JP5739080B2 - レベチラセタムの徐放性製剤 - Google Patents
レベチラセタムの徐放性製剤 Download PDFInfo
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- JP5739080B2 JP5739080B2 JP2007552811A JP2007552811A JP5739080B2 JP 5739080 B2 JP5739080 B2 JP 5739080B2 JP 2007552811 A JP2007552811 A JP 2007552811A JP 2007552811 A JP2007552811 A JP 2007552811A JP 5739080 B2 JP5739080 B2 JP 5739080B2
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- levetiracetam
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- 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
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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
- A61K31/40—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
- A61K31/4015—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 having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, 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
- A61K9/20—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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
Description
徐放性または制御放出性医薬組成物を製造するための高い粘度グレードの親水性および疎水性ポリマーの使用は当該技術分野で知られている。徐放性のために、薬物を含んだ錠剤も高い粘度グレードの親水性ポリマーを含む。もし要求されるなら、該錠剤は疎水性ポリマーとコア形成剤でコーティングされる。固形製剤が周囲の媒体と接触するとすぐに、孔が形成され、薬物がこれらの孔を通して放散する。媒体は錠剤コアに入って、ポリマーの水和を生じ、薬物の放出もコントロールする。放出速度のコントロールは活性成分の一定の血液血漿レベルを生じさせ、投与頻度を減少されることで治療に利益をもたらし、それにより投与計画への患者の適応性を改善する。本発明は、ヒト患者への1日1回投与に適したレベチラセタムの徐放性錠剤の医薬組成物を提供する。
不活性なマトリックス、親水性もしくは脂質のマトリックス、不活性で脂質のマトリックスの混合物、および親水性で不活性のマトリックスの混合物の中から選択される少なくとも1つのマトリックス賦形剤(化合物の全重量の比で5〜95重量%);
少なくとも1つの腸溶性ポリマー(化合物の全重量の比で2〜50重量%)および
生理的pHの条件下水相に可溶な少なくとも1つのアルカリ化剤(化合物の全重量の比で少なくとも0.5〜50重量%)
を含む均一な混合物からなっている。
本発明の目的は、レベチラセタムの徐放性医薬組成物を提供することであり、それは経口摂取において、徐放期間、プラトーな効果を有する血液血漿レベルをもたらす。
本発明は、レベチラセタム、適宜結合剤、親水性の速度調節ポリマーおよび通常の医薬的に許容される賦形剤を含むレベチラセタムの徐放性医薬組成物の製造方法に関する。そのブレンド混合されたものは錠剤に圧縮され、成形された錠剤は疎水性の速度調節ポリマーを含む機能的なコーティング剤でさらにコーティングされる。その機能的被膜には適宜親水性のポリマーまたは水溶性の物質であり得るチャネリング剤が含まれる。その組成物は更にポリマー基質の非機能的な被膜でコーティイングされ得る。構成は所定の方法でレベチラセタムの徐放性を与える方法で選択される。
i.レベチラセタムまたは速度調節ポリマーと乾式または湿式造粒して調製したその顆粒を混合し、
ii.混合した混合物に滑沢剤を加え、適当な形状の錠剤に打錠し、
iii.水難溶性および水溶性ポリマーの水分散物で錠剤をコーティングし、
iv.非機能的ポリマーの水分散物で錠剤をコーティングする
工程が含まれる。
本発明の態様において、徐放性錠剤は、活性成分および水溶性の速度調節ポリマー、並びに適宜加えてもよい通常の賦形剤(例えば結合剤)を含む。これらの錠剤は水難溶性ポリマーの組合せでコーティングされる。該コーティング剤には適宜水溶性ポリマーまたはチャネリング剤としての物質が含まれる。機能的なコーティングをされた錠剤は更に、非機能的なコーティングとして水溶性ポリマーでコーティングされる。
実施例1から実施例6の徐放性錠剤を、溶出溶媒としてpH 6.8のリン酸緩衝液(900ml)を用い、40メッシュのバスケット(USP 1型)中37℃100rpmで、レベチラセタムの溶出試験を行った。溶出プロフィールは表5に記録されている。
実施例8から実施例13の徐放性錠剤を、溶出溶媒としてpH 6.8のリン酸緩衝液(900ml)を用い、40メッシュのバスケット(USP 1型)中37℃100rpmで、レベチラセタムの溶出試験を行った。溶出プロフィールは表12に記録されている。
実施例8の徐放性錠剤として製剤化したレベチラセタムのバイオアベイラビリティを評価するのに、速放出のレベチラセタム錠剤での参考処置と比較して、インビボでの試験を健常人のボランティアで行った。
試験は、非盲検で、2つの処置、2つの期間、摂食条件下の健康な成人男子のヒトの被験者における比較経口バイオアベイラビリティ試験に従った。被験者は、単一のセンターで行われている試験のコースの間、2つの処置の各々を受けた。被験者は1500mgのレベチラセタムの経口製剤が与えられた。IR(速放出)製剤の場合、ケプラ(Keppra、登録商標)錠剤として提供されるが、2つの等しく分けた用量の750mg各々を、朝の開始から12時間の間隔で投与された。実施例8の徐放性製剤の場合、750mgの2つの錠剤を朝一度に投与した。血漿レベチラセタム濃度はHPLC法で定量した。サンプルはすべてのサンプルが定量限界以内であったので、分析前に希釈しなかった。レベチラセタムの薬物動態的パラメータは、ノンコンパートメント法で測定した。パラメータTmax、Cmax、AUC0→t、AUC0→∞は試験の間測定され、表13に記録された。
36時間の測定時間にわたる平均血漿レベチラセタム濃度は、図2に示される。
Claims (3)
- 30重量%から85重量%のレベチラセタム、および2重量%溶液中15cpsより大きい粘度を有し、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ナトリウムアルギン酸塩、カルボマー、ナトリウムカルボキシメチルセルロース、キサンタンガム、グアーガム、ローカストビーンガム、ポリ酢酸ビニル、ポリビニルアルコール、およびヒドロキシプロピルメチルセルロースからなる群より選択される20重量%〜40重量%の少なくとも1つの親水性速度調節ポリマーを含み;
ポリビニルピロリドン、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、ポリアクリルアミド、ポリ−N−ビニルアミド、ナトリウムカルボキシメチルセルロース、ポリエチレングリコール、ゼラチン、ポリエチレンオキシド、ポリプロピレングリコール、トラガント、アルギン酸、それらの組合せからなる群より選択される結合剤を適宜含んでいてもよく;
1つまたはそれ以上の滑沢剤、抗接着剤、流動促進剤を単独またはそれらの組み合わせにおいて適宜含んでいてもよく;
親水性フィルム形成ポリマー、着色料および不透明化剤を含む非機能的な被膜を適宜含んでいてもよいレベチラセタムの徐放性錠剤であって、
溶出溶媒としてpH6.8のリン酸緩衝液(900ml、37℃)を用いた40メッシュのバスケット(USP1型)中において下表の溶出プロフィールを有する徐放性錠剤。
- 該錠剤が1日1回投与に適した血漿レベルを提供し、8〜16時間後においてレベチラセタムのピーク血漿レベルを提供する請求項1のレベチラセタムの徐放性錠剤。
- 該錠剤が50重量%〜75重量%のレベチラセタムおよび20重量%〜45重量%のヒドロキシプロピルメチルセルロースを含み、適宜0.5重量%〜5重量%のポビドンを含んでいてもよい、請求項1のレベチラセタムの徐放性錠剤。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IN81/MUM/2005 | 2005-01-27 | ||
IN81MU2005 | 2005-01-27 | ||
PCT/IN2005/000275 WO2006080029A1 (en) | 2005-01-27 | 2005-08-12 | Extended release formulation of levetiracetam |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008528571A JP2008528571A (ja) | 2008-07-31 |
JP5739080B2 true JP5739080B2 (ja) | 2015-06-24 |
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Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007552811A Expired - Fee Related JP5739080B2 (ja) | 2005-01-27 | 2005-08-12 | レベチラセタムの徐放性製剤 |
Country Status (18)
Country | Link |
---|---|
US (4) | US7858122B2 (ja) |
EP (1) | EP1843761B1 (ja) |
JP (1) | JP5739080B2 (ja) |
KR (1) | KR20070095456A (ja) |
CN (1) | CN101111245A (ja) |
AU (1) | AU2005325930B2 (ja) |
BR (1) | BRPI0518506A2 (ja) |
CA (1) | CA2595988A1 (ja) |
DE (1) | DE05815688T1 (ja) |
EA (1) | EA014249B1 (ja) |
ES (1) | ES2294979T1 (ja) |
IL (1) | IL184822A0 (ja) |
MX (1) | MX2007009088A (ja) |
NO (1) | NO20074316L (ja) |
NZ (1) | NZ556630A (ja) |
UA (1) | UA89216C2 (ja) |
WO (1) | WO2006080029A1 (ja) |
ZA (1) | ZA200707250B (ja) |
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- 2005-08-12 KR KR1020077019524A patent/KR20070095456A/ko not_active Application Discontinuation
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AU2005325930A1 (en) | 2006-08-03 |
BRPI0518506A2 (pt) | 2008-12-02 |
AU2005325930B2 (en) | 2012-01-19 |
KR20070095456A (ko) | 2007-09-28 |
EP1843761B1 (en) | 2018-01-31 |
CN101111245A (zh) | 2008-01-23 |
NO20074316L (no) | 2007-08-23 |
EA200701575A1 (ru) | 2008-02-28 |
JP2008528571A (ja) | 2008-07-31 |
ZA200707250B (en) | 2009-06-24 |
WO2006080029A1 (en) | 2006-08-03 |
US7863316B2 (en) | 2011-01-04 |
US20060165796A1 (en) | 2006-07-27 |
DE05815688T1 (de) | 2008-06-26 |
EA014249B1 (ru) | 2010-10-29 |
US7858122B2 (en) | 2010-12-28 |
CA2595988A1 (en) | 2006-08-03 |
US20110064807A1 (en) | 2011-03-17 |
MX2007009088A (es) | 2007-09-13 |
US20110064808A1 (en) | 2011-03-17 |
US20070092569A1 (en) | 2007-04-26 |
EP1843761A1 (en) | 2007-10-17 |
IL184822A0 (en) | 2007-12-03 |
NZ556630A (en) | 2010-12-24 |
ES2294979T1 (es) | 2008-04-16 |
UA89216C2 (ru) | 2010-01-11 |
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