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Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant

A surfactant, liquid drug technology, used in luteinizing hormone preparations, FSH and LH mixtures, and follicle-stimulating hormone pharmaceutical preparations, which can solve problems such as disappearance of biological efficacy

Active Publication Date: 2009-05-20
ARES TRADING SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Dissociation of subunits results in loss of biological potency 4

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
  • Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0228] Comparative preparation

[0229] Material

[0230] 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, Ph Eur, 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

[0231] 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

Syringe Driven Filters - Durapore Millipore

Durapore filter membrane 0...

Embodiment 2

[0264] Liquid single-dose formulation of recombinant FSH for subcutaneous or intramuscular injection

[0265] Based on the results of Example 1, the following formulations were prepared.

[0266] 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.

[0267] Because of the use of recombinant FSH, the biological activity and specificity are consistent, so that a large amount of filling FSH (fill-by-mass) can be achieved instead of filling through biological tests.

[0268]

[0269] Fill and seal vials under aseptic conditions. These preparations can be stored at room temperature for up to 2 years.

Embodiment 3

[0271] Liquid multiple-dose formulation of recombinant FSH for subcutaneous or intramuscular injection

[0272] Based on the results of Example 1, the following multi-dose formulations were prepared.

[0273] 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.

[0274] Fill and seal syringe barrels under aseptic conditions. These multi-dose formulations may be stored at about 2-8°C, preferably at about 4-5°C, up to a maximum of 2 years after first use. After first use, the syringe should be stored at about 2-8°C, preferably at about 4-5°C, for a period of 24 hours, 2 days, or up to 12 or 14 days.

[0275]

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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 the group consisting of Pluronic(R) 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 Patents(China)
IPC IPC(8): A61K47/10A61K38/24A61P5/06
Inventor F·萨马利塔尼P·多纳蒂
Owner ARES TRADING SA
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