Particle Formation And Morphology
The present disclosure relates to compositions and methods that enable the formation of pharmaceutically relevant particles that can be used for therapy. In particular, the methods disclosed herein allow the controlled formation of circular particles having low internal void spaces comprising bioactive therapeutic agents.
1 . A particle comprising greater than about 70% antibody or a fragment thereof by weight, and an amino acid, wherein the particle has less than about 10% internal void space, a circularity of about 0.80 to about 1.00, and a diameter of about 10 μm to about 50 μm.
2 . The particle of claim 1 , wherein the particle has less than about 5% internal void space.
3 . The particle of claim 1 , wherein the particle has less than about 1% internal void space.
4 . The particle of claim 1 , wherein the particle has a diameter of about 20 μm to about 40 μm.
5 . The particle of claim 1 , further comprising a pH adjusting agent, a bactericide, or a combination thereof.
6 . The particle of claim 1 , wherein the particle has less than about 5% residual moisture by weight.
7 . The particle of claim 1 , wherein the particle has less than about 3% residual moisture by weight.
8 . The particle of claim 1 , wherein the particle has less than about 1% residual moisture by weight.
9 . The particle of claim 1 , wherein the particle has greater than about 80% antibody or a fragment thereof by weight.
10 . The particle of claim 1 , wherein the particle has greater than about 90% antibody or a fragment thereof by weight.
11 . The particle of claim 1 , wherein the particle has greater than about 95% antibody or a fragment thereof by weight.
12 . The particle of claim 1 , wherein the amino acid is L-arginine, histidine, proline, methionine, or a combination thereof.
13 . The particle of claim 1 , further comprising a carbohydrate, a salt, a surfactant, or a combination thereof.
14 . The particle of claim 13 , wherein the carbohydrate is dextran, trehalose, sucrose, agarose, mannitol, lactose, sorbitol, maltose, or a combination thereof.
15 . The particle of claim 13 , wherein the salt is sodium chloride, calcium chloride, potassium chloride, sodium hydroxide, stannous chloride, magnesium sulfate, sodium glucoheptonate, sodium pertechnetate, guanidine hydrochloride, potassium hydroxide, or a combination thereof.
16 . The particle of claim 13 , wherein the surfactant is a polysorbate, magnesium stearate, sodium dodecyl sulfate, TRITON™ N-101, glycerin, polyoxyethylated castor oil, docusate, sodium stearate, decyl glucoside, nonoxynol-9, cetyltrimethylammonium bromide, sodium bis(2-ethylhexyl) sulfosuccinate, sodium laureth sulfate, lecithin, a sorbitan ester, or a combination thereof.