Crystalline form of (r)-2-(tert-butylamino)-1-(5-fluoropyridin-3-yl)-ethan-1-ol hemi-tartrate salt for the treatment of hyperglycemia and diabetes 2
AssigneeAtrogi AB
InventorBenjamin Pelcman
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Abstract
The present invention discloses a crystalline form of the (R)-2-(tert-butylamino)-1-(5-fluoropyridin-3-yl)ethanol (formula (I)) hemi-(2R,3R)-tartrate salt characterised by a melting point of 211° C. and the XRPD pattern of FIG. 1. The present invention also relates to said hemi-tartrate salt for use in the treatment of hyperglycaemia and type 2 diabetes through activation of the beta2-adrenergic receptor. Importantly, such salts are thought to have a beneficial side-effect profile as they do not exert their effect through significant cAMP release.
Claims17
A hemi-tartrate salt of a compound of formula I:
The salt according to any one of the previous claims, wherein the salt has a purity of greater than about 90%, preferably greater than about 95%, more preferably greater than about 99%.
The salt according to any one of the previous claims, wherein the salt has a melting point of from about 209 to about 213° C. at atmospheric pressure, such as from about 210 to about 212° C., e.g. about 211° C.
The salt according to any one of the preceding claims for use in medicine.
A pharmaceutical composition comprising the salt as defined in any of the preceding claims, and optionally one or more pharmaceutically acceptable adjuvant, diluent and/or carrier.
Dependencies are inferred from the claim text.