JP5235839B2 - メサラジン制御放出経口医薬組成物 - Google Patents
メサラジン制御放出経口医薬組成物 Download PDFInfo
- Publication number
- JP5235839B2 JP5235839B2 JP2009250047A JP2009250047A JP5235839B2 JP 5235839 B2 JP5235839 B2 JP 5235839B2 JP 2009250047 A JP2009250047 A JP 2009250047A JP 2009250047 A JP2009250047 A JP 2009250047A JP 5235839 B2 JP5235839 B2 JP 5235839B2
- Authority
- JP
- Japan
- Prior art keywords
- matrix
- acid
- active ingredient
- oral pharmaceutical
- pharmaceutical composition
- 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.)
- Expired - Lifetime
Links
Classifications
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
-
- 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
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
- A61K9/2846—Poly(meth)acrylates
-
- 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
-
- 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
-
- 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]
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
1.不活性マトリックス、ここで、該マトリックス構造の主成分は水性の液体への親和力が乏しいために溶媒の浸透に対して幾分抵抗性を示す(このような特性は親油性として知られる)、の使用。
2.親水性マトリックス、ここで該マトリックス構造の主成分は、主に分岐した鎖における強い親水基の存在により水和層内部の粘性が著しく増すために溶媒の浸透に高い抵抗性を示す、の使用
3.ある生物成分から成る酵素により分解されることができる生物分解可能なマトリックスの使用。
不活性マトリックスは、例えば一般に、非線形性である、指数関数的な活性成分の放出を必然的に伴う。
-有機溶媒中で活性成分を胃抵抗性親水性ポリマーと共に溶解させること、
-該懸濁液を乾燥させること、
-次いで、親水性または親油性マトリックス中で、この2タイプの適用間で効果を区別することなくペレットを捏和および形成すること、
を含む、親水性マトリックス中でのペレットの調製法を開示するWO93/00889に開示される方法により得られる生成物も属する。
a)90℃未満の融点を有する物質から成る、活性成分が少なくとも部分的に含有されている内部親油性マトリックス;
b)該親油性マトリックスが分散されている外部親水性マトリックス;
c)任意に他の賦形剤;
を含む、5-アミノ-サリチル酸を活性成分として含む制御放出経口医薬組成物が提供される。
a)まず活性成分を、低融点賦形剤または賦形剤混合物中に、賦形剤自体を軟質化および/または溶解するよう加熱しつつ取り込ませ、これにより活性成分が単なる分散により組み込まれる。
室温で冷却して不活性マトリックスが形成される。これは、サイズを減じて、活性成分粒子を含むマトリックス顆粒が得られ得る。
b)不活性マトリックス顆粒が次いで、1またはそれ以上の、水で膨張させることができる親水性賦形剤と混合される。
不活性親油性マトリックスは、押し出し成形および/または顆粒化法または、出発混合物の均質な分散および、マトリックス構造を確保するあらゆる他の公知方法により顆粒化される。
770gの5-アミノサリチル酸を、20gのカルナウバワックスと50gのステアリン酸と共に、均質に分散するまで加熱しながら添加し、次いで小型の顆粒に冷却しながら押し出し成形する。
Claims (5)
- 不飽和および/または水素化脂肪酸、それらの塩、エステルまたはアミド、脂肪酸モノ-、ジ-またはトリグリセリド、ワックス、セラミドおよびコレステロール誘導体から選択される90℃未満の融点を有する物質から成る、活性成分が少なくとも部分的に分散されている内部親油性マトリックス;
アクリル酸またはメタクリル酸のポリマーまたはコポリマー、アルキルビニルポリマー、ヒドロキシアルキルセルロース、カルボキシアルキルセルロース、ポリサッカライド、デキストリン、ペクチン、スターチおよび誘導体、アルギン酸ならびに天然または合成ゴムから選択される、該親油性マトリックスおよび該活性成分が分散されている外部親水性マトリックス、および
胃抵抗性外部コーティング
を含み、親油性マトリックス中の活性成分の含有重量が5から95%の間であり、親水性マトリックスに対する親油性マトリックスの重量比が100:0.5から100:20の間であり、活性成分として5-アミノ-サリチル酸を含む制御放出経口医薬組成物。 - 親油性マトリックスの融点が40℃から90℃の間である請求項1に記載の組成物。
- 親水性マトリックスがヒドロゲル形成化合物である請求項1または2に記載の組成物。
- 77重量%の5-アミノサリチル酸、2重量%のカルナウバワックス、5重量%のステアリン酸、3重量%のカルボポール971P、6.5重量%のヒドロキシプロピルメチルセルロース、6重量%のミクロクリスタリンセルロースおよび0.5重量%のステアリン酸マグネシウムを含有する請求項1ないし3のいずれかに記載の制御放出経口医薬組成物。
- 87.41重量%の5-アミノサリチル酸、0.87重量%のカルナウバワックス、1.74重量%のステアリン酸、7重量%のヒドロキシプロピルメチルセルロース、1.05重量%のナトリウムスターチグリコレート、0.96重量%のコロイド状シリカおよび0.96重量%のステアリン酸マグネシウムを含有する請求項1ないし3のいずれかに記載の制御放出経口医薬組成物。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT1999MI001316A ITMI991316A1 (it) | 1999-06-14 | 1999-06-14 | Composizioni farmaceutiche orali a rilascio modificato di mesalazina |
ITMI99A001316 | 1999-06-14 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001502815A Division JP4727875B2 (ja) | 1999-06-14 | 2000-06-08 | メサラジン制御放出経口医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2010024241A JP2010024241A (ja) | 2010-02-04 |
JP5235839B2 true JP5235839B2 (ja) | 2013-07-10 |
Family
ID=11383159
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001502815A Expired - Lifetime JP4727875B2 (ja) | 1999-06-14 | 2000-06-08 | メサラジン制御放出経口医薬組成物 |
JP2009250047A Expired - Lifetime JP5235839B2 (ja) | 1999-06-14 | 2009-10-30 | メサラジン制御放出経口医薬組成物 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001502815A Expired - Lifetime JP4727875B2 (ja) | 1999-06-14 | 2000-06-08 | メサラジン制御放出経口医薬組成物 |
Country Status (18)
Country | Link |
---|---|
US (1) | US6773720B1 (ja) |
EP (2) | EP1287822B1 (ja) |
JP (2) | JP4727875B2 (ja) |
CN (2) | CN100448448C (ja) |
AT (2) | ATE235234T1 (ja) |
AU (1) | AU5077200A (ja) |
CA (1) | CA2377299C (ja) |
DE (2) | DE60001835T2 (ja) |
DK (2) | DK1287822T3 (ja) |
ES (2) | ES2194732T3 (ja) |
HK (2) | HK1046247B (ja) |
IT (1) | ITMI991316A1 (ja) |
MX (1) | MXPA01012888A (ja) |
NO (1) | NO329402B1 (ja) |
PT (2) | PT1287822E (ja) |
RU (1) | RU2245148C2 (ja) |
TR (1) | TR200200561T2 (ja) |
WO (1) | WO2000076481A1 (ja) |
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ITMI20012599A1 (it) * | 2001-12-11 | 2003-06-11 | Cosmo Spa | Composizioni farmaceutiche per la somministrazione orale di eparina osuoi derivati, utili per la terapia di malattie infiammatorie dell'int |
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-
1999
- 1999-06-14 IT IT1999MI001316A patent/ITMI991316A1/it unknown
-
2000
- 2000-06-08 JP JP2001502815A patent/JP4727875B2/ja not_active Expired - Lifetime
- 2000-06-08 ES ES00935194T patent/ES2194732T3/es not_active Expired - Lifetime
- 2000-06-08 EP EP02026576A patent/EP1287822B1/en not_active Expired - Lifetime
- 2000-06-08 US US10/009,491 patent/US6773720B1/en not_active Expired - Lifetime
- 2000-06-08 DE DE60001835T patent/DE60001835T2/de not_active Expired - Lifetime
- 2000-06-08 CN CNB2005100833798A patent/CN100448448C/zh not_active Expired - Lifetime
- 2000-06-08 DK DK02026576T patent/DK1287822T3/da active
- 2000-06-08 MX MXPA01012888A patent/MXPA01012888A/es unknown
- 2000-06-08 DE DE60027608T patent/DE60027608T2/de not_active Expired - Lifetime
- 2000-06-08 ES ES02026576T patent/ES2262749T3/es not_active Expired - Lifetime
- 2000-06-08 RU RU2002100365/15A patent/RU2245148C2/ru active
- 2000-06-08 TR TR2002/00561T patent/TR200200561T2/xx unknown
- 2000-06-08 EP EP00935194A patent/EP1198226B1/en not_active Expired - Lifetime
- 2000-06-08 PT PT02026576T patent/PT1287822E/pt unknown
- 2000-06-08 WO PCT/EP2000/005321 patent/WO2000076481A1/en active Search and Examination
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