NZ744294B2 - Stable liquid gonadotropin formulation - Google Patents
Stable liquid gonadotropin formulation Download PDFInfo
- Publication number
- NZ744294B2 NZ744294B2 NZ744294A NZ74429417A NZ744294B2 NZ 744294 B2 NZ744294 B2 NZ 744294B2 NZ 744294 A NZ744294 A NZ 744294A NZ 74429417 A NZ74429417 A NZ 74429417A NZ 744294 B2 NZ744294 B2 NZ 744294B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- pharmaceutical formulation
- formulation
- amount
- hmg
- comprised
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
Abstract
The present invention pertains in general to the field of the stabilization of gonadotropin formulations, in particular liquid formulations of gonadotropins. The stabilization is achieved by a particular combination of excipients, preferably arginine and methionine. In a preferred embodiment, the formulation does not comprise a buffer.
Claims (21)
1. A liquid pharmaceutical gonadotropin formulation, comprising a tropin, arginine in an amount of from 50 to 160 mM, and methionine in an amount of from 0.05 to 1.5 mg/ml, wherein the formulation does not comprise an additional buffer, and wherein the pH of the ation is n 6.0 and 7.5.
2. The pharmaceutical formulation of claim 1, wherein the gonadotropin comprises hCG (human nic gonadotropin), and optionally FSH and/or LH.
3. The pharmaceutical formulation of claim 1 or 2, wherein the tropin comprises hMG (human menopausal gonadotropin).
4. The pharmaceutical formulation of any one of claims 1 to 3, wherein the gonadotropin comprises human origin, urinary-derived FSH, LH and/or hCG.
5. The pharmaceutical formulation of any one of claims 1 to 3, wherein the gonadotropin comprises recombinant FSH, LH and/or hCG.
6. The pharmaceutical formulation of any one of the preceding claims, additionally comprising a preservative.
7. The pharmaceutical formulation of claim 6, wherein the preservative is phenol.
8. The pharmaceutical formulation of any one of the preceding claims, additionally comprising a surface-active agent.
9. The pharmaceutical formulation of claim 8, wherein the surface-active agent is a polysorbate.
10. The pharmaceutical formulation of claim 8 or claim 9, wherein the e-active agent is polysorbate 20.
11. The pharmaceutical ation of claims 6 or 7, wherein the preservative is comprised in an amount of 4 – 6 mg/ml.
12. The pharmaceutical formulation of claims 6 or 7, wherein the preservative is comprised in an amount of 5 mg/ml.
13. The pharmaceutical ation of any one of claims 8-10 , wherein the surface-active agent is comprised in an amount of 0.001 – 0.05 mg/ml.
14. The pharmaceutical formulation of any one of claims 8-10, wherein the surface-active agent is comprised in an amount of 0.005 mg/ml.
15. The pharmaceutical formulation of any one of the preceding claims, wherein the arginine is L-arginine HCl.
16. The ceutical formulation of any one of the preceding claims, wherein the hMG, if present, is comprised in an amount of 300 – 900 IU/ml.
17. The ceutical formulation of any one of the preceding claims, wherein the hMG, if present, is comprised in an amount of 500 – 700, IU/ml.
18. The ceutical formulation of any one of the preceding claims, which consists of - 625 IU/ml hMG - 0.15 mg/ml Methionine - 150 mM arginine - 5 mg/ml phenol - 0.005 mg/ml polysorbate 20 - Water for injection (WFI), and - wherein the formulation has a pH of 6.8 +/- 0.3.
19. Use of a liquid pharmaceutical formulation as described in any one of the preceding claims, in the manufacture of a medicament for treatment of infertility.
20. The use of claim 14, wherein the treatment of infertility is a treatment of ovulation induction (OI), assisted reproductive techniques (ART), and/or hypogonadotrophic nadism in
21. A method for stabilization of a liquid pharmaceutical formulation, comprising hMG, which comprises the step of - providing a sample of urine from a human woman, - extracting hMG from the sample, - compounding said extract with arginine and methionine, in s as defined in any of the preceding claims, - adjusting the pH of the ation to between 6.0 and 7.5, - wherein no additional buffer is added.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB1603280.7A GB201603280D0 (en) | 2016-02-24 | 2016-02-24 | Stable liquid gonadotropin formulation |
| PCT/EP2017/054325 WO2017144659A1 (en) | 2016-02-24 | 2017-02-24 | Stable liquid gonadotropin formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ744294A NZ744294A (en) | 2024-08-30 |
| NZ744294B2 true NZ744294B2 (en) | 2024-12-03 |
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