Compositions and Methods for the Delivery of Therapeutic Biologics for Treatment of Disease
The present disclosure provides compositions and methods for treating a disease or condition in a subject in need thereof, comprising administering to the subject a pharmaceutically effective amount of a composition comprising a plurality of particles comprising at least one therapeutic biologic suspended in a pharmaceutically acceptable liquid carrier.
1 . A composition comprising particles, wherein a plurality of the particles comprise greater than 65% of a therapeutic agent by weight; and wherein the composition is co-formulated with a hyaluronan degrading agent.
2 . The composition of claim 1 , wherein the therapeutic agent is a therapeutic biologic or salt thereof.
3 . The composition of claim 1 , wherein the hyaluronan degrading agent is a hyaluronidase enzyme.
4 . The composition of claim 1 , wherein the composition co-formulated with a hyaluronan degrading agent includes a water content of less than about 7% by weight.
5 . The composition of claim 4 , wherein the water content is less than about 2% by weight.
6 . The composition of claim 1 , further comprising a stabilizer.
7 . The composition of claim 6 , wherein the stabilizer comprises a salt, a carbohydrate, a saccharide, an amino acid, or a combination thereof.
8 . The composition of claim 6 , wherein the stabilizer is a sugar, an amino acid, or a protein.
9 . The composition of claim 1 , wherein the particles are suspended in a carrier.
10 . The composition of claim 9 , wherein the carrier comprises ethyl oleate or propylene glycol diesters.
11 . The composition of claim 1 , wherein the therapeutic agent is an antibody or a fragment thereof.
12 . The composition of claim 1 , wherein a plurality of particles have less than about 25% internal void space.
13 . The composition of claim 1 , wherein a plurality of the particles have less than about 10% aggregation of the therapeutic biologic or salt thereof.
14 . The composition of claim 1 , wherein a plurality of the particles have a circularity from about 0.80 to about 1.00.
15 . The composition of claim 1 , wherein a plurality of the particles have less than about 7% residual moisture by weight.
16 . The composition of claim 1 , wherein a plurality of the particles comprise greater than about 70% therapeutic biologic or salt thereof by weight.
17 . The composition of claim 1 , wherein a plurality of the particles have less than about 50% change in charge variants of the therapeutic biologic or salt thereof.
18 . The composition of claim 1 , wherein the concentration of the therapeutic biologic or salt thereof in the composition is from about 20 mg/mL to about 700 mg/mL.
19 . The composition of claim 1 , wherein the composition has a viscosity of less than about 200 mPa·s.
20 . The composition of claim 1 , wherein the composition is free of insoluble Subvisible Particles (SvPs) upon dissolution in water.
21 . The composition of claim 1 , wherein the therapeutic biologic or salt thereof in the composition is stable for at least three months.
22 . A composition comprising particles, wherein:
a plurality of the particles comprise greater than 65% of a therapeutic biologic or salt thereof by weight, and further comprise a surfactant, an amino acid, or a combination thereof;
the particles are suspended in a non-aqueous carrier; and
the concentration of the therapeutic biologic or salt thereof in the composition is from about 20 mg/mL to about 700 mg/mL, and
wherein the composition is co-formulated with a hyaluronan degrading agent.