NO327302B1 - Lagringsstabil sammensetning, forseglet ror eller patron inneholdende nevnte sammensetning samt fremgangsmate for deres fremstilling - Google Patents
Lagringsstabil sammensetning, forseglet ror eller patron inneholdende nevnte sammensetning samt fremgangsmate for deres fremstilling Download PDFInfo
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- NO327302B1 NO327302B1 NO20002945A NO20002945A NO327302B1 NO 327302 B1 NO327302 B1 NO 327302B1 NO 20002945 A NO20002945 A NO 20002945A NO 20002945 A NO20002945 A NO 20002945A NO 327302 B1 NO327302 B1 NO 327302B1
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- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Physical Education & Sports Medicine (AREA)
- Chemical Kinetics & Catalysis (AREA)
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- Endocrinology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Immunology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Rheumatology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US6907597P | 1997-12-09 | 1997-12-09 | |
PCT/US1998/026043 WO1999029337A1 (fr) | 1997-12-09 | 1998-12-08 | Solutions de teriparatide stabilisees |
Publications (3)
Publication Number | Publication Date |
---|---|
NO20002945D0 NO20002945D0 (no) | 2000-06-08 |
NO20002945L NO20002945L (no) | 2000-07-07 |
NO327302B1 true NO327302B1 (no) | 2009-06-02 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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NO20002945A NO327302B1 (no) | 1997-12-09 | 2000-06-08 | Lagringsstabil sammensetning, forseglet ror eller patron inneholdende nevnte sammensetning samt fremgangsmate for deres fremstilling |
Country Status (32)
Country | Link |
---|---|
EP (2) | EP0920873B1 (fr) |
JP (1) | JP4405666B2 (fr) |
KR (1) | KR100482703B1 (fr) |
CN (1) | CN1198644C (fr) |
AR (1) | AR018526A1 (fr) |
AT (1) | ATE260113T1 (fr) |
AU (1) | AU759726B2 (fr) |
BR (1) | BR9813463A (fr) |
CA (1) | CA2314313C (fr) |
CY (1) | CY1114000T1 (fr) |
CZ (1) | CZ302401B6 (fr) |
DE (1) | DE69821872T2 (fr) |
DK (2) | DK1417972T4 (fr) |
EA (1) | EA004761B1 (fr) |
EG (1) | EG23675A (fr) |
ES (2) | ES2405994T5 (fr) |
HK (1) | HK1021798A1 (fr) |
HU (1) | HU230784B1 (fr) |
ID (1) | ID27741A (fr) |
IL (1) | IL136662A (fr) |
MY (1) | MY120063A (fr) |
NO (1) | NO327302B1 (fr) |
NZ (1) | NZ505222A (fr) |
PE (1) | PE20000001A1 (fr) |
PL (1) | PL194268B1 (fr) |
PT (2) | PT920873E (fr) |
SK (1) | SK288203B6 (fr) |
TR (1) | TR200002134T2 (fr) |
TW (1) | TW570811B (fr) |
UA (1) | UA72884C2 (fr) |
WO (1) | WO1999029337A1 (fr) |
ZA (1) | ZA9811127B (fr) |
Families Citing this family (59)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU776823B2 (en) * | 1998-07-23 | 2004-09-23 | Ares Trading S.A. | FSH and FSH variant formulations, products and methods |
US20030166525A1 (en) | 1998-07-23 | 2003-09-04 | Hoffmann James Arthur | FSH Formulation |
DZ2873A1 (fr) | 1998-08-19 | 2003-12-15 | Lilly Co Eli | Procédé pour augmenter la dureté et la rigidité osseuse. |
US7022674B2 (en) | 1999-12-16 | 2006-04-04 | Eli Lilly And Company | Polypeptide compositions with improved stability |
CA2380423A1 (fr) * | 2000-05-17 | 2001-11-22 | Bionebraska, Inc. | Preparations pharmaceutiques peptidiques |
JP2004513069A (ja) * | 2000-05-19 | 2004-04-30 | レストラゲン,インコーポレイテッド | ペプチド医薬処方 |
US20040156835A1 (en) * | 2001-05-30 | 2004-08-12 | Taiji Imoto | Protein preparation |
EP1767213A3 (fr) * | 2001-11-05 | 2007-04-25 | Eli Lilly & Company | Procédé servant à ameliorer la stabilité d'un implant de liaison osseuse |
AU2002363412A1 (en) * | 2001-11-05 | 2003-05-19 | Eli Lilly And 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 |
DK1610822T4 (en) | 2003-04-02 | 2019-01-14 | Ares Trading Sa | Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant |
CA2526099C (fr) | 2003-06-20 | 2013-02-05 | Ares Trading Sa | Formulations lyophilisees a base de fsh/lh |
US7329725B1 (en) | 2003-10-29 | 2008-02-12 | Nastech Pharmaceutical Company Inc. | Phage displayed Trp cage ligands |
CN113304250A (zh) | 2003-11-20 | 2021-08-27 | 诺和诺德股份有限公司 | 对于生产和用于注射装置中是最佳的含有丙二醇的肽制剂 |
AU2004309395C1 (en) | 2003-12-23 | 2012-10-04 | Infinity Discovery, Inc. | Analogs of benzoquinone-containing ansamycins for the treatment of cancer |
US8642564B2 (en) | 2004-08-25 | 2014-02-04 | Aegis Therapeutics, Llc | Compositions for drug administration |
US8268791B2 (en) | 2004-08-25 | 2012-09-18 | Aegis Therapeutics, Llc. | Alkylglycoside compositions for drug administration |
US9895444B2 (en) | 2004-08-25 | 2018-02-20 | Aegis Therapeutics, Llc | Compositions for drug administration |
US20140162965A1 (en) | 2004-08-25 | 2014-06-12 | Aegis Therapeutics, Inc. | Compositions for oral drug administration |
WO2006025882A2 (fr) * | 2004-08-25 | 2006-03-09 | The Uab Research Foundation | Substances ameliorant l'absorption destinees a l'administration de medicaments |
US20060046962A1 (en) | 2004-08-25 | 2006-03-02 | Aegis Therapeutics Llc | Absorption enhancers for drug administration |
US9114069B2 (en) | 2004-08-25 | 2015-08-25 | Aegis Therapeutics, Llc | Antibacterial compositions for drug administration |
KR100700869B1 (ko) * | 2005-06-03 | 2007-03-29 | 재단법인 목암생명공학연구소 | Pth, 완충제 및 안정제를 포함하는 안정한 pth조성물 |
CA2628945A1 (fr) | 2005-11-10 | 2007-05-24 | Board Of Control Of Michigan Technological University | Parathormone de l'ours noir et procedes d'utilisation de la parathormone de l'ours noir |
US8226949B2 (en) | 2006-06-23 | 2012-07-24 | Aegis Therapeutics Llc | Stabilizing alkylglycoside compositions and methods thereof |
DK2957278T3 (en) * | 2006-10-03 | 2017-07-31 | Radius Health Inc | STABLE COMPOSITION COMPREHENSIVE PTHRP AND APPLICATIONS THEREOF |
US7803770B2 (en) | 2006-10-03 | 2010-09-28 | Radius Health, Inc. | Method of treating osteoporosis comprising administration of PTHrP analog |
USRE49444E1 (en) | 2006-10-03 | 2023-03-07 | Radius Health, Inc. | Method of treating osteoporosis comprising administration of PTHrP analog |
EP1958618A1 (fr) | 2007-02-15 | 2008-08-20 | Octapharma AG | Procédé destiné à la lyophilisation par reconstitution optimisée de biopolymères |
CA2684211A1 (fr) * | 2007-04-12 | 2008-10-23 | Infinity Discovery, Inc. | Formulations d'ansamycine hydroquinone |
WO2008150929A1 (fr) * | 2007-05-29 | 2008-12-11 | Manhattan Pharmaceuticals, Inc. | Compositions topiques comprenant une macromolécule et procédés d'utilisation de celles-ci |
US7951368B2 (en) | 2007-06-25 | 2011-05-31 | Amgen Inc. | Compositions of specific binding agents to hepatocyte growth factor |
ES2586032T3 (es) | 2008-03-28 | 2016-10-11 | Hale Biopharma Ventures, Llc | Administración de composiciones de benzodiazepinas |
JP5583680B2 (ja) | 2008-10-15 | 2014-09-03 | インフィニティー ファーマスーティカルズ インコーポレイテッド | アンサマイシンヒドロキノン組成物 |
US8440631B2 (en) | 2008-12-22 | 2013-05-14 | Aegis Therapeutics, Llc | Compositions for drug administration |
KR102424644B1 (ko) * | 2009-09-09 | 2022-07-25 | 아사히 가세이 파마 가부시키가이샤 | 1회당 100∼200 단위의 pth가 주 1회 투여되는 것을 특징으로 하는, pth 함유 골다공증 치료/예방제 |
AU2009356227A1 (en) | 2009-12-07 | 2012-06-21 | Michigan Technological University | Black bear parathyroid hormone and methods of using black bear parathyroid hormone |
WO2012174158A2 (fr) | 2011-06-14 | 2012-12-20 | Hale Biopharma Ventures, Llc | Administration de benzodiazépine |
CN102731643A (zh) * | 2012-06-26 | 2012-10-17 | 深圳翰宇药业股份有限公司 | 一种治疗骨质疏松多肽的制备方法 |
CN103301058A (zh) * | 2013-06-17 | 2013-09-18 | 深圳翰宇药业股份有限公司 | 一种特立帕肽注射用组合物及其制备方法和制剂 |
RU2737496C2 (ru) | 2015-04-29 | 2020-12-01 | Радиус Фармасьютикалз, Инк. | Способы лечения рака |
CN106309358A (zh) * | 2015-06-29 | 2017-01-11 | 成都金凯生物技术有限公司 | 含有人甲状旁腺激素的药物组合物及其制备方法与用途 |
JP6634758B2 (ja) * | 2015-09-25 | 2020-01-22 | ニプロ株式会社 | 液体組成物及び凍結乾燥製剤 |
CN115025239A (zh) | 2016-03-01 | 2022-09-09 | 阿森迪斯药物骨疾病股份有限公司 | Pth前药 |
AU2017336249B2 (en) | 2016-09-29 | 2024-08-01 | Ascendis Pharma Bone Diseases A/S | Dosage regimen for a controlled-release PTH compound |
AU2017336251B2 (en) | 2016-09-29 | 2024-02-22 | Ascendis Pharma Bone Diseases A/S | PTH compounds with low peak-to-trough ratios |
FI3565542T3 (fi) | 2017-01-05 | 2024-06-24 | Radius Pharmaceuticals Inc | Rad1901-2hcl:n polymorfisia muotoja |
US10996208B2 (en) | 2017-04-28 | 2021-05-04 | Radius Health, Inc. | Abaloparatide formulations and methods of testing, storing, modifying, and using same |
KR102665710B1 (ko) | 2017-08-24 | 2024-05-14 | 노보 노르디스크 에이/에스 | Glp-1 조성물 및 그 용도 |
JP2019060866A (ja) * | 2017-09-22 | 2019-04-18 | 旭化成ファーマ株式会社 | 液状医薬組成物の体内動態を予測する方法 |
EP3685849A4 (fr) * | 2017-09-22 | 2021-12-22 | Asahi Kasei Pharma Corporation | Composition pharmaceutique liquide contenant du tériparatide ayant une excellente stabilité |
CN111032073A (zh) * | 2017-09-22 | 2020-04-17 | 旭化成制药株式会社 | 药物动力学和/或安全性优异的含有特立帕肽的液态药物组合物 |
CN108159404B (zh) * | 2018-01-05 | 2019-08-27 | 北京博康健基因科技有限公司 | 重组人甲状旁腺激素制剂及其制备方法 |
WO2019220654A1 (fr) * | 2018-05-17 | 2019-11-21 | 旭化成ファーマ株式会社 | Préparation ayant une teneur réduite en n-formylpipéridine et/ou subissant rarement un affaissement ou un retrait de son gâteau lyophilisé |
WO2020165087A1 (fr) * | 2019-02-11 | 2020-08-20 | Ascendis Pharma Bone Diseases A/S | Formulations pharmaceutiques liquides de conjugués pth |
CN112439054B (zh) * | 2019-08-28 | 2023-05-16 | 深圳翰宇药业股份有限公司 | 一种特立帕肽缓释凝胶注射液及其制备方法 |
IL294521A (en) | 2020-02-18 | 2022-09-01 | Novo Nordisk As | glp-1 compounds and their uses |
US20230190880A1 (en) * | 2020-03-30 | 2023-06-22 | Sichuan Luzhou Buchang Bio-Pharmaceutical Co., Ltd. | Formulations of Human Parathyroid Hormone (PTH) and Methods for Producing Same |
CN113967249A (zh) * | 2021-12-10 | 2022-01-25 | 深圳先进技术研究院 | 甲状旁腺激素在制备治疗男性抑郁症的药物或保健品中的应用 |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
WO1993011785A1 (fr) * | 1991-12-09 | 1993-06-24 | Asahi Kasei Kogyo Kabushiki Kaisha | Composition a base d'hormone parathyroidienne stabilisee |
ATE220327T1 (de) | 1992-09-29 | 2002-07-15 | Inhale Therapeutic Syst | Pulmonale abgabe von aktiven fragmenten des parathormons |
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 | |
US5496801A (en) * | 1993-12-23 | 1996-03-05 | Allelix Biopharmaceuticals Inc. | Parathyroid hormone formulation |
DE19538687A1 (de) † | 1995-10-17 | 1997-04-24 | Boehringer Mannheim Gmbh | Stabile pharmazeutische Darreichungsformen enthaltend Parathormon |
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1998
- 1998-12-04 MY MYPI98005507A patent/MY120063A/en unknown
- 1998-12-04 ZA ZA9811127A patent/ZA9811127B/xx unknown
- 1998-12-07 DE DE69821872T patent/DE69821872T2/de not_active Revoked
- 1998-12-07 DK DK03104219.5T patent/DK1417972T4/en active
- 1998-12-07 ES ES03104219T patent/ES2405994T5/es not_active Expired - Lifetime
- 1998-12-07 PT PT98123225T patent/PT920873E/pt unknown
- 1998-12-07 EP EP98123225A patent/EP0920873B1/fr not_active Revoked
- 1998-12-07 EP EP03104219.5A patent/EP1417972B2/fr not_active Expired - Lifetime
- 1998-12-07 PT PT3104219T patent/PT1417972E/pt unknown
- 1998-12-07 ES ES98123225T patent/ES2215268T3/es not_active Expired - Lifetime
- 1998-12-07 AR ARP980106213A patent/AR018526A1/es active IP Right Grant
- 1998-12-07 DK DK98123225T patent/DK0920873T3/da active
- 1998-12-07 AT AT98123225T patent/ATE260113T1/de not_active IP Right Cessation
- 1998-12-07 EG EG151498A patent/EG23675A/xx active
- 1998-12-08 AU AU17177/99A patent/AU759726B2/en not_active Expired
- 1998-12-08 JP JP2000524006A patent/JP4405666B2/ja not_active Expired - Lifetime
- 1998-12-08 EA EA200000629A patent/EA004761B1/ru not_active IP Right Cessation
- 1998-12-08 TR TR2000/02134T patent/TR200002134T2/xx unknown
- 1998-12-08 SK SK1532-2000A patent/SK288203B6/sk not_active IP Right Cessation
- 1998-12-08 UA UA2000074034A patent/UA72884C2/uk unknown
- 1998-12-08 WO PCT/US1998/026043 patent/WO1999029337A1/fr active IP Right Grant
- 1998-12-08 HU HU0004447A patent/HU230784B1/hu unknown
- 1998-12-08 KR KR10-2000-7006211A patent/KR100482703B1/ko not_active IP Right Cessation
- 1998-12-08 PL PL98340902A patent/PL194268B1/pl unknown
- 1998-12-08 ID IDW20001318A patent/ID27741A/id unknown
- 1998-12-08 CN CNB988119641A patent/CN1198644C/zh not_active Ceased
- 1998-12-08 CA CA002314313A patent/CA2314313C/fr not_active Expired - Lifetime
- 1998-12-08 BR BR9813463-9A patent/BR9813463A/pt not_active Application Discontinuation
- 1998-12-08 CZ CZ20002115A patent/CZ302401B6/cs not_active IP Right Cessation
- 1998-12-08 IL IL13666298A patent/IL136662A/en not_active IP Right Cessation
- 1998-12-08 NZ NZ505222A patent/NZ505222A/en not_active IP Right Cessation
- 1998-12-09 PE PE1998001200A patent/PE20000001A1/es not_active IP Right Cessation
- 1998-12-09 TW TW087120429A patent/TW570811B/zh not_active IP Right Cessation
-
1999
- 1999-12-09 HK HK99105809A patent/HK1021798A1/xx not_active IP Right Cessation
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2000
- 2000-06-08 NO NO20002945A patent/NO327302B1/no not_active IP Right Cessation
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- 2013-05-17 CY CY20131100405T patent/CY1114000T1/el unknown
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