JPH09502740A - プロトンポンプ抑制剤を含有する複数単位の製剤 - Google Patents
プロトンポンプ抑制剤を含有する複数単位の製剤Info
- Publication number
- JPH09502740A JPH09502740A JP8504249A JP50424996A JPH09502740A JP H09502740 A JPH09502740 A JP H09502740A JP 8504249 A JP8504249 A JP 8504249A JP 50424996 A JP50424996 A JP 50424996A JP H09502740 A JPH09502740 A JP H09502740A
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- tablet
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/444—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring heteroatom, e.g. amrinone
-
- 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
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.錠剤賦形剤、および、少なくとも1つが腸溶コーティング層である1つまた はそれ以上の層で被覆されており、場合によりアルカリ化合物と混合された、酸 に不安定なH+K+-ATPase阻害剤またはその単一のエナンチオマーの1つまたはそ のアルカリ塩の形態の活性物質を含有するコア物質のそれぞれの腸溶コーティン グ層保有単位からなり、腸溶コーティング層が、錠剤賦形剤と混合された個々の 単位を複数単位の錠剤形の剤形へ圧縮してもそれぞれの腸溶コーティング層保有 単位の酸耐性に有意に影響しないような機械的性質を有する、経口用の複数単位 の錠剤形の剤形。 2.活性物質が一般式I: あり、 ここでベンズイミダゾール部分のNはR6〜R9で置換されている炭素原子の1 つが場合により置換基をもたない窒素原子と交換されることを意味しており; R1、R2およびR3は同じかまたは異なっていて、水素、アルキル、場合により フッ素で置換されたアルコキシ、アルキルチオ、アルコキシアルコキシ、ジアル キルアミノ、ピペリジノ、モルホリノ、ハロゲン、フェニルおよびフェニルアル コキシから選択され、 R4およびR5は同じかまたは異なっていて、水素、アルキルおよびアラルキル から選択され; R′6は水素、ハロゲン、トリフルオロメチル、アルキルおよびアルコキシで あり; R6〜R9は同じかまたは異なっていて、水素、アルキル、アルコキシ、ハロゲ ン、ハロアルコキシ、アルキルカルボニル、アルコキシカルボニル、オキサゾリ ル、トリフルオロアルキルから選択され、あるいは、隣接する基R6〜R9は更に置 換されていてもよい環構造を形成し; R10は水素であるか、またはR3と一緒になってアルキレン鎖を形成し、そし て、 R11およびR12は同じかまたは異なっていて、水素、ハロゲンまたはアルキル から選択される〕の化合物またはそのアルカリ塩またはその単一のエナンチオマ ーの1つまたはそのアルカリ塩であるが、ただし、化合物5−メトキシ−2〔〔 (4−メトキシ−3,5−ジメチル−2−ピリジニル)メチル〕スルフィニル〕−1H −ベンズイミダゾール、5−フルオロ−2〔〔(4−シクロプロピルメトキシ− 2−ピリジニル)メチル〕スルフィニル〕−1H−ベンズイ ミダゾールおよび5−カルボメトキシ−6−メチル−2〔〔(3,4−ジメトキシ− 2−ピリジニル)メチル〕スルフィニル〕−1H−ベンズイミダゾールまたはこれ らの単一のエナンチオマーまたはそのアルカリ塩は除く、請求項1記載の錠剤形 の剤形。 3.活性物質が下記化合物: の1つまたはそのアルカリ塩またはその単一のエナンチオマーの1つまたはその アルカリ塩である請求項1記載の錠剤形の形態。 4.それぞれの腸溶コーティング層保有単位が米国薬局法に記載された腸溶コー ティング物に関する基準に適合している請求項1記載の錠剤形の剤形。 5.それぞれの腸溶コーティング層保有単位が、それぞれの腸溶コーティング層 保有単位から複数単位の錠剤形の剤形への圧縮成形中に10%より大きく減少しな い請求項1記載の錠剤形の剤形。 6.それぞれの単位を被覆する腸溶コーティング層が可塑化腸溶コーティング層 物質を含有する請求項1記載の錠剤形の剤形。 8.それぞれの腸溶コーティング層保有単位が、薬学的に許容される賦形剤を含 有するオーバーコーティング層で更に被覆されてい る請求項1記載の錠剤形の剤形。 9.剤形が分割可能である請求項1記載の錠剤形の剤形。 10.剤形が水性液体中のそれぞれの腸溶コーティング層保有単位の懸濁液になる ように分散可能である請求項1記載の錠剤形の剤形。 11.場合により適用される分離層が水中で可溶または不溶であるが崩壊可能であ る薬学的に許容される賦形剤および場合によりアルカリ化合物を含有する請求項 1記載の錠剤形の剤形。 12.コア物質が活性物質の層を有するシードである請求項1記載の錠剤形の剤形 。 13.シードが0.1〜2mmの大きさである請求項12記載の錠剤形の剤形。 14.錠剤賦形剤、および、場合によりアルカリ化合物と混合された請求項1記載 の活性物質を含有するコア物質のそれぞれの腸溶コーティング層保有単位からな る複数単位の錠剤形の剤形の製造方法であって、コア物質を場合により1つまた はそれ以上の分離層で被覆し、そして更に、1つまたはそれ以上の腸溶コーティ ング層で被覆し、その後それぞれの腸溶コーティング層保有単位を圧縮成形して 錠剤とし、これにより腸溶コーティング層が、錠剤形の賦形剤と混合されたそれ ぞれの単位を複数単位の錠剤形の剤形へ圧縮してもそれぞれの腸溶コーティング 層保有単位の酸耐性に有意に影響しないような機械的性質を有するようにした、 上記方法。 15.それぞれの単位を複数単位の錠剤形の剤形へ圧縮成形する前にそれぞれの腸 溶コーティング層保有単位がオーバーコーティング 層で更に被覆される請求項14記載の方法。 16.治療で用いるための請求項1〜13の何れかに記載の錠剤形の剤形。 17.哺乳類およびヒトの胃酸分泌の抑制に用いる請求項1〜13の何れかに記載の 錠剤形の剤形。 18.哺乳類およびヒトの胃腸の炎症疾患の治療に用いるための請求項1〜13の何 れかに記載の錠剤形の剤形。 19.請求項1〜13の何れかに記載の複数単位の錠剤形の剤形の治療有効量を胃酸 分泌の抑制が必要な宿主に投与することによる、哺乳類およびヒトの胃酸分泌を 抑制する方法。 20.請求項1〜13の何れかに記載の複数単位の錠剤形の剤形の治療有効量を胃腸 の炎症性疾患の治療の必要な宿主に投与することによる、哺乳類およびヒトの胃 腸の炎症性疾患の治療方法。 21.請求項1〜13の何れかに記載の複数単位の錠剤形の剤形を含有するプレスス ルーブリスターバッケージ。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9402431-2 | 1994-07-08 | ||
SE9402431A SE9402431D0 (sv) | 1994-07-08 | 1994-07-08 | New tablet formulation |
PCT/SE1995/000678 WO1996001624A1 (en) | 1994-07-08 | 1995-06-07 | Multiple unit pharmaceutical preparation containing proton pump inhibitor |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH09502740A true JPH09502740A (ja) | 1997-03-18 |
JP3878669B2 JP3878669B2 (ja) | 2007-02-07 |
Family
ID=20394685
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP8504250A Pending JPH09502741A (ja) | 1994-07-08 | 1995-06-07 | プロトンポンプ抑制剤を含有する複数単位の錠剤形の剤形 |
JP50424996A Expired - Lifetime JP3878669B2 (ja) | 1994-07-08 | 1995-06-07 | プロトンポンプ抑制剤を含有する複数単位の製剤 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP8504250A Pending JPH09502741A (ja) | 1994-07-08 | 1995-06-07 | プロトンポンプ抑制剤を含有する複数単位の錠剤形の剤形 |
Country Status (36)
Country | Link |
---|---|
US (1) | US5753265A (ja) |
EP (3) | EP0723437B1 (ja) |
JP (2) | JPH09502741A (ja) |
KR (1) | KR100384961B1 (ja) |
CN (2) | CN1134667A (ja) |
AT (1) | ATE275396T1 (ja) |
AU (1) | AU695971B2 (ja) |
BR (2) | BR9506029A (ja) |
CA (2) | CA2170995A1 (ja) |
CZ (1) | CZ294380B6 (ja) |
DE (1) | DE69533470T2 (ja) |
DK (1) | DK0723437T3 (ja) |
EE (1) | EE03292B1 (ja) |
ES (1) | ES2227556T3 (ja) |
FI (2) | FI961059A0 (ja) |
HK (1) | HK1008298A1 (ja) |
HU (2) | HUT75934A (ja) |
IL (2) | IL114447A (ja) |
IS (3) | IS4328A (ja) |
MA (1) | MA23608A1 (ja) |
MY (1) | MY114388A (ja) |
NO (2) | NO960949L (ja) |
NZ (1) | NZ289949A (ja) |
PL (2) | PL313389A1 (ja) |
PT (1) | PT723437E (ja) |
RU (2) | RU2166935C2 (ja) |
SA (1) | SA95160092B1 (ja) |
SE (1) | SE9402431D0 (ja) |
SI (1) | SI0723437T1 (ja) |
SK (1) | SK283841B6 (ja) |
TN (1) | TNSN95076A1 (ja) |
TR (2) | TR199500826A2 (ja) |
TW (1) | TW421599B (ja) |
UA (1) | UA47390C2 (ja) |
WO (2) | WO1996001625A1 (ja) |
ZA (2) | ZA955546B (ja) |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2001525366A (ja) * | 1997-12-08 | 2001-12-11 | ビイク グルデン ロンベルク ヒエーミツシエ フアブリーク ゲゼルシヤフト ミツト ベシユレンクテル ハフツング | 酸不安定な活性化合物を含有する新規の投与形 |
JP2003081814A (ja) * | 2001-06-20 | 2003-03-19 | Takeda Chem Ind Ltd | 錠剤の製造方法 |
JP2003192579A (ja) * | 2001-10-17 | 2003-07-09 | Takeda Chem Ind Ltd | 酸に不安定な薬物の高含量顆粒 |
JP2006505540A (ja) * | 2002-10-04 | 2006-02-16 | エティファルム | スフェロイド、その製造方法および医薬組成物 |
JP2006282677A (ja) * | 2001-10-17 | 2006-10-19 | Takeda Chem Ind Ltd | 酸に不安定な薬物の高含量顆粒 |
JP2010540596A (ja) * | 2007-10-04 | 2010-12-24 | ラボラトリオス・デル・ドクトル・エステベ・ソシエダッド・アノニマ | 固形投薬形態のための機械的保護層 |
JP2011126912A (ja) * | 2003-05-08 | 2011-06-30 | Nycomed Gmbh | 活性成分としてのパントプラゾールを含有する投与形 |
US8105626B2 (en) | 2001-10-17 | 2012-01-31 | Takeda Pharmaceutical Company Limited | Granules containing acid-unstable chemical in large amount |
Families Citing this family (115)
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SE9402431D0 (sv) * | 1994-07-08 | 1994-07-08 | Astra Ab | New tablet formulation |
DE723436T1 (de) * | 1994-07-08 | 1997-09-11 | Astra Ab | Aus mehreren einzeleinheiten zusammengesetzte dosierungsform in tablettenform (i) |
ES2094694B1 (es) * | 1995-02-01 | 1997-12-16 | Esteve Quimica Sa | Nueva formulacion farmaceuticamente estable de un compuesto de bencimidazol y su proceso de obtencion. |
SE9500422D0 (sv) * | 1995-02-06 | 1995-02-06 | Astra Ab | New oral pharmaceutical dosage forms |
SE9500478D0 (sv) * | 1995-02-09 | 1995-02-09 | Astra Ab | New pharmaceutical formulation and process |
US6207198B1 (en) * | 1995-09-21 | 2001-03-27 | Schwarz Pharma Ag | Composition containing an acid-labile omeprazole and process for its preparation |
US6699885B2 (en) * | 1996-01-04 | 2004-03-02 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and methods of using same |
US5840737A (en) | 1996-01-04 | 1998-11-24 | The Curators Of The University Of Missouri | Omeprazole solution and method for using same |
US6645988B2 (en) | 1996-01-04 | 2003-11-11 | Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
US6489346B1 (en) * | 1996-01-04 | 2002-12-03 | The Curators Of The University Of Missouri | Substituted benzimidazole dosage forms and method of using same |
SE9600070D0 (sv) | 1996-01-08 | 1996-01-08 | Astra Ab | New oral pharmaceutical dosage forms |
SE512835C2 (sv) * | 1996-01-08 | 2000-05-22 | Astrazeneca Ab | Doseringsform innehållande en mångfald enheter alla inneslutande syralabil H+K+ATPas-hämmare |
SE9600072D0 (sv) * | 1996-01-08 | 1996-01-08 | Astra Ab | New oral formulation of two active ingredients II |
SE9600071D0 (sv) | 1996-01-08 | 1996-01-08 | Astra Ab | New oral formulation of two active ingredients I |
SE9602442D0 (sv) * | 1996-06-20 | 1996-06-20 | Astra Ab | Administration of pharmaceuticals |
US6623759B2 (en) | 1996-06-28 | 2003-09-23 | Astrazeneca Ab | Stable drug form for oral administration with benzimidazole derivatives as active ingredient and process for the preparation thereof |
CN1268137A (zh) | 1997-07-03 | 2000-09-27 | 杜邦药品公司 | 治疗神经失调的咪唑并嘧啶和咪唑并吡啶 |
ES2137862B1 (es) * | 1997-07-31 | 2000-09-16 | Intexim S A | Preparacion farmaceutica oral que comprende un compuesto de actividad antiulcerosa y procedimiento para su obtencion. |
US20050244497A1 (en) * | 1997-11-05 | 2005-11-03 | Wockhardt Limited | Delayed delivery system for acid-sensitive drugs |
US6602522B1 (en) * | 1997-11-14 | 2003-08-05 | Andrx Pharmaceuticals L.L.C. | Pharmaceutical formulation for acid-labile compounds |
US6174548B1 (en) * | 1998-08-28 | 2001-01-16 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
US6096340A (en) * | 1997-11-14 | 2000-08-01 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
SE9704870D0 (sv) | 1997-12-22 | 1997-12-22 | Astra Ab | New pharmaceutical formulation I |
FR2774288B1 (fr) | 1998-01-30 | 2001-09-07 | Ethypharm Sa | Microgranules d'omeprazole gastroproteges, procede d'obtention et preparations pharmaceutiques |
ATE348601T1 (de) * | 1998-05-18 | 2007-01-15 | Takeda Pharmaceutical | Im munde zerfallende tablette enthaltend ein benzimidazole |
US6365589B1 (en) | 1998-07-02 | 2002-04-02 | Bristol-Myers Squibb Pharma Company | Imidazo-pyridines, -pyridazines, and -triazines as corticotropin releasing factor antagonists |
DK1561458T3 (da) | 1998-07-28 | 2010-10-25 | Takeda Pharmaceutical | Hurtigt henfaldende fast middel |
DK1105105T3 (da) | 1998-08-12 | 2006-07-17 | Altana Pharma Ag | Oral administrationsform til pyridin-2-ylmethylsulfinyl-1H-benzimidazoler |
US6733778B1 (en) * | 1999-08-27 | 2004-05-11 | Andrx Pharmaceuticals, Inc. | Omeprazole formulation |
WO2000026185A2 (en) * | 1998-10-30 | 2000-05-11 | The Curators Of The University Of Missouri | Omeprazole solution and method of using same |
DK1131316T3 (da) | 1998-11-18 | 2004-09-27 | Astrazeneca Ab | Forbedret kemisk fremgangsmåde og farmaceutisk præparat |
US6174902B1 (en) | 1999-04-28 | 2001-01-16 | Sepracor Inc. | R-rabeprazole compositions and methods |
FR2793688B1 (fr) * | 1999-05-21 | 2003-06-13 | Ethypharm Lab Prod Ethiques | Microgranules gastroproteges, procede d'obtention et preparations pharmaceutiques |
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JP2001525366A (ja) * | 1997-12-08 | 2001-12-11 | ビイク グルデン ロンベルク ヒエーミツシエ フアブリーク ゲゼルシヤフト ミツト ベシユレンクテル ハフツング | 酸不安定な活性化合物を含有する新規の投与形 |
JP2003081814A (ja) * | 2001-06-20 | 2003-03-19 | Takeda Chem Ind Ltd | 錠剤の製造方法 |
JP2003192579A (ja) * | 2001-10-17 | 2003-07-09 | Takeda Chem Ind Ltd | 酸に不安定な薬物の高含量顆粒 |
JP2006282677A (ja) * | 2001-10-17 | 2006-10-19 | Takeda Chem Ind Ltd | 酸に不安定な薬物の高含量顆粒 |
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JP2006505540A (ja) * | 2002-10-04 | 2006-02-16 | エティファルム | スフェロイド、その製造方法および医薬組成物 |
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JP2011126912A (ja) * | 2003-05-08 | 2011-06-30 | Nycomed Gmbh | 活性成分としてのパントプラゾールを含有する投与形 |
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