DK1417972T4 - Stabiliserede teriparatid-opløsninger - Google Patents
Stabiliserede teriparatid-opløsninger Download PDFInfo
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- DK1417972T4 DK1417972T4 DK03104219.5T DK03104219T DK1417972T4 DK 1417972 T4 DK1417972 T4 DK 1417972T4 DK 03104219 T DK03104219 T DK 03104219T DK 1417972 T4 DK1417972 T4 DK 1417972T4
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- SYSWVVCYSXBVJG-RHYQMDGZSA-N Val-Leu-Thr Chemical compound C[C@H]([C@@H](C(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](C(C)C)N)O SYSWVVCYSXBVJG-RHYQMDGZSA-N 0.000 description 1
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- UREZNYTWGJKWBI-UHFFFAOYSA-M benzethonium chloride Chemical compound [Cl-].C1=CC(C(C)(C)CC(C)(C)C)=CC=C1OCCOCC[N+](C)(C)CC1=CC=CC=C1 UREZNYTWGJKWBI-UHFFFAOYSA-M 0.000 description 1
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- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
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Classifications
-
- 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
- A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
-
- 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
-
- 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
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physical Education & Sports Medicine (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Silver Salt Photography Or Processing Solution Therefor (AREA)
Claims (11)
1. Fremgangsmåde til fremstilling af en farmaceutisk sammensætning i form af en steril opløsning, der er klar til parenteral indgivelse, hvilken fremgangsmåde omfatter: at blande humant PTH(1-34), et buffermiddel og et hjælpestof for at danne en vandig opløsning, der indeholder PTH i et koncentrationsområde fra 25pg/mL til 1000pg/mL, hvilken derefter steril-filtreres og fyldes i et rør eller en patron til anvendelse, hvor hjælpestoffet omfatter et polyolstabilise-ringsmiddel, og hvor sammensætningen yderligere omfatter et parenteralt acceptabelt konserveringsmiddel.
2. Fremgangsmåde ifølge krav 1, hvor buffermidlet er udvalgt blandt citrat, tartrat eller acetat.
3. Fremgangsmåde ifølge krav 2, hvor buffermidlet er acetat.
4. Fremgangsmåde ifølge et hvilket som helst af kravene 1-3, hvor koncentrationen af buffermidlet i sammensætningen ligger i området 2mM til 500mM.
5. Fremgangsmåde ifølge et hvilket som helst af kravene 1 -4, hvor buffermidlet bibeholder en pH-værdi fra 3 til 6.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1-5, hvor polyolsta-biliseringsmidlet er et saccharid, en sukkeralkohol, såsom mannitol, eller en polyal kohol.
7. Fremgangsmåde ifølge krav 6, hvor polyolstabiliseringsmidlet foreligger i en mængde på 1-20 vægtprocent af sammensætningen.
8. Fremgangsmåde ifølge et af de foregående krav, hvor konserveringsmidlet er m-cresol eller benzoylalkohol.
9. Fremgangsmåde ifølge et hvilket som helst af kravene 1-8, hvor konserveringsmidlet foreligger i en mængde på 0,1-2 vægtprocent af sammensætningen.
10. Fremgangsmåde ifølge et hvilket som helst af kravene 1-9, hvor koncentrationen af PTH(1-34) ligger i området 100pg/mL til 500pg/mL.
11. Farmaceutisk sammensætning i form af en stabiliseret opløsning, omfattende: (a) en terapeutisk virksom mængde af humant PTH(1-34); (b) en virksom mængde af et polyolstabiliseringsmiddel; (c) et buffermiddel i en mængde, der er tilstrækkelig til at bibeholde pH-værdien af sammensætningen inden for et område på ca. 3-7; (d) et parenteralt acceptabelt konserveringsmiddel; og (e) balancen er vand.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US6907597P | 1997-12-09 | 1997-12-09 | |
| EP98123225A EP0920873B1 (en) | 1997-12-09 | 1998-12-07 | Stabilized teriparatide solutions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| DK1417972T3 DK1417972T3 (da) | 2013-05-13 |
| DK1417972T4 true DK1417972T4 (da) | 2018-10-22 |
Family
ID=22086574
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK03104219.5T DK1417972T4 (da) | 1997-12-09 | 1998-12-07 | Stabiliserede teriparatid-opløsninger |
| DK98123225T DK0920873T3 (da) | 1997-12-09 | 1998-12-07 | Stabiliserede teriparatidoplösninger |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK98123225T DK0920873T3 (da) | 1997-12-09 | 1998-12-07 | Stabiliserede teriparatidoplösninger |
Country Status (32)
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| EP (2) | EP0920873B1 (da) |
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| KR (1) | KR100482703B1 (da) |
| CN (1) | CN1198644C (da) |
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| AT (1) | ATE260113T1 (da) |
| AU (1) | AU759726B2 (da) |
| BR (1) | BR9813463A (da) |
| CA (1) | CA2314313C (da) |
| CY (1) | CY1114000T1 (da) |
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| ES (2) | ES2215268T3 (da) |
| HK (1) | HK1021798A1 (da) |
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| ID (1) | ID27741A (da) |
| IL (1) | IL136662A (da) |
| MY (1) | MY120063A (da) |
| NO (1) | NO327302B1 (da) |
| NZ (1) | NZ505222A (da) |
| PE (1) | PE20000001A1 (da) |
| PL (1) | PL194268B1 (da) |
| PT (2) | PT920873E (da) |
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| UA (1) | UA72884C2 (da) |
| WO (1) | WO1999029337A1 (da) |
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Families Citing this family (59)
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| US20030166525A1 (en) | 1998-07-23 | 2003-09-04 | Hoffmann James Arthur | FSH Formulation |
| WO2000004913A1 (en) * | 1998-07-23 | 2000-02-03 | Eli Lilly And Company | Fsh and fsh variant formulations, products and methods |
| AR033639A1 (es) | 1998-08-19 | 2004-01-07 | Lilly Co Eli | Uso de hormonas paratiroideas para preparar medicamentos para reducir el riesgo de fracturas oseas vertebrales o no vertebrales en seres humanos con riesgo de padecer o que padecen osteoporosis |
| US7022674B2 (en) | 1999-12-16 | 2006-04-04 | Eli Lilly And Company | Polypeptide compositions with improved stability |
| CA2380423A1 (en) * | 2000-05-17 | 2001-11-22 | Bionebraska, Inc. | Peptide pharmaceutical formulations |
| EP1301200A2 (en) * | 2000-05-19 | 2003-04-16 | Bionebraska, Inc. | Peptide pharmaceutical formulations |
| EP1391209A4 (en) * | 2001-05-30 | 2009-12-16 | Chugai Pharmaceutical Co Ltd | PROTEIN PREPARATION |
| WO2003039331A2 (en) * | 2001-11-05 | 2003-05-15 | Eli Lilly And Company | Method for improving stability of a bone-connecting implant |
| EP1767213A3 (en) * | 2001-11-05 | 2007-04-25 | Eli Lilly & Company | Method for improving stability of a bone-connecting implant |
| US8088734B2 (en) | 2003-01-21 | 2012-01-03 | Unigene Laboratories Inc. | Oral delivery of peptides |
| ATE492292T2 (de) | 2003-04-02 | 2011-01-15 | Ares Trading Sa | Flüssige oder gefriergetrocknete pharmazeutische zusammensetzung enthaltend fsh und/oder lh, das nichtionische tensid poloxamer 188 und ein antibakterielles mittel |
| EP1638595B1 (en) | 2003-06-20 | 2013-03-20 | Ares Trading S.A. | Freeze-dried fsh / lh formulations |
| US7329725B1 (en) | 2003-10-29 | 2008-02-12 | Nastech Pharmaceutical Company Inc. | Phage displayed Trp cage ligands |
| CA2545034C (en) | 2003-11-20 | 2013-03-05 | Novo Nordisk A/S | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
| DK1716119T3 (da) | 2003-12-23 | 2013-06-10 | Infinity Discovery Inc | Analoger af benzoquinonholdige ansamyciner til behandling af cancer |
| US8268791B2 (en) | 2004-08-25 | 2012-09-18 | Aegis Therapeutics, Llc. | Alkylglycoside compositions for drug administration |
| EP2457580A1 (en) * | 2004-08-25 | 2012-05-30 | The UAB Research Foundation | Absorption enhancers for drug administration |
| US9114069B2 (en) | 2004-08-25 | 2015-08-25 | Aegis Therapeutics, Llc | Antibacterial compositions for drug administration |
| US20140162965A1 (en) | 2004-08-25 | 2014-06-12 | Aegis Therapeutics, Inc. | Compositions for oral drug administration |
| US9895444B2 (en) | 2004-08-25 | 2018-02-20 | Aegis Therapeutics, Llc | Compositions for drug administration |
| US8642564B2 (en) | 2004-08-25 | 2014-02-04 | Aegis Therapeutics, Llc | Compositions for drug administration |
| US20060046962A1 (en) | 2004-08-25 | 2006-03-02 | Aegis Therapeutics Llc | Absorption enhancers for drug administration |
| KR100700869B1 (ko) * | 2005-06-03 | 2007-03-29 | 재단법인 목암생명공학연구소 | Ｐｔｈ, 완충제 및 안정제를 포함하는 안정한 ｐｔｈ조성물 |
| WO2007059470A2 (en) | 2005-11-10 | 2007-05-24 | Board Of Control Of Michigan Technological University | Black bear parathyroid hormone and methods of using black bear parathyroid hormone |
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| USRE49444E1 (en) | 2006-10-03 | 2023-03-07 | Radius Health, Inc. | Method of treating osteoporosis comprising administration of PTHrP analog |
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| EP1958618A1 (de) | 2007-02-15 | 2008-08-20 | Octapharma AG | Verfahren zur Gefriertrocknung mit optimierter Rekonstitution von Biopolymeren |
| BRPI0810835A2 (pt) * | 2007-04-12 | 2015-06-16 | Infinity Discovery Inc | Formulações de hidroquinona ansamicina |
| WO2008150929A1 (en) * | 2007-05-29 | 2008-12-11 | Manhattan Pharmaceuticals, Inc. | Topical compositions comprising a macromolecule and methods of using same |
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| CN102245021B (zh) | 2008-10-15 | 2014-09-17 | 无限药品公司 | 安莎霉素氢醌组合物 |
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| KR20190095552A (ko) * | 2009-09-09 | 2019-08-14 | 아사히 가세이 파마 가부시키가이샤 | 1회당 100∼200 단위의 ｐｔｈ가 주 1회 투여되는 것을 특징으로 하는, ｐｔｈ 함유 골다공증 치료/예방제 |
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| JPS6360940A (ja) † | 1986-09-01 | 1988-03-17 | Toyo Jozo Co Ltd | 白内障の予防または治療剤 |
| JP2505812B2 (ja) * | 1987-07-10 | 1996-06-12 | 旭化成工業株式会社 | ｈ―ＰＴＨ（１―３４）凍結乾燥組成物 |
| US5059587A (en) * | 1987-08-03 | 1991-10-22 | Toyo Jozo Company, Ltd. | Physiologically active peptide composition for nasal administration |
| DE3935738A1 (de) * | 1989-10-27 | 1991-05-08 | Forssmann Wolf Georg | Arzneimittel, enthaltend das humane parathormon-fragment (1-37) als aktiven wirkstoff |
| GB9020544D0 (en) † | 1990-09-20 | 1990-10-31 | Sandoz Ltd | Improvements in or relating to organic compounds |
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| IT1255723B (it) † | 1992-10-09 | 1995-11-13 | Uso di paratormone,suoi frammenti biologicamente attivi e peptidi correlati, per la preparazione di composizioni farmaceutiche utili nella prevenzione e terapia dell'aborto e del parto pretermine ed in generale per il trattamento della gestazione | |
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| DE19538687A1 (de) † | 1995-10-17 | 1997-04-24 | Boehringer Mannheim Gmbh | Stabile pharmazeutische Darreichungsformen enthaltend Parathormon |
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1998
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