Pharmaceutical compositions and methods for fabrication of solid masses comprising anti-interleukin antibodies
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 interleukin neutralizing antibody (AI-antibody), the shaped mass formed by compression of a precursor material comprising the AI-antibody, wherein at least about 65% of the AI-antibody in the shaped mass has affinity for an epitope on an interleukin molecule, wherein the AI-antibody is an immunoglobulin G (IgG), 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 0.85 to about 1.05 mg/mm 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 3 .
4. The shaped mass of claim 1 , wherein the precursor material has a particle size in a range of about 100 to 400 μm.
5. The shaped mass of claim 1 , wherein at least about 80% of AI-antibody in the shaped mass has affinity for an epitope on an interleukin molecule.
6. The shaped mass of claim 1 , wherein the AI-antibody comprises an antibody to a member of the interleukin-17 family of cytokines.
7. The shaped mass of claim 6 , wherein the AI-antibody is secukinumab.
8. The shaped mass of claim 6 , wherein the AI-antibody is ixekizumab.
9. The shaped mass of claim 6 , wherein the AI-antibody is brodalumab.
10. The shaped mass of claim 6 , wherein a dose of AI-antibody in the shaped mass is in a range from about 1 to 5 mg.
11. The shaped mass of claim 1 , wherein the compression is performed in a mold or fixture.
12. The shaped mass of claim 1 , wherein the shaped mass is formed by compression of a powder comprising the AI-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 is configured to penetrate and be inserted into the wall of the small intestine by the application of force.
16. The shaped mass of claim 1 , wherein the shaped mass comprises a pharmaceutical excipient.
17. The shaped mass of claim 16 , wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent, a bulking agent or polyethylene glycol (PEG).
18. A shaped mass comprising an AI-antibody, the shaped mass formed by compression of a precursor material comprising the AI-antibody, wherein at least about 65% of the AI-antibody in the shaped mass has affinity for an epitope on an interleukin molecule, wherein the AI-antibody is an immunoglobulin G (IgG), and wherein the precursor material has a particle size in a range of about 50 to 450 μm.
19. The shaped mass of claim 18 , wherein the precursor material has a particle size in the range of 100 to 400 μm.
20. The shaped mass of claim 18 , wherein the shaped mass has a density in a range of about 0.80 to about 1.10 mg/mm 3 .
21. The shaped mass of claim 18 , wherein the AI-antibody comprises an antibody to a member of the interleukin-17 family of cytokines.
22. The shaped mass of claim 21 , wherein the AI-antibody is secukinumab.
23. The shaped mass of claim 21 , wherein the AI-antibody is ixekizumab.
24. The shaped mass of claim 21 , wherein the AI-antibody is brodalumab.
25. The shaped mass of claim 21 , wherein a dose of AI-antibody in the shaped mass is in a range from about 1 to 5 mg.