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
- 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
-
- 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
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Endocrinology (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Reproductive Health (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Diabetes (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Pregnancy & Childbirth (AREA)
- Gynecology & Obstetrics (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 | 2007-11-01 | ||
| EP07119832.9 | 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 |
Family
ID=39167502
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 |
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| AU2009203809B2 (en) | 2008-01-09 | 2013-07-25 | Sanofi-Aventis Deutschland Gmbh | Novel insulin derivatives having an extremely delayed time-action profile |
| PT3228320T (pt) | 2008-10-17 | 2020-03-26 | Sanofi Aventis Deutschland | Combinação de uma insulina e de um agonista do glp-1 |
| JP2011001273A (ja) * | 2009-06-16 | 2011-01-06 | Eci Inc | ｅＭＩＰを有効成分とする水溶性製剤 |
| KR101853606B1 (ko) * | 2009-07-06 | 2018-05-03 | 사노피-아벤티스 도이칠란트 게엠베하 | 메티오닌을 함유하는 수성 인슐린 제제 |
| DK2498802T3 (en) | 2009-11-13 | 2015-04-13 | Sanofi Aventis Deutschland | Pharmaceutical composition comprising a GLP-1 agonist, insulin and a methionine |
| KR101337322B1 (ko) | 2009-11-13 | 2013-12-06 | 사노피-아벤티스 도이칠란트 게엠베하 | Ｇｌｐ-1 효능제 및 메티오닌을 포함하는 약제학적 조성물 |
| WO2011099036A2 (en) * | 2010-02-12 | 2011-08-18 | Intas Biopharmaceuticals Limited | Liquid formulation of follicle stimulating hormone |
| ES2606554T3 (es) | 2010-08-30 | 2017-03-24 | Sanofi-Aventis Deutschland Gmbh | Uso de AVE0010 para la fabricación de un medicamento para el tratamiento de la diabetes mellitus de 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 |
| PL2750699T3 (pl) | 2011-08-29 | 2015-12-31 | Sanofi Aventis Deutschland | Kombinacja farmaceutyczna do stosowania w kontroli glikemii u pacjentów z cukrzycą typu 2 |
| AR087744A1 (es) | 2011-09-01 | 2014-04-16 | Sanofi Aventis Deutschland | Composicion farmaceutica para uso en el tratamiento de una enfermedad neurodegenerativa |
| BR112015013223A2 (pt) * | 2012-12-26 | 2017-07-11 | Wockhardt Ltd | composição farmacêutica |
| 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 |
| EP3091965A1 (en) | 2014-01-09 | 2016-11-16 | Sanofi | Stabilized glycerol free pharmaceutical formulations of insulin analogues and/or insulin derivatives |
| SG11201604706TA (en) | 2014-01-09 | 2016-07-28 | Sanofi Sa | Stabilized pharmaceutical formulations of insulin aspart |
| CN112957455A (zh) | 2014-01-09 | 2021-06-15 | 赛诺菲 | 胰岛素类似物和/或胰岛素衍生物的稳定化药物制剂 |
| AU2015359376B2 (en) | 2014-12-12 | 2021-09-09 | Sanofi-Aventis Deutschland Gmbh | Insulin glargine/lixisenatide fixed ratio formulation |
| 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 |
| ES2166841T3 (es) * | 1995-03-21 | 2002-05-01 | Applied Research Systems | Formulaciones liquidas de hcg. |
| TW518235B (en) * | 1997-01-15 | 2003-01-21 | Akzo Nobel Nv | A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage |
| IL140984A0 (en) * | 1998-07-23 | 2002-02-10 | Lilly Co Eli | Fsh and fsh variant formulations, products and methods |
| DK1599222T3 (da) * | 2003-01-08 | 2009-04-27 | Novartis Vaccines & Diagnostic | Stabiliserede vandige pr parater omfattende v vsfaktorvej-inhibitor (TFPI) eller v vsfaktorvej-inhibitorvariant |
| US7387998B2 (en) | 2003-03-28 | 2008-06-17 | New York University | STQ peptides |
| AU2004226666B9 (en) * | 2003-04-02 | 2010-04-08 | Ares Trading S.A. | Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant |
-
2008
- 2008-10-29 CA CA2700662A patent/CA2700662C/en not_active Expired - Fee Related
- 2008-10-29 PT PT08844750T patent/PT2219607E/pt unknown
- 2008-10-29 EA EA201070549A patent/EA019432B1/ru not_active IP Right Cessation
- 2008-10-29 BR BRPI0818324A patent/BRPI0818324B8/pt active IP Right Grant
- 2008-10-29 DK DK08844750.3T patent/DK2219607T3/da active
- 2008-10-29 HR HRP20120660AT patent/HRP20120660T1/hr unknown
- 2008-10-29 ES ES08844750T patent/ES2393233T3/es active Active
- 2008-10-29 MY MYPI2010001950A patent/MY153976A/en unknown
- 2008-10-29 AU AU2008320844A patent/AU2008320844B2/en active Active
- 2008-10-29 PL PL08844750T patent/PL2219607T3/pl unknown
- 2008-10-29 UA UAA201006712A patent/UA101484C2/ru unknown
- 2008-10-29 NZ NZ583991A patent/NZ583991A/en unknown
- 2008-10-29 JP JP2010531519A patent/JP5551601B2/ja active Active
- 2008-10-29 WO PCT/EP2008/064679 patent/WO2009056569A1/en not_active Ceased
- 2008-10-29 EP EP08844750A patent/EP2219607B1/en active Active
- 2008-10-29 US US12/681,688 patent/US8664369B2/en active Active
- 2008-10-29 SI SI200830735T patent/SI2219607T1/sl unknown
- 2008-10-29 KR KR1020107012131A patent/KR101513181B1/ko active Active
- 2008-10-29 RS RS20120484A patent/RS52566B/sr unknown
- 2008-10-29 CN CN2008801145250A patent/CN101842083B/zh active Active
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