JP2020530433A - 単位面積質量の大きい急速崩壊性発泡体ウェハ - Google Patents
単位面積質量の大きい急速崩壊性発泡体ウェハ Download PDFInfo
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
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Abstract
Description
デキストロメトルファンを含む発泡したウェハを、以下の組成物を用いて製造した:
ポリビニルアルコール(Mowiol 4−88) 38.00重量%
赤染料 0.20重量%
サッカリンナトリウム(甘味料) 1.0重量%
スクラロース(甘味料) 2.0重量%
グリセリン(可塑剤) 4.5重量%
香味料 6.0重量%
有効成分 19.7重量%
矯味剤 28.6重量%
Claims (19)
- 少なくとも1種の有効成分を体の開口部または体腔に放出するための、水性環境下で崩壊または溶解する平板状剤形であって、
空隙を有する固化発泡体の形態であるポリマーマトリックス、および
少なくとも1種の医薬有効成分
を含み、
50〜350g/m2の範囲の単位面積質量を有することを特徴とする、前記平板状剤形。 - 50〜300g/m2の範囲、好ましくは130〜250g/m2、より好ましくは150〜220g/m2の範囲、さらにより好ましくは165〜210g/m2の範囲の単位面積質量を有することを特徴とする、請求項1に記載の剤形。
- ポリマーマトリックスは、ポリビニルアルコール、ポリビニルアルコール−ポリエチレングリコールグラフトコポリマー、およびヒドロキシプロピルメチルセルロースを含む群から選択されるポリマーをベースとすることを特徴とする、請求項1または2に記載の剤形。
- 空隙は、互いに離れており、好ましくは気泡の形態で存在することを特徴とする、請求項1〜3のいずれか1項に記載の剤形。
- 空隙は、互いに連結しており、好ましくはポリマーマトリックスを貫通するチャネル系を形成することを特徴とする、請求項1〜3のいずれか1項に記載の剤形。
- 空隙は、空気またはガス、好ましくは不活性ガス、特に好ましくは窒素、二酸化炭素、ヘリウム、これらのガスの混合物で、または複数のこれらのガスの混合物で充填されていることを特徴とする、請求項1〜5のいずれか1項に記載の剤形。
- 前記空隙は、剤形の総体積に基づいて、5〜98%、好ましくは50〜80%の体積分率を有することを特徴とする、請求項1〜6のいずれか1項に記載の剤形。
- ウェハとして形成され、厚さは、好ましくは100μmから5mmの間、特に好ましくは0.5から3mmの間であることを特徴とする、請求項1〜7のいずれか1項に記載の剤形。
- 医薬有効成分は、好ましくはS−ケタミンの形態であるケタミン、またはデキストロメトルファン、または医薬として許容されるその塩を含有することを特徴とする、請求項1〜8のいずれか1項に記載の剤形。
- 医薬有効成分は、剤形の総重量に基づいて、38〜60重量%、好ましくは42〜55重量%、特に好ましくは45〜52重量%の範囲の割合を占めることを特徴とする、請求項1〜9のいずれか1項に記載の剤形。
- 好ましくはイオン交換樹脂の形態にある、矯味成分を含有することを特徴とする、請求項1〜10のいずれか1項に記載の剤形。
- 請求項1〜11のいずれか1項に記載の剤形を製造する方法であって、
− 少なくとも1種のマトリックスポリマーおよび少なくとも1種の医薬有効成分を含有する溶液または分散液を製造する工程;
− 場合により発泡安定剤の予添加後に、ガスもしくはガス混合物の導入によって、または化学ガスの発生によって、または溶解ガスの膨張によって、溶液または分散液を起泡する工程;
− 発泡溶液または分散液をコーティング基材上に延展する工程;および
− 溶媒を乾燥および除去することによって、延展溶液または分散液を固化させる工程
を特徴とする、方法。 - 請求項1〜11のいずれか1項に記載の剤形を製造するための方法であって、
a)少なくとも1種のマトリックスポリマーおよび少なくとも1種の医薬有効成分を含有する溶液または分散液を製造する工程;
b)ガスの形成が可能な助剤または助剤の組合せを添加する工程;
c)溶液または分散液をコーティング基材上に延展する工程;および
d)溶媒の乾燥および除去によって、延展溶液または分散液を固化させる工程
を特徴とする、方法。 - 請求項1〜11のいずれか1項に記載の剤形を製造するための方法であって、
a)少なくとも1種のマトリックスポリマーおよび少なくとも1種の医薬有効成分を含有するポリマー含有メルト(ホットメルト)を製造する工程;
b)場合により発泡安定剤を予添加後に、ガスもしくはガス混合物の導入によって、または化学ガスの発生によって、または溶解ガスの膨張によって、メルトを起泡する工程;
c)コーティング基材上にメルトを延展する工程;および
d)冷却によってフィルムを固化させる工程
を特徴とする、方法。 - 工程c)およびd)を、以下の工程e)およびf):
e)溶液もしくは分散液からまたはメルトから出発するブロックの形態にあるポリマーマトリックスを製造する工程;
f)平板状形態を得るために、固化ブロックを切断する工程
で置き換えるまたはにより変更することを特徴とする、請求項12〜14のいずれか1項に記載の方法。 - 医薬有効成分を口腔内に投与するための、請求項1〜11のいずれか1項に記載の剤形または請求項14〜16のいずれか1項に記載の方法の生成物の使用。
- 医薬有効成分の直腸内投与、膣内投与または鼻腔内投与のための、請求項1〜11のいずれか1項に記載の剤形または請求項12〜15のいずれか1項に記載の方法の生成物の使用。
- 疼痛、好ましくは慢性疼痛、または鬱病の治療的処置または予防的処置のための、ケタミン、S−ケタミンまたは医薬として許容されるその塩を有する、請求項9または請求項9に従属する請求項に記載の剤形。
- 咳、感情調節障害、または筋萎縮性側索硬化症の治療的処置または予防的処置のための、デキストロメトルファンまたは医薬として許容されるその塩を有する、請求項9または請求項9に従属する請求項に記載の剤形。
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2018
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JP2022076476A (ja) * | 2020-11-09 | 2022-05-19 | エルテーエス ローマン テラピー-ジステーメ アーゲー | 経口薄フィルム |
JP7217794B2 (ja) | 2020-11-09 | 2023-02-03 | エルテーエス ローマン テラピー-ジステーメ アーゲー | 経口薄フィルム |
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EP3634379A1 (de) | 2020-04-15 |
KR102398857B1 (ko) | 2022-05-16 |
AU2018281944B2 (en) | 2021-09-23 |
KR20200013762A (ko) | 2020-02-07 |
CN110709064A (zh) | 2020-01-17 |
MX2019014738A (es) | 2020-02-07 |
CA3064168C (en) | 2023-02-28 |
US20200138714A1 (en) | 2020-05-07 |
DE102017112527A1 (de) | 2018-12-13 |
JP2024069308A (ja) | 2024-05-21 |
JP2022095893A (ja) | 2022-06-28 |
RU2019144316A (ru) | 2021-07-09 |
RU2019144316A3 (ja) | 2021-07-09 |
WO2018224591A1 (de) | 2018-12-13 |
JP7471823B2 (ja) | 2024-04-22 |
DE102017112527B4 (de) | 2019-01-03 |
BR112019024798A2 (pt) | 2020-06-09 |
CA3064168A1 (en) | 2018-12-13 |
AU2018281944A1 (en) | 2020-01-02 |
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