CA2700662C - Lh liquid formulations - Google Patents
Lh liquid formulations Download PDFInfo
- Publication number
- CA2700662C CA2700662C CA2700662A CA2700662A CA2700662C CA 2700662 C CA2700662 C CA 2700662C CA 2700662 A CA2700662 A CA 2700662A CA 2700662 A CA2700662 A CA 2700662A CA 2700662 C CA2700662 C CA 2700662C
- Authority
- CA
- Canada
- Prior art keywords
- formulation
- formulation according
- hlh
- formulations
- fsh
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 239000012669 liquid formulation Substances 0.000 title claims description 31
- 108010073521 Luteinizing Hormone Proteins 0.000 claims abstract description 154
- 102000009151 Luteinizing Hormone Human genes 0.000 claims abstract description 154
- 229940040129 luteinizing hormone Drugs 0.000 claims abstract description 152
- 239000008194 pharmaceutical composition Substances 0.000 claims abstract description 10
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical compound OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims description 240
- 239000000203 mixture Substances 0.000 claims description 185
- 238000009472 formulation Methods 0.000 claims description 169
- KDXKERNSBIXSRK-YFKPBYRVSA-N L-lysine Chemical compound NCCCC[C@H](N)C(O)=O KDXKERNSBIXSRK-YFKPBYRVSA-N 0.000 claims description 97
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims description 97
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- 229940028334 follicle stimulating hormone Drugs 0.000 claims description 78
- 229960000686 benzalkonium chloride Drugs 0.000 claims description 62
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 claims description 62
- 150000003839 salts Chemical class 0.000 claims description 46
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 claims description 44
- 238000003860 storage Methods 0.000 claims description 39
- 239000000243 solution Substances 0.000 claims description 34
- 239000000022 bacteriostatic agent Substances 0.000 claims description 33
- 239000004475 Arginine Substances 0.000 claims description 31
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 31
- 235000009697 arginine Nutrition 0.000 claims description 31
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- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims description 29
- 229930182817 methionine Natural products 0.000 claims description 29
- 229960004217 benzyl alcohol Drugs 0.000 claims description 28
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 25
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- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 23
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 22
- 238000000034 method Methods 0.000 claims description 19
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 16
- WVDDGKGOMKODPV-ZQBYOMGUSA-N phenyl(114C)methanol Chemical compound O[14CH2]C1=CC=CC=C1 WVDDGKGOMKODPV-ZQBYOMGUSA-N 0.000 claims description 15
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims description 14
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- BVHLGVCQOALMSV-JEDNCBNOSA-N L-lysine hydrochloride Chemical compound Cl.NCCCC[C@H](N)C(O)=O BVHLGVCQOALMSV-JEDNCBNOSA-N 0.000 claims description 7
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- KWTQSFXGGICVPE-WCCKRBBISA-N Arginine hydrochloride Chemical compound Cl.OC(=O)[C@@H](N)CCCN=C(N)N KWTQSFXGGICVPE-WCCKRBBISA-N 0.000 claims description 5
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Classifications
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- A—HUMAN NECESSITIES
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- 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
- 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]
-
- 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
-
- 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
-
- 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
-
- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Reproductive Health (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Gynecology & Obstetrics (AREA)
- Pregnancy & Childbirth (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP07119832.9 | 2007-11-01 | ||
| EP07119832 | 2007-11-01 | ||
| US448107P | 2007-11-28 | 2007-11-28 | |
| US61/004,481 | 2007-11-28 | ||
| PCT/EP2008/064679 WO2009056569A1 (en) | 2007-11-01 | 2008-10-29 | Lh liquid formulations |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2700662A1 CA2700662A1 (en) | 2009-05-07 |
| CA2700662C true CA2700662C (en) | 2015-10-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2700662A Expired - Fee Related CA2700662C (en) | 2007-11-01 | 2008-10-29 | Lh liquid formulations |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US8664369B2 (enExample) |
| EP (1) | EP2219607B1 (enExample) |
| JP (1) | JP5551601B2 (enExample) |
| KR (1) | KR101513181B1 (enExample) |
| CN (1) | CN101842083B (enExample) |
| AU (1) | AU2008320844B2 (enExample) |
| BR (1) | BRPI0818324B8 (enExample) |
| CA (1) | CA2700662C (enExample) |
| CY (1) | CY1113121T1 (enExample) |
| DK (1) | DK2219607T3 (enExample) |
| EA (1) | EA019432B1 (enExample) |
| EC (1) | ECSP10010224A (enExample) |
| ES (1) | ES2393233T3 (enExample) |
| HR (1) | HRP20120660T1 (enExample) |
| IL (1) | IL205105A (enExample) |
| MX (1) | MX2010004639A (enExample) |
| MY (1) | MY153976A (enExample) |
| NZ (1) | NZ583991A (enExample) |
| PL (1) | PL2219607T3 (enExample) |
| PT (1) | PT2219607E (enExample) |
| RS (1) | RS52566B (enExample) |
| SI (1) | SI2219607T1 (enExample) |
| UA (1) | UA101484C2 (enExample) |
| WO (1) | WO2009056569A1 (enExample) |
| ZA (1) | ZA201001907B (enExample) |
Families Citing this family (22)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2613152T3 (es) | 2008-01-09 | 2017-05-22 | Sanofi-Aventis Deutschland Gmbh | Nuevos derivados de insulina con perfil tiempo/acción extremadamente retardado |
| CA3016451A1 (en) | 2008-10-17 | 2010-04-22 | Sanofi-Aventis Deutschland Gmbh | Combination of an insulin and a glp-1 agonist |
| JP2011001273A (ja) * | 2009-06-16 | 2011-01-06 | Eci Inc | ｅＭＩＰを有効成分とする水溶性製剤 |
| SG10201403840VA (en) * | 2009-07-06 | 2014-10-30 | Sanofi Aventis Deutschland | Aqueous insulin preparations containing methionine |
| DK2498802T3 (en) | 2009-11-13 | 2015-04-13 | Sanofi Aventis Deutschland | Pharmaceutical composition comprising a GLP-1 agonist, insulin and a methionine |
| PL3345593T3 (pl) | 2009-11-13 | 2024-04-08 | Sanofi-Aventis Deutschland Gmbh | Kompozycja farmaceutyczna zawierająca desPro36-eksendynę-4(1-39)-Lys6-NH2 i metioninę |
| WO2011099036A2 (en) * | 2010-02-12 | 2011-08-18 | Intas Biopharmaceuticals Limited | Liquid formulation of follicle stimulating hormone |
| PT2611458T (pt) | 2010-08-30 | 2016-12-16 | Sanofi Aventis Deutschland | Utilização de ave0010 para o fabrico de um medicamento para o tratamento da diabetes mellitus tipo 2 |
| US9821032B2 (en) | 2011-05-13 | 2017-11-21 | Sanofi-Aventis Deutschland Gmbh | Pharmaceutical combination for improving glycemic control as add-on therapy to basal insulin |
| CN102293756A (zh) * | 2011-08-24 | 2011-12-28 | 蚌埠丰原涂山制药有限公司 | 一种尿促性素冻干粉针剂及其制备方法 |
| DK2750699T3 (en) | 2011-08-29 | 2015-10-26 | Sanofi Aventis Deutschland | A pharmaceutical combination for use in glycemic control in diabetes type 2 patients |
| TWI559929B (en) | 2011-09-01 | 2016-12-01 | Sanofi Aventis Deutschland | Pharmaceutical composition for use in the treatment of a neurodegenerative disease |
| AU2013368990B2 (en) * | 2012-12-26 | 2017-05-18 | Wockhardt Limited | Pharmaceutical composition |
| TWI641381B (zh) | 2013-02-04 | 2018-11-21 | 法商賽諾菲公司 | 胰島素類似物及／或胰島素衍生物之穩定化醫藥調配物 |
| US20160024181A1 (en) | 2013-03-13 | 2016-01-28 | Moderna Therapeutics, Inc. | Long-lived polynucleotide molecules |
| KR20160104724A (ko) | 2014-01-09 | 2016-09-05 | 사노피 | 인슐린 유사체 및/또는 인슐린 유도체의 안정화된 약제학적 제형 |
| MX2016008977A (es) | 2014-01-09 | 2016-10-04 | Sanofi Sa | Formulaciones farmaceuticas de insulina aspart estabilizadas. |
| WO2015104311A1 (en) | 2014-01-09 | 2015-07-16 | Sanofi | Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives |
| ES2949095T3 (es) | 2014-12-12 | 2023-09-25 | Sanofi Aventis Deutschland | Formulación de relación fija de insulina glargina/lixisenatida |
| TWI748945B (zh) | 2015-03-13 | 2021-12-11 | 德商賽諾菲阿凡提斯德意志有限公司 | 第２型糖尿病病患治療 |
| TW201705975A (zh) | 2015-03-18 | 2017-02-16 | 賽諾菲阿凡提斯德意志有限公司 | 第２型糖尿病病患之治療 |
| GB201603280D0 (en) * | 2016-02-24 | 2016-04-13 | Ferring Bv | Stable liquid gonadotropin formulation |
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| IE64738B1 (en) * | 1990-03-20 | 1995-09-06 | Akzo Nv | Stabilized gonadotropin containing preparations |
| IT1250075B (it) * | 1991-12-18 | 1995-03-30 | Serono Cesare Ist Ricerca | Composizioni farmaceutiche contenenti gonadotropine. |
| US5681302A (en) * | 1994-06-14 | 1997-10-28 | Minnesota Mining And Manufacturing Company | Elastic sheet-like composite |
| JP4165718B2 (ja) * | 1995-03-21 | 2008-10-15 | ラボラトワール セローノ ソシエテ アノニム | ｈＣＧ液体製剤 |
| IL122732A0 (en) * | 1997-01-15 | 1998-08-16 | Akzo Nobel Nv | Liquid gonadotropin-containing formulation its preparation and a device containing same |
| WO2000004913A1 (en) * | 1998-07-23 | 2000-02-03 | Eli Lilly And Company | Fsh and fsh variant formulations, products and methods |
| PT1599222E (pt) * | 2003-01-08 | 2009-06-12 | Novartis Vaccines & Diagnostic | Composições aquosas estabilizadas que contêm um inibidor da via do factor tecidular (tfpi) ou uma variante do inibidor da via do factor tecidular |
| US7387998B2 (en) | 2003-03-28 | 2008-06-17 | New York University | STQ peptides |
| RS57872B1 (sr) * | 2003-04-02 | 2018-12-31 | Ares Trading Sa | Tečne farmaceutske formulacije fsh i lh zajedno sa nejonskim surfaktantom |
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- 2008-10-29 UA UAA201006712A patent/UA101484C2/ru unknown
- 2008-10-29 ES ES08844750T patent/ES2393233T3/es active Active
- 2008-10-29 KR KR1020107012131A patent/KR101513181B1/ko active Active
- 2008-10-29 NZ NZ583991A patent/NZ583991A/en unknown
- 2008-10-29 RS RS20120484A patent/RS52566B/sr unknown
- 2008-10-29 PL PL08844750T patent/PL2219607T3/pl unknown
- 2008-10-29 HR HRP20120660AT patent/HRP20120660T1/hr unknown
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- 2008-10-29 WO PCT/EP2008/064679 patent/WO2009056569A1/en not_active Ceased
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- 2008-10-29 JP JP2010531519A patent/JP5551601B2/ja active Active
- 2008-10-29 SI SI200830735T patent/SI2219607T1/sl unknown
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2010
- 2010-03-17 ZA ZA2010/01907A patent/ZA201001907B/en unknown
- 2010-04-15 IL IL205105A patent/IL205105A/en active IP Right Grant
- 2010-05-31 EC EC2010010224A patent/ECSP10010224A/es unknown
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2012
- 2012-09-13 CY CY20121100836T patent/CY1113121T1/el unknown
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