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Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant

A surfactant and liquid drug technology, applied in the field of luteinizing hormone preparations, FSH and LH mixtures, and follicle stimulating hormone pharmaceutical preparations, can solve the problems of biological efficacy disappearance, etc.

Active Publication Date: 2006-06-28
ARES TRADING SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Dissociation of subunits leads to loss of biological potency4

Method used

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  • Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant
  • Liquid pharmaceutical formulations of fsh and lh together with a non-ionic surfactant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0226] Comparative preparation

[0227] name

manufacturer

r-hFSH Bulk Solution for Candidate Formulations

Laboratoires Serono SA

D-Mannitol

(DAB, Ph Eur, BP, FU, USP, FCC, E421)

Merck

sucrose

(DAB, PhEur, BP, NF)

Merck

NaCl (ACS, ISO)

Merck

Na 2 HPO 4 2H 2 o

(analytical pure)

Merck

NaH 2 PO 4 h 2 o

(analytical pure)

Merck

name

manufacturer

Benzyl alcohol

(analytical pure)

Merck

m-cresol

(for synthesis)

Merck

TWEEN 20 (Polysorbate 20)

(for synthesis)

Merck

Pluronic F68 (Poloxamer 188)

Sigma

L-methionine

(for biochemistry)

Merck

Orthophosphoric acid 85%

(Ph Eur, BP, NF)

Merck

1.5mL glass syringe

SFAM

(siliconed at Aguettant)

Type A rubber

West Company

Crim cover

Aguettant

Millex-GV

Syrin...

Embodiment 2

[0253] Liquid single-dose formulation of recombinant FSH for subcutaneous or intramuscular injection

[0254] Based on the results of Example 1, the following formulations were prepared.

[0255] Components 1 to 7 listed in Table 3 were prepared as equivalent standard solutions in WFI. Add aliquots of each solution to a mixing vessel to form a "mother solution." This stock solution was dispensed into vials containing 10.9 micrograms (150 IU) or 5.45 micrograms (75 IU) of FSH.

[0256] Table 3. Components of FSH single-dose liquid formulations

[0257] Fill and seal vials under aseptic conditions. These preparations can be stored at room temperature for up to 2 years.

Embodiment 3

[0259] Liquid multiple-dose formulation of recombinant FSH for subcutaneous or intramuscular injection

[0260] Based on the results of Example 1, the following multi-dose formulations were prepared.

[0261] Components 1 to 7 listed in Table 4 were prepared as equivalent standard solutions in WFI. Add aliquots of each solution to a mixing vessel to form a "mother solution." This stock solution was dispensed into vials containing 22.2 micrograms (305 IU), 33.3 micrograms (458 IU) and 66.7 micrograms (916 IU) of FSH. The resulting formulations delivered a total of 300, 450 and 900 IU FSH.

[0262] Table 4. Components of FSH Multiple-Dose Liquid Formulations

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PUM

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Abstract

The present invention relates to the field of pharmaceutical preparations of follicle stimulating hormone (FSH), luteinizing hormone (LH) and mixtures of FSH and LH and methods for the production of these preparations. The present invention also provides liquid or lyophilized formulations of FSH, or LH, or FSH and LH, which contain a surfactant selected from Pluronic® F77, Pluronic F87, Pluronic F88 and Pluronic F68.

Description

technical field [0001] The present invention relates to the fields of follicle stimulating hormone (FSH) pharmaceutical preparations, luteinizing hormone (LH) preparations and mixtures of FSH and LH, and also relates to methods for producing these preparations. Background of the invention [0002] Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and chorionic gonadotropin (CG) are all injectable proteins that belong to the class of gonadotropins. FSH, LH and hCG can be used alone or in combination to treat infertility and reproductive disorders in male and female patients. [0003] Natural FSH and LH are produced by the pituitary gland. FSH and LH and their variants for pharmaceutical use can be produced by recombinant techniques (rFSH and rLH) or they can be produced from the urine of postmenopausal women (uFSH and uLH). [0004] Female patients in assisted reproductive technology (ART) use FSH for ovulation induction (OI) and controlled ovulation hyperovulat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/10A61K38/24
Inventor F·萨马利塔尼P·多纳蒂
Owner ARES TRADING SA
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