JP2008530217A - 制御送達システムを有する経皮システム - Google Patents
制御送達システムを有する経皮システム Download PDFInfo
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- JP2008530217A JP2008530217A JP2007556252A JP2007556252A JP2008530217A JP 2008530217 A JP2008530217 A JP 2008530217A JP 2007556252 A JP2007556252 A JP 2007556252A JP 2007556252 A JP2007556252 A JP 2007556252A JP 2008530217 A JP2008530217 A JP 2008530217A
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- adhesive layer
- delivery system
- active agent
- transdermal delivery
- adhesive
- Prior art date
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Classifications
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- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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Abstract
Description
本出願は、「制御送達システムを有する経皮システム」というタイトルで、2005年2月18日に提出された米国特許出願No.11/062084の利益を請求し、その開示は、引用することにより本明細書の一部をなすものとする。
本発明は、経皮送達システムに関する。更に詳細には、本発明は、患者の皮膚又は粘膜に活性薬剤を送達するための経皮送達システムに関する。更により詳細には、本発明は、ポリマー膜を利用して、活性薬剤の移送速度を制御する経皮送達システムに関する。
経皮送達システムを患者の皮膚又は粘膜に貼付するための接着剤層を調製するステップと、
ポリマー膜を設けるステップと、
患者の皮膚又は粘膜を通って活性薬剤を移送する速度を変えるための流体媒体の所定量をポリマー膜に含浸させるステップと、
ポリマー膜を乾燥させることなく接着剤層を乾燥させるステップと、
接着剤層を含浸ポリマー膜に適用するステップと、
支持層を設けるステップと、接着剤層とポリマー膜を支持層の内側に組み込むステップと、
剥離性ライナーを接着剤層に隣接して設けるステップと、経皮送達システムを患者の皮膚又は粘膜に適用する前に該接着剤層を保護するステップと
を含む。好ましい実施形態では、流体媒体は、活性薬剤のための溶媒、又は活性薬剤のための促進剤、又は活性薬剤のための賦形剤(又は賦形剤溶液)又は活性薬剤自体を含む
4オンスのガラスジャー中で、エストラジオール半水和物と200プルーフ(200 proof)のエチルアルコールとを超音波処理することにより、活性エストラジオール混合物を製造した。ポリビニルピロリドン、ヒュームドシリカ、プロピレングリコール及びDuroTak(登録商標)87−2194接着剤を添加し、圧縮空気駆動ミキシングブレードを使用して、混合物を混合した。活性混合物を、Medirelease(登録商標)2226上に皮膚接触層として、ウェットで、18milの厚さにロール式ナイフ塗布し、その後、54℃で5分間、85℃で8分間乾燥させた。アンカー層は、Medirelease(登録商標)2226上に8milの厚さにウェットで塗布されたプラセボポリイソブチレンであり、これは、54℃で5分間、85℃で8分間乾燥させ、その後、0.5milのPETと重ね合わせた。剥離ライナーを、ポリイソブチレンアンカー層から剥がした。アンカー接着剤と同一寸法のCoTran(登録商標)9711のピースを露出したアンカー接着剤上に置いた。CoTran(登録商標)9711を備えたアンカー層を、200プルーフのエチルアルコールの浴中に、2分間浸した。アンカー層を浴から取り出した。次いで、活性皮膚接触層を、エチルアルコールを含浸させた露出した膜上に重ね合わせた。パッチを打ち抜き、Barexパウチングで、パウチにいれた。パッチは、インビトロで送達「スパイク」を示した。
エストラジオール半水和物が、分散するまで(約3分)、エストラジオール半水和物とエタノールとを超音波処理することにより、活性接着剤混合物を製造した。ポリビニルピロリドンを予混合物に添加し、溶解させた。次に、プロピレングリコールを添加し、回転させた。最後に、DuroTak(登録商標)87−2194接着剤及びヒュームドシリカを添加した。ガラスジャー中で、圧縮空気駆動ミキシングブレードを使用して、混合物を混合した。その後、混合物をジャーロラー上で一晩回転させ、ガス抜きした。活性接着剤混合物を、Medirelease(登録商標)2226上に、2回ロール式ナイフ塗布した。アンカー層は、ウェットで8milの厚さに塗布され、皮膚接触層は、ウェットで、19milの厚さに塗布された。両方の層を、41℃で4分間、77℃で4分間乾燥させた。パッチを完成させるために、アンカー層は、Mediflex(登録商標)1000に重ね合わせた。剥離ライナーを、アンカー層から剥がした。9%のエチレンビニルアセテート膜(2.0mil)を、エチルアルコール浴中に膜を沈めることにより、200プルーフのエチルアルコールで飽和させた。飽和した膜を、浴から取り出し、アンカー層の接着側に置いた。皮膚接触層(接着側)を、露出したエタノール含有膜上に重ね合わせた。この製剤は、インビトロで送達「スパイク」を示した。
エストラジオール半水和物(0.41g)を200プルーフのエチルアルコール(3.09g)中で3分間、超音波処理することにより、活性混合物を製造した。ポリビニルピロリドン(1.04g)を予混合物に溶解させ、3分間超音波処理した。プロピレングリコール(4.80g)、DuroTak(登録商標)87−2194(60.79g)及びヒュームドシリカ(0・17g)を、予混合物に添加した。圧縮空気駆動ミキシングブレードを使用して、混合物全体を、3分間混合した。その後、ガラスジャーをジャーロラー上で一晩回転させ、ガス抜きをした。ラミネートは、Medirelease(登録商標)2249上に、ウェットで14milの厚さに、ロール式ナイフ塗布し、被膜重量55.0g/m2が得られた。ラミネートを、41℃で4分間、77℃で4分間乾燥させた。第一のラミネートを、アンカー層として、Mediflex(登録商標)1500支持材と重ね合わせた。剥離ライナーを、アンカー層から剥がした。1枚のDSM Solupor 10P05A膜は、200プルーフのエチルアルコール浴中に、少なくとも1分間、沈めた。膜を、浴から取り出し、柔らかい雑巾で拭って、過剰のエチルアルコールを除去した。外気中に1分間置いた後、湿った膜を、アンカー層の露出した接着剤上に置いた。第二のラミネート(皮膚接触層)を、露出したエチルアルコール含有膜上に、直接に重ね合わせた。適切なサイズのパッチを、直接にラミネートから打ち抜き、ポリエチレンパウチング材料中に封入した。この製剤は、インビトロで送達「スパイク」を示した。
酢酸エチル中のアルブテロールスルフェートを4オンスのガラスジャー中で5分間、超音波処理することにより、活性混合物を製造した。鉱油、ラウリルアルコール及びラウリン酸を予混合物に添加した。ポリイソブチレン接着剤をジャーに添加し、混合物を、圧縮空気駆動ミキシングブレードを使用して、3分間混合した。その後、混合物をジャーロラーで回転させ、ガス抜きをした。混合物を、Medirelease(登録商標)2226上に、ウェットで10milの厚さに、2回塗布し、55℃で5分間、85℃で8分間乾燥させた。一つのラミネートを、Mediflex(登録商標)1500支持材と重ね合わせ、剥離ライナーを剥がした。CoTran(登録商標)9711の7cm2ピースを露出した接着剤上に置いた。CoTran(登録商標)9711の各ピース上に、50μlの1−オクタノールをピペットで添加した。他のラミネートを、1−オクタノールを含浸させたCoTran(登録商標)9711上に重ね合わせ、10cm2のパッチを打ち抜いた。パッチを即座にパウチに入れた。インビトロでの流束ラグタイム(flux lag time)は、1−オクタノールを含浸させた膜を備えない対照と比較して短縮された。
酢酸エチル中のアルブテロールスルフェートを3分間、4オンスのガラスジャー中で超音波処理することにより、活性混合物を製造した。鉱油及びラウリン酸を予混合物に添加した。ポリイソブチレン接着剤をジャーに添加し、混合物を、圧縮空気駆動ミキシングブレードを使用して、3分間混合した。その後、混合物をジャーローラーで回転させ、ガス抜きをした。混合物を、Medirelease(登録商標)2226上に、2回塗布し(50g/cm2)、55℃で5分間、85℃で8分間乾燥させた。一つのラミネートを、Mediflex(登録商標)1500支持材と重ね合わせ、剥離ライナーを剥がした。ラウリルアルコールを含浸させたCoTran(登録商標)9711の10cm2ピースを露出した接着剤上に置いた。第二のラミネートを、ラウリルアルコールを含浸させたCoTran(登録商標)9711上に重ね合わせ、10cm2のパッチを打ち抜いた。
Claims (42)
- 患者の皮膚又は粘膜に活性薬剤を送達するための経皮送達システムであって、支持層と、前記支持層の内側に配置されたポリマー膜と、前記患者の前記皮膚又は粘膜に前記経皮送達システムを貼付するための接着剤層と、前記患者の前記皮膚又は粘膜に前記経皮送達システムを貼付する前に前記接着剤層を覆うための剥離層とを含み、前記ポリマー膜には、前記ポリマー膜を通って前記患者の前記皮膚又は粘膜に前記活性薬剤を移送する速度を変えるための所定量の流体媒体が含浸されており、前記所定量の前記流体媒体は、前記ポリマー膜の乾燥時に前記ポリマー膜に保有される前記流体媒体量より実質的に多い、経皮送達システム。
- 前記流体媒体が、前記活性薬剤のための溶媒、前記活性薬剤のための促進剤、前記活性薬剤のための賦形剤及び前記活性薬剤からなる群から選択される液体を含む、請求項1に記載の経皮送達システム。
- 前記接着剤層が、第一の接着剤層を含み、かつ前記支持層と前記ポリマー膜との間に配置される第二の接着剤層を含む、請求項1に記載の経皮送達システム。
- 前記第一の接着剤層と第二の接着剤層とのそれぞれが、アクリル、シリコーン、ポリイソアルカリ、ゴム、酢酸ビニル、ポリイソブチレンゴム、ポリブタジエン、スチレン−ブタジエン、セルロース誘導体、多糖類、ポリウレタンエラストマー及びポリエステルエラストマーからなる群から選択される接着剤を含む接着マトリックスを含む、請求項3に記載の経皮送達システム。
- 前記接着剤が、アクリル、シリコーン、ゴム、スチレン−ブタジエンゴム、及びポリイソブチレンからなる群から選択される、請求項4に記載の経皮送達システム。
- 前記接着剤が、アクリル接着剤を含む、請求項5に記載の経皮送達システム。
- 前記流体媒体が、前記活性薬剤のための溶媒を含む、請求項2に記載の経皮送達システム。
- 前記溶媒が、C2〜C8アルコールを含む、請求項7に記載の経皮送達システム。
- 前記第一の接着剤層が、前記活性薬剤を含む、請求項4に記載の経皮送達システム。
- 前記第二の接着剤層が、前記活性薬剤を含む、請求項4に記載の経皮送達システム。
- 前記第一の接着剤層と第二の接着剤層との両方が、前記活性薬剤を含む、請求項4に記載の経皮送達システム。
- 前記ポリマー膜が、親水性及び疎水性の、ポリマー及びコポリマーからなる群から選択されるポリマーを含む、請求項1に記載の経皮送達システム。
- 前記ポリマー膜が、ポリオレフィン、エチレン−酢酸ビニル、ポリ酢酸ビニル、ポリエーテルブロックアミド、ポリウレタン、ポリアミド、セルロース、セルロース誘導体、ポリ塩化ビニル、ポリビニルアルコール、ポリスチレン、ポリメチルメタクリレート、ポリシラン、及びポリシロキサンからなる群から選択される、請求項12に記載の経皮送達システム。
- 前記流体媒体の前記所定量が、約0.5mg/cm2から10mg/cm2である、請求項1に記載の経皮送達システム。
- 前記流体媒体の前記所定量が、約1mg/cm2から7mg/cm2である、請求項14に記載の経皮送達システム。
- 前記流体媒体の前記所定量が、約3.0mg/cm2である、請求項15に記載の経皮送達システム。
- 前記第一の接着剤層と第二の接着剤層とが、前記活性薬剤のための溶媒による可塑化に対し、少なくとも部分的に耐性のある接着剤を含む、請求項3に記載の経皮送達システム。
- 患者の皮膚又は粘膜に活性薬剤を送達するための経皮送達システムであって、支持層と、前記支持層の内側に配置されたポリマー膜と、前記患者の前記皮膚又は粘膜に前記経皮送達システムを貼付するための接着剤層と、前記患者の前記皮膚又は粘膜に前記経皮送達システムを貼付する前に前記接着剤層を覆うための剥離層と、流体媒体とを含み、前記流体媒体の約25%〜100%が、前記ポリマー膜中に配置されるように、前記接着剤層と前記ポリマー膜とに分配される、経皮送達システム。
- 前記流体媒体の約50%〜100%が、前記ポリマー膜中に配置される、請求項18に記載の経皮送達システム。
- 前記流体媒体が、前記接着剤層に配置されるより大きい割合で、前記ポリマー膜中に配置される、請求項18に記載の経皮送達システム。
- 前記流体媒体が、前記活性薬剤のための溶媒、前記活性薬剤のための促進剤、前記活性薬剤のための賦形剤及び前記活性薬剤からなる群から選択される液体を含む、請求項18に記載の経皮送達システム。
- 前記接着剤層が、第一の接着剤層を含み、かつ前記支持層と前記ポリマー膜との間に配置された第二の接着剤層を含む、請求項18に記載の経皮送達システム。
- 前記ポリマー膜が、前記流体媒体を5mg/10cm2より多く保有する容量を有する、請求項18に記載の経皮送達システム。
- 前記流体媒体が、短鎖アルコールを含む、請求項23に記載の経皮送達システム。
- 前記接着剤層が、アクリル、シリコーン、ゴム、スチレン−ブタジエンゴム、及びポリイソブチレンからなる群から選択される感圧接着剤を含む、請求項18に記載の経皮送達システム。
- 前記感圧接着剤が、アクリル−酢酸ビニル樹脂を含む、請求項25に記載の経皮送達システム。
- 前記ポリマー膜が、親水性又は疎水性の、ポリマー又はコポリマーを含む、請求項18に記載の経皮送達システム。
- 活性薬剤を患者に送達するための経皮送達システムを製造する方法であって、
前記経皮送達システムを前記患者の皮膚又は粘膜に貼付するための接着剤層を調製するステップと、
ポリマー膜を設けるステップと、
前記ポリマー膜に、前記ポリマー膜を通って前記患者の前記皮膚又は粘膜に前記活性薬剤を移送させる速度を変えるための流体媒体を所定量含浸させるステップと、
前記ポリマー膜を乾燥させることなく前記接着剤層を乾燥させるステップと、
前記接着剤層を前記含浸ポリマー膜に適用するステップと、
支持層を設けるステップと、前記接着剤層と前記ポリマー膜を前記支持層の内側に組み込むステップと、
剥離性ライナーを前記接着剤層に隣接して設けるステップと、前記経皮送達システムを前記患者の前記皮膚又は粘膜に適用する前に前記接着剤層を保護するステップと
を含む、経皮送達システムの製造方法。 - 前記流体媒体が、前記活性薬剤のための溶媒、前記活性薬剤のための促進剤、前記活性薬剤のための賦形剤及び前記活性薬剤からなる群から選択される液体を含む、請求項28に記載の方法。
- 前記接着剤層が、第一の接着剤層を含み、かつ第二の接着剤層を、前記支持層と前記ポリマー膜との間に適用するステップを含む、請求項28に記載の方法。
- 前記第一の接着剤層と第二の接着剤層とが、アクリル、シリコーン、ポリイソアルカリ、ゴム、酢酸ビニル、ポリイソブチレンゴム、ポリブタジエン、スチレン−ブタジエン、セルロース誘導体、多糖類、ポリウレタンエラストマー及びポリエステルエラストマーからなる群から選択される接着剤を含む接着マトリックスを含む、請求項30に記載の方法。
- 前記流体媒体が、前記活性薬剤のための溶媒を含む、請求項29に記載の方法。
- 前記活性薬剤のための前記溶媒が、C2〜C18アルコールを含む、請求項32に記載の方法。
- 前記第一の接着剤層に、前記活性薬剤を添加するステップを含む、請求項31に記載の方法。
- 前記第二の接着剤層に、前記活性薬剤を添加するステップを含む、請求項31に記載の方法。
- 前記第一の接着剤層と第二の接着剤層とに、前記活性薬剤を添加するステップを含む、請求項31に記載の方法。
- 前記ポリマー膜が、親水性及び疎水性の、ポリマー及びコポリマーからなる群から選択されるポリマーを含む、請求項28に記載の方法。
- 前記ポリマーが、ポリオレフィン、エチレン−酢酸ビニル、ポリ酢酸ビニル、ポリエーテルブロックアミド、ポリウレタン、ポリアミド、セルロース、セルロース誘導体、ポリ塩化ビニル、ポリビニルアルコール、ポリスチレン、ポリメチルメタクリレート、ポリシラン、及びポリシロキサンからなる群から選択される、請求項37に記載の方法。
- 前記液体組成物の前記所定量が、0.5mg/cm2から10mg/cm2である、請求項28に記載の方法。
- 前記液体組成物の前記所定量が、1mg/cm2から7mg/cm2である、請求項39に記載の方法。
- 前記液体組成物の前記所定量が、約3.0mg/cm2である、請求項40に記載の方法。
- 前記第一の接着剤層と第二の接着剤層とが、前記活性薬剤のための溶媒による可塑化に対し少なくとも部分的に耐性のある接着剤を含む、請求項30に記載の方法。
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PCT/US2006/005257 WO2006091442A2 (en) | 2005-02-18 | 2006-02-14 | Transdermal systems having control delivery system |
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EP (1) | EP1848412A2 (ja) |
JP (1) | JP2008530217A (ja) |
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AU (1) | AU2006216955B2 (ja) |
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MX2007010055A (es) | 2007-10-16 |
WO2006091442A3 (en) | 2006-12-14 |
WO2006091442A2 (en) | 2006-08-31 |
US20060188558A1 (en) | 2006-08-24 |
CA2598308C (en) | 2012-05-01 |
KR20070103038A (ko) | 2007-10-22 |
EP1848412A2 (en) | 2007-10-31 |
US20090234308A1 (en) | 2009-09-17 |
AU2006216955A1 (en) | 2006-08-31 |
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AU2006216955B2 (en) | 2011-02-10 |
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