JP2007529456A - 有機化合物のガレヌス製剤 - Google Patents
有機化合物のガレヌス製剤 Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
Abstract
Description
アリスキレンおよび添加剤の好ましい量は、さらに説明的実施例に示す。
・該湿式造粒は、造粒中のアリスキレンの嵩容積を減少させる;
・原体品質の変化への影響が最小限である;
・単位投与形態あたり46重量%を超える高薬剤充填を容易に達成し得る;
・十分な硬さ、破砕性への抵抗性、崩壊時間、溶解速度などの錠剤の製剤が可能である;
・原体の固着性および低い流動性を最小限まで減少させる;
・DPの高加圧の製造工程が達成される;
・再現性のあるDP性能をもたらす製剤および方法のスケールアップが達成される;および
・合理的な貯蔵寿命をもたらす十分な安定性が達成される。
1)活性成分と添加剤を混合し、そして該成分を造粒液と共に造粒し;
2)得られた顆粒を乾燥させ;
3)乾燥した顆粒を外相賦形剤と混合し;
4)得られた混合物を圧縮して錠剤核としての経口投与形態を形成させ;そして
5)所望により得られた錠剤核をコーティングしてフィルムコート錠を得る。
上記の通り、本核錠剤を所望によりフィルムコートしてよい。
Claims (20)
- 治療的有効量のアリスキレン、または薬学的に許容されるその塩を含む、固体経口投与形製剤であって、該活性成分が、経口投与形製剤の重量に基づいて46重量%以上の量で含まれている、固体経口投与形製剤。
- 該活性成分が48重量%以上の量で含まれている、請求項1記載の固体経口投与形製剤。
- 該活性成分が46から60重量%の範囲の量で含まれている、請求項1記載の固体経口投与形製剤。
- 該活性成分が全てアリスキレン、または薬学的に許容されるその塩から成り、単位投与形態あたり、約75から約600mgの範囲の遊離塩基の量で含まれている、請求項3記載の固体経口投与形製剤。
- 該活性成分が全てアリスキレン、または薬学的に許容されるその塩から成り、そして単位投与形態あたり約75から約300mgの範囲の遊離塩基の量で含まれている、請求項4記載の固体経口投与形製剤。
- 該アリスキレンがそのヘミ−フマル酸塩の形であり、単位投与形態あたり約83、約166または約332mgの量で含まれている、請求項5記載の固体経口投与形製剤。
- 該投与形製剤がさらに増量剤を含む、請求項6記載の固体経口投与形製剤。
- 該増量剤が微結晶性セルロースである、請求項7記載の固体経口投与形製剤。
- 該投与形製剤がさらに崩壊剤を含む、請求項7記載の固体経口投与形製剤。
- 該投与形製剤がさらに滑剤を含む、請求項9記載の固体経口投与形製剤。
- 該投与形製剤がさらに流動促進剤を含む、請求項10記載の固体経口投与形製剤。
- 該投与形製剤がさらに結合剤を含む、請求項11記載の固体経口投与形製剤。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症(diabetic cardiac myopathy)、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置用の、請求項12記載の固体経口投与形製剤。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置用の、請求項1記載の固体経口投与形製剤。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置法であって、それを必要とする患者に治療的有効量の請求項1記載の固体経口投与形製剤を投与することを含む、方法。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置法であって、それを必要とする患者に治療的有効量の請求項12記載の固体経口投与形製剤を投与することを含む、方法。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置用医薬の製造のための、請求項1記載の固体経口投与形製剤の使用。
- 高血圧、鬱血性心不全、狭心症、心筋梗塞、アテローム性動脈硬化症、糖尿病性腎症、糖尿病性心筋症、腎不全、末梢血管疾患、左室肥大、認知障害、卒中、頭痛および慢性心不全の処置用医薬の製造のための、請求項12記載の固体経口投与形製剤の使用。
- 請求項12記載の固体経口投与形製剤の製造法であって:
1)活性成分と添加剤を混合し、そして該成分を造粒液と共に造粒し;
2)得られた顆粒を乾燥させ;
3)乾燥した顆粒を外相賦形剤と混合し;
4)得られた混合物を圧縮して錠剤核としての経口投与形態を形成させ;そして
5)所望により得られた錠剤核をコーティングしてフィルムコート錠を得る
ことを含む、方法。 - 工程(1)における添加剤が増量剤、崩壊剤および結合剤から選択され;そして工程(3)における外相賦形剤が増量剤、崩壊剤、滑剤および流動促進剤から選択される、請求項19記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US55387804P | 2004-03-17 | 2004-03-17 | |
PCT/EP2005/002798 WO2005089729A2 (en) | 2004-03-17 | 2005-03-16 | Galenic formulations of organic compounds |
Related Child Applications (1)
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JP2012129230A Division JP5925607B2 (ja) | 2004-03-17 | 2012-06-06 | 有機化合物のガレヌス製剤 |
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JP2007529456A true JP2007529456A (ja) | 2007-10-25 |
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JP2007503280A Withdrawn JP2007529456A (ja) | 2004-03-17 | 2005-03-16 | 有機化合物のガレヌス製剤 |
JP2012129230A Active JP5925607B2 (ja) | 2004-03-17 | 2012-06-06 | 有機化合物のガレヌス製剤 |
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JP2012129230A Active JP5925607B2 (ja) | 2004-03-17 | 2012-06-06 | 有機化合物のガレヌス製剤 |
Country Status (24)
Country | Link |
---|---|
US (3) | US8617595B2 (ja) |
EP (2) | EP1729736A2 (ja) |
JP (2) | JP2007529456A (ja) |
KR (2) | KR101353736B1 (ja) |
CN (2) | CN103462913A (ja) |
AR (1) | AR048431A1 (ja) |
AU (2) | AU2005224010B2 (ja) |
BR (1) | BRPI0508833A (ja) |
CA (1) | CA2554633C (ja) |
EC (1) | ECSP066807A (ja) |
ES (1) | ES2747941T3 (ja) |
IL (1) | IL177424A0 (ja) |
MA (1) | MA28490B1 (ja) |
MX (1) | MX347617B (ja) |
MY (2) | MY144477A (ja) |
NO (1) | NO343217B1 (ja) |
NZ (1) | NZ548823A (ja) |
PE (3) | PE20110121A1 (ja) |
RU (3) | RU2384328C2 (ja) |
SG (1) | SG153830A1 (ja) |
TN (1) | TNSN06294A1 (ja) |
TW (1) | TWI406656B (ja) |
WO (1) | WO2005089729A2 (ja) |
ZA (1) | ZA200606220B (ja) |
Cited By (6)
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JP2010031006A (ja) * | 2008-07-17 | 2010-02-12 | Novartis Ag | 有機化合物の使用 |
JP2010280601A (ja) * | 2009-06-04 | 2010-12-16 | Suntory Holdings Ltd | キシロオリゴ糖高含有錠剤 |
JP2010540489A (ja) * | 2007-09-28 | 2010-12-24 | ノバルティス アーゲー | 有機化合物のガレヌス製剤 |
JP2011527316A (ja) * | 2008-07-11 | 2011-10-27 | ラティオファルム ゲー・エム・ベー・ハー | 直接打錠によるアリスキレン錠剤 |
JP2012503665A (ja) * | 2008-09-24 | 2012-02-09 | ノバルティス アーゲー | アリスキレンを含むガレヌス製剤および溶融押出し造粒によるその調製方法 |
US9616242B2 (en) | 2008-09-23 | 2017-04-11 | Incube Labs, Llc | Energy harvesting mechanism for medical devices |
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WO2004096982A2 (en) * | 2002-11-05 | 2004-11-11 | Smithkline Beecham Corporation | Antibacterial agents |
US20070191487A1 (en) * | 2004-03-17 | 2007-08-16 | Rigassi-Dietrich Petra G | Galenic formulations of organic compounds |
TW200804241A (en) * | 2006-02-24 | 2008-01-16 | Novartis Ag | New salt |
GB0605688D0 (en) | 2006-03-21 | 2006-05-03 | Novartis Ag | Organic compounds |
AU2007234917B2 (en) * | 2006-04-03 | 2011-05-12 | Novartis Ag | Renin inhibitors for the treatment of hypertension |
GB0612540D0 (en) * | 2006-06-23 | 2006-08-02 | Novartis Ag | Galenical formulations of organic compounds |
EP1891937A1 (en) * | 2006-08-25 | 2008-02-27 | Novartis AG | Galenic formulations of aliskiren |
CA2563690C (en) * | 2006-10-12 | 2014-10-07 | Pharmascience Inc. | Pharmaceutical compositions comprising intra- and extra- granular fractions |
MY148758A (en) * | 2006-11-07 | 2013-05-31 | Novartis Ag | Crystalline forms of aliskiren hemifumarate |
PE20081167A1 (es) * | 2006-11-09 | 2008-10-03 | Novartis Ag | Sal de alisquireno |
WO2008098992A1 (en) * | 2007-02-16 | 2008-08-21 | Novartis Ag | Use of organic compounds |
EP1972335A1 (en) * | 2007-03-23 | 2008-09-24 | Krka | Solid dosage forms comprising aliskiren and pharmaceutically acceptable salts thereof |
US20090082458A1 (en) * | 2007-09-26 | 2009-03-26 | Protia, Llc | Deuterium-enriched aliskiren |
US20100247645A1 (en) * | 2007-09-28 | 2010-09-30 | Catherine Curdy | Pharmaceutical combination of aliskiren and valsartan |
US20100209480A1 (en) * | 2007-09-28 | 2010-08-19 | Ralf Altenburger | Galenical formulations of organic compounds |
JP2011503185A (ja) | 2007-11-13 | 2011-01-27 | テバ ファーマシューティカル インダストリーズ リミティド | ヘミフマル酸アリスキレンの多形形態及びその調製プロセス |
EP2062874B1 (en) | 2007-11-20 | 2014-12-17 | KRKA, tovarna zdravil, d.d., Novo mesto | Process and intermediates for the preparation of aliskiren |
KR20100135970A (ko) * | 2008-06-06 | 2010-12-27 | 테바 파마슈티컬 인더스트리즈 리미티드 | 알리스키렌 유리 염기의 고체 상태 |
JO3239B1 (ar) * | 2008-09-22 | 2018-03-08 | Novartis Ag | تركيبات جالينية من مركبات عضوية |
EP2189442B1 (en) | 2008-11-20 | 2014-10-01 | Krka Tovarna Zdravil, D.D., Novo Mesto | Process and intermediates for the preparation of aliskiren |
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