mass comprising a TNF inhibiting antibody, wherein: i) at least about 75% of the TNF inhibiting antibody in the shaped mass has affinity for an epitope on a TNF molecule; ii) the shaped mass has a density in a range of about 0.80 to about 1.10 mg/ mm.sup.3; and iii) the shaped mass degrades in a tissue to release the TNF inhibiting antibody into a bloodstream. 27. The shaped mass of claim 26, wherein the tissue is an intestinal tissue or an intestinal wall tissue. 28. The shaped mass of claim 27, where the intestinal wall is a wall of a small intestine. 29. The shaped mass of claim 28, wherein the tissue is an intramuscular tissue. 30. The shaped mass of claim 29, wherein the density is in a range of about 1.00 to about 1.01 mg/mm.sup.3.

Details for Patent 10,058,595

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	12/31/2002		2034-05-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	02/21/2008		2034-05-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	04/24/2013		2034-05-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	09/23/2014		2034-05-15
Abbvie Inc.	HUMIRA	adalimumab	Injection	125057	11/23/2015		2034-05-15