JP2017527608A - 経鼻組成物と該経鼻組成物の使用方法の改善 - Google Patents
経鼻組成物と該経鼻組成物の使用方法の改善 Download PDFInfo
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Abstract
Description
ここで、本発明の一実施形態を添付の図面を参照して記載する。
使用した第1の成分は、その中に充血緩和に有効な物質オキシメタゾリンを0.05%含有する、AFRIN(登録商標)(Merck Consume Care,Incにより販売)と称する液体の充血緩和剤製品であった。使用した第2の成分は、アレルギー性鼻炎の治療用として認可されているNoAL(Nasaleze Ltdより提供)と称するメチルセルロース微粉末であった。第1及び第2の成分は患者によって鼻腔に順に、1つの成分が投与された後、直ちに次が投与された。投薬計画は、7日間、1日に1回、AFRINを1パフ/回(puff/squirt)、その直後、NoALを1パフ/回(puff/squirt)とし、それのみとした。
PNIFは正規分布しており、グループ内の違いを対応するデータ用のスチューデントt検定で分析し、グループ間の違いを対応しないデータ用のスチューデントt検定で分析した。患者が救急薬に頼った回数は正規分布していないため、これらの結果は中央値(25〜75%範囲)で示し、グループの差はマン・ホイットニU検定で評価した。検定は全て、両側検定とし、統計的有意性の閾値はP<0.05とした。
この研究に採用された患者40人のうち、2人が(1人はノンコンプライアンスのため、他は頭痛のため)試験治療グループから脱落し、2人が(1人は合併症のため、他は猫に対する激しい反応のため)プラセボグループから脱落した。残りの36人の患者が、3回全て来院し、最終の分析に含まれた。
Claims (30)
- 使用時、患者に経鼻塗布するための液体の形態の第1の成分と、使用時、前記患者に経鼻塗布するための粉末の形態の第2の成分とを含むか、又はそれらの成分からなり、前記第1及び第2の成分は、必要に応じて、個別に又は一緒に前記患者に塗布される経鼻組成物。
- 前記第1の液体成分は、1種以上の治療に有効な物質、医薬品、医薬製品、充血緩和剤、アレルギー治療物質、生薬物質、ホメオパシー物質、補助食品、プロバイオティック又は気道拡張剤の任意の1種、又は任意の組み合わせを含むか、又はそれからなる請求項1に記載の経鼻組成物。
- 前記第1の液体成分は、適切な経鼻ディスペンサを使用して、液体スプレーの形態で、又は液滴として前記患者の鼻腔に塗布される請求項1に記載の経鼻組成物。
- 前記第2の粉末組成物は、患者の吸入によって鼻腔に塗布される請求項1に記載の経鼻組成物。
- 前記第2の粉末成分は、セルロース粉末、ヒドロキシメチルセルロース(HPMC)粉末、1種以上の治療に有効な物質、医薬物質、医薬品、シグナル伝達物質、気道拡張物質、生薬物質、ホメオパシー物質、プロバイオティック、補助食品、アレルギー治療物質、充血緩和剤、又は前記第1の液体成分に含まれるプロドラッグの触媒及び/又は促進剤などの任意の1種、又は任意の組み合わせを含むか、又はそれからなる請求項1に記載の経鼻組成物。
- 前記治療物質、ホメオパシー物質及び/又は生薬物質は、次の特性:抗菌性、抗真菌性、抗ウイルス性、抗生性、免疫調節性、抗炎症性、反不眠症、認識促進性、又は循環機能に影響する特性の1つ以上の特性を含む請求項5に記載の経鼻組成物。
- 前記治療に有効な物質は、アスピリン、イソプリノシン、アシクロビル、セント・ジョーンズ・ワート、ヴァレリアン抽出物、イチョウ葉抽出物、ビタミン、ニンニク、ライムジンジャー、エラグ酸、エキナセア、スウエーデンの花の花粉、クロクルミの外皮、レモングラス、ニガヨモギ、グレープフルーツ種子抽出物、ブロッコリ、消化酵素、ヒアルロン酸、アストラルグス(astralgus)、ローズヒップ、リンドウ、オトギリソウ、セイヨウトチノキ、チョウセンニンジン、緑茶、ホスファチジルセリン、ホスファチジルコリン、柑橘類、ピクノジェノール、カフェイン、ケルセチン、コエンザイムQ10、ノコギリソウ、ティーツリー、ノニジュース、リパーゼ、フラクトオリゴ糖、イヌリン、ブラッククミン若しくはアリシン、ミント種、ウコンの任意の1種、又は任意の組み合わせを含む請求項5に記載の経鼻組成物。
- 前記第2の成分は、その中に、セルロース粉末又はヒドロキシメチルセルロース(HPMC)粉末を有意の割合で含む請求項1に記載の経鼻組成物。
- 前記第2の成分は、HPMC又はセルロース粉末を少なくとも50%含む請求項8に記載の経鼻組成物。
- 前記第2の成分は、HPMC又はセルロース粉末を、前記第2の成分の全重量の少なくとも60、70、80、90、95又は99%含む請求項8に記載の経鼻組成物。
- 前記第2の成分の投薬量は、患者の鼻孔当たり、1mg〜10mgである請求項1に記載の経鼻組成物。
- 前記第2の成分の投薬量は、患者の鼻孔当たり、2.5mg〜7.5mg、3〜7mg、4〜6mg、又は5mgである請求項1に記載の経鼻組成物。
- 前記第2の成分は、セルロース粉末又はヒドロキシメチルセルロース(HPMC)粉末を含むか又はそれからなり、前記粉末の2%水溶液での20℃における粘度は、10〜20Pa.sである請求項1に記載の経鼻組成物。
- 前記粉末は、13〜17Pa.s、14〜16Pa.s又は15Pa.sの粘度を有する請求項13に記載の経鼻組成物。
- 前記第2の成分は、カリ・ビクロミカム;増粘剤、ゴム、デンプン;崩壊剤、グリコール酸ナトリウム、架橋ポビドン、離型剤、ステアリン酸マグネシウム;乳化剤、界面活性剤、固結防止剤、造粒剤、防腐剤又は着色剤の1種、又は任意の組み合わせを含む請求項1に記載の経鼻組成物。
- 前記第2の成分は、使用の際に、心地良い感覚フィードバックを前記患者に提供し得るシグナル伝達物質又は香味料を含む請求項1に記載の経鼻組成物。
- 前記シグナル伝達物質は、ミント、メントール、スペアミント、任意のミント種、ウコン、レモン、ライム、ペパーミント、ユーカリ、イチゴ、ラベンダー、柑橘類又はカプサイシンの任意の1種、又は任意の組み合わせを含む請求項16に記載の経鼻組成物。
- 前記シグナル伝達物質は、前記第2の成分の50%まで含まれる請求項16に記載の経鼻組成物。
- 前記シグナル伝達物質は、前記第2の成分の全重量の40%、30%、20%、10%、5%、2%、1%、0.5%又は0.25%まで含まれる請求項16に記載の経鼻組成物。
- 前記第2の成分は、前記第1の成分の前記患者への投与前又は投与直前に、前記患者に投与される請求項1に記載の経鼻組成物。
- 前記第1の成分は、前記第2の成分の投与前又は投与直前に、前記患者に投与される請求項1に記載の経鼻組成物。
- 前記第1の成分及び前記第2の成分は、同時に又は実質的に同時に投与される請求項1に記載の経鼻組成物。
- 前記第1の成分及び前記第2の成分は、投与の順序に関わりなく、次々と順次に投与される請求項1に記載の経鼻組成物。
- 前記第1及び第2の成分は、互いに一方の投与後、5分以内に投与される請求項1に記載の経鼻組成物。
- 前記第1及び第2の成分は、互いに一方の投与後、2分以内に、互いに一方の投与後、1分以内に、互いに一方の投与後、30秒以内に、互いに一方の投与後、20秒以内に、互いに一方の投与後、10秒以内に、互いに一方の投与後、5秒以内に、又は互いに一方の投与後、1秒以内に投与される請求項1に記載の経鼻組成物。
- 第3の成分及び/又はさらなる成分を含むか、又はそれからなる請求項1に記載の経鼻組成物。
- 前記第1、第2、第3及び/又はさらなる成分は、患者の鼻腔に塗布されるまでは一緒に混合されない、又は互いに接触した状態とされない、個別に塗布される独立した成分である請求項1又は26に記載の経鼻組成物。
- 前記第2の成分は、使用時、患者の鼻粘膜に対する前記第1の成分の1種以上の構成成分の粘膜付着を増大させるように調製される請求項1に記載の経鼻組成物。
- 前記第1の成分及び前記第2の成分を含む請求項1に記載の経鼻組成物用成分キット。
- 患者の気道、アレルギー性疾患、鼻炎、上気道、及び/又は下気道に関連する病気の治療用薬剤を製造するための経鼻組成物であって、患者の経鼻塗布に使用される液体の形態の第1の成分、及び前記患者の経鼻塗布に使用される粉末の形態の第2の成分を含むか、又はそれらからなり、前記第1及び第2の成分は必要に応じて個別に又は一緒に前記患者に塗布される経鼻組成物。
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GBGB1410250.3A GB201410250D0 (en) | 2014-06-10 | 2014-06-10 | Improvements to nasal compositions and method of use thereof |
GB1410250.3 | 2014-06-10 | ||
PCT/GB2015/051661 WO2015189579A1 (en) | 2014-06-10 | 2015-06-08 | Improvements to nasal compositions and method of use thereof |
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GB201410250D0 (en) | 2014-06-10 | 2014-07-23 | Nasaleze Patents Ltd | Improvements to nasal compositions and method of use thereof |
CA2923767A1 (en) | 2016-03-14 | 2017-09-14 | Timothy R. St. Germain | Method of using n-hydroxy-1,4-napthalenedione as a novel herbicide |
CN106361688B (zh) * | 2016-08-26 | 2019-12-06 | 朱高 | 鼻腔洗液及其制备方法和应用 |
CN106890197B (zh) * | 2017-04-11 | 2018-07-31 | 成都益植生物科技有限公司 | 一种定植益生菌制剂及其应用和药物 |
CN107582573A (zh) * | 2017-08-23 | 2018-01-16 | 江苏微康生物科技有限公司 | 一种益生菌滴剂及其制备方法 |
CN109966324A (zh) * | 2017-12-27 | 2019-07-05 | 北京盈科瑞药物安全有效性研究有限公司 | 一种银杏叶提取物雾化吸入用溶液制剂及其制备方法 |
TR201900055A2 (tr) * | 2019-01-03 | 2019-03-21 | Helvacizade Gida Ilac Kimya Sanayi Ve Ticaret Anonim Sirketi | Burun spreyi̇ formülasyonu |
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US11583519B2 (en) | 2023-02-21 |
WO2015189579A1 (en) | 2015-12-17 |
EP3154515A1 (en) | 2017-04-19 |
RU2016151683A (ru) | 2018-07-10 |
WO2015189579A9 (en) | 2017-02-23 |
US20170239220A1 (en) | 2017-08-24 |
ES2869912T3 (es) | 2021-10-26 |
PL3154515T3 (pl) | 2021-08-09 |
RU2016151683A3 (ja) | 2019-01-24 |
GB201410250D0 (en) | 2014-07-23 |
CN106794137B (zh) | 2021-10-15 |
JP6762931B2 (ja) | 2020-09-30 |
BR112016029013A2 (pt) | 2017-08-22 |
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US20200054609A1 (en) | 2020-02-20 |
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