JP4949625B2 - 経皮送達デバイスに含有された活性薬剤の誤用を防止する、経皮送達デバイスの廃棄システム - Google Patents
経皮送達デバイスに含有された活性薬剤の誤用を防止する、経皮送達デバイスの廃棄システム Download PDFInfo
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- JP4949625B2 JP4949625B2 JP2004510792A JP2004510792A JP4949625B2 JP 4949625 B2 JP4949625 B2 JP 4949625B2 JP 2004510792 A JP2004510792 A JP 2004510792A JP 2004510792 A JP2004510792 A JP 2004510792A JP 4949625 B2 JP4949625 B2 JP 4949625B2
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B09—DISPOSAL OF SOLID WASTE; RECLAMATION OF CONTAMINATED SOIL
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Description
本発明の1つの実施形態は、その表面に粘着性コーティングを有する少なくとも1つの第一基材;及び少なくとも粘着性コーティングの中若しくは上又は第一基材の中若しくは上に存在する以下の成分:
(a)モノマー、及び場合により少なくとも1つのコモノマー;
(b)開始剤、及び場合により少なくとも1つの共開始剤;
(c)少なくとも1つの架橋剤;及び
(d)少なくとも1つの活性薬剤不活化剤、例えばオピオイドアゴニストを含むTDDによる使用のためのオピオイドアンタゴニスト;
の1以上若しくはそのいずれかの組み合わせを含む、TDD廃棄システムに関する。
(a)モノマー、及び場合により少なくとも1つのコモノマー;
(b)開始剤、及び場合により少なくとも1つの共開始剤;
(c)少なくとも1つの架橋剤;及び
(d)少なくとも1つの活性薬剤不活化剤
の1以上若しくはそのいずれかの組み合わせをさらに含む、TDD廃棄システムに関する。
(i)その表面に粘着性コーティングを有する少なくとも1つの第一基材;
(ii)粘着性コーティングの中若しくは上又は第一基材の中若しくは上に存在する以下の成分:
(a)モノマー、及び場合により少なくとも1つのコモノマー;
(b)開始剤、及び場合により少なくとも1つの共開始剤;
(c)少なくとも1つの架橋剤;及び
(d)少なくとも1つの活性薬剤不活化剤;
の1以上若しくはそのいずれかの組み合わせを含む。
(a)実質的に溶媒不浸透性;
(b)実質的に溶媒非膨潤性;
(c)実質的に耐裂性;
(d)実質的に耐切断性;
の1以上を示す、TDD廃棄システム及び/又はそれを含むキットに関する。
「経皮送達デバイス」又は「TDD」という句は本明細書で使用される際、患者の皮膚に接触させたときに、いかなる生物活性薬剤、例えば医薬的化合物、例えばオピオイドの治療上有効な量をも、皮膚を通じて全身循環に経皮送達可能である、いずれかのデバイスを指す。
本出願は、ここでの明確な参照によりその全体が本明細書に組み込まれている、2002年6月10日に提出された米国仮出願第60/387,800号の優先権を主張する。
代表的なTDDは、医薬的化合物、例えば少なくとも1つのオピオイド、及び場合により、オピオイド及びオピオイドアンタゴニストが、例えば経口的に、静脈内に、頬側に、経鼻的に、非経口的に、直腸により及び/又は経膣的に哺乳動物、通常はヒトに投与された場合に、オピオイドの多幸効果を抑制するために十分な量の少なくとも1つのオピオイドアンタゴニストを含む。そのような代表的なTDDは、患者の皮膚に接触させたときに、オピオイドの経皮投与を許容するが、(a)オピオイドの鎮静効果を抑制するために有効ではないオピオイドアンタゴニストの経皮投与を許容するか、又は(b)オピオイドアンタゴニストの経皮投与を許容しない。しかしながら、そのような少量のみのTDDを使用して、経皮以外の例えば静脈内、頬側、経鼻、経口、非経口、直腸及び/又は膣の経路によってオピオイドを送達する場合、そのときオピオイドアンタゴニストはオピオイドの多幸効果を鈍化又は抑制する。好ましくはそのようなTDDは、デバイスが疼痛を処置又は予防するために以前に適切に使用されたかどうかにはかかわらず経皮以外で使用された場合にオピオイドの多幸効果を抑制する。
2.TDD廃棄システム
予測実施例2では、図2Bによる経皮送達デバイスに、実施例1と同様にBUPを装填する。次にBUP TDDを図1CによるTDD廃棄システムを用いて固定及び隔離する。続いて、ある場合においてTDD廃棄システムに含有されるTDDから抽出可能な(及びそれゆえ乱用に利用可能な)BUPの量を、以下の溶媒:蒸留水、水道水、0.026M重曹水溶液、5%酢、アセトン、メタノール、エタノール、エチルアセテート、及び/又はエチルエーテルを用いた抽出によって測定する。抽出は以下の条件下:室温、約25℃、及び還流下(すなわち抽出溶媒のほぼ沸騰温度)にて抽出溶媒中で5分、60分、及び120分後に実施した。各抽出溶媒では、TDDは以下の隔離状態で存在する:(1)第一基材(すなわちTDDにすでに付着している)を第二基材(粘着剤面を上にして付着したデバイス)に付着させていない(「開放面」)、(2)TDDが第一及び第二基材の間に付着させる(「サンドイッチ型」)、(3)TDDが第一及び第二基材の間に付着させて、次に約10〜約50片に切断する(「折畳及び切断」)、及び(4)第一基材(すなわちTDDにすでに付着している)を第二基材(粘着剤側を下にして付着したデバイス)に付着させていない(「粘着剤フィルム被覆」)。
Claims (25)
- 経皮送達デバイスを廃棄するためのシステムであって、その1つの表面に粘着性コーティングを有し、かつ、経皮送達デバイスを中に収容するように構成及び寸法作成された凹部を有する少なくとも1つの第一の剛性で非平面の基材;及び
少なくとも前記粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの活性薬剤不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
を含む、前記経皮送達デバイスを廃棄するためのシステム。 - 前記第一の剛性で非平面の基材上の粘着性コーティングに付着しうる第二の剛性基材をさらに含む、請求項1に記載のシステム。
- 前記粘着性コーティングが前記第二の剛性基材の1つの面に配置されている、請求項2に記載のシステム。
- 少なくとも前記第二の剛性基材の粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの活性薬剤不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
をさらに含む、請求項3に記載のシステム。 - 前記第一の剛性で非平面の基材が以下の特性:
(a)溶媒不浸透性;
(b)溶媒非膨潤性;
(c)耐裂性;及び
(d)耐切断性;
の1以上を示す、請求項1から4のいずれかに記載のシステム。 - 前記存在する成分がモノマーをさらに含む、請求項1から5のいずれかに記載のシステム。
- 前記存在する成分が少なくとも1つのコモノマーをさらに含む、請求項6に記載のシステム。
- 前記存在する成分が、重合及び/又は架橋を開始するための開始剤をさらに含む、請求項6に記載のシステム。
- 前記存在する成分が少なくとも1つの架橋剤をさらに含む、請求項6に記載のシステム。
- 粘着性コーティングから容易に除去できるように、前記第一の剛性で非平面の基材の粘着性コーティング上に配置された少なくとも1つの粘着性裏打ち材料をさらに含む、請求項1から9のいずれかに記載のシステム。
- 少なくとも1つの活性薬剤を含む経皮送達デバイスと;
前記経皮送達デバイスを廃棄するためのシステムであり:
(i)その1つの表面に粘着性コーティングを有する少なくとも1つの第一の剛性で非平面の基材;及び
(ii)少なくとも前記粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの活性薬剤不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
を含む前記システムと;
を含むキット。 - ボックスをさらに含み、前記経皮送達デバイスは前記ボックスの内部に配置され、前記システムは、前記ボックスの外側に取付けられている、請求項11に記載のキット。
- ブックレットを形成するために、前記第一の剛性で非平面の基材の一端と第二の剛性で非平面の基材の一端とが固定されている、請求項12に記載のキット。
- 経皮送達デバイスを、請求項1から10のいずれかに記載のシステムの第一の剛性で非平面の基材上の粘着性コーティングに付着させることを含む、経皮送達デバイスを廃棄する方法。
- 経皮送達デバイスを廃棄するためのシステムを使用することによる経皮送達デバイスを廃棄する方法であって、経皮送達デバイスを、第一の剛性で非平面の基材の1つの面上にあり、そして少なくとも前記第一の剛性で非平面の基材の粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの活性薬剤不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
を有する、粘着性コーティングに付着させることと;
前記経皮送達デバイスを、前記第一の剛性で非平面の基材上の粘着性コーティングに付着しうる第二の剛性基材の1つの面上に配置された粘着性コーティングに付着させること;を含み、
前記システムが、少なくとも前記第二の剛性基材の粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの活性薬剤不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
を含む;前記方法。 - 経皮送達デバイスを廃棄するためのシステムであって、その1つの表面に粘着性コーティングを有する少なくとも1つの第一の剛性で非平面の基材;及び
前記粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの非−μ−オピオイド不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
を含む、前記システム。 - 前記第一の剛性で非平面の基材上の粘着性コーティングに付着させることが可能である第二の剛性で非平面の基材をさらに含む、請求項17に記載のシステム。
- 前記粘着性コーティングは、前記第二の剛性で非平面の基材の1つの面の上に配置される、請求項17に記載のシステム。
- 前記第二の剛性で非平面の基材の粘着性コーティングの中若しくは上に存在する以下の成分:
少なくとも1つの非-μ-オピオイド不活化剤、ここで該不活性剤はオピオイドアンタゴニストである;
をさらに含む、請求項18に記載のシステム。 - 前記第一の剛性で非平面の基材又は前記第二の剛性で非平面の基材の少なくとも1つが、中に経皮送達デバイスを収容するために構成及び寸法形成された凹部を画成する、請求項19に記載のシステム。
- 前記第一の剛性で非平面の基材が以下の特性:
(a)溶媒不浸透性;
(b)溶媒非膨潤性;
(c)耐裂性;及び
(d)耐切断性;
の1以上を示す、請求項16から20のいずれかに記載のシステム。 - 前記存在する成分がモノマーをさらに含む、請求項16から21のいずれかに記載のシステム。
- 前記存在する成分が少なくとも1つのコモノマーをさらに含む、請求項22に記載のシステム。
- 前記存在する成分が、重合及び/又は架橋を開始するための開始剤をさらに含む、請求項22に記載のシステム。
- 前記存在する成分が少なくとも1つの架橋剤をさらに含む、請求項22に記載のシステム。
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US38780002P | 2002-06-10 | 2002-06-10 | |
US60/387,800 | 2002-06-10 | ||
PCT/US2003/018256 WO2003103673A1 (en) | 2002-06-10 | 2003-06-10 | Disposal systems of transdermal delivery devices to prevent misuse of the active agents contained therein |
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