Reconstitutable teverelix-TFA composition
AssigneeAntev Limited
InventorsFinn Larsen, Francois Boutignon, Guy Poland
Life of this patent
Estimating the term…
Abstract
The present invention relates to a reconstitutable teverelix-TFA composition having a predefined molar ratio of teverelix to trifluoroacetate which is below the molar ratio required for microcrystal formation. Said composition remains stable during storage e.g. at a temperature around 2-8° C. Upon reconstitution a fixed amount of trifluoroacetate can be added to said composition thereby effectively and simply achieving an exact and desired molar ratio in order to obtain a fluid, milky microcrystalline aqueous teverelix-TFA suspension.
Claims12
A stable reconstitutable teverelix-TFA composition having a molar ratio of teverelix (Ac-D-Nal-D-pClPhe-D-Pal-Ser-Tyr-D-Hci-Leu-Lys(iPr)-Pro-D-Ala-NH2) to trifluoroacetate below the molar ratio required for microcrystal formation,
- wherein the composition comprises between 1.3 mol trifluoroacetate and 1.6 mol trifluoroacetate per mol teverelix,
- wherein the reconstitutable composition is a powder,
- wherein water is present in the reconstitutable teverelix-TFA composition in an amount between 0.3% and 5% by weight based on the total weight of the reconstitutable teverelix-TFA composition, and
- wherein the composition forms a gel without any insoluble teverelix in the form of microcrystals.
Dependencies are inferred from the claim text.