Pharmaceutical compositions and methods for fabrication of solid masses comprising polypeptides and/or proteins
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) and a pharmaceutical excipient, wherein:
a percentage by weight of biologically active protein of the IgG in the shaped mass is in a range of about 54% to about 95%; and
the shaped mass has a density in a range of about 0.96 mg/mm 3 to about 1.19 mg/mm 3 .
2. The shaped mass of claim 1 , wherein the shaped mass has a mass in a range of about 1.03 mg to about 1.39 mg.
3. The shaped mass of claim 1 , wherein IgG is an antibody.
4. The shaped mass of claim 1 , wherein the shaped mass has a pellet shape.
5. The shaped mass of claim 1 , wherein the shaped mass has a cylindrical shape.
6. The shaped mass of claim 1 , wherein the shaped mass has a tablet shape.
7. The shaped mass of claim 1 , wherein the shaped mass has a tissue penetrating shape.
8. The shaped mass of claim 1 , wherein the pharmaceutical excipient comprises at least one of a lubricant, a binding agent, or a bulking agent.
9. The shaped mass of claim 1 , wherein the shaped mass degrades in tissue to release the IgG into a patient's blood stream.
10. The shaped mass of claim 9 , wherein the shaped mass comprises a biodegradable material which breaks down in tissue to release the IgG.
11. The shaped mass of claim 9 , wherein the tissue is gastro-intestinal tissue.
12. The shaped mass of claim 11 , wherein the tissue is intestinal wall tissue.
13. The shaped mass of claim 12 , where the intestinal wall is a wall of a small intestine.
14. The shaped mass of claim 9 , wherein the tissue is an intramuscular tissue.