IR DYES FOR FLUORESCENCE IMAGING
A composition comprising: a polymorphic form of 2-((E)-2-((E)-3-(2-((E)-3,3-dimethyl-5-sulfonato-1-(4-sulfonatobutyl)indolin-2-ylidene)ethylidene)-2-phenoxycyclohex-1-en-1-yl)vinyl)-3,3-dimethyl-1-(4-ulfonatobutyl)-3H-indol- 1- ium-5-sulfonate or 2-((E)-2-((E)-3-(2-((E)-3,3-dimethyl-5-sulfonato-1-(4-sulfonatobutyl)indolin-2-ylidene)ethylidene)-2-(4-sulfonatophenoxy)cyclohex-1-en-1-yl)vinyl)-3,3-dimethyl-1-(4-sulfonatobutyl)-3H-indol-1-ium-5-sulfonate and an acceptable excipient.
1 . A pharmaceutical composition, the composition comprising:
a polymorphic form of Formula 1 having the formula:
wherein the polymorph is a member selected from the group consisting of Form A having an X-ray powder diffraction pattern comprising peaks at 2-theta at 4.3°±0.2°, 9.6°±0.2° and 12.9°0.2° and Form B having an X-ray powder diffraction pattern comprising peaks at 2-theta at 5.3°±0.2°, 14.2°±0.2° and 21.2°±0.2°; and
a pharmaceutically acceptable excipient.
2 . The pharmaceutical composition of claim 1 , wherein the polymorphic form of Formula 1 is Form A.
3 . The pharmaceutical composition of claim 1 , wherein the polymorphic form of Formula 1 is Form B.
4 . The pharmaceutical composition of claim 1 , wherein the pharmaceutically acceptable excipient is a saccharide stabilizing agent.
5 . The pharmaceutical composition of claim 4 , wherein the saccharide stabilizing agent is a member selected from the group consisting of a monosaccharide, a disaccharide or dextran.
6 . The pharmaceutical composition of claim 4 , wherein the saccharide stabilizing agent is a member selected from the group consisting of glucose, galactose, xylose, glucuronic acid, trehalose, hydroxyethyl starch, mannitol, or 5% dextrose.
7 . The pharmaceutical composition of claim 6 , wherein the saccharide is mannitol.
8 . The pharmaceutical composition of claim 1 , wherein the composition further comprises a pharmaceutically acceptable carrier, which is a member selected from the group consisting of physiological sterile saline solution, sterile water solution, pyrogen-free water solution, isotonic saline solution, and phosphate buffer solution.
9 . The pharmaceutical composition of claim 8 , wherein the composition is a lyophilized powder.
10 . The pharmaceutical composition of claim 9 , wherein the lyophilized composition is in a vial.
11 . The pharmaceutical composition of claim 10 , wherein the lyophilized powder is reconstituted with a pharmaceutical carrier.
12 . A kit, the kit comprising a pharmaceutical composition comprising a polymorphic form of Formula 1 having the formula:
wherein the polymorph is a member selected from the group consisting of Form A having an X-ray powder diffraction pattern comprising peaks at 2-theta at 4.3°±0.2°, 9.6°±0.2° and 12.9°±0.2° and Form B having an X-ray powder diffraction pattern comprising peaks at 2-theta at 5.3°±0.2°, 14.2°±0.2° and 21.2°±0.2°; and a pharmaceutically acceptable excipient, wherein the composition is a lyophilized powder contained within a vial.
13 . The kit of claim 12 , wherein the polymorphic form of Formula 1 is Form A.
14 . The kit of claim 12 , wherein the polymorphic form of Formula 1 is Form B.
15 . The kit of claim 12 , wherein the pharmaceutically acceptable excipient is a saccharide stabilizing agent.
16 . The kit of claim 12 , wherein the kit further comprises a pharmaceutical carrier for reconstituting the lyophilized powder.
17 . The kit of claim 16 , wherein the pharmaceutically acceptable carrier is a member selected from the group consisting of physiological sterile saline solution, sterile water solution, pyrogen-free water solution, isotonic saline solution, and phosphate buffer solution.
18 . The kit of claim 12 , wherein the kit further comprises an instruction manual.
19 . A kit, the kit comprising a polymorphic form of Formula 1 having the formula:
wherein the polymorph is a member selected from the group consisting of Form A having an X-ray powder diffraction pattern comprising peaks at 2-theta at 4.3°±0.2°, 9.6°±0.2° and 12.9°±0.2° and Form B having an X-ray powder diffraction pattern comprising peaks at 2-theta at 5.3°±0.2°, 14.2°±0.2° and 21.2°±0.2°; and wherein the polymorphic form of Formula 1is inavial.