JP2015514801A - 基質に有効成分を送達するためのシリコーン系賦形剤を含有する局所用製剤組成物 - Google Patents
基質に有効成分を送達するためのシリコーン系賦形剤を含有する局所用製剤組成物 Download PDFInfo
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Abstract
Description
シリコーン系賦形剤は、シリコーンエラストマー配合物、シリコーン有機エラストマー配合物、シリコーン樹脂、シリコーンエラストマー、感圧接着剤、シリコーンガム、シリコーンワックス、エラストマーベース封止剤(elastomer base sealant)、接着剤、又はそれらの任意の組み合わせを含む、任意のシリコーン含有ポリマー材料であってよい。シリコーン系賦形剤は、ジメチコーンクロスポリマー、ジメチコーン/ビス−イソブチルプロピレングリコールクロスポリマー、ポリエチレングリコール−12ジメチコーン/ビス−イソブチルプロピレングリコール−20クロスポリマー、又はそれらの任意の組み合わせであってもよい。
本開示による製剤は、揮発性溶媒を含む。シリコーン系賦形剤は、本局所用製剤を提供するような揮発性溶媒(又は担体流体)中に含有されてもよい。典型的には、揮発性溶媒は、ヒドロシリル化反応を行ってシリコーン系賦形剤を形成するために使用される。好適な揮発性溶媒としては、揮発性溶媒、有機液体(油及び溶媒)、シリコーン、及びそれらの混合物が挙げられる。
有効薬剤及びシリコーン系賦形剤に加えて、様々な賦形剤及び/又は促進薬剤が局所用製剤中に組み込まれてもよい。当業者によって一般的に理解される通り、賦形剤は、有効薬剤を基質への適用のために好適な適切な剤形へと転換するために使用される添加剤である。賦形剤はまた、製剤を安定化するため、及び流動性等の適用特徴を最適化するために添加されてもよい。
製剤は、任意のパーソナルケア、ヘルスケア、又は薬学的有効成分から選択される有効成分を含んでもよい。本明細書で使用するとき、「パーソナルケア有効成分」は、パーソナルケア製剤中の添加剤として当該技術分野において既知であり、典型的には、毛髪又は皮膚を処理して美容的及び/又は美観的利益を提供するために添加される、任意の化合物又は化合物の混合物を意味する。「ヘルスケア有効成分」は、薬学的又は医学的効果をもたらすのに当該技術分野において既知である、任意の化合物又は化合物の混合物を意味する。したがって、「ヘルスケア有効成分」としては、一般的に使用され、the Code of Federal Regulations,Parts 200〜299及びParts 300〜499のTitle 21,Chapter Iに記されるthe United States Department of Health & Human Services Food and Drug Administrationに定義される有効物質、又は薬物有効物質と考えられる材料が挙げられる。
製剤は、製剤が皮膚の上部に適用されるときに閉塞性を提供するように構成される閉塞剤を含んでもよい。閉塞剤は、ペトロラタム、有機ワックス、シリコーンワックス、ポリアクリレート及びメタクリレート(Eudragit(登録商標)E100、S100、L100、及びL100−55によって例示されるがこれらに限定されない)、ポリビニルピロリドン、ポリビニルアルコール、酢酸ビニル−ビニルピロリドンコポリマー、又はそれらの任意の組み合わせを含んでもよい。被膜形成ポリマーの大部分は、製剤に閉塞特性を提供すると考えることができ、したがって任意の好適な被膜形成ポリマーが本製剤中に使用されてもよい。
製剤はまた、多数の任意の物質を含有してもよい。具体的には、これらの任意の構成成分は、パーソナルケア又は薬学的製剤中に使用される物質として当該技術分野において既知であるものから選択される。例証的な非限定的例としては、界面活性剤、溶媒、粉末、着色剤、粘度増加剤、ワックス、ゲル化剤若しくは粘度、安定剤、pH調整剤、シリコーン、又は他の好適な薬剤が挙げられる。
製剤実施例1を、0.1590gのIBPをスピードミキサカップ内で計量した後、0.3158gのPG、0.0351gのOLAC、及び0.6514gのIPAを添加することによって調製した。スピードミキサカップをふたで閉じ、IBPが完全に溶解するまで優しく手動回転(振盪)させた。これに、2.0054gのシリコーンエラストマー配合物SEB1(26.2%固体含有量を有する)をスピードミキサカップ内へ計量し、スピードミキサカップをふたで閉じ、内容物を、均一で均質な材料が得られるまでスピードミキサ内で混合した。製剤材料を、均質な製剤を達成するようにスピードミキサ混合周期の間にへらを用いて混合した。SEB1シリコーンエラストマー配合物は、約15%の固体含有量を有し、イソドデカンと配合されたシリコーンエラストマー材料を含有する。製剤の調製の前に、26.2%固体含有量を得るように、SEB1シリコーンエラストマー配合物を、材料をオーブン内で100℃に維持することによってイソドデカンをSEB1シリコーンエラストマー配合物から蒸発させることによって濃縮した。重力測定判定を、蒸発プロセス中に実施して、26.2%固体含有量に到達した。
製剤実施例4〜21を、一般に使用される局所用製剤における非シリコーン系賦形剤、ペトロラタム、Carbopol(登録商標)、及びアクリルポリマーを上述の実施例1〜3Aに使用したシリコーン賦形剤の代わりに用いて調製した。他のPG、OLAC、IPAは、同様の製剤を達成するために製剤実施例1〜3Aの通りに使用した。得られた製剤(4〜21)のフラックスプロファイルを、試験し、皮膚を通じたIBP送達の効率に関してシリコーン製剤1〜3Aと比較した。シリコーン製剤実施例1〜3Aは、1時間でベンチマーク及び製剤実施例4〜21より高い量の薬物を送達した。更に、シリコーン製剤実施例1〜3Aはまた、8時間後により高い量の薬物を放出した。
製剤実施例4を、3.0050gのペトロラタムをスピードミキサカップ内で計量した後、0.5413gのPG、0.0601gのOLACを添加し、スピードミキサ内で均質になるまで混合することによって調製した。0.1897gのイブプロフェンを次に計量、スピードミキサに添加して、薬物が完全に溶解するまで再び混合した。製剤実施例5及び6に関して、IBPを添加した後に適量のIPAも添加した(表2参照)。製剤を、均質な製剤を達成するようにスピードミキサ混合周期の間にへらを用いて混合した。
製剤実施例7を、0.2017gのCarbopol(登録商標)971P NFをシンチレーションバイアル瓶内で計量した後、3.5040gのIPAを添加することによって調製した。混合物を、ボルテックスミキサ内で混合した後、1.5078gの水を添加した。水の添加後、再びボルテックスミキサ内で混合した。バイアル瓶へ0.0941gのPG、0.0105gのOLAC、及び0.2796gのIBPを添加し、ボルテックスミキサを用いて混合して、イブプロフェンが完全に溶解した均質で透明な製剤を得た。同様の手順を続け、下記の表3に示される通り個々の構成成分の量を変更することによって製剤実施例8及び9を調製した。
製剤実施例10、11、及び12の調製に関して、初めにEudragit(登録商標)E100の約50%固体原液を、50%固体を達成するように所定の量のIPAにそれを溶解することによって作製した。製剤実施例10を、4.0142gの上述のEudragit(登録商標)E100の50%固体溶液をシンチレーションバイアル瓶内へ計量した後、0.9196gのPG、0.1022gのOLAC、及び0.2565gのIBPを添加することによって調製した。混合物をボルテックスミキサ内で混合して、イブプロフェンが完全に溶解した均質で透明な製剤を得た。同様の手順を続け、下記の表4に示される通り個々の構成成分の量を変更することによって製剤実施例11及び12を調製した。
製剤実施例22を、0.0397gのDCFをスピードミキサカップ内へ計量した後、0.9193gのIPA、0.4528gのPG、及び0.0503gのOLACを添加することによって調製した。カップをふたで閉じ、DCFが完全に溶解されるまでボルテックスミキサを用いて優しく混合した。同じカップ内へ、26.2%固体含有量を有する2.5076gのSEB1を添加し、カップをふたで閉じた。カップを、均質な材料が得られるまでスピードミキサ内で混合した。製剤材料を、均質な製剤を達成するように混合周期の間にへらを用いて混合した。実施例23〜26を、個々の構成成分の量を下記表6に示される通りに変更することによって、上述のものと同様の手順を用いて調製した。実施例27及び28を、同様の方法であるが26%固体含有量を有するSEB2を用いて調製した。
製剤実施例29を、0.0025gのCLPをスピードミキサカップ内へ計量した後、1.4352gのIPA、0.4762gのPG、及び0.0529gのOLACを添加することによって調製した。カップをふたで閉じ、CLPが完全に溶解されるまでボルテックスミキサを用いて優しく混合した。同じカップ内へ、3.0082gのSEB1(26.2%固体含有量を有する)を添加し、カップをふたで閉じた。カップを、均質な材料が得られるまでスピードミキサ内で混合した。製剤材料を、均質な製剤を達成するようにスピードミキサ混合周期の間にへらを用いて混合した。製剤実施例30を、下記表7に示される通り、26%固体含有量を有するSEB2を用いて、個々の構成成分の量を変更することによって上述のものと同様の手順を用いて調製した。
製剤実施例32〜34を、下記の表8に示される通り、SGMを用いて調製した。製剤実施例32を、0.0506gのSGMをシンチレーションバイアル瓶内へ計量した後、0.5005gのIBP及び9.4523gのHMDSを添加することによって調製した。バイアル瓶をふたで閉じ、内容物をボルテックスミキサを用いて混合した。IBPは、得られた溶液中で完全には溶解せず、代わりに溶液中で分散した。実施例33及び34を、下記表8に示される通り個々の構成成分の量を変更することによって、上述のものと同様の手順を用いて調製した。
製剤実施例35を、0.0504gのSGMをシンチレーションバイアル瓶内へ計量した後、0.0505gのHCO及び9.9046gのHMDSを添加することによって調製した。バイアル瓶をふたで閉じ、ボルテックスミキサを用いて混合した。HCOは溶解しなかったが、溶液中に分散した。製剤実施例36及び37を、下記表8に示される通りに個々の構成成分の量を変更することによって、上述のものと同様の手順を用いて調製した。
Claims (15)
- 半固体局所用薬物送達製剤であって、
(a)シリコーン系賦形剤と、
(b)少なくとも1つの揮発性溶媒と、
(c)意図される治療用途のために患者の皮膚を通じて局所に送達されるように構成される少なくとも1つの有効成分と、
(d)少なくとも1つの促進剤と、
(e)任意に、前記製剤が前記患者の皮膚に適用されるときに閉塞性を提供するように構成される少なくとも1つの薬剤と、を含む、製剤。 - 前記シリコーン系賦形剤が、シリコーンエラストマー配合物、シリコーン有機エラストマー配合物、シリコーン樹脂、シリコーンゴム、感圧接着剤、シリコーンガム、若しくはそれらの任意の組み合わせであるか、又は前記シリコーン系賦形剤が、ジメチコーンクロスポリマー、ジメチコーン/ビス−イソブチルプロピレングリコールクロスポリマー、ポリエチレングリコール−12ジメチコーン/ビス−イソブチルプロピレングリコール−20クロスポリマー、若しくはそれらの任意の組み合わせである、請求項1に記載の製剤。
- 前記シリコーン系賦形剤が、イソドデカン、シクロペンタシロキサン、イソデシルネオペンタノエート、及びカプリリルメチコンから選択される担体流体中に含まれるシリコーン有機エラストマーである、請求項1に記載の製剤。
- 前記少なくとも1つの促進剤が、プロピレングリコール、ブチレングリコール、ジプロピレングリコール、ポリエチレングリコール−20、オレイン酸、オレイルアルコール、ミリスチン酸イソプロピル、ジメチルイソソルビド、ジメチルスルホキシド、又はそれらの任意の組み合わせである請求項1〜3のいずれか一項に記載の製剤。
- 前記少なくとも1つの促進剤が、非揮発性賦形剤及び皮膚浸透促進剤を含み、前記非揮発性賦形剤の前記浸透促進剤に対する重量比が、任意に、約100:1〜約50:50である、請求項1〜3のいずれか一項に記載の製剤。
- 前記少なくとも1つの揮発性溶媒が、イソプロピルアルコール、エタノール、酢酸エチル、ヘキサメチルジシロキサン、ポリジメチルシロキサン、水、又はそれらの任意の組み合わせである、請求項1〜5のいずれか一項に記載の製剤。
- 前記製剤が前記患者の皮膚に適用されるときに閉塞性を提供するように構成される前記少なくとも1つの薬剤を更に含み、閉塞性を提供するように構成される前記少なくとも1つの薬剤が、ペトロラタム、有機ワックス、シリコーンワックス、又はそれらの任意の組み合わせである、請求項1〜6のいずれか一項に記載の製剤。
- 前記少なくとも1つの有効成分が、非ステロイド性抗炎症薬、ステロイド、レチノイド、アゾール、漢方薬、抗ニキビ薬、抗生物質、又はそれらの任意の組み合わせである、請求項1〜7のいずれか一項に記載の製剤。
- 前記製剤が、乳剤である、請求項1〜8のいずれか一項に記載の製剤。
- 前記製剤が、ヒドロアルコールゲルである、請求項1〜9のいずれか一項に記載の製剤。
- 前記製剤が、無水である、請求項1〜10のいずれか一項に記載の製剤。
- 防腐剤を含まない、請求項1〜11のいずれか一項に記載の製剤。
- 前記患者の皮膚に、治療的に有効な量の前記少なくとも1つの有効成分を長期間送達するように構成される、請求項1〜12のいずれか一項に記載の製剤。
- 前記患者の皮膚に、治療的に有効な量の前記少なくとも1つの有効成分を4時間超又は8時間超送達するように構成される、請求項1〜13のいずれか一項に記載の製剤。
- 哺乳動物の皮膚を通じた薬学的有効物質の浸透を増大させるための方法であって、前記皮膚に、請求項1〜14のいずれか一項に記載の化学的及び物理的に安定した製剤を局所投与することを含む、方法。
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US201261639611P | 2012-04-27 | 2012-04-27 | |
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PCT/US2013/030212 WO2013162723A1 (en) | 2012-04-27 | 2013-03-11 | Topical formulation compositions containing silicone based excipients to deliver actives to a substrate |
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EP (1) | EP2841106A1 (ja) |
JP (1) | JP6093007B2 (ja) |
CN (1) | CN104271160B (ja) |
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JP2019533648A (ja) * | 2016-09-23 | 2019-11-21 | ニーム バイオテック リミテッド | 皮膚障害の治療のための過マンガン酸カリウムを含むパッチ |
JP2020508993A (ja) * | 2017-02-15 | 2020-03-26 | ボタニクス ファーマシューティカルズ リミテッド | ざ瘡を処置するための組成物 |
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US11452701B2 (en) | 2017-12-04 | 2022-09-27 | Johnson & Johnson Consumer Inc. | Topical emulsion composition containing nonsteroidal anti-inflammatory drug |
US20190224137A1 (en) * | 2018-01-24 | 2019-07-25 | Botanix Pharmaceuticals Ltd. | Cannabinoid Dosing Regime for Acne |
JP2021512067A (ja) * | 2018-01-24 | 2021-05-13 | ボタニクス ファーマシューティカルズ リミテッド | ざ瘡のためのカンナビノイド投薬レジメン |
AT521126A2 (de) * | 2018-03-29 | 2019-10-15 | Bcsk Biocid Gmbh | Sprühpflasterzusammensetzung |
WO2019213142A1 (en) * | 2018-04-30 | 2019-11-07 | Eleblend Llc | Cosmetic compositions |
US11304416B2 (en) * | 2018-09-24 | 2022-04-19 | Relevo Labs, Llc | Cyclopentasiloxane and cationic biocide as a formulation additive to enhance persistent sanitizing and miscibility |
CA3138194A1 (en) | 2019-04-30 | 2020-11-05 | Bayer Healthcare Llc | Topical analgesic gel compositions |
TWI691343B (zh) * | 2019-05-02 | 2020-04-21 | 邵明遠 | 液體繃帶組成物之用途 |
WO2021061913A1 (en) * | 2019-09-27 | 2021-04-01 | Encube Ethicals, Pvt. Ltd. | Diclofenac sodium topical solution |
CN117750951A (zh) * | 2021-07-29 | 2024-03-22 | 3M创新有限公司 | 包含水杨酸的成膜组合物和使用方法 |
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CN104271160A (zh) | 2015-01-07 |
US20150141389A1 (en) | 2015-05-21 |
IN2014DN09817A (ja) | 2015-07-31 |
JP6093007B2 (ja) | 2017-03-08 |
CN104271160B (zh) | 2017-08-08 |
EP2841106A1 (en) | 2015-03-04 |
WO2013162723A1 (en) | 2013-10-31 |
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