JP2015145410A5 - - Google Patents
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- Publication number
- JP2015145410A5 JP2015145410A5 JP2015079415A JP2015079415A JP2015145410A5 JP 2015145410 A5 JP2015145410 A5 JP 2015145410A5 JP 2015079415 A JP2015079415 A JP 2015079415A JP 2015079415 A JP2015079415 A JP 2015079415A JP 2015145410 A5 JP2015145410 A5 JP 2015145410A5
- Authority
- JP
- Japan
- Prior art keywords
- composition according
- tablet
- composition
- substituted
- disintegrant
- 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.)
- Granted
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- 239000000203 mixture Substances 0.000 claims 12
- 239000003795 chemical substances by application Substances 0.000 claims 4
- 239000007884 disintegrant Substances 0.000 claims 4
- 102000003982 Parathyroid hormone Human genes 0.000 claims 3
- 108090000445 Parathyroid hormone Proteins 0.000 claims 3
- 125000000217 alkyl group Chemical group 0.000 claims 3
- 239000000199 parathyroid hormone Substances 0.000 claims 3
- 229960001319 parathyroid hormone Drugs 0.000 claims 3
- XRTHAPZDZPADIL-UHFFFAOYSA-N 8-[(5-chloro-2-hydroxybenzoyl)amino]octanoic acid Chemical group OC(=O)CCCCCCCNC(=O)C1=CC(Cl)=CC=C1O XRTHAPZDZPADIL-UHFFFAOYSA-N 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinylpyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 125000002947 alkylene group Chemical group 0.000 claims 2
- 239000003085 diluting agent Substances 0.000 claims 2
- 238000004090 dissolution Methods 0.000 claims 2
- 230000002496 gastric Effects 0.000 claims 2
- UFHFLCQGNIYNRP-UHFFFAOYSA-N hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 claims 2
- 229910052739 hydrogen Inorganic materials 0.000 claims 2
- 239000001257 hydrogen Substances 0.000 claims 2
- -1 5-CNAC disodium salt Chemical class 0.000 claims 1
- OGBMKVWORPGQRR-UMXFMPSGSA-N 52232-67-4 Chemical compound C([C@H](NC(=O)[C@H](CCSC)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H](N)CO)C(C)C)[C@@H](C)CC)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCSC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC=1N=CNC=1)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC=1C=CC=CC=1)C(O)=O)C1=CNC=N1 OGBMKVWORPGQRR-UMXFMPSGSA-N 0.000 claims 1
- 229960000913 Crospovidone Drugs 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 102000035443 Peptidases Human genes 0.000 claims 1
- 108091005771 Peptidases Proteins 0.000 claims 1
- 229940069328 Povidone Drugs 0.000 claims 1
- 125000004450 alkenylene group Chemical group 0.000 claims 1
- 125000003545 alkoxy group Chemical group 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 125000003118 aryl group Chemical group 0.000 claims 1
- 125000000732 arylene group Chemical group 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 239000002702 enteric coating Substances 0.000 claims 1
- 238000009505 enteric coating Methods 0.000 claims 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 1
- 229910052736 halogen Inorganic materials 0.000 claims 1
- 150000002367 halogens Chemical class 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 230000002401 inhibitory effect Effects 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 239000008203 oral pharmaceutical composition Substances 0.000 claims 1
- MYMOFIZGZYHOMD-UHFFFAOYSA-N oxygen Chemical compound O=O MYMOFIZGZYHOMD-UHFFFAOYSA-N 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000019833 protease Nutrition 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 239000011780 sodium chloride Substances 0.000 claims 1
- 239000007787 solid Substances 0.000 claims 1
- 239000012453 solvate Substances 0.000 claims 1
Claims (13)
- (i)副甲状腺ホルモン(PTH)または少なくとも1−28位のアミノ酸を含むそのフラグメント;
(ii)式I:
R1、R2、R3およびR4は、独立して、水素、-OH、-NR6R7、ハロゲン、C1-C4アルキル、またはC1-C4アルコキシであり;
R5は、置換または非置換C2-C16アルキレン、置換または非置換C2-C16アルケニレン、置換または非置換C1-C12アルキル(アリーレン)、または置換または非置換アリール(C1-C12アルキレン)であり;そして
R6およびR7は、独立して、水素、酸素、またはC1-C4アルキルである]
で示される化合物またはその水和物もしくはアルコール溶媒和物である送達剤;
(iii)崩壊剤;および
(iv)希釈剤
を含み、該送達剤は胃腸環境で固体不溶性型から可溶性型に変換され、胃媒体(gastric media)中で20分以下で80%以上の溶解(溶出)時間を有する、錠剤形態の経口医薬組成物。 - 2分以下の崩壊時間を有する、請求項1に記載の組成物。
- 崩壊剤が超崩壊剤である、請求項1または2に記載の組成物。
- 錠剤が3Kpから20Kpの硬度を有する、請求項1〜3のいずれかに記載の組成物。
- 錠剤が5Kpから15Kpの硬度を有する、請求項1〜4のいずれかに記載の組成物。
- 錠剤が1分未満の崩壊時間および5Kpから7Kpの硬度を有する、請求項4に記載の組成物。
- PTHがPTH 1-34である、請求項1〜6のいずれかに記載の組成物。
- 送達剤がN-(5-クロロサリチロイル)-8-アミノカプリル酸(5-CNAC)またはその塩である、請求項1〜7のいずれかに記載の組成物。
- 送達剤が5-CNACの二ナトリウム塩である、請求項8に記載の組成物。
- 希釈剤が微結晶性セルロースである、請求項1〜9のいずれかに記載の組成物。
- 錠剤が腸溶性コーティングを含まない、請求項1〜10のいずれかに記載の組成物。
- 錠剤がペプチダーゼ阻害剤を含まない、請求項11に記載の組成物。
- 崩壊剤がクロスポビドンおよび/またはポビドンである、請求項1〜12のいずれかに記載の組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US73763105P | 2005-11-17 | 2005-11-17 | |
US60/737,631 | 2005-11-17 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012135063A Division JP6049317B2 (ja) | 2005-11-17 | 2012-06-14 | 医薬組成物 |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2015145410A JP2015145410A (ja) | 2015-08-13 |
JP2015145410A5 true JP2015145410A5 (ja) | 2015-09-24 |
JP6147290B2 JP6147290B2 (ja) | 2017-06-14 |
Family
ID=37875983
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008541365A Withdrawn JP2009515993A (ja) | 2005-11-17 | 2006-11-16 | 医薬組成物 |
JP2012135063A Expired - Fee Related JP6049317B2 (ja) | 2005-11-17 | 2012-06-14 | 医薬組成物 |
JP2015079415A Expired - Fee Related JP6147290B2 (ja) | 2005-11-17 | 2015-04-08 | 医薬組成物 |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2008541365A Withdrawn JP2009515993A (ja) | 2005-11-17 | 2006-11-16 | 医薬組成物 |
JP2012135063A Expired - Fee Related JP6049317B2 (ja) | 2005-11-17 | 2012-06-14 | 医薬組成物 |
Country Status (10)
Country | Link |
---|---|
US (3) | US20080255048A1 (ja) |
EP (1) | EP1951207A2 (ja) |
JP (3) | JP2009515993A (ja) |
KR (2) | KR101432313B1 (ja) |
CN (1) | CN101309674A (ja) |
AU (1) | AU2006318815B2 (ja) |
BR (1) | BRPI0618723A2 (ja) |
CA (1) | CA2626933C (ja) |
RU (1) | RU2469709C2 (ja) |
WO (1) | WO2007061829A2 (ja) |
Families Citing this family (14)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8497258B2 (en) | 2005-11-12 | 2013-07-30 | The Regents Of The University Of California | Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract |
WO2007061829A2 (en) * | 2005-11-17 | 2007-05-31 | Novartis Ag | Pharmaceutical composition |
US20110097401A1 (en) | 2009-06-12 | 2011-04-28 | Meritage Pharma, Inc. | Methods for treating gastrointestinal disorders |
PL2651398T3 (pl) | 2010-12-16 | 2018-05-30 | Novo Nordisk A/S | Stałe kompozycje zawierające agonistę GLP-1 i sól kwasu N-(8-(2-hydroksybenzoilo)amino)kaprylowego |
CN103619175B (zh) | 2011-04-12 | 2016-08-17 | 诺沃—诺迪斯克有限公司 | 双酰化glp-1衍生物 |
JP6356660B2 (ja) | 2012-03-22 | 2018-07-11 | ノヴォ ノルディスク アー/エス | 送達剤を含む組成物およびその調製 |
HRP20231060T1 (hr) | 2012-03-22 | 2023-12-22 | Novo Nordisk A/S | Pripravci peptida glp-1 i njihova priprava |
TR201903918T4 (tr) | 2012-03-22 | 2019-04-22 | Novo Nordisk As | Bir dağıtım ajanı içeren bileşimler ve bunların hazırlanması. |
CN104487056A (zh) | 2012-06-20 | 2015-04-01 | 诺和诺德A/S(股份有限公司) | 包含肽和递送剂的片剂制剂 |
CN104095828A (zh) * | 2014-07-29 | 2014-10-15 | 中国药科大学 | 一种降钙素口服肠溶组合物及其制备方法 |
IL283258B2 (en) * | 2015-02-09 | 2023-11-01 | Entera Bio Ltd | A preparation for the treatment of hypothyroidism |
AU2017311698A1 (en) * | 2016-08-17 | 2019-04-04 | Entera Bio Ltd. | Formulations for oral administration of active agents |
EP3746111B1 (en) | 2018-02-02 | 2023-07-19 | Novo Nordisk A/S | Solid compositions comprising a glp-1 agonist, a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid and a lubricant |
CN111116684B (zh) * | 2019-12-31 | 2020-09-25 | 厦门甘宝利生物医药有限公司 | 一种具有甲状腺激素受体激动剂特性的肝靶向化合物及其药物组合物 |
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US536A (en) | 1837-12-26 | Beady binder for binding newspapers | ||
US647A (en) | 1838-03-21 | Improved fishing-seine for deep water | ||
US5866A (en) | 1848-10-17 | Dentist s deill | ||
US5773A (en) | 1848-09-19 | Sizing and drying cotton-batting | ||
US608618A (en) | 1898-08-09 | Thomas millen | ||
AU508480B2 (en) * | 1977-04-13 | 1980-03-20 | Asahi Kasei Kogyo Kabushiki Kaisha | Microcrystalline cellulose excipient and pharmaceutical composition containing thesame |
DE3524572A1 (de) * | 1985-07-10 | 1987-01-15 | Thomae Gmbh Dr K | Feste arzneimittelformen zur peroralen anwendung enthaltend 9-deoxo-11-deoxy-9,11-(imino(2-(2-methoxyethoxy)ethyliden)-oxy)-(9s)-erythromycin und verfahren zu ihrer herstellung |
US5096714A (en) * | 1988-06-28 | 1992-03-17 | Hauser-Kuhrts, Inc. | Prolonged release drug tablet formulations |
JP2609022B2 (ja) * | 1990-11-29 | 1997-05-14 | 北陸製薬株式会社 | ポリカルボフィルカルシウム含有製剤 |
US5359030A (en) | 1993-05-10 | 1994-10-25 | Protein Delivery, Inc. | Conjugation-stabilized polypeptide compositions, therapeutic delivery and diagnostic formulations comprising same, and method of making and using the same |
US6191105B1 (en) | 1993-05-10 | 2001-02-20 | Protein Delivery, Inc. | Hydrophilic and lipophilic balanced microemulsion formulations of free-form and/or conjugation-stabilized therapeutic agents such as insulin |
US5681811A (en) | 1993-05-10 | 1997-10-28 | Protein Delivery, Inc. | Conjugation-stabilized therapeutic agent compositions, delivery and diagnostic formulations comprising same, and method of making and using the same |
BR9607189A (pt) * | 1995-02-08 | 1997-11-11 | Yamanouchi Europ Bv | Formas de dosagem oral contendo um antibiótico de b-lactama |
TW442301B (en) * | 1995-06-07 | 2001-06-23 | Sanofi Synthelabo | Pharmaceutical compositions containing irbesartan |
US5912014A (en) | 1996-03-15 | 1999-06-15 | Unigene Laboratories, Inc. | Oral salmon calcitonin pharmaceutical products |
US6361794B1 (en) * | 1996-06-12 | 2002-03-26 | Basf Corporation | Method of making ibuprofen and narcotic analgesic composition |
ES2235854T3 (es) | 1999-04-05 | 2005-07-16 | Emisphere Technologies, Inc. | Sales disodicas, monohidratos y solvatos etanolicos para aportar agentes activos. |
US6309633B1 (en) | 1999-06-19 | 2001-10-30 | Nobex Corporation | Amphiphilic drug-oligomer conjugates with hydroyzable lipophile components and methods for making and using the same |
US6380405B1 (en) | 1999-09-13 | 2002-04-30 | Nobex Corporation | Taxane prodrugs |
US6436990B1 (en) | 1999-10-27 | 2002-08-20 | Nobex Corporation | 6-methoxy-2-naphthylacetic acid prodrugs |
IL154537A0 (en) | 2000-08-29 | 2003-09-17 | Nobex Corp | 5-asa derivatives having anti-inflammatory and antibiotic activity and methods of treating diseases therewith |
US7049283B2 (en) * | 2000-12-06 | 2006-05-23 | Novartis Ag | Pharmaceutical compositions for the oral delivery of pharmacologically active agents |
US6479692B1 (en) | 2001-05-02 | 2002-11-12 | Nobex Corporation | Methods of synthesizing acylanilides including bicalutamide and derivatives thereof |
CZ307145B6 (cs) * | 2001-06-01 | 2018-02-07 | Novartis Ag | Kompozice pro orální podání, použití této kompozice a souprava pro stimulaci nové kostní tvorby |
US20050054557A1 (en) * | 2002-05-09 | 2005-03-10 | Goldberg Michael M. | Compositions for delivering parathyroid hormone and calcitonin |
KR20050046776A (ko) * | 2002-09-13 | 2005-05-18 | 사이덱스 인크 | 유도체화된 사이클로덱스트린으로 안정화한 수성 충전조성물을 포함하는 캅셀 |
EP1643978A1 (en) * | 2003-07-04 | 2006-04-12 | Nycomed Danmark A/S | Parathyroid hormone (pth) containing pharmaceutical compositions for oral use |
CN1856321B (zh) | 2003-07-23 | 2012-10-03 | 诺瓦提斯公司 | 降钙素在骨关节炎中的用途 |
GB0422644D0 (en) * | 2004-10-12 | 2004-11-10 | Novartis Ag | Organic compounds |
WO2007061829A2 (en) * | 2005-11-17 | 2007-05-31 | Novartis Ag | Pharmaceutical composition |
-
2006
- 2006-11-16 WO PCT/US2006/044642 patent/WO2007061829A2/en active Application Filing
- 2006-11-16 US US12/093,383 patent/US20080255048A1/en not_active Abandoned
- 2006-11-16 RU RU2008123380/15A patent/RU2469709C2/ru not_active IP Right Cessation
- 2006-11-16 EP EP06837887A patent/EP1951207A2/en not_active Withdrawn
- 2006-11-16 CN CNA2006800429006A patent/CN101309674A/zh active Pending
- 2006-11-16 BR BRPI0618723-4A patent/BRPI0618723A2/pt not_active IP Right Cessation
- 2006-11-16 CA CA2626933A patent/CA2626933C/en not_active Expired - Fee Related
- 2006-11-16 AU AU2006318815A patent/AU2006318815B2/en not_active Ceased
- 2006-11-16 JP JP2008541365A patent/JP2009515993A/ja not_active Withdrawn
- 2006-11-16 KR KR1020087011726A patent/KR101432313B1/ko not_active IP Right Cessation
- 2006-11-16 KR KR1020147010618A patent/KR20140053419A/ko not_active Application Discontinuation
-
2011
- 2011-04-04 US US13/079,400 patent/US20110218148A1/en not_active Abandoned
-
2012
- 2012-06-14 JP JP2012135063A patent/JP6049317B2/ja not_active Expired - Fee Related
-
2015
- 2015-04-08 JP JP2015079415A patent/JP6147290B2/ja not_active Expired - Fee Related
- 2015-05-21 US US14/718,595 patent/US9622975B2/en not_active Expired - Fee Related
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