A lyophilization process and a teverelix-tfa lyophilizate obtained thereby
AssigneeAntev Limited
InventorsGuy Poland, Francois Boutignon
Life of this patent
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Abstract
The present invention relates to a lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps: a) providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio sufficient for providing a microcrystalline teverelix-TFA suspension without formation of a gel, and b) lyophilizating the lyophilization suspension, thereby providing a teverelix-TFA lyophilizate. The process provides the possibility of obtaining a “pure” teverelix-TFA lyophilizate i.e. without any undesirable residues in the composition.
Claims13
A lyophilization process for preparing a teverelix-TFA lyophilizate, said process comprises the following steps:
- i. providing a lyophilization suspension by mixing teverelix and trifluoroacetate at a molar ratio of teverelix to trifluoroacetate sufficient for providing a microcrystalline teverelix-TFA suspension without formation of a gel, and wherein the composition comprises at least 2.1 mol trifluoroacetate per mol teverelix,
- ii. lyophilizating the lyophilization suspension from step a) thereby providing a teverelix-TFA lyophilizate having a mol content of trifluoroacetate per mol teverelix which is lower than the mol content of trifluoroacetate per mol teverelix in the lyophilization suspension,
- wherein that step a) further comprises the following steps:
- a′) centrifuging or filtering the microcrystalline teverelix-TFA suspension thereby respectively providing a teverelix-TFA pellet or a teverelix-TFA filter cake, and
- a″) suspending said teverelix-TFA pellet or said teverelix-TFA filter cake in an aqueous suspension solution.
Dependencies are inferred from the claim text.