JP2007070363A - 持続性放出被覆を有する不溶性医薬品の即時放出錠剤コア - Google Patents
持続性放出被覆を有する不溶性医薬品の即時放出錠剤コア Download PDFInfo
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- A—HUMAN NECESSITIES
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- 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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- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
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- 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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Abstract
【構成】アセトアミノフェンおよびオピオイドを含有する即時放出錠剤コアを、上記コア上に形成されたセルロースポリマー、アクリレート又はメタクリレートのポリマー又はコポリマー、脂肪族アルコール及びこれらの混合物からなる群より選択される疎水性材料を含む膜被覆物で被覆し、約60℃、60〜100%の相対湿度で48時間以上硬化させ持続性放出経口錠剤。
【選択図】 図1
Description
放出制御被覆物で被覆された即時放出APAP錠剤即時放出APAP錠剤は、アセトアミノフェン粉末をポリビニルピロリドンとコレット(Collette)混合機中で5分間混合して製造する。次に、適量の精製水を使用して粉末を顆粒化する。
溶解結果の再現性 − 同一ロットのアセトアミノフェン粉末を使用し、放出制御被覆物で被覆した即時放出APAPコアバッチ対バッチで得られる溶解プロフィルが、同一ロットのアセトアミノフェン粉末原料を使用したとき、または同じ等級で別のロットのアセトアミノフェン粉末、若しくはより小さい粒子サイズで等級が異なるアセトアミノフェン粉末を使用したとき、許容できる程類似しているか否かを決定するために、以下の実施例を準備した。
溶解結果の再現性 − ロットが異なるアセトアミノフェン粉末を使用し、放出制御被覆物で被覆した即時放出APAPコア実施例5及び6では、ロットが異なるアセトアミノフェン粉末を使用したバッチ対バッチで得られる溶解プロフィルが許容できる程類似しているか否かを決定するために、実施例1〜2の錠剤(放出制御被覆物で被覆された即時放出APAP錠剤)の新しいバッチを製造する。錠剤は、実施例1〜2に関して上記したのと同じ方法で製造し、被覆し、そして硬化させる。実施例5の錠剤は、重量が約5%増加するまで被覆し(平均錠剤重量、711.3mg )、一方実施例6の錠剤は、重量が約10%増加するまで被覆する(平均錠剤重量、745.8mg )。その後、上記したのと同じUSPバスケット法、37℃、100RPMによって溶解試験を実施した。
溶解結果の再現性 − より微細な粒子サイズのアセトアミノフェン粉末を使用し、放出制御被覆物で被覆した即時放出APAPコア実施例7及び8では、より微細な粒子サイズのアセトアミノフェン粉末を使用して得られる溶解プロフィルが、実施例1及び2の溶解プロフィルと許容できる程類似しているか否かを決定するために、実施例1〜2の錠剤(放出制御被覆物で被覆された即時放出APAP錠剤)の新しいバッチを製造する。錠剤は、実施例1〜2に関して上記したのと同じ方法で製造し、被覆し、そして硬化させる。実施例7の錠剤は、重量が約5%増加するまで被覆し(平均錠剤重量、711.5mg)、一方実施例8の錠剤は、重量が約10%増加するまで被覆する(平均錠剤重量、751.7mg )。その後、上記したのと同じUSPバスケット法、37℃、100RPMによって溶解試験を実施した。
Claims (9)
- アセトアミノフェンおよびオピオイドを含有する即時放出錠剤コアと、上記コア上に形成されたセルロースポリマー、アクリレート又はメタクリレートのポリマー又はコポリマー、脂肪族アルコール及びこれらの混合物からなる群より選択される疎水性材料を含む膜被覆物とを含む持続性放出経口錠剤において、膜被覆物の量が、アセトアミノフェンおよびオピオイドとを持続的に放出させるのに十分な、重量を3から25%増加させるような量であり、上記膜被覆物は、約60℃、60〜100%の相対湿度で48時間以上硬化させて得られるものであることを特徴とする持続性放出経口錠剤。
- 上記アセトアミノフェンの持続的放出がオピオイドの存在によって実質的影響を受けないことを特徴とする請求項1記載の錠剤。
- 上記セルロースポリマーがアルキルセルロース、ヒドロキシプロピルセルロース又はその混合物のいずれかから選択されることを特徴とする請求項1記載の錠剤。
- 上記アセトアミノフェンが300mgから500mg含まれることを特徴とする請求項1記載の錠剤。
- 上記オピオイドが、ヒドロモルホン、オキシコドン、ジヒドロコデイン、コデイン、ジヒドロモルヒネ、モルヒネ、ブプレノルフィン、上記の何れかの塩、及び上記の何れかの混合物からなる群から選択されることを特徴とする請求項1記載の錠剤。
- 上記オピオイドが、コデインまたはその塩であることを特徴とする請求項1記載の錠剤。
- 上記コデインまたはその塩が15mgから60mg含まれること特徴とする請求項6記載の錠剤。
- 即時放出錠剤コアが、錠剤コアを900ml の0.1 N塩酸に入れたとき、45分間 75%以上のアセトアミノフェンの溶解性を示すことを特徴とする請求項1記載の錠剤。
- アセトアミノフェンおよびオピオイド鎮痛剤を含む即時放出錠剤コアを、セルロースポリマー、アクリレート又はメタクリレートのポリマー又はコポリマー、脂肪族アルコール及びこれらの混合物からなる群より選択される疎水性材料を含む持続性放出膜被覆物で重量を3から25%増加させるように被覆し、これにより錠剤が水溶液に暴露された時少なくともアセトアミノフェンもしくはオピオイドのいずれかを一つを所望の速度で長期間にわたって再現可能に放出することを可能とする工程、上記膜被覆物を、約60℃、60〜100%の相対湿度で48時間以上硬化させる工程を含むことを特徴とする、請求項1に記載の錠剤の製造方法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US08/156,460 US5500227A (en) | 1993-11-23 | 1993-11-23 | Immediate release tablet cores of insoluble drugs having sustained-release coating |
Related Parent Applications (1)
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JP6290209A Division JPH07252140A (ja) | 1993-11-23 | 1994-11-24 | 持続性放出被覆を有する不溶性医薬品の即時放出錠剤コア |
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JP2007070363A true JP2007070363A (ja) | 2007-03-22 |
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JP2006309717A Pending JP2007070363A (ja) | 1993-11-23 | 2006-11-15 | 持続性放出被覆を有する不溶性医薬品の即時放出錠剤コア |
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Cited By (1)
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Also Published As
Publication number | Publication date |
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US20010026809A1 (en) | 2001-10-04 |
US6210714B1 (en) | 2001-04-03 |
US6387404B2 (en) | 2002-05-14 |
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