Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant
AssigneeAres Trading S.A.
InventorsFabrizio Samaritani, Piergiorgio Donati
Life of this patent
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Abstract
The invention relates to the field of pharmaceutical formulations of follicle-stimulating hormone (FSH), luteinising hormone (LH), and mixtures of FSH and luteinising hormone (LH), and to methods of producing such formulations. The invention provides a liquid or freeze-dried formulation of FSH, or LH, or FSH and LH comprising a surfactant selected from Pluronic® F77, Pluronic F87, Pluronic F88 and Pluronic F68.
Claims58
A liquid pharmaceutical composition, comprising:
- a follicle stimulating hormone,
- m-cresol,
- a diluent, and
- poloxamer 188,
- the composition having a stability sufficient to avoid precipitation.
A liquid pharmaceutical composition, comprising:
- a follicle stimulating hormone,
- a luteinising hormone,
- a bacteriostatic agent selected form the group consisting of phenol and m-cresol,
- poloxamer 188, and
- a diluent
- wherein either the follicle stimulating hormone is human follicle stimulating hormone, or the luteinising hormone is human luteinising hormone, or both the follicle stimulating hormone is human follicle stimulating hormone and the luteinising hormone is human luteinising hormone,
- the composition having a stability sufficient to avoid precipitation.
A liquid pharmaceutical composition, comprising:
- a follicle stimulating hormone,
- a luteinising hormone,
- a bacteriostatic agent selected form the group consisting of phenol and m-cresol,
- poloxamer 188, and
- a diluent
- wherein either the follicle stimulating hormone is urinary human follicle stimulating hormone, or the luteinising hormone is urinary human luteinising hormone, or both the follicle stimulating hormone is urinary human follicle stimulating hormone and the luteinising hormone is urinary human luteinising hormone,
- the composition having a stability sufficient to avoid precipitation.
A liquid pharmaceutical composition, comprising:
- a follicle stimulating hormone,
- a luteinising hormone,
- a bacteriostatic agent selected form the group consisting of phenol and m-cresol,
- poloxamer 188, and
- a diluent
- wherein either the follicle stimulating hormone is recombinant human follicle stimulating hormone, or the luteinising hormone is recombinant human luteinising hormone, or both the follicle stimulating hormone is recombinant human follicle stimulating hormone and the recombinant luteinising hormone is human luteinising hormone,
- the composition having a stability sufficient to avoid precipitation.
A liquid pharmaceutical composition, comprising:
- a follicle stimulating hormone,
- phenol,
- a diluent, and
- poloxamer 188,
- the composition having a stability sufficient to avoid precipitation.
Dependencies are inferred from the claim text.