Claims for Patent: 10,098,931

Summary for Patent: 10,098,931

Title:	Pharmaceutical compositions and methods for fabrication of solid masses comprising immunoglobulins
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:	14/714,120
Patent Claims:	1. A shaped mass comprising an immunoglobulin G (IgG), the shaped mass formed by compression of a precursor material comprising the IgG, wherein at least about 67% of the IgG in the shaped mass has affinity for an antigen, 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 1.00 to about 1.01 mg/mm.sup.3. 3. The shaped mass of claim 1, wherein the precursor material has a particle size in a range of about 50 to about 450 .mu.m. 4. The shaped mass of claim 1, wherein the compression is performed in a mold or fixture. 5. The shaped mass of claim 1, wherein the shaped mass is formed by compression of a powder comprising the IgG. 6. The shaped mass of claim 1, wherein the shaped mass has a pellet or cylindrical shape. 7. The shaped mass of claim 1, wherein the shaped mass has a tablet shape. 8. The shaped mass of claim 1, wherein the shaped mass has a tissue penetrating shape. 9. The shaped mass of claim 1, wherein the shaped mass comprises a biodegradable material said biodegradable material configured to breakdown in a wall of a small intestine so as to release the IgG. 10. The shaped mass of claim 1, wherein the shaped mass comprises a pharmaceutical excipient. 11. The shaped mass of claim 10, wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent or a bulking agent. 12. A shaped mass comprising an immunoglobulin G (IgG), the shaped mass formed by compression of a precursor material comprising the IgG, wherein at least about 67% of the IgG in the shaped mass has affinity for an antigen, and wherein the precursor material has a particle size in the range of 50 to 450 .mu.m. 13. The shaped mass of claim 12, wherein the precursor material has a particle size in the range of 100 to 400 .mu.m. 14. The shaped mass of claim 12, wherein the compression is performed in a mold or fixture. 15. The shaped mass of claim 12, wherein the shaped mass is formed by compression of a powder comprising the IgG. 16. The shaped mass of claim 12, wherein the shaped mass has a cylindrical or pellet shape. 17. The shaped mass of claim 12, wherein the shaped mass has a tablet shape. 18. The shaped mass of claim 12, wherein the shaped mass has a tissue penetrating shape. 19. The shaped mass of claim 12, wherein the shaped mass comprises a biodegradable material said biodegradable material configured to breakdown in a wall of a small intestine so as to release the immunoglobulin G. 20. The shaped mass of claim 12, wherein the shaped mass comprises a pharmaceutical excipient. 21. The shaped mass of claim 20, wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent or a bulking agent. 22. A shaped mass comprising an immunoglobulin G (IgG), wherein: i) at least about 67% of the IgG in the shaped mass has affinity for an antigen; 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 IgG into a bloodstream. 23. The shaped mass of claim 22, wherein the tissue is an intestinal tissue or an intestinal wall tissue. 24. The shaped mass of claim 23, where the intestinal wall is a wall of a small intestine. 25. The shaped mass of claim 22, wherein the tissue is an intramuscular tissue. 26. The shaped mass of claim 22, wherein the density is in a range of about 1.00 to about 1.01 mg/mm.sup.3.

Details for Patent 10,098,931

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Octapharma Pharmazeutika Produktionsges.m.b.h.	CUTAQUIG	immune globulin subcutaneous (human)-hipp	Solution	125668	12/12/2018		2034-05-15