JPH10511407A - 高用量難溶性薬物用持続放出マトリックス - Google Patents
高用量難溶性薬物用持続放出マトリックスInfo
- Publication number
- JPH10511407A JPH10511407A JP10505408A JP50540898A JPH10511407A JP H10511407 A JPH10511407 A JP H10511407A JP 10505408 A JP10505408 A JP 10505408A JP 50540898 A JP50540898 A JP 50540898A JP H10511407 A JPH10511407 A JP H10511407A
- Authority
- JP
- Japan
- Prior art keywords
- ibuprofen
- dosage form
- sustained release
- xanthan gum
- gum
- 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
Links
Classifications
-
- 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
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
Landscapes
- 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)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.約500 mg〜約1000 mg の難溶性NSAIDおよび有効量の持続放出担体を含 む持続放出剤形であって、該剤形の放出により、USPII型(パドル)法によっ て測定すると該NSAIDの約6重量%が約2時間後に放出され、約12〜約16時 間後にt50となる該NSAIDのin vitroでの溶解を提供する剤形。 2.該持続放出担体がキサンタンガムおよび架橋剤を含む、請求項1に記載の剤 形。 3.該架橋剤がガラクトマンナンである、請求項2に記載の剤形。 4.該ガラクトマンナンがローカストビーンガムである、請求項3に記載の剤形 。 5.さらに不活性希釈剤を含む、請求項1に記載の剤形。 6.該NSAIDが、イブプロフェン、カルシウムフェノプロフェン、ナプロキ セン、エトドラック、メフェナム酸、トルメチンおよびそれらの混合物から成る 群から選択される、請求項1に記載の剤形。 7.該NSAIDがイブプロフェンである、請求項1に記載の剤形。 8.錠剤の形状である、請求項1に記載の剤形。 9.該架橋剤が、ガラクトマンナンガム、イオン化可能なゲル強度増強剤または それらの組み合わせを含む、請求項2に記載の剤形。 10.約500 mg〜約1000 mg の難溶性NSAIDおよび有効量の持続放出担体を 含む持続放出剤形であって、該剤形の放出により、USPII型(パドル)法によ って測定すると該イブプロフェンの約20重量%が約4時間後に放出され、約12〜 約16時間後にt50となる該NSAIDのin vitroでの溶解が得られる剤形。 11.該持続放出担体がキサンタンガムおよび架橋剤を含む、請求項10に記載 の剤形。 12.該架橋剤がガラクトマンナンである、請求項11に記載の剤形。 13.該ガラクトマンナンがローカストビーンガムである、請求項12に記載の 剤形。 14.さらに不活性希釈剤を含む、請求項11に記載の剤形。 15.該NSAIDが、イブプロフェン、カルシウムフェノプロフェン、ナプロ キセン、エトドラック、メフェナム酸、トルメチンおよびそれらの混合物から成 る群から選択される、請求項10に記載の剤形。 16.該NSAIDがイブプロフェンである、請求項10に記載の剤形。 17.該架橋剤が、ガラクトマンナンガム、イオン化可能なゲル強度増強剤また はそれらの組み合わせを含む、請求項12に記載の剤形。 18.約500 mg〜約1000 mg のイブプロフェン;疎水性物質を含む持続放出被覆 剤;およびキサンタンガムを含む錠剤コアを含む持続放出イブプロフェン剤形で あって、該イブプロフェンの約1〜約20重量%が該錠剤上に被覆され、該剤形の 放出により、USPII型(パドル)法によって測定すると該NSAIDの約6重 量%が約2時間後に放出され、約12〜約16時間後にt50となる該NSAIDのin vitroでの溶解が得られる剤形。 19.約500 mg〜約1000 mg のイブプロフェンならびに約5〜約95 %のキサンタ ンガムおよびローカストビーンガムを含む架橋剤を含む持続放出担体を含むマト リックスを含み、該キサンタンガムおよび該ローカストビーンガムの合計重量に 対する該イブプロフェンの重量比が約1:0.06〜約1:0.4 である、経口持続放出剤 形。 20.該キサンタンガムおよび該ローカストビーンガムの合計重量に対する該N SAIDの重量比が約0.08〜約0.25である、請求項19に記載の経口持続放出剤 形。 21.約 800〜約1000 mg のイブプロフェンを含む請求項19に記載の経口持続 放出錠剤。 22.キサンタンガム、ローカストビーンガム、不活性希釈剤および難溶性イブ プロフェンの混合物の湿式造粒を、キサンタンガムのローカストビーンガムに対 する比を約1:20〜約20:1とし、イブプロフェンの全重量の該キサンタンガムおよ び該ローカストビーンガムの合計重量に対する比を約1:0.06〜約1:0.4 として行 い;および得られた顆粒を、約 500〜約1000 mg のイブプロフェンを含む錠剤に 打錠する工程を含む、経口持続放出錠剤の製造法。 23.キサンタンガム、水溶液の存在下で該キサンタンガムを架橋し得るガラク トマンナン、および約20〜約35重量%の不活性希釈剤を含む、経口固体剤形で使 用するための持続放出薬剤賦形剤。 24.キサンタンガムおよびローカストビーンガムを含む持続放出マトリックス に約500 mg〜約1000 mg の難溶性NSAIDを含む持続放出錠剤であって、該錠 剤の合計重量が該難溶性NSAIDの約 110〜約 140重量%であり、該キサンタ ンガムおよび該ローカストビーンガムが錠剤の約 7〜約40重量%を含む持続放出 錠剤。 25.該NSAIDがイブプロフェンであり、該キサンタンガムおよび該ローカ ストビーンガムの合計重量がイブプロフェンの約 119〜約 136 %である、請求項 24に記載の持続放出錠剤。 26.キサンタンガムを含む持続放出イブプロフェン錠剤からのイブプロフェン の放出を、錠剤が水性環境に暴露されたときに遅らせる方法であって、該方法が 、持続放出イブプロフェン錠剤の約 5〜約95重量%のキサンタンガムを等量のロ ーカストビーンガムで置き換え、該キサンタンガムの該ローカストビーンガムに 対する比が約1:20〜約20:1の範囲であることを含む方法。 27.約 600〜約1000 mg のイブプロフェン;キサンタンガム;ローカストビー ンガム;および不活性希釈剤を含む持続放出イブプロフェン錠剤であって、該キ サンタンガムおよび該ローカストビーンガムの合計重量が最終の錠剤の重量の約 7〜約40重量%であり、該キサンタンガムおよび該ローカストビーンガムの合計 重量に対するイブプロフェンの比が約1:0.06〜約1:0.4 である持続放出イブプロ フェン錠剤。 28.該キサンタンガムおよび該ローカストビーンガムの合計重量に対するイブ プロフェンの比が約1:0.08〜約1:0.25である、請求項27に記載の持続放出イブ プロフェン錠剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US2133596P | 1996-07-08 | 1996-07-08 | |
US60/021,335 | 1996-07-08 | ||
PCT/US1997/013331 WO1998001117A1 (en) | 1996-07-08 | 1997-07-08 | Sustained release matrix for high-dose insoluble drugs |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH10511407A true JPH10511407A (ja) | 1998-11-04 |
JP3148256B2 JP3148256B2 (ja) | 2001-03-19 |
Family
ID=21803631
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP50540898A Expired - Fee Related JP3148256B2 (ja) | 1996-07-08 | 1997-07-08 | 高用量難溶性薬物用持続放出マトリックス |
Country Status (12)
Country | Link |
---|---|
US (4) | US6093420A (ja) |
EP (1) | EP0859603B1 (ja) |
JP (1) | JP3148256B2 (ja) |
KR (1) | KR100321489B1 (ja) |
AT (1) | ATE417604T1 (ja) |
AU (1) | AU695734B2 (ja) |
CA (1) | CA2231195C (ja) |
DE (1) | DE69739165D1 (ja) |
ES (1) | ES2322405T3 (ja) |
IL (1) | IL123505A (ja) |
MX (1) | MX9801835A (ja) |
WO (1) | WO1998001117A1 (ja) |
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1997
- 1997-07-08 IL IL12350597A patent/IL123505A/en not_active IP Right Cessation
- 1997-07-08 JP JP50540898A patent/JP3148256B2/ja not_active Expired - Fee Related
- 1997-07-08 KR KR1019980701734A patent/KR100321489B1/ko not_active IP Right Cessation
- 1997-07-08 CA CA002231195A patent/CA2231195C/en not_active Expired - Fee Related
- 1997-07-08 DE DE69739165T patent/DE69739165D1/de not_active Expired - Lifetime
- 1997-07-08 MX MX9801835A patent/MX9801835A/es unknown
- 1997-07-08 WO PCT/US1997/013331 patent/WO1998001117A1/en active IP Right Grant
- 1997-07-08 ES ES97935184T patent/ES2322405T3/es not_active Expired - Lifetime
- 1997-07-08 AU AU38183/97A patent/AU695734B2/en not_active Ceased
- 1997-07-08 AT AT97935184T patent/ATE417604T1/de not_active IP Right Cessation
- 1997-07-08 EP EP97935184A patent/EP0859603B1/en not_active Expired - Lifetime
- 1997-07-08 US US08/889,424 patent/US6093420A/en not_active Expired - Lifetime
-
1999
- 1999-10-19 US US09/420,247 patent/US6245355B1/en not_active Expired - Lifetime
-
2001
- 2001-04-25 US US09/842,289 patent/US6689386B2/en not_active Expired - Fee Related
-
2003
- 2003-12-09 US US10/731,859 patent/US20040121012A1/en not_active Abandoned
Cited By (5)
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JP2009149691A (ja) * | 2001-03-13 | 2009-07-09 | Penwest Pharmaceuticals Co | 時間治療(chronotherapeutic)投与形態 |
JP2007505921A (ja) * | 2003-09-19 | 2007-03-15 | ペンウェスト ファーマシューティカルズ カンパニー | 遅延放出剤形 |
WO2005037264A1 (ja) * | 2003-10-17 | 2005-04-28 | Medrx Co., Ltd. | ビグアナイド系薬剤を含有するゼリー製剤 |
JP2009519326A (ja) * | 2005-12-16 | 2009-05-14 | ハンミ ファーム. シーオー., エルティーディー. | 低融点の活性成分を含む溶融状の固体分散体、及びこれを含む経口投与用錠剤 |
JP2012515765A (ja) * | 2009-01-22 | 2012-07-12 | アボット ヘルスケア プライベート リミテッド | 時間治療用医薬組成物 |
Also Published As
Publication number | Publication date |
---|---|
EP0859603A1 (en) | 1998-08-26 |
EP0859603A4 (en) | 2006-05-24 |
AU695734B2 (en) | 1998-08-20 |
US6093420A (en) | 2000-07-25 |
EP0859603B1 (en) | 2008-12-17 |
US20010021392A1 (en) | 2001-09-13 |
KR19990044486A (ko) | 1999-06-25 |
US6689386B2 (en) | 2004-02-10 |
WO1998001117A1 (en) | 1998-01-15 |
ATE417604T1 (de) | 2009-01-15 |
IL123505A0 (en) | 1998-10-30 |
KR100321489B1 (ko) | 2002-10-09 |
JP3148256B2 (ja) | 2001-03-19 |
AU3818397A (en) | 1998-02-02 |
MX9801835A (es) | 1998-08-30 |
US20040121012A1 (en) | 2004-06-24 |
ES2322405T3 (es) | 2009-06-19 |
US6245355B1 (en) | 2001-06-12 |
DE69739165D1 (de) | 2009-01-29 |
CA2231195C (en) | 2003-01-21 |
IL123505A (en) | 2004-12-15 |
CA2231195A1 (en) | 1998-01-15 |
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