Pharmaceutical compositions and methods for fabrication of solid masses comprising immunoglobulins
View Patent ↗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.
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 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 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 μm.
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 μm.
13. The shaped mass of claim 12 , wherein the precursor material has a particle size in the range of 100 to 400 μm.
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 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 3 .