5, 2017 which are hereby incorporated by reference in their entirety. continuation of PCT/US2017/067655 filed Dec. The composition of claim 1, wherein the raw tablets direct compression tablets are compressed at a hardness of about 3 to about 7 kp, or about 3.5 to about 7 kp, or about 3.5 to about 5.5 kp, or about 4 to about 5 kp, or about 5 kp, or about 6 to about 7 kp, or about 6.6 kp hardness. The composition of claim 1, wherein the raw or coated tablets have a dissolution rate of at least about 95, 96, 97, 98, or 99% after about 15, 30, or 45 minutes.ġ2. The composition of claim 1, wherein the raw tablets are prepared by dry blending and direct tablet compression.ġ1. The composition of claim 1, wherein the raw tablets comprise about 0.1 to about 0.3%, or about 0.2% of colloidal silicon dioxide.ġ0. The composition of claim 1, wherein the raw tablets comprise about 0.25 to 0.75%, or about 0.4 to about 0.6%, or about 0.5% by weight of magnesium stearate.ĩ. The composition of claim 1, wherein the raw tablets comprise from about 2 to about 4% by weight of croscarmellose sodium.Ĩ.
The composition of claim 1, wherein the asimadoline is present at a drug loading of about 1 to about 3% by weight relative to the raw tablet weight.ħ. The composition of claim 1, wherein the raw tablets comprise asimadoline or a pharmaceutically acceptable salt thereof and lactose monohydrate, wherein the asimadoline or a pharmaceutically acceptable salt thereof is about 0.25 to about 3.0 mg per tablet and the asimadoline or a pharmaceutically acceptable salt thereof and the lactose monohydrate together are 80 to about 97% by weight, or about 85 to about 97% by weight, or about 85 to 90% by weight, or about 90 to about 98%, or about 93 to about 98%, or about 95 to about 98%, or about 96 to about 97% by weight of the composition.Ħ. The composition of claim 1, wherein the raw tablets are coated with a tablet coating comprising an iron oxide pigment.ĥ. The composition of claim 1, wherein the raw tablet further comprises croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.Ĥ. The composition of claim 1, wherein the raw tablet further comprises one or more of croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate.ģ. A pharmaceutical composition comprising a raw tablet comprising asimadoline or a pharmaceutically acceptable salt thereof and lactose monohydrate, wherein the raw tablet lacks microcrystalline cellulose and/or hypromellose.Ģ.