JPH07509702A - ペレット薬剤組成物 - Google Patents
ペレット薬剤組成物Info
- Publication number
- JPH07509702A JPH07509702A JP6504817A JP50481794A JPH07509702A JP H07509702 A JPH07509702 A JP H07509702A JP 6504817 A JP6504817 A JP 6504817A JP 50481794 A JP50481794 A JP 50481794A JP H07509702 A JPH07509702 A JP H07509702A
- Authority
- JP
- Japan
- Prior art keywords
- weight
- core
- active ingredient
- pellet
- coating
- 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.)
- Pending
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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.ペレット徐放性薬剤組成物であって、コア要素が、 該コア要素の全重量に基く約0.1重量%〜95重量%の低水溶性の活性成分約 0.1重量%〜55重量%の結合剤;約5重量%〜99重量%のコア種子 を含む上記コァ要素;並びに 該コァ要素のためのコアコーティングが、充填剤を除くコアコーティングの全重 量に基く約30重量%〜97重量%の腸溶性ポリマー; 約3重量%〜50重量%の不溶性ポリマー;および0〜約50重量%の可塑剤 を含む上記コァコーティングを含み; 該腸溶性ポリマーは、該腸溶性ポリマーおよび不溶性ポリマーの全重量の少なく とも約70重量%を含み; 該コアコーティングは、活性成分を制御様式で長期間にわたって腸管内に放出す るが、胃の酸性環境においてはほとんど放出が起こらないし、しかも活性成分の 血中濃度が治療的範囲内で長期間にわたって保持されるようにある上記ペレット 徐放性薬剤組成物。 2.活性成分がエリスロマイシンである請求項1に記載のペレット薬剤組成物。 3.活性成分が、非ステロイド抗炎症性薬剤(NSAID)またはその酸若しく は塩である請求項1に記載のペレット薬剤組成物。 4.活性成分が、低水溶性の形のジクロフェナク、ケトロラクおよびインドメタ シンから選択される請求項3に記載のペレット薬剤組成物。 5.活性成分がジクロフェナクを含む請求項4に記載の薬剤組成物。 6.コアコーティングが、 最大75重量%までの充填剤;および 最大60重量%までの水溶性成分 を更に含む請求項1に記載の薬剤組成物。 7.コァ要素が、ポリビニルピロリドン(ポビドン)、ヒドロキシプロピルセル ロース、ヒドロキシプロピルメチルセルロース、メチルセルロース、ヒドロキシ エチルセルロース、糖およびそれらの混合物から選択される約0.1重量%〜4 5重量%の結合剤を含む請求項1に記載のペレット薬剤組成物。 8.コァコーティングが、 酪酸フタル酸セルロース、フタル酸水素セルロース、プロピオン酸フタル酸セル ロース、ポリ酢酸フタル酸ビニル、酢酸フタル酸セルロース、酢酸トリメリット 酸セルロース、フタル酸ヒドロキシプロピルメチルセルロース、酢酸ヒドロキシ プロピルメチルセルロース、コハク酸ジオキシプロピルメチルセルロース、アク リルメタクリル酸コポリマー、シェラック、サンダラク(登録商標)、コパルコ ロホリウム、酢酸フタル酸セルロースおよびそれらの混合物から成る群より選択 される約70重量%〜87重量%の腸溶性ポリマー;並びにエチルセルロース、 詐酸セルロースおよびそれらのエステル、アクリルメタクリル酸コポリマー、酢 酸ヒドロキシプロピルメチルセルロース並びにそれらの混合物から成る群より選 択される約3重量%〜50重量%の不溶性ポリマーを含む請求項7に記載のペレ ット薬剤組成物。 9.コアコーティングが、フタル酸ジエチル、クエン酸トリエチル、クエン酸ト リエチルアセチル、トリアセチン、クエン酸トリブチル、ポリエチレングリコー ル、グリセロールおよびそれらの混合物から選択される約2.5重量%〜30重 量%の可塑剤を含む請求項8に記載のペレット薬剤組成物。 10.ペレット徐放性薬剤組成物の製造法であって、コア要素が、 該コア要素の全重量に基く約0.1重量%〜95重量%の低水溶性の活性成分約 0.1重量%〜55重量%の結合剤;約5重量%〜99重量%のコア種子 を含む上記コァ要素;並びに 上記コア要素のためのコアコーティングが、充填剤を除くコアコーティングの全 重量に基く約30重量%〜97重量%の腸溶性ポリマー; 約3重量%〜50重量%の不溶性ポリマーを含む上記コアコーティングを提供し 、該腸溶性ポリマーは、該腸溶性ポリマーおよび不溶性ポリマーの全重量の少な くとも約70重量%を含み;そして該コアコーティング組成物を該コア要素上に 噴霧することを含む上記方法。 11.低水溶性の活性成分; 結合剤;および コァ種子を提供し;そして 該コア種子を該活性成分および結合剤でコーティングしてコア要素を生成する予 備工程を更に含む請求項10に記載の方法。 12.少なくとも1種類の低水溶性の活性成分;有効量の溶媒または顆粒液を提 供し、上記成分を混合し;そして該成分に押出を施した後、マルメライゼーショ ンを行なってコア要素を生成する 予備工程を更に含む請求項10に記載の方法。 13.治療を必要としている患者の症状の治療的または予防的処置法であって、 コア要素が、 ジクロフェナク、ケトロラクおよびインドメタシンから選択される、該コア要素 の全重量に基く約0.1重量%〜95重量%の低水溶性の活性成分、約0.1重 量%〜55重量%の結合剤;約5重量%〜99重量%のコア種子 を含む上記コア要素;並びに 該コア要素のためのコアコーティングが、充填剤を除くコアコーティングの全重 量に基く約30重量%〜97重量%の腸溶性ポリマー; 約3重量%〜50重量%の不溶性マトリックスポリマー;および0〜約50重量 %の可塑剤 を含む上記コアコーティングを含み、 該腸溶性ポリマーは、該腸溶性ポリマーおよび不溶性マトリックスポリマーの全 重量の少なくとも約70重量%を含み;該コアコーティングは、活性成分を制御 様式で長期間にわたって腸管内に放出するが、胃の酸性環境においてはほとんど 放出が起こらないし、しかも活性成分の血中濃度が治療的範囲内で長期間にわた って保持されるようにあるペレット徐放性薬剤組成物の有効量を患者に対して投 与することを含む上記方法。 14.実施例のいずれか一つに関して実質的に本明細書中に記載のペレット徐放 性薬剤組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU3921 | 1992-08-05 | ||
AUPL392192 | 1992-08-05 | ||
PCT/AU1993/000371 WO1994003160A1 (en) | 1992-08-05 | 1993-07-23 | Pelletised pharmaceutical composition |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH07509702A true JPH07509702A (ja) | 1995-10-26 |
Family
ID=3776337
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP6504817A Pending JPH07509702A (ja) | 1992-08-05 | 1993-07-23 | ペレット薬剤組成物 |
Country Status (11)
Country | Link |
---|---|
US (1) | US5800836A (ja) |
EP (1) | EP0653935B1 (ja) |
JP (1) | JPH07509702A (ja) |
AT (1) | ATE217188T1 (ja) |
CA (1) | CA2141582C (ja) |
DE (1) | DE69331906T2 (ja) |
ES (1) | ES2173096T3 (ja) |
NZ (1) | NZ253999A (ja) |
SG (1) | SG42869A1 (ja) |
WO (1) | WO1994003160A1 (ja) |
ZA (1) | ZA935650B (ja) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2008501736A (ja) * | 2004-06-09 | 2008-01-24 | エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング | 活性成分のコリルサルコシンを含有する剤形 |
JP2011518139A (ja) * | 2008-04-18 | 2011-06-23 | フラメル テクノロジーズ | 多粒子系を含む二段階の放出プロフィールを有する固形経口剤 |
JP2012144554A (ja) * | 2003-04-07 | 2012-08-02 | Supernus Pharmaceuticals Inc | テトラサイクリンの1日1回製剤 |
JP2012528134A (ja) * | 2009-05-29 | 2012-11-12 | フラメル・テクノロジーズ | 浮遊性放出制御医薬組成物 |
JP2020090460A (ja) * | 2018-12-06 | 2020-06-11 | 三生医薬株式会社 | 造粒方法 |
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JPH07509702A (ja) * | 1992-08-05 | 1995-10-26 | エフ・エイチ・フォールディング・アンド・カンパニー・リミテッド | ペレット薬剤組成物 |
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- 1993-07-23 NZ NZ253999A patent/NZ253999A/en not_active IP Right Cessation
- 1993-07-23 EP EP93915549A patent/EP0653935B1/en not_active Expired - Lifetime
- 1993-07-23 WO PCT/AU1993/000371 patent/WO1994003160A1/en active IP Right Grant
- 1993-07-23 AT AT93915549T patent/ATE217188T1/de active
- 1993-07-23 SG SG1996000321A patent/SG42869A1/en unknown
- 1993-07-23 ES ES93915549T patent/ES2173096T3/es not_active Expired - Lifetime
- 1993-07-23 DE DE69331906T patent/DE69331906T2/de not_active Expired - Lifetime
- 1993-08-04 ZA ZA935650A patent/ZA935650B/xx unknown
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JP2012144554A (ja) * | 2003-04-07 | 2012-08-02 | Supernus Pharmaceuticals Inc | テトラサイクリンの1日1回製剤 |
JP2008501736A (ja) * | 2004-06-09 | 2008-01-24 | エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツング | 活性成分のコリルサルコシンを含有する剤形 |
JP2011518139A (ja) * | 2008-04-18 | 2011-06-23 | フラメル テクノロジーズ | 多粒子系を含む二段階の放出プロフィールを有する固形経口剤 |
JP2012528134A (ja) * | 2009-05-29 | 2012-11-12 | フラメル・テクノロジーズ | 浮遊性放出制御医薬組成物 |
JP2020090460A (ja) * | 2018-12-06 | 2020-06-11 | 三生医薬株式会社 | 造粒方法 |
Also Published As
Publication number | Publication date |
---|---|
ES2173096T3 (es) | 2002-10-16 |
EP0653935B1 (en) | 2002-05-08 |
DE69331906T2 (de) | 2002-12-19 |
ZA935650B (en) | 1994-03-07 |
DE69331906D1 (de) | 2002-06-13 |
ATE217188T1 (de) | 2002-05-15 |
SG42869A1 (en) | 1997-10-17 |
US5800836A (en) | 1998-09-01 |
CA2141582C (en) | 2003-09-30 |
CA2141582A1 (en) | 1994-02-17 |
NZ253999A (en) | 1996-07-26 |
EP0653935A4 (en) | 1995-06-07 |
EP0653935A1 (en) | 1995-05-24 |
WO1994003160A1 (en) | 1994-02-17 |
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