Crystalline form of linaclotide
View Patent ↗The present invention relates to crystalline forms of linaclotide, as well as to various methods and processes for the preparation and use of the crystalline forms.
1. A crystalline form of linaclotide having an X-ray powder diffraction pattern comprising peaks at about 6.2, about 7.8, about 22.6 and about 23.9+/−0.5 degrees 2θ.
2. The crystalline form of claim 1 , wherein the X-ray powder diffraction pattern further comprises a peak at about 19.5+/−0.5 degrees 2θ.
3. A pharmaceutical composition comprising the crystalline form of claim 1 .
4. A process for preparing a crystalline form of linaclotide having an X-ray powder diffraction pattern comprising peaks at about 6.2, about 7.8, about 22.6 and about 23.9+/−0.5 degrees 2θ, comprising crystallizing linaclotide to form the crystalline form of linaclotide and optionally isolating the crystalline form of linaclotide.
5. The crystalline form of claim 1 , wherein the crystalline form has a melting endotherm at about 270° C. as determined by DSC.
6. A crystalline form of linaclotide having a melting endotherm at about 270° C. as determined by DSC and X-ray powder diffraction pattern comprising characteristic peaks at about 7.8 and about 23.9+/−0.5 degrees 2θ.