JP5046946B2 - 低乱用性薬学的製剤 - Google Patents
低乱用性薬学的製剤 Download PDFInfo
- Publication number
- JP5046946B2 JP5046946B2 JP2007537002A JP2007537002A JP5046946B2 JP 5046946 B2 JP5046946 B2 JP 5046946B2 JP 2007537002 A JP2007537002 A JP 2007537002A JP 2007537002 A JP2007537002 A JP 2007537002A JP 5046946 B2 JP5046946 B2 JP 5046946B2
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- JP
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- Prior art keywords
- dosage form
- drug
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- tablets
- beads
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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
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/58—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
- A61K47/585—Ion exchange resins, e.g. polystyrene sulfonic acid resin
-
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- 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
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
-
- 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
- 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
Description
[実施例]
ラウリル硫酸ナトリウム(200g)を、タルク(50g)と微結晶セルロース(750g)とともに、造粒化液体であるイソプロピルアルコールを用いて高剪断造粒機(high shear granulator)により顆粒状にした。湿潤塊(wet mass)を1.2mmスクリーンサイズを用いて押出し、押出速度は約30rpm〜50rpmである。押出物は、約400rpm〜1000rpmに速度設定されたspheronizer / marumarizer中で球状化された。得られた球状ペレットを40℃のオーブン中で乾燥させた。
酢酸セルロース(60g)を、攪拌パドル(stirring paddle)を用いてアセトンと酢酸エチル(1:1比、全量1200g)に溶解する。セルロースアセテートコーティング溶液をヴルスター(Wurster)カラムを用いて流動床中のラウリル硫酸ナトリウムビーズ(540g)に噴霧した。噴霧速度は、約5〜15g/分である。内部温度を40〜50℃に設定し、床温度を30〜35℃に維持する。適切な流動化を維持するために空気流量は1秒あたり約5〜8mである。
スルホコハク酸ジオクチルナトリウム(150g)、Dowex 50X8-200(350g)、微結晶セルロース(480g)をV型混合機で10分間混合する。ステアリン酸マグネシウム(10g)と二酸化ケイ素(10g)を粉末混合物中に添加し、5分間混合した。潤滑化された粉末混合物を7/32”円形工具(round tooling)を有するロータリープレスにより、ミニ錠剤を圧縮する。目的とするタブレットの重量は90mgであり、タブレットの硬度は5kpであり、もろさ(friability)は0.8%未満であった。
酢酸セルロース(60g)を、攪拌パドル(stirring paddle)を用いてアセトンと酢酸エチル(1:1比、全量1200g)に溶解する。酢酸セルロースコーティング溶液をサイドベントパン(side-vented pan)中のスルホコハク酸ジオクチルナトリウム/Dowex 50X8-200のミニ錠剤(540g)に噴霧する。パン速度は、約10〜20rpmである。噴霧速度は、約5〜15g/分である。内部温度は、40〜50℃に設定し、床の温度は30〜35℃に維持する。空気流量は30〜45cfmである。
実施例2〜4からのビーズとミニ錠剤は、活性ビーズやミニ錠剤としてまったく同じ外観を有するようにオーバコートされ得る。引き続いて、該ビーズとミニ錠剤は活性単位と共にカプセル封入され得る。
Claims (13)
- 正電荷を有するアミノ基を含む精神活性化薬物、および水溶液環境中で該薬物とイオン性結合をする少なくとも1つの負電荷を有する薬剤を含み、
前記負電荷を有する薬剤が、適切に投与されたときには該薬物と相互作用しないが、破砕されるか剤形から抽出されたときには相互作用をする形態である、
減少された乱用潜在性を有する剤形。 - 前記負電荷を有する薬剤が、顆粒、ビーズまたはミニ錠剤中に含まれ、薬物を含まない、請求項1記載の剤形。
- 前記顆粒、ビーズまたはミニ錠剤が、薬学的に許容される保護コーティング及び/または腸溶性コーティングでコートされている、請求項2記載の剤形。
- 前記保護コーティングが、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、ヒドロキシプロピルメチルセルロース、ポリビニルピロリドン、ポリ(ブチルメタクリレート(2−ジメチルアミノエチル)メタクリレート、メチルメタクリレート)およびポリビニルピロリドン/酢酸ビニル共重合体からなる群から選ばれる、請求項3記載の剤形。
- 前記腸溶性コーティングが、セルロースアセテートフタレート、セルロースアセテートトリメリテート、ヒドロキシプロピルメチルセルロースフタレート、ポリビニルアセテートフタレート、カルボキシメチルエチルセルロース、および共重合化メタクリル酸/メタクリル酸メチルエステルからなる群から選ばれる、請求項3記載の剤形。
- 前記顆粒、ビーズまたは錠剤が、胃腸管中で溶解しないコーティングでコートされている、請求項2記載の剤形。
- 前記胃腸管中で溶解しないコーティングが、セルロースアセテート、セルロースアセテートブチレート、セルロースアセテートプロピオネート、エチルセルロース、ポリ(エチルアクリレート)、ポリ(メチルメタクリレート)およびポリ(トリメチルアンモニオエチルメタクリレートクロリド)からなる群から選ばれる、請求項6記載の剤形。
- 前記負電荷を有する薬剤が、アニオン界面活性剤、アクリル酸ポリマー、スチレン−ジビニルベンゼンスルホネート、色素およびアルカリ剤からなる群から選ばれる、請求項1記載の剤形。
- 前記電荷を有する薬剤がアニオン界面活性剤からなる群から選ばれる、請求項1記載の剤形。
- 前記アニオン界面活性剤が、ラウリル硫酸ナトリウムおよびスルホコハク酸ジオクチルナトリウムから選ばれる、請求項8又は9記載の剤形。
- 前記負電荷を有する色素が、アルラレッド、アマランス、ブリリアントブルー、カンタキサンチン、カルミンエリスロシン、インディゴカルミン、ポンソー4R、キノリンイエロー、タートラジン、チモールブルー、ブロモチモールブルー、ブロムクレゾールグリーン、ブロモピロガロールレッド、フェノールレッドおよびクレゾールレッドから選ばれる、請求項8記載の剤形。
- 前記アルカリ剤が、炭酸水素ナトリウム、炭酸カルシウム、メグルミンおよびリン酸カルシウムから選ばれる、請求項8記載の剤形。
- 酸可溶性コーティングが、ミニ錠剤、顆粒またはビーズに適用され、アルカリ可溶性の別のコーティングがそれに適用される、請求項3記載の剤形。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US61958904P | 2004-10-15 | 2004-10-15 | |
US60/619,589 | 2004-10-15 | ||
PCT/US2005/037259 WO2006044805A2 (en) | 2004-10-15 | 2005-10-14 | Less abusable pharmaceutical preparations |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008516981A JP2008516981A (ja) | 2008-05-22 |
JP5046946B2 true JP5046946B2 (ja) | 2012-10-10 |
Family
ID=36203634
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007537002A Expired - Fee Related JP5046946B2 (ja) | 2004-10-15 | 2005-10-14 | 低乱用性薬学的製剤 |
Country Status (7)
Country | Link |
---|---|
US (1) | US9308176B2 (ja) |
EP (1) | EP1809259B1 (ja) |
JP (1) | JP5046946B2 (ja) |
AU (1) | AU2005295482B2 (ja) |
CA (1) | CA2581002C (ja) |
ES (1) | ES2531735T3 (ja) |
WO (1) | WO2006044805A2 (ja) |
Families Citing this family (17)
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PT1492511E (pt) | 2002-04-09 | 2009-04-09 | Flamel Tech Sa | Formulação farmacêutica oral na forma de suspensão aquosa de microcápsulas para libertação modificada de princípio(s) activo(s) |
US8906413B2 (en) | 2003-05-12 | 2014-12-09 | Supernus Pharmaceuticals, Inc. | Drug formulations having reduced abuse potential |
CA2581002C (en) | 2004-10-15 | 2012-01-10 | Supernus Pharmaceuticals, Inc. | Less abusable pharmaceutical preparations |
CN101400343B (zh) | 2006-03-16 | 2012-01-11 | 特瑞斯制药股份有限公司 | 含有药物-离子交换树脂复合物的经修饰释放的制剂 |
FR2901478B1 (fr) * | 2006-05-24 | 2015-06-05 | Flamel Tech Sa | Forme pharmaceutique orale multimicroparticulaire a liberation prolongee |
US9023400B2 (en) | 2006-05-24 | 2015-05-05 | Flamel Technologies | Prolonged-release multimicroparticulate oral pharmaceutical form |
US8187636B2 (en) | 2006-09-25 | 2012-05-29 | Atlantic Pharmaceuticals, Inc. | Dosage forms for tamper prone therapeutic agents |
ES2414856T3 (es) * | 2008-12-12 | 2013-07-23 | Paladin Labs Inc. | Formulaciones de fármaco narcótico con potencial de adicción disminuido |
CA2750144C (en) | 2008-12-31 | 2016-10-25 | Upsher-Smith Laboratories, Inc. | Opioid-containing oral pharmaceutical compositions and methods |
BR112012008317A2 (pt) | 2009-09-17 | 2016-03-22 | Upsher Smith Lab Inc | produto de liberação sustentada compreendendo uma combinação de uma amina não-opioide e uma droga anti-inflamatória não-esteroidal |
WO2011104275A1 (en) * | 2010-02-23 | 2011-09-01 | Da Volterra | Formulations for oral delivery of adsorbents in the gut |
FR2962331B1 (fr) * | 2010-07-06 | 2020-04-24 | Ethypharm | Forme pharmaceutique pour lutter contre la soumission chimique, methode la mettant en oeuvre |
US20120222979A1 (en) * | 2011-03-04 | 2012-09-06 | Elwha LLC, a limited liability company of the State of Delaware | Glassy compositions |
WO2015035423A2 (en) * | 2013-09-09 | 2015-03-12 | Nova Southeastern University | Deterring abuse of pharmaceutical products and alcohol |
WO2015145459A1 (en) * | 2014-03-26 | 2015-10-01 | Sun Pharma Advanced Research Company Ltd. | Abuse deterrent immediate release coated reservoir solid dosage form |
CA2910865C (en) | 2014-07-15 | 2016-11-29 | Isa Odidi | Compositions and methods for reducing overdose |
WO2019032975A1 (en) * | 2017-08-10 | 2019-02-14 | Mec Device Pharma International Llc | ANTI-ABUSE MEDICINAL FORMULATIONS |
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-
2005
- 2005-10-14 CA CA2581002A patent/CA2581002C/en not_active Expired - Fee Related
- 2005-10-14 AU AU2005295482A patent/AU2005295482B2/en not_active Ceased
- 2005-10-14 ES ES05808388.2T patent/ES2531735T3/es active Active
- 2005-10-14 JP JP2007537002A patent/JP5046946B2/ja not_active Expired - Fee Related
- 2005-10-14 EP EP05808388.2A patent/EP1809259B1/en not_active Not-in-force
- 2005-10-14 US US11/250,309 patent/US9308176B2/en active Active
- 2005-10-14 WO PCT/US2005/037259 patent/WO2006044805A2/en active Application Filing
Also Published As
Publication number | Publication date |
---|---|
WO2006044805A3 (en) | 2006-06-08 |
CA2581002A1 (en) | 2006-04-27 |
JP2008516981A (ja) | 2008-05-22 |
AU2005295482A1 (en) | 2006-04-27 |
WO2006044805A2 (en) | 2006-04-27 |
US20060083690A1 (en) | 2006-04-20 |
US9308176B2 (en) | 2016-04-12 |
AU2005295482B2 (en) | 2011-03-31 |
ES2531735T3 (es) | 2015-03-18 |
EP1809259A4 (en) | 2012-12-12 |
EP1809259B1 (en) | 2014-12-03 |
EP1809259A2 (en) | 2007-07-25 |
CA2581002C (en) | 2012-01-10 |
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