JP2010195807A - 乱用の可能性が低減したオピオイド製剤 - Google Patents
乱用の可能性が低減したオピオイド製剤 Download PDFInfo
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
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- 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
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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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
- A61K9/2004—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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—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
- A61K9/28—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
Abstract
【解決手段】オピオイド製剤は、少なくとも1種のオピオイドと、徐放性送達システムとを含む。徐放性送達システムは、少なくとも1種の親水性化合物を含み、更に、架橋剤、薬学的希釈剤、疎水性ポリマー、カチオン性架橋化合物から選ばれる特定の組み合せを含む。
【選択図】なし
Description
鼻粘膜からの薬物の摂取に理想的な粒子サイズは10μm前後である。鼻エーロゾールは、通常、粒子サイズ分布が可能な限り狭い、10μmの平均粒子サイズを目標として製剤化される。10μmより小さい粒子は口から吐き出されると予想される。肺への薬物の最大吸収のためには、2〜5μmの最適な平均粒子サイズ直径が望ましい。
市販のオピオイド製剤(例:OxyContin(登録商標))と比較して、本発明のオピオイド徐放性製剤(例:オキシモルフォン製剤)が、注射器への取込み及び注射器からの排出が不十分であることを証明するために、以下の実験を実施した。本発明のオピオイド製剤は、市販のオピオイド製剤と比較して、注射器への取込み及び注射器からの排出が極めて不十分であるため、本発明のオピオイド製剤ではオピオイドに容易に到達することができず、市販のオピオイド製剤により得られる多幸感が提供されない。これは、本発明のオピオイド製剤は、従来のオピオイド製剤と比較して、乱用の可能性が有意に低いことを意味する。
Claims (6)
- オキシモルフォン又は薬学的に許容されるその塩と、顆粒化した徐放性送達システムを含む、乱用の可能性が低減された徐放性製剤を製造する方法であって、該方法は、
キサンタンガム、ローカストビーンガム、薬学的希釈剤、及び硫酸カルシウム、塩化ナトリウム、硫酸カリウム、炭酸ナトリウム、塩化リチウム、リン酸トリカリウム、ホウ酸ナトリウム、臭化カリウム、フッ化カリウム、炭酸水素ナトリウム、塩化カルシウム、塩化マグネシウム、クエン酸ナトリウム、酢酸ナトリウム、乳酸カルシウム、硫酸マグネシウム、フッ化ナトリウム、及びそれらの混合物から成る群から選択される少なくとも1種のカチオン性架橋剤を混合し、ここで、該キサンタンガムと該ローカストビーンガムの比は約1:3〜約3:1であり、該キサンタンガムと該カチオン性架橋剤の比は約1:3〜約3:1であり、
該徐放性送達システムの顆粒をオキシモルフォン又は薬学的に許容されるその塩と混合して顆粒化組成物を形成し、そして
該顆粒化組成物に圧力をかけて徐放性製剤を製造する、
ことを含む、上記方法。 - 徐放性製剤の少なくとも一部上に外側被膜を施すことを更に含む、請求項1に記載の方法。
- オキシモルフォン又は薬学的に許容されるその塩が、乱用の可能性が低減された徐放性製剤において、約1ミリグラム〜約100ミリグラムの量存在する、請求項1に記載の方法。
- オキシモルフォン又は薬学的に許容されるその塩が、徐放性送達システム中に微細かつ均質に分散している、請求項1に記載の方法。
- 薬学的希釈剤がデキストロースであって、キサンタンガムとデキストロースの比が約1:3〜約3:1である、請求項1に記載の方法。
- 徐放性製剤が錠剤である、請求項1に記載の方法。
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US32454601P | 2001-09-26 | 2001-09-26 |
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JP2003530373A Division JP2005523876A (ja) | 2001-09-26 | 2002-09-25 | 乱用の可能性が低減したオピオイド製剤 |
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JP2010091222A Pending JP2010195807A (ja) | 2001-09-26 | 2010-04-12 | 乱用の可能性が低減したオピオイド製剤 |
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US (2) | US20030091635A1 (ja) |
EP (1) | EP1429730A4 (ja) |
JP (2) | JP2005523876A (ja) |
AU (1) | AU2002337686B2 (ja) |
CA (1) | CA2459976A1 (ja) |
WO (1) | WO2003026743A2 (ja) |
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2002
- 2002-09-25 US US10/254,207 patent/US20030091635A1/en not_active Abandoned
- 2002-09-25 WO PCT/US2002/030393 patent/WO2003026743A2/en active Application Filing
- 2002-09-25 CA CA002459976A patent/CA2459976A1/en not_active Abandoned
- 2002-09-25 JP JP2003530373A patent/JP2005523876A/ja active Pending
- 2002-09-25 EP EP02773571A patent/EP1429730A4/en not_active Withdrawn
- 2002-09-25 AU AU2002337686A patent/AU2002337686B2/en not_active Ceased
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2007
- 2007-02-09 US US11/704,848 patent/US20070140975A1/en not_active Abandoned
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2010
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WO2003026743A2 (en) | 2003-04-03 |
EP1429730A2 (en) | 2004-06-23 |
US20030091635A1 (en) | 2003-05-15 |
AU2002337686B2 (en) | 2008-05-15 |
CA2459976A1 (en) | 2003-04-03 |
WO2003026743A3 (en) | 2003-10-16 |
JP2005523876A (ja) | 2005-08-11 |
US20070140975A1 (en) | 2007-06-21 |
EP1429730A4 (en) | 2010-06-16 |
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