JP2013501718A5 - - Google Patents

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JP2013501718A5
JP2013501718A5 JP2012523938A JP2012523938A JP2013501718A5 JP 2013501718 A5 JP2013501718 A5 JP 2013501718A5 JP 2012523938 A JP2012523938 A JP 2012523938A JP 2012523938 A JP2012523938 A JP 2012523938A JP 2013501718 A5 JP2013501718 A5 JP 2013501718A5
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実施例１１−局所ｐＨ３．５及び局所ｐＨ５．５における２重膜製剤の吸収データ
約３．５の局所ｐＨを有しかつその中に拮抗薬を含有する第１の膜の層、及び約５．５の局所ｐＨを有しかつその中に作動薬を含有する第２の膜の層を有する、２重膜製剤を調製した。この２重膜製剤においては、第１の膜の層（拮抗薬を有する）は即溶性の膜であり、同時に第２の膜の層（作動薬を有する）は中度の溶性の膜である。上記調査からのデータを用いて、膜の中の生成物の様々な量の吸収の値を下記表１４に提示する。

表１４−作動薬の局所ｐＨが３．５及びナロキソンの局所ｐＨが
５．５における２重構造の膜の推定吸収データ
Figure 2013501718
従って、０．５−４．０ｍｇの量において、ナロキソンのＣｍａｘレベルは約３２．５から約２６０ｐｇ／ｍｌまでの間であり、かつナロキソンのＡＵＣは約９０．５から約７２４時間×ｐｇ／ｍｌまでの間であった。理解されるように、様々な型及びレベルの緩衝剤は吸収の値を増加又は減少させることができる。換言すれば、拮抗薬（すなわち、ナロキソン）の吸収を阻害しようとするときは、作動薬領域の特定の局所ｐＨ及び拮抗薬領域の第２の局所ｐＨを選択することができる。これらの領域の局所ｐＨは、領域に含まれる有効成分の量に依存し得る。製剤に包含された有効成分の量は、適切な吸収レベルを提供するために変更されてもよく、ミリグラム、ナノグラム、ピコグラムでの量、又は有効成分の任意の所望の量であってもよい。
次に、本発明の好ましい態様を示す。
１．
ａ．ポリマー担体マトリクス；
ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｃ．作動薬の吸収を最大にするのに十分な緩衝剤を含む自立膜製剤組成物。
２．作動薬が部分作動薬である、前記１に記載の組成物。
３．作動薬がオピオイド作動薬である、前記１に記載の組成物。
４．組成物が約４から約９の局所ｐＨを有する、前記１に記載の組成物。
５．さらに、治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩を含む前記１に記載の組成物。
６．組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、前記５に記載の組成物。
７．第１の領域が約４から約９の局所ｐＨを有する、前記６に記載の組成物。
８．局所ｐＨが約５．５である、前記７に記載の組成物。
９．第２の領域が約２から約４の局所ｐＨを有する、前記６に記載の組成物。
１０．局所ｐＨが約２である、前記９に記載の組成物。
１１．ポリマー担体マトリクスが、少なくとも１つのポリマーを組成物の少なくとも２５質量％含む、前記１に記載の組成物。
１２．緩衝剤が約２：１から約１：５の緩衝剤対作動薬の量で存在する、前記１に記載の組成物。
１３．組成物が少なくとも１つの自立膜形成ポリマーを含む、前記１に記載の組成物。
１４．作動薬が１用量あたり約２ｍｇから約１６ｍｇの量で存在する、前記１に記載の膜製剤組成物。
１５．緩衝剤が、クエン酸ナトリウム、クエン酸、及びこれらの組合せを含む、前記１に記載の膜製剤組成物。
１６．緩衝剤が、酢酸、酢酸ナトリウム、及びこれらの組合せを含む、前記１に記載の膜製剤組成物。
１７．
ａ．ポリマー担体マトリクス；
ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｄ．緩衝剤系を含む自立膜製剤組成物であって、緩衝系が、組成物が使用者の口腔内にある時間拮抗薬の吸収を阻害するのに十分な緩衝能力を有する自立膜製剤組成物。
１８．作動薬が部分作動薬である、前記１７に記載の組成物。
１９．作動薬がオピオイド作動薬である、前記１７に記載の組成物。
２０．組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、前記１７に記載の組成物。
２１．作動薬が約４から約９の局所ｐＨを有する、前記１７に記載の組成物。
２２．拮抗薬が約２から約４の局所ｐＨを有する、前記１７に記載の組成物。
２３．
ａ．
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．作動薬の吸収を最大にするのに十分な量の緩衝剤を含む膜製剤組成物を提供し；及び
ｂ．膜製剤組成物を患者へ投与する段階を含む治療方法。
２４．作動薬が部分作動薬である、前記２３に記載の方法。
２５．作動薬がオピオイド作動薬である、前記２３に記載の方法。
２６．作動薬が約４から約９の局所ｐＨを有する、前記２３に記載の方法。
２７．組成物がさらに治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩を含む、前記２３に記載の方法。
２８．拮抗薬が約２から約４の局所ｐＨを有する、前記２７に記載の方法。
２９．膜製剤組成物が患者の粘膜を通じて使用者に投与される、前記２３に記載の方法。
３０．膜製剤組成物が患者の粘膜に少なくとも１分間にわたって維持される、前記２９に記載の方法。
３１．
ａ．
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；
ｉｖ．約４から約９の作動薬の局所ｐＨを得るために十分な量の第１の緩衝剤；
ｖ．約２から約４の拮抗薬の局所ｐＨを得るために十分な量の第２の緩衝剤を含む膜製剤組成物を提供し；及び
ｂ．膜製剤組成物を使用者へ投与する段階を含む治療方法。
３２．組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、前記３１に記載の方法。
３３．作動薬が部分作動薬である、前記３１に記載の方法。
３４．作動薬がオピオイド作動薬である、前記３１に記載の方法。
３５．
ａ．
ｉ．第１のポリマーマトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
ｂ．
ｉ．第２のポリマーマトリクス；
ｉｉ．治療上効果のある量の拮抗薬；及び
ｉｉｉ．拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む自立膜製剤組成物。
３６．作動薬が部分作動薬である、前記３５に記載の組成物。
３７．作動薬がオピオイド作動薬である、前記３５に記載の組成物。
３８．第１の緩衝系が、約４から約９の第１の領域の局所ｐＨを提供するのに十分な量で存在する、前記３５に記載の組成物。
３９．第１の緩衝系が、約５．５の第１の領域の局所ｐＨを提供するのに十分な量で存在する、前記３５に記載の組成物。
４０．第２の緩衝系が、約２から約４の第２の領域の局所ｐＨを提供するのに十分な量で存在する、前記３５に記載の組成物。
４１．第２の領域が第１の領域の少なくとも１つの表面上に被覆される、前記３５に記載の組成物。
４２．第２の領域が第１の領域の少なくとも１つの表面に貼合される、前記３５に記載の組成物。
４３．治療上効果のある量の作動薬を含む第１の領域及び治療上効果のある量の拮抗薬を含む第２の領域を含み、約０．６２４−５．６３８ｎｇ／ｍｌの作動薬のＣｍａｘを有するｉｎ ｖｉｖｏ血漿プロファイル及び約４６．０４−３２３．７５ｐｇ／ｍｌの拮抗薬のＣｍａｘを有するｉｎ ｖｉｖｏ血漿プロファイルを提供する経口溶解性膜製剤。
４４．作動薬が部分作動薬である、前記４３に記載の製剤。
４５．作動薬がオピオイド作動薬である、前記４３に記載の製剤。
４６．製剤が約５．４３１−５６．２３８時間×ｎｇ／ｍｌの作動薬の平均ＡＵＣを提供する、前記４３に記載の製剤。
４７．製剤が約１０２．８８−８１２．００時間×ｐｇ／ｍｌの拮抗薬の平均ＡＵＣを提供する、前記４３に記載の製剤。
４８．製剤が作動薬を約２から約１６ｍｇ含む、前記４３に記載の製剤。
４９．製剤が拮抗薬を約０．５から約４ｍｇ含む、前記４３に記載の製剤。
５０．
ａ．ポリマー担体マトリクス；
ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｄ．約２から約４の拮抗薬の局所ｐＨを得るために十分な緩衝系を含む自立膜製剤組成物。
５１．
ａ．ポリマー担体マトリクス；
ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｄ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害し、かつ作動薬の吸収を最適化するのに十分な緩衝剤を含む自立膜製剤組成物。
５２．
ａ．
ｉ．第１のポリマーマトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
ｂ．
ｉ．第２のポリマーマトリクス；
ｉｉ．治療上効果のある量の拮抗薬；及び
ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む、自立膜製剤組成物。
５３．第１及び第２の緩衝系が同じである、前記５２に記載の組成物。
５４．
ａ．膜形成組成物が、
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｉｖ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量かつ拮抗薬の吸収を阻害するのに十分な量の緩衝剤を含む膜形成組成物を成型し；及び
ｂ．自立膜製剤組成物を形成するためにその膜形成組成物を乾燥する段階を含む膜製剤組成物の形成方法。
５５．
ａ．
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｉｖ．約０．６２４−５．６３８ｎｇ／ｍｌの作動薬のＣｍａｘを有するｉｎ ｖｉｖｏでの血漿プロファイル及び約４１．０４−３２３．７５ｐｇ／ｍｌの拮抗薬のＣｍａｘを有するｉｎ ｖｉｖｏでの血漿プロファイルを提供するのに十分な量の緩衝系を含む膜製剤組成物を提供し；及び
ｂ．膜製剤組成物を使用者へ投与する段階を含む治療方法。
５６．
ａ．
ｉ．第１のポリマーマトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
ｂ．
ｉ．第２のポリマーマトリクス；
ｉｉ．治療上効果のある量の拮抗薬；及び
ｉｉｉ．拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む自立膜製剤組成物であって、第２の領域が使用者の口腔内に設置された際に第１の領域よりも速い速度で溶解する自立膜製剤組成物。
５７．第１のポリマーマトリクスが中度の溶性のポリマーを含む、前記５６に記載の組成物。
５８．第２のポリマーマトリクスが即溶性のポリマーを含む、前記５６に記載の組成物。
５９．第１の緩衝系が約４から約９の作動薬の局所ｐＨを提供するのに十分である、前記５６に記載の組成物。
６０．第２の緩衝系が約２から約４の拮抗薬の局所ｐＨを提供するのに十分である、前記５６に記載の組成物。
６１．
ａ．第１の膜形成組成物が、
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量の緩衝剤を含む、第１の膜形成組成物を成型し；
ｂ．第２の膜形成組成物が、
ｉ．ポリマー担体マトリクス；
ｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害するのに十分な量の緩衝剤を含む、第２の膜形成組成物を成型し；及び
ｃ．第１の膜形成組成物及び第２の膜形成組成物を貼合して自立膜製剤組成物を形成する段階を含む膜製剤組成物の形成方法。
６２．第１の膜形成組成物が第１の膜形成組成物及び第２の膜形成組成物の貼合段階の前に乾燥される、前記６１に記載の方法。
６３．第２の膜形成組成物が第１の膜形成組成物及び第２の膜形成組成物の貼合段階の前に乾燥される、前記６１に記載の方法。
６４．第１の膜形成組成物が第１の膜形成組成物及び第２の膜形成組成物の貼合段階の前に少なくとも部分的に乾燥される、前記６１に記載の方法。
６５．第２の膜形成組成物が第１の膜形成組成物及び第２の膜形成組成物の貼合段階の前に少なくとも部分的に乾燥される、前記６１に記載の方法。

Claims (48)

  1. ａ．ポリマー担体マトリクス；
    ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
    ｃ．作動薬の吸収を最大にするのに十分な緩衝剤を含む自立膜製剤組成物。
  2. 作動薬が部分作動薬である、請求項１に記載の組成物。
  3. 作動薬がオピオイド作動薬である、請求項１に記載の組成物。
  4. 組成物が約４から約９の局所ｐＨを有する、請求項１に記載の組成物。
  5. さらに、治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩を含む請求項１に記載の組成物。
  6. 組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、請求項５に記載の組成物。
  7. 第１の領域が約４から約９の局所ｐＨを有する、請求項６に記載の組成物。
  8. 局所ｐＨが約５．５である、請求項７に記載の組成物。
  9. 第２の領域が約２から約４の局所ｐＨを有する、請求項６に記載の組成物。
  10. 局所ｐＨが約２である、請求項９に記載の組成物。
  11. ポリマー担体マトリクスが、少なくとも１つのポリマーを組成物の少なくとも２５質量％含む、請求項１に記載の組成物。
  12. 緩衝剤が約２：１から約１：５の緩衝剤対作動薬の量で存在する、請求項１に記載の組成物。
  13. 組成物が少なくとも１つの自立膜形成ポリマーを含む、請求項１に記載の組成物。
  14. 作動薬が１用量あたり約２ｍｇから約１６ｍｇの量で存在する、請求項１に記載の膜製剤組成物。
  15. 緩衝剤が、クエン酸ナトリウム、クエン酸、及びこれらの組合せを含む、請求項１に記載の膜製剤組成物。
  16. 緩衝剤が、酢酸、酢酸ナトリウム、及びこれらの組合せを含む、請求項１に記載の膜製剤組成物。
  17. ａ．ポリマー担体マトリクス；
    ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｄ．緩衝剤系を含む自立膜製剤組成物であって、緩衝系が、組成物が使用者の口腔内にある時間拮抗薬の吸収を阻害するのに十分な緩衝能力を有する自立膜製剤組成物。
  18. 作動薬が部分作動薬である、請求項１７に記載の組成物。
  19. 作動薬がオピオイド作動薬である、請求項１７に記載の組成物。
  20. 組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、請求項１７に記載の組成物。
  21. 作動薬が約４から約９の局所ｐＨを有する、請求項１７に記載の組成物。
  22. 拮抗薬が約２から約４の局所ｐＨを有する、請求項１７に記載の組成物。
  23. ｉ．ポリマー担体マトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；
    ｉｖ．約４から約９の作動薬の局所ｐＨを得るために十分な量の第１の緩衝剤；
    ｖ．約２から約４の拮抗薬の局所ｐＨを得るために十分な量の第２の緩衝剤を含む膜製剤組成物。
  24. 組成物が第１及び第２の領域を含み、第１の領域が作動薬を含み、かつ第２の領域が拮抗薬を含む、請求項２３に記載の組成物。
  25. 作動薬が部分作動薬である、請求項２３に記載の組成物。
  26. 作動薬がオピオイド作動薬である、請求項２３に記載の組成物。
  27. ａ．
    ｉ．第１のポリマーマトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
    ｉｉｉ．作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
    ｂ．
    ｉ．第２のポリマーマトリクス；
    ｉｉ．治療上効果のある量の拮抗薬；及び
    ｉｉｉ．拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む自立膜製剤組成物。
  28. 作動薬が部分作動薬である、請求項２７に記載の組成物。
  29. 作動薬がオピオイド作動薬である、請求項２７に記載の組成物。
  30. 第１の緩衝系が、約４から約９の第１の領域の局所ｐＨを提供するのに十分な量で存在する、請求項２７に記載の組成物。
  31. 第１の緩衝系が、約５．５の第１の領域の局所ｐＨを提供するのに十分な量で存在する、請求項２７に記載の組成物。
  32. 第２の緩衝系が、約２から約４の第２の領域の局所ｐＨを提供するのに十分な量で存在する、請求項２７に記載の組成物。
  33. 治療上効果のある量の作動薬を含む第１の領域及び治療上効果のある量の拮抗薬を含む第２の領域を含み、約０．６２４−５．６３８ｎｇ／ｍｌの作動薬のＣｍａｘを有するｉｎ ｖｉｖｏ血漿プロファイル及び約４６．０４−３２３．７５ｐｇ／ｍｌの拮抗薬のＣｍａｘを有するｉｎ ｖｉｖｏ血漿プロファイルを提供する経口溶解性膜製剤。
  34. 作動薬が部分作動薬である、請求項３３に記載の製剤。
  35. 作動薬がオピオイド作動薬である、請求項３３に記載の製剤。
  36. 製剤が約５．４３１−５６．２３８時間×ｎｇ／ｍｌの作動薬の平均ＡＵＣを提供する、請求項３３に記載の製剤。
  37. 製剤が約１０２．８８−８１２．００時間×ｐｇ／ｍｌの拮抗薬の平均ＡＵＣを提供する、請求項３３に記載の製剤。
  38. 製剤が作動薬を約２から約１６ｍｇ含む、請求項３３に記載の製剤。
  39. 製剤が拮抗薬を約０．５から約４ｍｇ含む、請求項３３に記載の製剤。
  40. ａ．ポリマー担体マトリクス；
    ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｄ．約２から約４の拮抗薬の局所ｐＨを得るために十分な緩衝系を含む自立膜製剤組成物。
  41. ａ．ポリマー担体マトリクス；
    ｂ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｃ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｄ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害し、かつ作動薬の吸収を最適化するのに十分な緩衝剤を含む自立膜製剤組成物。
  42. ａ．
    ｉ．第１のポリマーマトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
    ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
    ｂ．
    ｉ．第２のポリマーマトリクス；
    ｉｉ．治療上効果のある量の拮抗薬；及び
    ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む、自立膜製剤組成物。
  43. ａ．膜形成組成物が、
    ｉ．ポリマー担体マトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｉｖ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量かつ拮抗薬の吸収を阻害するのに十分な量の緩衝剤を含む膜形成組成物を成型し；及び
    ｂ．自立膜製剤組成物を形成するためにその膜形成組成物を乾燥する段階を含む膜製剤組成物の形成方法。
  44. ｉ．ポリマー担体マトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；
    ｉｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｉｖ．約０．６２４−５．６３８ｎｇ／ｍｌの作動薬のＣｍａｘを有するｉｎ ｖｉｖｏでの血漿プロファイル及び約４１．０４−３２３．７５ｐｇ／ｍｌの拮抗薬のＣｍａｘを有するｉｎ ｖｉｖｏでの血漿プロファイルを提供するのに十分な量の緩衝系を含む膜製剤組成物。
  45. ａ．
    ｉ．第１のポリマーマトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
    ｉｉｉ．作動薬の吸収を最適化するのに十分な量の第１の緩衝系を含む第１の領域；及び
    ｂ．
    ｉ．第２のポリマーマトリクス；
    ｉｉ．治療上効果のある量の拮抗薬；及び
    ｉｉｉ．拮抗薬の吸収を阻害するのに十分な量の第２の緩衝系を含む第２の領域を含む自立膜製剤組成物であって、第２の領域が使用者の口腔内に設置された際に第１の領域よりも速い速度で溶解する自立膜製剤組成物。
  46. 第１の緩衝系が約４から約９の作動薬の局所ｐＨを提供するのに十分である、請求項４５に記載の組成物。
  47. 第２の緩衝系が約２から約４の拮抗薬の局所ｐＨを提供するのに十分である、請求項４５に記載の組成物。
  48. ａ．第１の膜形成組成物が、
    ｉ．ポリマー担体マトリクス；
    ｉｉ．治療上効果のある量の作動薬又はその薬学的に許容可能な塩；及び
    ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に作動薬の吸収を最適化するのに十分な量の緩衝剤を含む、第１の膜形成組成物を成型し；
    ｂ．第２の膜形成組成物が、
    ｉ．ポリマー担体マトリクス；
    ｉｉ．治療上効果のある量の拮抗薬又はその薬学的に許容可能な塩；及び
    ｉｉｉ．膜製剤組成物が使用者の口の中に設置された際に拮抗薬の吸収を阻害するのに十分な量の緩衝剤を含む、第２の膜形成組成物を成型し；及び
    ｃ．第１の膜形成組成物及び第２の膜形成組成物を貼合して自立膜製剤組成物を形成する段階を含む膜製剤組成物の形成方法。
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