JP2021536466A - 厳密な活性剤溶解プロファイルを有する口腔用フィルム組成物及び剤形 - Google Patents
厳密な活性剤溶解プロファイルを有する口腔用フィルム組成物及び剤形 Download PDFInfo
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- JP2021536466A JP2021536466A JP2021512652A JP2021512652A JP2021536466A JP 2021536466 A JP2021536466 A JP 2021536466A JP 2021512652 A JP2021512652 A JP 2021512652A JP 2021512652 A JP2021512652 A JP 2021512652A JP 2021536466 A JP2021536466 A JP 2021536466A
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Abstract
Description
本開示は、約160ミクロン未満の平均粒径D90を有する、クロバザムなどの1以上の活性剤の送達のための各単位用量の口腔用フィルム(この口腔用フィルムは、厳密な制御された活性剤溶解速度を有する)、並びに癲癇及び発作を含む様々な疾患を、それを必要とする患者にそれを投与することにより処置する方法に関する。
薬物又は医薬などの有効成分は、正確且つ一貫した投与を可能とするために錠剤形態で調製することができる。しかしながら、この形態の薬物の調製及び分配には、取り扱い可能な大きさとするために大きな割合の補助剤を添加しなければならない、より大きな薬物形態が更なる保存スペースを要する、及び分配が不正確の傾向を持つ錠剤の計数を含むなどの多くの欠点がある。加えて、集団の28%であると見積もられる多数にとって嚥下困難である。錠剤は嚥下困難を克服する手段としてより小さく割られたり、更には砕かれたりすることがあるが、これは多くの錠剤又は丸剤形態では好適な溶液とならない。例えば、経口摂取を助けるために、錠剤又は丸剤形態を単独で又は食品と混合して砕く又は破壊することは、放出制御特性も損なう。
薬物、医薬などの有効成分を運ぶために錠剤及び丸剤の代わりにフィルムが使用されることがある。しかしながら、歴史的には、フィルム及びこの剤形を用いた薬物送達システムを作製する方法は、製剤、加工及び薬物動態の両分野でいくつかの独自の課題が提示されていた。特に、フィルム及びフィルムから切り取られた経口投与単位は、進歩がフィルムを極めて望ましい剤形にした近年までそれらの実用を許容して来なかったいくつかの不利な特徴に苦慮してきた。
従来の錠剤及び丸剤と同様に、口腔用フィルムの形態で投与された薬物の吸収は、フィルムからの原薬の放出、生理条件下での薬物の溶解及び可溶化を含むいくつかの因子によって異なる。1つの様式では、in vitro溶解がin vivo性能の適切な予測因子となる。即放性経口剤形のin vitro溶解試験は、ロット間の医薬品の品質を評価するため;新製剤の開発の指針とするため;並びに製品に変化が起こるとともに製品品質、生体内利用率等価性、及び性能を保証するために使用される。
各単位用量において約160ミクロン未満の平均粒径D90を有する、所望の量の活性剤を送達するための口腔用フィルムが開示される。このフィルムは、水溶性ポリマー基材、水膨潤性ポリマー基材、又は水溶性且つ水膨潤性ポリマー基材;及び添加剤を含む。活性剤は、クロバザム、リルゾール、ジアゼパム、又はこれらの任意の組合せを含む本明細書で開示されるものなどの多様な活性剤から選択され得る。添加剤は、甘味剤、着香剤、調味料、充填剤、可塑剤、色素、顔料、浸透促進剤、緩衝剤、保存剤、二酸化ケイ素、粘着防止剤、及びこれらの任意の組合せからなる群から選択され得る。このフィルムを媒体に入れた際に、約3分後に約2%を超える活性剤が媒体に溶解する。
各単位用量中に活性剤を含有する口腔用フィルムを、それを必要とするヒトに投与することにより癲癇及び発作を処置する方法も又、開示される。
バッチ間の一貫性を保証するため、及び医薬活性剤のバイオアベイラビリティに関する潜在的問題を特定するために、口腔用フィルム、及び活性剤を含む医薬品の溶解プロファイル、より具体的には、溶解速度が確立される。より正確且つ精密に溶解プロファイルを試験するための驚くべき新たな手段が、光ファイバーUVモニタリングシステムであるPION技術を用いて開発された。
本明細書では、各単位用量において約160ミクロン未満の平均粒径D90を有する、所望の量の活性剤を送達するための口腔用フィルムであって、フィルム剤形に関して現在知られている従来の溶解試験及びプロファイルに比べて、精度が改善され、サンプリング点が多く、且つ、変化評価が迅速化された活性剤溶解プロファイルを有するフィルムが開示される。
フィルムは、活性剤が全体に実質的に均一に分布するように加工され得る。例えば、流延フィルムなどのフィルムが、実質的に同じ大きさの各単位用量に切断される場合、単位用量中の活性剤の量は、かなりの精度があると知られている。用量におけるこの精度は特に有利であり、実際に、活性剤が薬剤、すなわち、薬物である場合には、米国FDAなどの政府規制機関に求められている。
本発明のフィルムに配合可能な活性剤としては、限定されるものではないが、医薬及び化粧料活性剤、薬物、薬剤、ブタクサ花粉などの抗原又はアレルゲン、胞子、細菌を含む微生物、種子、塩素酸塩又は亜塩素酸塩などの口内洗浄剤成分、着香剤、芳香剤、酵素、保存剤、甘味剤、着色剤、スパイス、ビタミン並びにこれらの組合せが含まれる。
、ジフェノキシン、ジフロラゾン酢酸エステル、ジフロキサシン塩酸塩、ジフルアニン塩酸塩、ジフルコルトロン、ジフルミドンナトリウム、ジフルニサル、ジフルプレドネート、ジフタロン、ジギタリス、
、ミフェプリストン、ミホバート、ミグリトール、ミラセミド、ミラメリン、ミルドロナート、ミレンペロン、ミリペルチン、ミルナシプラン、ミルリノン、ミルテホシン、ミンバン塩酸塩、ミナプリン、ミナキソロン、ミノクロミル、ミノサイクリン、ミノキシジル、ミオフラジン塩酸塩、ミオカマイシン、ミプラゴシド(mipragoside)、ミルフェンタニル、ミリモスチム、ミリンカマイシン塩酸塩、ミリセトロンマレアート、ミルタザピン、ミスマッチ二本鎖RNA、ミソニダゾール、ミソプロストル、ミチンドミド、ミトカルシン、ミトクロミン、ミトジリン、ミトグアゾン、ミトラクトール、ミトマルシン、マイトマイシン、ミトナフィド、ミトスペル、ミトタン、ミトキサントロン、塩化ミバクリウム、ミバゼロール、ミキサンプリル、ミキシジン、ミゾラスチン、ミゾリビン、モクロベミド、モダフィニル、硫酸モダリン、モデカイニド、モエキシプリル、モファロテン、モフェギリン塩酸塩、モフェゾラク、モルグラモスチム、モリナゾン、モリンドン塩酸塩、モルシドミン、モメタゾン、モナテピルマレイン酸塩、モネンシン、モノクタノイン、モンテルカストナトリウム、モンチレリン、モピダモール、モラシジン、モランテル酒石酸塩、モリシジン、モルニフルマート、硫酸モルヒネ、モルイン酸ナトリウム、モサプラミン、モサプリド、モチライド、モトレチニド、モキサラクタム二ナトリウム、モキサゾシン、モキシラプリン、モクスニダゾール、モクソニジ、流行性耳下腺炎皮膚試験抗原、マスタード抗癌剤、ムゾリミン、ミカペルオキシドB、ミコフェノール酸、ミリアポロン、ナバゼニル、ナビロン、
Tolindate)、トルメチン、トルナフタート、トルポビドン1 131、トルピラミド、トルレスタット、トメルカスト、トモキセチン塩酸塩、トナゾシンメシル酸塩、トピラメート、トポテカン、トポテカン塩酸塩、トプセンチン、トプテロン、トキジン、トラセミド、トレミフェン、トルセミド、トシフェン、トスフロキサシン、全能性幹細胞因子、トラカゾレート、トラフェルミン、トラロニド、トラマドール塩酸塩、トラマゾリン塩酸塩、トランドラプリル、トラネキサム酸、トラニラスト、トランスカイニド、翻訳阻害剤、トラキサノクス、トラゾドン塩酸塩、トラゾドン−HCL、トレベンゾミン塩酸塩、トレフェンタニル塩酸塩、トレロキシネート、トレピパムマレイン酸塩、トレストロン酢酸塩、トレチノイン、トリアセチン、トリアセチルウリジン、トリアフンギン、トリアムシノロン、トリアムピジン硫酸塩、トリアムテレン、トリアゾラム、トリベノシド、トリカプリリン、トリセタミド、トリクロルメチアジド、トリコヒアリン、トリシリビン、トリシトレート、トリクロフェノールピペラジン、トリクロホスナトリウム、トリクロニド、トリエンチン、トリフェナグレル、トリフラビン、トリフロシン、トリフルバザム、トリフルミダート、トリフルオペラジン塩酸塩、トリフルペリドール、トリフルオペラジン、トリフルプロマジン塩酸塩、トリフルリジン、トリヘキシフェニジル塩酸塩、トリロスタン、トリマゾシン塩酸塩、トリメゲストン、トリメプラジン酒石酸塩、トリメタジオン、カンシル酸トリメタファン、トリメトベンザミド塩酸塩、トリメトプリム、トリメトジン、トリメトレキサート、トリミプラミン、トリモプロスチル、トリモキサミン塩酸塩、トリオレイン1 125、トリオレイン1 131、トリオキシフェンメシレート、トリパミド、トリペレナミン塩酸塩、
頭痛及び/又は片頭痛の治療のための活性剤又は薬剤も又、本明細書で使用可能である。特定の活性剤の例としては、限定されるものではないが、エレトリプタン、ナラトリプタン、リザトリプタン(リザトリプタン安息香酸塩)、スマトリプタン、及びゾルミトリプタンなどのトリプタンが含まれる。ある実施形態では、活性剤は、任意選択によりNSAIDと組み合わせたリザトリプタンである。
活性剤はジアゼパムであり得る。活性剤がジアゼパムである場合、各個の単位用量は、約1mg、約2mg、約2.5mg、約5mg、約10mg、約15mg又は約20mgのジアゼパムを含有し得る。特定の実施形態では、口腔用フィルムは、約5mg、約10mg、又は約15mgのジアゼパムを含有する。
活性剤はリルゾールであり得る。活性剤がリルゾールである場合、各個の単位用量は、約10mg、約20mg、約25mg、約30mg、又は約50mgのリルゾールを含有し得る。ある実施形態では、口腔用フィルムは、約50mgのリルゾールを含有する。
活性剤はクロバザムであり得る。活性剤がクロバザムである場合、各個の単位用量は、約1mg、約2mg、約2.5mg、約5mg、約10mg、約15mg又は約20mgのクロバザムを含有し得る。特定の実施形態では、口腔用フィルムは、約5mg、又は約20mgのクロバザムを含有する。
本明細書に開示される口腔用フィルムで使用される活性剤は微粉化してもよい。活性剤は当技術分野で公知のいずれの手段によって微粉化してもよい。
活性剤は、約160ミクロン未満、約120ミクロン未満、約100ミクロン未満、約80ミクロン未満、約50ミクロン未満、約20ミクロン未満、約10ミクロン未満、又は約8ミクロンの平均粒径D90を有し得る。活性剤は、約30ミクロン未満、約20ミクロン未満、約10ミクロン未満、約5ミクロン未満、約4ミクロン未満の平均粒径D50、又は約3ミクロンのD50を有し得る。活性剤は、約10ミクロン未満、約5ミクロン未満、約3ミクロン未満、約2ミクロン未満の平均粒径D10、又は約1ミクロンのD10を有し得る。活性剤は、約15ミクロン未満の平均粒径D90、約4ミクロン未満のD50、及び約2ミクロン未満のD10を有し得る。活性剤は、約8ミクロンの平均粒径D90、約3ミクロンのD50、及びの約1ミクロンのD10を有し得る。
滑らかな口腔用フィルムを得るには200ミクロン未満の平均粒径が好ましいことが知られていた。しかしながら、更なる開発によって、より小さい平均粒径、すなわち、微粉粒子でフィルムの美観及び溶解の向上が可能であることが示された。更に、より低用量のフィルム(例えば、5mg及び10mg)の溶解試験の結果は、微粉化活性剤のほうが粉砕活性剤(例えば、平均粒径D90で約100ミクロン)を含むフィルムよりも性能が良いことを示したことが判明した。
PION Rainbow Dynamic Dissolution Monitor(RDDM(登録商標))(「PION技術」)などのPION装置は、リアルタイムで精密かつ効果的に溶解パーセントを測定する有力な分析機器である。PION技術は、in situ速度論的溶解度に高度光ファイバーを、又、原薬の放出速度及びその溶解を経時的に決定するための溶解試験に過飽和UVモニタリングを利用する。PION技術は、個々のダイオードアレイ分光光度計を使用し、6〜8のアクイジションチャネル、浸漬式プローブ、及び相互交換可能な光路長チップを備えている。PION技術はリアルタイムデータディスプレーを備え、それにより、活性剤、製剤、及び医薬品の試験に迅速且つ再現性のある結果をもたらす。これらの測定は、少容量で複雑な基質であっても正確である。
1.オフライン分析が不要である。
2.利用可能なサンプリング点が多い。
3.複数の波長を評価することができる。
4.変化速度(例えば、変曲点許容基準)を評価することができる。
5.プロファイルの比較が強度と保存条件の間に潜在的識別能を示す。
PION技術により測定した本明細書に開示される口腔用フィルムの活性剤溶解プロファイル及び速度は一般に、曲線がより厳密且つより正確であり、そのために変曲点が決定可能であること以外は、従来の溶解により測定した溶解プロファイル及び速度に匹敵していたことが判明した。PION技術などの光ファイバーUVモニタリングシステムを使用すると口腔用フィルムのより正確且つ厳密な溶解プロファイルが可能である。溶解プロファイルは、t=0から100%の剤形又は活性剤が溶解する時点を過ぎるまで経時的に剤形又は活性剤の溶解パーセントを示すデータ点の平均的集合体である。「活性剤溶解プロファイル」は、フィルムから放出された後の活性剤の溶解プロファイルを指す。フィルム自体及びその中の担体は、活性剤が口腔用フィルム剤形から放出された後に溶解するにつれ、その活性剤の溶解速度にいくらかの影響を及ぼす。
例えば、図9及び10は活性剤溶解プロファイルを示し、又、図13〜23は、PION技術で可能な改善され、且つより厳密なデータ及び微分を示す。これに対し、図8は、放出の速い剤形の極めて早い時点では識別能を欠く従来の溶解により測定した活性剤溶解プロファイルを示す。
活性剤が異なるフィルム剤形において同じ粒度分布を有する場合、活性剤溶解プロファイルは同じになると考えられる。しかしながら、常にそうとは限らない。PION技術を使用することにより、剤形間に識別可能な差違が見て取れ、このことはフィルム及び担体が活性剤の溶解速度に影響を及ぼすことを示す。
二次微分グラフは、曲線の質的評価を与える。一次微分曲線と二次微分曲線は両方とも、最大値、最小値、及び変曲点を与え、曲線がいつ増加しているか/減少しているか、及びその速度を決定することを可能とする。
そうではないことが述べられない限り、活性剤の溶解は、約0か月〜約36か月、0か月を超え約36か月まで、約6〜約36か月、約6〜約24か月、約9か月〜約18か月、又は約12か月、約20℃〜約60℃、約25℃〜約40℃、又は約25℃、及び最大約75%の相対湿度(RH)、例えば、RH約60%での口腔用フィルムの保存条件下で測定される。
医薬品のより主要な変化として、参照品と変化した製品で同一の条件下で行われる溶解プロファイルの比較が推奨される(“Guidance for Industry, Dissolution Testing of Immediate Release Solid Oral Dosage Forms”、米国保健福祉省、食品医薬品局、医薬品評価センター(CDER)、1997年8月(http://www.fda.gov/cder/guidance.htmで利用可能))。溶解プロファイルは、(1)総合的なプロファイルの類似度、及び(2)溶解サンプル時点ごとの類似度を根拠として類似と見なすことができる。
類似度係数(f2)は、誤差の2乗の合計の対数逆平方根変換であり、2つの曲線間の溶解パーセント(%)の類似度の尺度である。
a.試験品(変化前)及び参照品(変化後)の2品の溶解プロファイルを決定する。
b.各時間間隔において両曲線からの平均溶解値を用い、上式を用いて相違係数(f1)及び類似度係数(f2)を計算する。
c.これらの曲線は、f1値が15以下(0〜15)であり、f2値が50より大きい(すなわち50〜100)場合に類似と見なされ、従って、これら2品の同一性が保証される。
PION技術の改善された精度及び強化をもってすれば、より高精度で、又、溶解において計算可能な差違を得るためにこれまでに理解されていなかった変数に関して活性剤の溶解プロファイルを比較することができる。
フィルム及び/又はその成分は水溶性、水膨潤性、水不溶性、又はこれらの1以上の組合せであり得る。用語「水溶性」は、限定されるものではないが水を含む水性溶媒に少なくとも部分的に溶解可能な物質を指し得る。用語「水溶性」は、物質が水性溶媒に100%溶解可能であることを必ずしも意味しなくてよい。用語「水不溶性」は、限定されるものではないが水を含む水性溶媒に溶解可能でない物質を指す。溶媒は水を含むことができ、又は、その代わりに他の溶媒(好ましくは、極性溶媒)を単独で若しくは水と組み合わせて含むことができる。
ポリマー基材は、ポリマーを含む。ポリマーは、ポリエチレンオキシドであり得る。ポリマーは、セルロース、セルロース誘導体又はガムを含み得る。ポリマーは、ポリエチレンオキシド、セルロース、セルロース誘導体、例えば、セルロースエーテル、又はこれらの組合せを含み得る。ポリマーは、セルロース系ポリマーであり得る。特定の実施形態では、セルロース系ポリマーは、ヒドロキシプロピルメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシエチルメチルセルロース、ヒドロキシプロピルセルロース、メチルセルロース、カルボキシメチルセルロース及び/又はカルボキシメチルセルロースナトリウムであり得る。特定の実施形態では、ポリマーは、ヒドロキシプロピルメチルセルロースを含み得る。特定の実施形態では、ポリマーは、ポリエチレンオキシド及びセルロースエーテル、例えば、ヒドロキシプロピルメチルセルロースを含み得る。特定の実施形態では、ポリマーは、ポリエチレンオキシド及び/又はポリビニルピロリドンを含み得る。特定の実施形態では、ポリマー基材は、ポリエチレンオキシド及び/又は多糖を含み得る。特定の実施形態では、ポリマー基材は、ポリエチレンオキシド、ヒドロキシプロピルメチルセルロース及び/又は多糖を含み得る。特定の実施形態では、ポリマー基材は、ポリエチレンオキシド、セルロース系ポリマー、多糖及び/又はポリビニルピロリドンを含み得る。特定の実施形態では、ポリマー基材は、プルラン、ポリビニルピロリドン、ポリビニルアルコール、アルギン酸ナトリウム、ポリエチレングリコール、キサンタンガム、トラガカントガム(tragancanth gum)、グアーガム、アカシアガム、アラビアガム、ポリアクリル酸、メチルメタクリレートコポリマー、カルボキシビニルコポリマー、デンプン、ゼラチン、エチレンオキシド、プロピレンオキシドコポリマー、コラーゲン、アルブミン、ポリアミノ酸、ポリホスファゼン、多糖、キチン、キトサン、及びこれらの誘導体の群から選択される少なくとも1種類のポリマーを含み得る。有用な水溶性ポリマーの他の例としては、限定されるものではないが、ポリエチレンオキシド、プルラン、ヒドロキシプロピルメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ポリビニルピロリドン、カルボキシメチルセルロース、ポリビニルアルコール、アルギン酸ナトリウム、ポリエチレングリコール、キサンタンガム、トラガカントガム(tragancanth gum)、グアーガム、アカシアガム、アラビアガム、ポリアクリル酸、メチルメタクリレートコポリマー、カルボキシビニルコポリマー、デンプン、ゼラチン、多糖、及びこれらの組合せが含まれる。
ポリマー基材は、構造に不完全性を有する高分岐型ポリマーである超分岐ポリマーを含み得る。しかしながら、それらは他の樹枝状構造より有利であり得る一段階反応で合成することができ、従って、嵩のある体積の適用には好適である。球形構造の他、これらのポリマーの特性は、豊富な官能基、分子内空洞、低粘度及び高い溶解度である。樹枝状ポリマーは、いくつかの薬物送達適用に使用されてきた。例えば、本明細書の一部として援用される、Dendrimers as Drug Carriers: Applications in Different Routes of Drug Administration. J Pharm Sci, VOL. 97, 2008, 123−143参照。
好適な樹枝状ポリマーの例としては、限定されるものではないが、ポリ(エーテル)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(エステル)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(チオエーテル)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(アミノ酸)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(アリールアルキレンエーテル)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(アルキレンイミン)系デンドロン、デンドリマー及び超分岐ポリマー、ポリ(アミドアミン)系デンドロン、デンドリマー又は超分岐ポリマーが含まれる。
超分岐ポリマーの他の例としては、ポリ(アミン)、ポリカーボネート、ポリ(エーテルケトン)、ポリウレタン、ポリカーボシラン、ポリシロキサン、ポリ(エステルアミン、ポリ(スルホンアミン)、ポリ(尿素ウレタン)及びポリエーテルポリオール、例えば、ポリグリセロールが含まれる。
又、単独で使用する場合に、軟質フィルムを達成するために通常、可塑剤を必要とする特定のポリマーは、可塑剤を組み合わせなくてもやはり軟質フィルムを達成することも認められている。例えば、HPMC及びHPCは、組み合わせて使用した場合、製造及び保存に適当な可塑性及び弾性を持った柔軟で強いフィルムをもたらす。柔軟性に付加的な可塑剤又はポリアルコールの必要はない。
本明細書に開示されるフィルムに添加剤を加えてもよい。本発明のフィルムに配合可能な様々な添加剤は様々な異なる機能を提供し得る。添加剤種の例としては、賦形剤、滑沢剤、緩衝剤、安定剤、発泡剤、顔料、着色剤、充填剤、増量剤、甘味剤、香味剤、芳香剤、放出調整剤、アジュバント、可塑剤、流動促進剤、離型剤、ポリオール、造粒剤、希釈剤、結合剤、緩衝剤、吸収剤、滑剤、接着剤、固結防止剤、酸味料、軟化剤、樹脂、粘滑剤、溶媒、界面活性剤、乳化剤、エラストマー及びこれらの混合物が含まれる。これらの添加剤は、活性剤の前に又は活性剤と共に添加され得る。フィルム中の添加剤の量は、フィルム組成物の質量(その中の全成分の総質量である)に対して最大約80%、約0.005%〜約50%、約1%〜約20%、又は約3%〜約20%の範囲であり得、例えば、約1%を超える、約5%を超える、約10%を超える、約20%を超える、約30%を超える、約40%を超える、約50%を超える、約60%を超える、約80%未満、約70%未満、約60%未満、約50%未満、約40%未満、約30%未満、約20%未満、約10%未満、約5%未満、約3%、又は約1%未満である。
添加剤は、甘味剤、着香剤、調味料、充填剤、可塑剤、着色剤、例えば、色素又は顔料、浸透促進剤、緩衝剤、保存剤、二酸化ケイ素、粘着防止剤、及びこれらの任意の組合せからなる群から選択され得る。
有用な着香剤又は香味剤には、天然及び人工着香剤が含まれる。これらの香料は、合成香味油及び香味芳香油、及び/又はオイル、含油樹脂及び植物、葉、花、果実などに由来する抽出物、並びにこれらの組合せから選択され得る。限定されない香味油としては、スペアミント油、シナモン油、ペパーミント油、チョウジ油、ベイ油、タイム油、ニオイヒバ油、ナツメグ油、セージ油、及びビターアーモンド油が含まれる。又、バニラ、チョコレート、コーヒー、ココア、並びにレモン、オレンジ、ブドウ、ライム及びグレープフルーツを含む柑橘油、並びにリンゴ、セイヨウナシ、モモ、イチゴ、ラズベリー、サクランボ、プラム、パイナップル、アンズなどを含む果実精油といった人工、天然又は合成果実着香剤も有用である。これらの香料は個々に又は組み合わせて使用可能である。慣用される着香剤としては、個々に使用するのであれ組み合わせて使用するのであれ、ペパーミントなどのミント類、人工バニラ、シナモン誘導体、及び様々な果実着香剤が含まれる。酢酸シンナミル、シナモンアルデヒド、シトラール、ジエチルアセタール、酢酸ジヒドロカルビル、ギ酸オイゲニル、p−メチルアニソールなどを含むアルデヒド及びエステルなどの香料も使用可能である。アルデヒド香料の更なる例としては、限定されるものではないが、アセトアルデヒド(リンゴ);ベンズアルデヒド(サクランボ、アーモンド);桂皮酸アルデヒド(シナモン);シトラール、すなわち、αシトラール(レモン、ライム);ネラール、すなわち、βシトラール(レモン、ライム);デカナール(オレンジ、レモン);エチルバニリン(バニラ、クリーム);ヘリオトロピン、すなわち、ピペロナール(バニラ、クリーム);バニリン(バニラ、クリーム);α−アミルシンナムアルデヒド(スパイス果実着香剤);ブチルアルデヒド(バター、チーズ);バレルアルデヒド(バター、チーズ);シトロネラール(修飾、多種);デカナール(柑橘果実);アルデヒドC−8(柑橘果実);アルデヒドC−9(柑橘果実);アルデヒドC−12(柑橘果実);2−エチルブチルアルデヒド(ベリー果実);ヘキサナール、すなわち、トランス−2(ベリー果実);トリルアルデヒド(サクランボ、アーモンド);ベラトルアルデヒド(バニラ);12,6−ジメチル−5−ヘプテナール、すなわち、メロナール(メロン);2ジメチルオクタナール(未熟果);及び2−ドデセナール(柑橘、マンダリン);サクランボ;ブドウ;これらの混合物などが含まれる。
ある実施形態では、フィルムはベリー香料を含む。ベリー香料は、ラズベリー、イチゴ、ブルーベリー、ボイセンベリー、ブラックベリー、又はこれらの組合せであり得る。別の実施形態では、フィルムは、ラズベリー香料を含む。ベリー、ラズベリー、イチゴ、ブルーベリー、ボイセンベリー、又はブラックベリー香料は、天然又は人工であり得、購入してもよく、及び/又は当技術分野で公知のいずれの手段によって製造してもよい。例えば、芳香を含むラズベリー香料(favoring)は、全内容が本明細書の一部として援用される“Volatile Compounds of Raspberry Fruit: From Analytical Methods to Biological Role and Sensory Impact,” E. Aprea et al., Molecules 2015, 20, 2445−2474に開示されている揮発性化合物の混合を組み込むことにより達成可能である。使用する場合、ベリー香料は、組成物の約0.1〜約15質量%で存在し得る。その特定の実施形態では、ベリー香料は、組成物の約0.5〜約10質量%、約1〜約8質量%、約2〜約7質量%、約3質量%、約4質量%、約5質量%、約6質量%、又は約7質量%で存在する。
甘味剤は、スクラロース、ステビア、アセスルファムカリウム、サッカリン、フルクトース、アスパルテーム、及びこれらの任意の組合せからなる群から選択することができ、組成物の約0.5〜約5質量%、約1〜約5質量%、約1.5〜約4質量%、約1.5質量%、約2質量%、約2.5質量%、約3質量%、約3.5質量%、約4質量%、又は約5質量%で存在する。ある実施形態では、組成物の約3〜約4質量%、約3質量%、又は約3.5質量%のスクラロース、サッカリン、アスパルテーム、及びこれらの任意の組合せがフィルム中に存在する。
着色剤の他の例には、既知のアゾ色素、有機若しくは無機顔料、又は天然起源の着色剤が含まれる。酸化物又は鉄又はチタン、これらの酸化物などの無機顔料が好ましく、全成分の質量に対して約0.001〜約10%、好ましくは約0.5〜約3%の範囲の濃度で添加される。フィルムは、限定されるものではないが、白、透明、青、緑、赤、桃、紫、橙、又は黄を含むいずれの色であってもよい。ある実施形態では、フィルムは、透明及び半透明である。
二酸化ケイ素、ケイ酸カルシウム、又は二酸化チタンを総組成物の約0.02〜約1質量%の濃度で添加することが有用であり得る。これらの化合物は、調質剤として働く。
これらの添加剤は、それらの意図される目的を達成するために十分な量で使用されるべきである。一般に、これらの添加剤の特定の組合せは有効成分の総合的放出プロファイルを変更し、放出を改変、すなわち、抑制又は促進するために使用可能である。
粘着防止剤として使用するために好適な滑沢剤の例としては、限定されるものではないが、ステアリン酸塩、例えば、ステアリン酸マグネシウム、ステアリン酸カルシウム、及びステアリン酸ナトリウム;ステアリン酸;植物油(ステロテックスとして市販);タルク;ワックス;ステアリン酸マグネシウムとラウリル硫酸ナトリウムのブレンド(ステアロウェットとして市販);ホウ酸;安息香酸ナトリウム;酢酸ナトリウム;塩化ナトリウム;DL−ロイシン;分子量4000のポリエチレングリコール(カーボワックス4000として市販);分子量6000のポリエチレングリコール(カーボワックス6000として市販);オレイン酸ナトリウム;ラウリル硫酸ナトリウム;ラウリル硫酸マグネシウム;及びこれらの組合せが含まれる。
好適な付着防止剤(antiadherants)の例としては、限定されるものではないが、タルク;コーンスターチ;合成非晶質二酸化ケイ素クリスタリンフリー(Cab−O−Silとして市販;シロイド);DL−ロイシン;ラウリル硫酸ナトリウム;金属ステアリン酸塩;及びこれらの組合せが含まれる。好適な滑剤の例としては、限定されるものではないが、タルク;コーンスターチ;合成非晶質二酸化ケイ素クリスタリンフリー(Cab−O−Silとして市販);シロイド;エアゾール;及びこれらの組合せが含まれる。
存在する場合、粘着防止剤は、フィルム組成物の約0.01〜約20質量%で含めることができる。より具体的には、粘着防止剤は、フィルム組成物の約0.01〜約10質量%、更により具体的にはフィルム組成物の約0.25〜約5質量%の量で存在してよい。
粘着防止剤はフィルム組成物自体に含まれてよい。例えば、粘着防止剤を含む単層又は多層フィルムが形成可能である。多層フィルムは例えば、2層、3層又はそれを超える層のフィルムを実質的に互いに接触して含み得る。これらのフィルム層は互いに積層されてよい。粘着防止剤は、多層フィルムの層の1以上に存在してよい。例えば、いくつかの実施形態は、粘着防止剤が2層のフィルム層のうち一方に存在する2層フィルムを含み得る。いくつかの実施形態は、粘着防止剤が3層フィルムの各外層に存在するが内層又は中間層には存在しない3層フィルムを含み得る。それに従って、層の様々な異なる組合せが形成可能である。
いくつかの実施形態は脂肪及び/又はワックスを粘着防止剤として含んでもよい。
上記に示される同一出願人による米国特許第7,425,292号及び同第8,765,167号に記載されている他のいずれの任意選択成分も又、本明細書に記載のフィルムに含まれてよい。
本明細書に開示されるフィルムは浸透促進剤を含有し得る。活性剤は、フィルムの単一の層で浸透活性促進剤と組み合わせてもよいし、それぞれ別の層に含有されてもよいし、又はそうでなければ同じ剤形の離散した領域にそれぞれ含有されてもよい。特定の実施形態では、ポリマー基材に含有される活性剤は、そのマトリックス内に分散させることができる。特定の実施形態では、ポリマー基材に含有される浸透促進剤は、そのマトリックス内に分散させることができる。
当技術分野で使用するための既知のいずれの浸透促進剤も本開示のフィルムに配合可能である。用語「浸透促進剤」は、吸収促進剤及び透過促進剤と互換的である。フィルムを介して口腔内に送達された際、浸透促進剤は、対象の粘膜から血中へ医薬活性剤の浸透性を向上させ得る成分である。
浸透促進剤は、組成物中の他の成分によって、医薬活性剤の吸収速度及び吸収量を5%を超えて、10%を超えて、20%を超えて、30%を超えて、40%を超えて、50%を超えて、60%を超えて、70%を超えて、80%を超えて、90%を超えて、100%を超えて、150%を超えて、約200%以上、又は200%未満、150%未満、100%未満、90%未満、80%未満、70%未満、60%未満、50%未満、40%未満、30%未満、20%未満、10%未満、若しくは5%未満、又はこれらの範囲の組合せで向上させることができる。
脂肪酸は、いくつかの薬物の皮膚を経た浸透を促進することが示されており、示差走査熱量測定法及びフーリエ変換赤外線分光法により、細胞間脂質の流動性の増大に関連していることが示されている。
加えて、エタノールでの前処理は、腹側舌粘膜を経たトリチウム化水及びアルブミンの浸透性を高めること、並びにブタ口腔粘膜を経たカフェインの浸透性を高めることが示されている。又、口腔粘膜を経た化合物の浸透性に対するAzone.RTM.の促進効果の報告もいくつかある。更に、生体適合性及び生分解性ポリマーであるキトサンは、腸及び鼻腔粘膜を含む種々の組織を経た薬物送達を増進することが示されている。
胆汁酸塩、界面活性剤、脂肪酸及びそれらの誘導体、キレーター、シクロデキストリン及びキトサンなどの種々のクラスの経粘膜及び経皮透過促進剤を使用することにより口内透過が向上し得ることが示されている。薬物浸透促進に使用されるこれらの化学物質の中で胆汁酸塩が最も一般的である。
キトサンも又、動物モデル及びヒトボランティアにおける鼻腔粘膜を経た小さな極性分子及びペプチド/タンパク質薬物の吸収を促進することが示されている。他の研究でも腸管粘膜及び培養Caco−2細胞の化合物の透過に対する増進効果が示されている。
C3−C22アルコール又は酸は、直鎖C3−C22炭化水素鎖、例えば、任意選択により少なくとも1つの二重結合、少なくとも1つの三重結合、又は少なくとも1つの二重結合と1つの三重結合を含有するC3−C22炭化水素鎖を有するアルコール又は酸であり得;前記炭化水素鎖は、任意選択によりC1-4アルキル、C2-4アルケニル、C2-4アルキニル、C1-4アルコキシ、ヒドロキシル、ハロ、アミノ、ニトロ、シアノ、C3-5シクロアルキル、3〜5員ヘテロシクロアルキル、単環式アリール、5〜6員ヘテロアリール、C1-4アルキルカルボニルオキシ、C1-4アルキルシロキシカルボニル、C1-4アルキルカルボニル、又はホルミルで置換されていてもよく;更に、任意選択により−−O−−、−−N(Ra)−−、−−N(Ra)−−C(O)−−O−−、−−O−−C(O)−−N(Ra)−−、−−N(Ra)−−C(O)−−N(Rb)−−、又は−−O−−C(O)−−O−−が挿入されていてもよい。Ra及びRbはそれぞれ独立に、水素、アルキル、アルケニル、アルキニル、アルコキシ、ヒドロキシルアルキル、ヒドロキシル、又はハロアルキルである。
アドレナリン受容体相互作用因子は、リノール酸などの不飽和脂肪酸であり得る。特定の実施形態では、浸透促進剤はファルネソールであり得る。ファルネソールは、非環式セスキテルペンアルコールである15炭素の有機化合物であり、ピロリン酸ファルネシルの天然の脱リン酸化形態である。標準条件下で、ファルネソールは無色の液体である。ファルネソールは疎水性であり、従って、水に不溶であるが、油と混和する。ファルネソールは、シトロネラ、ネロリ、シクラメン、及びゲッカコウなどの植物の脂から抽出することができる。それは脊椎動物におけるメバロン酸からのコレステロールの生物合成における中間工程である。ファルネソールは繊細なフローラル又は弱い柑橘−ライムの香りを持ち、芳香剤及び着香剤に使用されている。ファルネソールは初代造血系細胞よりも急性骨髄性白血病芽細胞及び白血病細胞株を選択的に死滅させることが報告されている。本明細書の一部として援用されるRioja A. et al., FEBS Lett 467 (2−3): 291−5 (2000)参照。ファルネシル類似体の血管作用特性が報告されている。本明細書の一部として援用されるRoullet, J.−B., et al., J. Clin. Invest., 1996, 97:2384−2390参照。ファルネソール及びファルネシル化タンパク質のカルボキシル末端の合成模倣物であるN−アセチル−S−トランス,トランス−ファメシル−L−システイン(AFC)は両方ともラット大動脈輪において血液収縮を阻害する。
ある実施形態では、フィルムは、植物抽出物である浸透促進剤を含む。植物抽出物は、チョウジ植物の精油抽出物、チョウジ植物の葉の精油抽出物、チョウジ植物の花蕾の精油抽出物、チョウジ植物の茎の精油抽出物、又はこれらの組合せであり得る。ある実施形態では、植物抽出物は合成品であり得る。植物抽出物としては、約20%〜約95%のオイゲノール、約40%〜約95%のオイゲノール、約60%〜約95%のオイゲノール、又は約80%〜約95%のオイゲノールを含み得る。
本発明の目的では、自己凝集しない均一な異種性(non-self-aggregating uniform heterogeneity)という用語は、極性溶媒に加えて1以上の成分から形成される本発明のフィルムの、乾燥オーブン、乾燥トンネル、真空乾燥機、又は他のこのような乾燥器具を用いた高温の空気浴などの従来の乾燥方法によってフィルムが形成された場合に通常受けるようなフィルム内の成分の強凝集又は弱凝集の発生の実質的低減(すなわち、ほとんどない又は全くない)をもたらす能力を指す。異種性という用語は、本発明で使用する場合、ポリマーなどの単一の成分、並びにポリマーと活性剤などの成分の組合せを配合したフィルムを含む。均一な異種性は、フィルムを形成するために使用される従来の混合及び熱乾燥に一般的であるような強凝集又は弱凝集が実質的に存在しないことを含む。
更に、本明細書に開示されるフィルムは実質的に均一な厚さを有し、これも又、水ベースのポリマー系を乾燥させるために使用される従来の乾燥法の使用によっては提供されない。均一な厚さが存在しなければ、所与のフィルムの領域又は範囲への成分分布の均一性に悪影響を及ぼし得る。
次に、流延及び乾燥させたフィルムを実質的に等しい大きさ(長さ、幅及び厚さ)の個々の投与単位に切断することができ、それらの投与単位は、所望の量(表示量)の活性剤から10%を超える変動のない活性剤含量を有する。
制御された乾燥は又、フィルムの深度から上方に乾燥が始まるようにまずフィルムの底表面に熱を向けることも含み得る。これは、上部気流を実質的に用いずにフィルムの底表面に熱をかけるか、又は早期スキニングのリップリングを起こすことなく底部と上部に同時に熱をかけることによって達成され得る。
或いは、乾燥は、フィルム内の水又は他の極性溶媒を蒸発させるために制御されたマイクロ波を導入することにより達成され得る。マイクロ波を適用する場合、基材の温度が基材の沸騰(その中の活性剤の不均一性が起こる)が起こるような高温にならないように注意しなければならない。
このフィルムの乾燥様式は、いくつかの利点を提供する。これらには、より速い乾燥時間及びより均一なフィルム表面、並びにフィルム中のいずれの所与の領域にも成分が均一に分布していることがある。加えて、より速い乾燥時間は、フィルム内で粘度が急速に高まること、更には成分の均一な分布を促すこと、及び最終的なフィルム製品における成分の強凝集を軽減することを可能とする。望ましくは、フィルムの乾燥は約10分以内、又はより望ましくは約5分以内に起こる。
本発明では、組成物成分の強凝集を軽減することに注意すると格段に均一なフィルム製品が得られる。更に、混合工程で余分な空気が入らないようにすること及び余分な空気を抜くことが、フィルム及びそれから切断された投与形の均一性を促す上で望ましく;加えて、フィルムのリップリング又は物質移動を回避しつつ、制御可能な粘度を提供するためにポリマー及び溶媒を選択すること、及び上述のように迅速な方法でフィルムを乾燥させることは、フィルム及び表示量にまで縮小した際に活性剤含量の所望の均一性を有するフィルムから切断された投与形を維持及び提供する上で望ましい。従って、このような投与単位の活性剤含量の均一性は、これらのパラメーターへの注意によって達成される。
フィルム又はフィルム形成成分又は基材の粘度に加え、望ましいフィルム均一性を得るために考慮される他の事項がある。例えば、非コロイド適用において固体(薬物粒子など)沈積を防ぐ安定懸濁液が達成される。本発明により提供される1つのアプローチは、粒子密度(ρp)と液相密度(ρ1)のバランスをとり、液相粘度(μ)を増すことである。単離された粒子では、ストークスの法則は、以下のように粘稠な流体の半径(r)の剛球体の限界沈降速度(Vo)に関する。
Vo=(2gr r)(ρp−ρ1)/9μ.
しかしながら、高い粒子濃度では、局部粒子濃度は、局所粘度及び密度に影響を与える。懸濁液の粘度は固体体積分率の強い関数であり、粒子−粒子及び粒子−液体相互作用は更に沈降速度を障害する。
v/Vo=1/(1+κφ)
ここで、κ=定数、φは、分散相の体積分率である。液相に懸濁している粒子が多いと、速度が低下する。粒子の直径は粒子−粒子流動相互作用に影響を及ぼすので粒子の幾何学も重要な因子である。
同様に、懸濁液の粘度も分散している固体の体積分率に依存する。相互作用のない球形粒子の希釈懸濁液では、懸濁液粘度の表現は以下のように表すことができる。
μ/μo=1+2.5φ
ここで、μoは連続相の粘度であり、φは固体体積分率である。より高い体積分率では、分散物の粘度は以下のように表すことができる。
μ/μo=1+2.5φ+C1φ2+C2φ3+
ここで、Cは定数である。
懸濁液の水相へのヒドロコロイドの添加は、ヒドロコロイドのタイプ、その濃度及び粒子組成物、幾何学、大きさ、並びに体積分率に応じて、粘度を増し、粘弾性をもたらすことがあり、安定性を付与することができる。分散相の平均粒度分布は、高粘度媒体中での最小の実際の平均粒径、すなわち<500μmを選択することによって制御する必要がある。低剪断速度でのわずかな降伏応力又は弾性体の存在も又、見掛けの粘度に関わらずに恒久的な安定性をもたらし得る。分離臨界粒径は、降伏応力値から計算することができる。単離された球形粒子の場合、所与の粘度の媒体での沈降の際に生じる最大剪断応力は以下のように示すことができる。
τmax=3Vμ/2r
擬塑性流体の場合、この剪断応力レジームにおける粘度は、ニュートンプラトーにおいて十分にゼロ剪断速度粘度であり得る。
本発明の組成物及びフィルムのレオロジー要件は極めて厳格である。これは粒子の安定懸濁液を生産するための必要によるものであり、広い剪断速度範囲で許容される粘度値を有する粘弾性流体基材中、例えば、30〜60質量%である。混合、ポンピング、及びフィルム流延中、10〜105秒-1の剪断速度を受ける可能性があり、擬可塑性が好ましい実施形態である。
フィルムの流延又はコーティングにおいて、レオロジーは又、所望の均一性を有するフィルムを形成する能力に関して決定因子でもある。剪断粘度、伸張粘度、粘弾性、構造回復はフィルムの品質に影響を及ぼす。具体例として、ずり流動化擬可塑性流体のレベリングは次のように導かれた。
α(n-1/n)=αo(n-1/n)−((n−1)/(2n−1))(τ/K)1/n(2π/λ)(3+n)/nh(2n+1)/nt
ここで、αは表面波振幅であり、αoは初期振幅であり、λは表面粗さの波長であり、「n」及び「K」は両方とも、粘度べき乗則指数である。この例では、レベリング挙動は粘度に関連し、nが増すと増し、Kが増すと減る。
よって、成分混合物の均一性は多くの変数に依存する。本明細書に記載するように、成分の粘度、混合技術及び得られる混合組成物及び湿潤流延フィルムのレオロジー特性は本発明の重要な態様である。加えて、平均粒径及び粒子形状の制御も更なる考慮事項である。望ましくは、平均粒径は200ミクロン以下、150ミクロン以下、又は100ミクロン以下であり得る。更に、このような粒子は、球形、実質的球形、又は非球形、例えば、不規則形の粒子又は楕円形粒子であり得る。楕円形粒子又は楕円体は、球形粒子に比べて沈降程度が小さい傾向があるので、フィルム形成基材中で均一性を維持するそれらの能力のために望ましい。
任意の添加剤及び有効成分に加えてフィルム形成ポリマー及び極性溶媒を含む基材が形成される場合、これは複数の段階で行うことができる。例えば、成分は全て一緒に添加してもよいし、又はプレミックスが好ましいものであり得る。プレミックスの利点は、活性剤以外の全ての成分を予め合わせ、活性剤はフィルム形成の直前に添加するということである。このことは、水、空気又は別の極性溶媒に長時間曝されると分解する可能性のある活性剤には特に重要である。
本発明のフィルムの作製のための装置は、例えば、米国特許第8,765,167号に開示されており、その全内容は本明細書の一部として援用される。
更に、粒子又は粒状物質は、組成物又は基材を流延してフィルムとした後にフィルム形成組成物又は基材に添加してよい。例えば、粒子は、フィルムの乾燥前にフィルムに添加してよい。粒子はフィルムに制御可能に計量供給し、フィルム表面にわずかに軽く触れ、フィルム表面に粒子を制御可能に施すドクターブレード(示されていない)によるなどの好適な技術によって施してもよい。限定されるものではないが、他の好適な技術は、粒子をフィルム表面に配する付加的ローラー、フィルム表面への粒子の噴霧などの使用を含む。粒子は相対するフィルム表面、すなわち、フィルムの上面及び/又は底面の一方又は両方に配してもよい。望ましくは、粒子は、フィルムに包埋するなど、フィルムに固定可能に施す。更に、このような粒子は望ましくは、フィルムに完全に封入又は完全に包埋されず、粒子が部分的に包埋又は部分的に封入されている場合など、フィルム表面に露出して留まる。
粒子は、いずれの有用な官能剤、化粧料剤、医薬剤、又はこれらの組合せであってもよい。望ましくは、医薬剤は、矯味剤又は徐放性医薬剤である。有用な官能剤としては、着香剤及び甘味剤が含まれる。有用な化粧料剤としては、メントール結晶を含むメントールなどの口臭清涼剤又は鬱血除去剤が含まれる。
フィルム製品は一般に、適宜選択されたポリマー及び極性溶媒、並びに所望により任意の有効成分又は充填剤を組み合わせることにより形成される。望ましくは、組合せの溶媒含量は、総組合せの少なくとも約30質量%である。この組合せにより形成される基材は望ましくはロールコーティングによりフィルムに形成され、次に、望ましくはフィルムの均一性、より具体的には、自己凝集しない均一な異種性を維持するために迅速・制御乾燥工程により乾燥させる。得られるフィルムは望ましくは、約10質量%未満の溶媒、より望ましくは約8質量%未満の溶媒、一層より望ましくは約6質量%未満の溶媒、もっとも望ましくは約2%未満を含有する。溶媒は、水、極性有機溶媒、例えば、限定されるものではないが、エタノール、イソプロパノール、アセトン、塩化メチレン、又はこれらの任意の組合せであり得る。
本明細書に開示されるフィルムは、乾燥前に、連続的に流延された湿潤フィルム又は湿潤シートに形成しなければならない。用語「連続的に流延された」とは、その上に湿潤フィルム基材が流延及び形成され、次に、オーブンなどの乾燥装置に続き、更にその後に保存用にロールアップマンドレル又は直接的に切断及び包装ステーションへと連続的に運ばれるコンベヤー基板を用いた比較的高速の製造工程を指すものとする。連続的という用語は、例えば湿潤フィルム基材がトレイ上に流延されるような実験室で実施されるものなどの工程を区別することを意図する。
ポリマー、水、及び所望により活性剤又は他の成分を含む多成分の実質的に均一な基材を形成するために所望の成分を合わせた後、この組合せを多成分基材の押出、コーティング、散布、流延又は引出などの当技術分野で公知の方法のいずれかにより湿潤シート又はフィルムに成形する。多層フィルムが望まれる場合、これは、同じであっても異なっていてもよい成分の2つ以上の組合せの共押出によって達成してもよい。多層フィルムは又、既に形成された、望ましくは既に乾燥されたフィルム層の上へ湿潤フィルム基材を連続コーティング、連続散布、又は連続流延することによって達成してもよい。
様々な異なる連続的フィルム形成技術が使用可能であるが、リバースロールコーティングなどの軟質フィルムを提供する方法を選択することが望ましい。フィルムの柔軟性は、保存のための又は個々の剤形へ切断する前のフィルムシートの巻き取り及び輸送を可能とする。望ましくは、フィルムは又、自立性であり、又は言い換えれば、独立した支持体の不在下でそれらの完全性及び構造を維持することができる。更に、本発明のフィルムは、可食又は摂取可能な材料から選択してもよい。
連続ロールコーティング、又はより具体的には、リバースロールコーティングは、本発明に従ってフィルムを形成する際に特に望ましい。この手法は、得られるフィルムの優れた制御及び均一性を提供し、それは本発明において望まれるものである。この手法では、コーティング材料を、上方のメータリングローラーとその下のアプリケーションローラーの間のギャップの精度設定によってアプリケーターローラー上で測定する。コーティングは、アプリケーションローラーに隣接するサポートローラーを通過する際にアプリケーションローラーから基板へ移動する。3ロール法と4ロール法の両方が一般的である。
オフセットグラビアが一般的であり、コーティングが基板へ移動する前に中間ローラーに付着する。
浸漬又はディップコーティングの簡単な方法では、基板がコーティング槽に漬けられ、これは、基板が現れた際にコーティングが層内に戻ることができるように通常は低粘度である。
スロットダイ法では、重力により、又はスロットから基板への加圧下でコーティングが絞り出される。コーティングが100%固体であれば、この工程は「押出」と呼ばれ、この場合には、ライン速度は押出速度よりもかなり速い場合が多い。これによりコーティングをスロットの幅よりもかなり薄くすることができる。
ギャップ又はナイフオーバーロール法は、基板にコーティングを施し、その後これを「ナイフ」とサポートローラーの間の「ギャップ」に通すことによるものである。コーティングと基板が通過すると、余分なものはそぎ落とされる。
エアナイフコーティングは、基板にコーティングが施され、余分なものがエアナイフからの強力なジェットによって「吹き飛ばされる」ものである。この手法は水性コーティングに有用である。
カーテンコーティング法では、底部にスロットが付いた槽が、コーティングの連続カーテンが2つのコンベヤーの間のギャップに落ちることを可能とする。コーティングする対象は、コンベヤーに沿って制御された速度で通過し、従って、その上面にコーティングを受ける。
基板は当技術分野で使用が知られているいずれの材料であってもよい。例えば、材料は、任意選択によりコーティングされていてもよい、ポリエチレンテレフタレートなどのポリエステルフィルム、プラスチックシート、ガラス又はセルロース系ペーパーであり得る。基板は、ポリエチレンテレフタレート(例えば、マイラー)又は硫酸紙であり得る。基板がポリエチレンテレフタレートである場合、それは任意選択によりその底面又は上面にコロナ処理が施された二軸延伸ポリエチレンテレフタレートであり得る。
乾燥段階も又、フィルム組成物の均一性の維持に関する寄与因子である。制御された乾燥法は、増粘組成物又は例えばポリマーの選択により粘度が制御される組成物の不在下で、フィルム内の成分が強凝集又は集塊化傾向が増し得る場合に特に重要である。制御された乾燥法を必要としない、正確な用量のフィルムを形成する別の方法は、所定のウェル上にフィルムを流延すること、又は製造ライン上で連続流延フィルム(活性剤を含有しない)から投与単位を切断した後に個々の投与単位に所望の量の活性剤を適用することである。これらの2つの別法は、流延前にフィルム基材に活性剤を配合する連続流延フィルムと同じ、混合工程から乾燥工程までの活性剤含量の均一性の維持に伴う問題を持たない。これらの別法では、隣接する剤形への活性剤の移動が起こる機会が存在しない。整序された又は迅速な乾燥工程が望まれる場合、これは様々な方法によって達成され得る。熱の適用を必要とするものを含め、様々な方法が使用可能である。液体担体は、湿潤フィルムにおいて得られる均一性、又はより具体的には、自己凝集しない均一な異種性が維持されるような様式でフィルムから除去される。
よって、乾燥工程の一態様では、フィルムは、フィルムの底部からフィルムの上部に向かって乾燥させることができる。望ましくは、存在する上部気流は上述の不均一性状態を引き起こしてはならない。初期設定期間が経過し、十分に固化すると、粘弾性構造が形成れ、リップル及び早期スキニングを生じる可能性はなくなりはしなくても大幅に減る。これは乾燥工程の最初の数分以内、例えば、ほぼ最初の0.5〜約4.0分で起こり得る。この方法での乾燥の制御は、従来の乾燥法から生じるフィルムの上面の破壊及び再形成を防ぐ。製造状況において連続的に流延された湿潤フィルムを乾燥させると、運搬基板上に湿潤流動性フィルム基材を流延することを含む。
単独で又は上記に開示した他の制御された方法と組み合わせて使用され得る乾燥工程を制御する別法としては、フィルムが乾燥される乾燥装置内の湿度を制御及び変更することを含む。この様式では、フィルム上面の早期乾燥が回避され得る。
加えて、乾燥時間の長さは、適切に制御することができること、すなわち、成分、特に芳香油及び薬物の熱感受性及び揮発性とバランスをとることができることが判明した。エネルギーの量、温度並びにコンベヤーの長さ及び速度は、このような活性剤に適合させるため、及び最終フィルムでの損失、分解又は無効性を最小化するためにバランスをとることができる。
Magoonの方法及び装置は、水の興味深い特性に基づいている。水は内部及びその周囲への伝導及び対流によってエネルギーを伝えるが、内部及び水にエネルギーを放射するだけである。従って、Magoonの装置は、赤外線透過性の、果肉が置かれる表面を含む。表面の下側は温度が制御されている水浴と接触している。水浴の温度は望ましくは、水の沸点よりやや低い温度に制御されている。含水果肉が装置の表面に置かれると、これは「反射率窓」を作り出す。これは、赤外線エネルギーが表面から果肉が占有している表面の領域にのみ、果肉が乾燥するまでの間のみ放射可能であることを意味する。Magoonの装置は、フィルムの成分の強凝集の例を軽減する効果的な乾燥時間を有する本発明のフィルムを提供する。
最終的な自立性フィルム製品(又はそれから作製された投与単位)が2層を有する場合、総フィルム厚は約0.005mm〜約2mm、約0.01mm〜約1mm、又は約0.1mm〜約0.5mmの範囲であり得る。総フィルム厚は、約0.1mmを超えても、約0.2mm超、約0.5mm超、約0.5mm超、約0.5mm未満、約0.2mm未満、又は約0.1mm未満であり得る。各層の厚さは、積層自立性フィルムの総厚の約10%〜約90%、又は約30%〜約60%で可変である。いずれの1層も積層自立性フィルムの総厚の10%超、20%超、30%超、40%超、50%超、70%超、90%超、約90%、90%未満、70%未満、50%未満、40%未満、30%未満、20%未満、又は10%未満であり得る。各層の好ましい厚さは、約0.01mm〜約0.9mm、又は約0.03mm〜約0.5mmで可変である。
より具体的には、口腔内溶解フィルム投与単位(「単位用量」とも呼ばれる)は、速溶性、中速溶解性及び低速溶解性の主要な3種類に属する。口腔内溶解フィルム投与単位は、上記カテゴリーのいずれかの組合せも含み得る。速溶性フィルム投与単位は、口腔内で約1秒〜約30秒、例えば、約1秒超、約5秒超、約10秒超、約20秒超、及び約30秒未満で溶解し得る。中速溶解フィルム投与単位は、口腔内で約1〜約30分、例えば、約1分超、約5分超、約10分超、約20分超、及び約30分未満で溶解し得る。低速溶解フィルム投与単位は、口腔内で約30分超、例えば、約30分〜約24時間、約30分〜約12時間、約30分〜約10時間、及び約1時間〜約10時間で溶解し得る。速溶性フィルム投与単位は、低分子量親水性ポリマー(例えば、約1,000〜約9,000ダルトンの分子量を有するポリマー、又は約200,000ダルトンまでの分子量を有するポリマー)を含み得る(又はからなり得る)。これに対して、低速溶解フィルム投与単位は、高分子量ポリマー(例えば、数百万の分子量を有する)を含み得る。
自立性とは、任意の独立した支持体の不在下でフィルムがその完全性と構造を維持することを意味する。本開示のフィルムは、口腔粘膜、すなわち、例えば頬側又は舌下での吸収のために調剤される。様々な異なるフィルム形成技術が使用可能であるが、リバースロールコーティングなどの軟質フィルムを提供する方法を選択することが望ましい。フィルムの柔軟性は、保存のための又は個々の剤形へ切断する前のフィルムシートの巻き取り及び輸送を可能とする。
本明細書に開示される薄膜フィルムは、多くの使用によく適している。フィルム成分の高い均一度は、これらを医薬配合に特によく適合したものとする。更に、フィルムの構築に使用されるポリマーは、フィルムのある範囲の崩壊時間を可能とするように選択され得る。フィルムが崩壊する時間の変更又は延長により、活性剤が放出される速度の制御を達成することができ、これは徐放送達系を可能とする。加えて、フィルムは、いくつかの体表のいずれにも、特に、口腔、肛門、膣、眼、皮膚表面又は手術中の体内の創傷表面、及び同様の表面といった粘膜への活性剤の投与に使用することもできる。
フィルムは、活性剤を経口投与するために使用可能である。これは上記のようにフィルムを作製し、それらを哺乳動物の口腔に導入することにより達成される。このフィルムは作製され、使用、すなわち、口腔への導入の前にそれが取り外される第2の層又は支持層に接着される。支持材料又は下地材料にフィルムを付着させるために接着剤を使用することができ、この接着剤は当技術分野で公知のもののいずれであってもよく、好ましくは非水可溶である。接着剤が使用される場合、それは望ましくは摂取可能な食品級の接着剤であり、活性剤の特性を変化させない。粘膜付着性組成物は特に有用である。フィルム組成物は多くの場合、粘膜付着剤、それ自体として働く。
本明細書に開示されるフィルムのもう1つの使用は、液体に入れた際にすぐに溶解するフィルムの傾向を利用する。活性剤は、本発明に従ってフィルムを作製し、それを液体に入れ、及びその溶解を可能とすることにより液体に導入され得る。これは活性剤の液体剤形を調製するため、又は飲料を着香するために使用され得る。
本発明のフィルムは望ましくは、酸化、加水分解、揮発及び環境との相互作用に対する曝露から活性剤を保護するために密閉、気密及び防湿包装中に包装される。更に、本発明のフィルムは、唾液又は粘膜領域と接触した際にすぐに溶解し、用量を水で流し込む必要を無くす。
望ましくは、一連のこのような単位用量を、特定の療法に応じて例えば10〜90日供給などの規定のレジメン又は処置に従って一緒に包装する。個々の自立性フィルムは、下地無しで、又は下地上に包装し、使用のために剥離することができる。
又、ヒトにおいて癲癇、癲癇発作、及び他の形態の発作を治療する方法であって、そのヒトに各単位用量中の所望の量の活性剤の送達のための口腔用フィルムを投与することを含む方法も本明細書に開示される。フィルムは、a)水溶性ポリマー基材、水膨潤性ポリマー基材、又は水溶性且つ水膨潤性ポリマー基材;b)約160ミクロン未満の平均粒径D90を有する活性剤;並びにc)甘味剤、着香剤、調味料、充填剤、可塑剤、色素、顔料、浸透促進剤、緩衝剤、保存剤、二酸化ケイ素、粘着防止剤、及びこれらの任意の組合せからなる群から選択される添加剤を含む。口腔用フィルム中の活性剤は、上述の溶解プロファイル及び速度のいずれかを有し得る。
活性剤は、本明細書に記載のいずれの活性剤であってもよい。特定の実施形態では、活性剤は、クロバザム、ジアゼパム、リルゾール、又はこれらの任意の組合せであり得る。
別の実施形態は、ヒトにおいてレノックス・ガストー症候群を治療する方法であって、そのヒトに本明細書に開示される口腔用フィルムを投与することを含む方法を対象とする。
これらの実施形態(使用方法)に関して使用される用語は、上述と同じ意味及び定義を有する。
よって、微粉化クロバザムを含有する口腔用フィルムは粉砕クロバザムを含有する口腔用フィルムよりも良好な性能であった(すなわち、有意に速く溶解した)。
5mg及び15mgの活性剤を含有する、ジアゼパム(DBSF)含有口腔用薄膜フィルムを作製した。12か月、25℃での保存条件下の5mg及び15mgのDBSFの溶解を、従来の溶解及びPION技術を用いて試験した。従来の溶解は、本明細書で使用する場合、錠剤及びカプセル剤などの固体経口剤形の溶解特徴を試験するための一般的なアプローチである。従来の溶解方法は、フィルムを静止して保持するために必要な改良型のサンプルホルダーを備え、改良型のUSP装置5セットアップを使用する。従来の溶解方法の他の全ての側面は、手動サンプル採取及び特定の時点でのサンプル収集、その後のHPLCを用いたサンプルのオフライン分析を含む、他の固体経口剤形のものと同様である。従来の溶解方法は、手動サンプル採取及びサンプルアリコートの取り出しの頻度及び一貫性という実際面で限定される。PION技術は、従来の設定でない従来の溶解槽を使用する。この槽は、装置2(パドル)を用いて設定され、そのパドルの上に改良型のサンプルホルダーが取り付けられている。インライン光ファイバープローブが容器内に配置されている。サンプルは所定の間隔でin−situで試験される。サンプル採取は自動であり、インラインで分析され、サンプルの取り出し、手動サンプル採取、又はオフラインのHPLC試験の必要はない。DBSF試験に関する従来の溶解とPION技術のシステムパラメーターの比較を表3に示す。
50mgのリルゾール(ROSF)を含有する口腔用薄膜フィルムを作製した。約6か月、25℃で保存後の50mgのROSFの溶解を、0.1N HCL(胃条件を模倣する媒体)中で従来の溶解及びPION技術を用いて試験した。ROSFを試験するための従来の溶解及びPION技術に関して使用したパラメーターは上記の表3に示す。
図6は、従来の溶解試験により測定したROSFの活性剤溶解プロファイルのグラフである。図7は、PION技術により測定したROSFの活性剤溶解プロファイルのグラフである。いくつかのデータ点及び従来の溶解により得られた結果とPION技術で得られた結果の比較を表6に示す。
上記の表6に表す計算によれば、リルゾールを含有する50mgの口腔用フィルムに関する活性剤溶解プロファイルは類似している。しかしながら、PION技術を使用すれば、活性剤溶解プロファイルは、利用可能なより多くの時間間隔ではるかに厳密となり、向上した。従来の溶解では、活性剤溶解プロファイルは6つのデータ点を含むに過ぎないが、PION技術を用いて得られる活性剤溶解プロファイルはその量の5倍である。加えて、PION技術を用いた場合にはデータは即得られるが、従来の溶解を用いた最初のデータ点は5分である。これらの速溶性剤形では、5分までの活性が重要な相違因子となり得る。
5mg及び20mgのCOSFの溶解を、従来の溶解及びPION技術を用いて試験した。COSFを試験するために従来の溶解及びPION技術に関して使用したパラメーターを上記表3に示す。
図11及び12は、図9及び10でPION技術により測定した活性剤溶解プロファイルの二次微分をプロットしたものである。これを用いれば、正確な変曲点(図の上で特定)の計算が達成可能である。
表7に示すような組成を有し、5mg、10mg及び20mgの活性剤を含有するクロバザム(COSF)含有口腔用薄膜フィルムを作製した。これらのフィルムを約24か月、約25℃、RH60で保存し、その後、異なる量の活性剤を含有するCOSF間でどのように活性剤溶解プロファイルが異なったかを決定するためにPION技術を用いて試験した。PION技術に使用したパラメーターは上記の表3に示す。
図13は実際に得られたデータ点のグラフであり、図14は図13に示されるデータ点の、平滑化した曲線である。これらの図に示されるように、各フィルムの活性剤溶解プロファイル間には検出可能な差違がある。5mgのCOSFは速放性を有し(最も急勾配の曲線、2.5分で100%に達する)、次いで10mgのCOSF(3.0分で100%に達する)、最後に20mgのCOSFは最も遅い放出プロファイルを有し、7.0分後に100%に近づく。
上記で図8に関して述べたようにこの場合にも、図13、14及び15に示されるこれらの差違は、従来の溶解を用いた場合には表されない。それはこれらの差違が検出及び記録可能なPION技術の高められた識別能がある場合だけである。
上記のように作製した5mg、10mg及び20mgのCOSFを、1)約24か月、RH60、約25℃での保存後;2)約24か月、RH60、約40℃での保存後;又は3)完成品の完了時(保存時間無し、T=約0か月)のいずれかで、PION技術を用いて試験した。PION技術に関して使用したパラメーターは上記の表3に示す。異なる保存条件が溶解速度にどのように影響を及ぼすかを決定するために、活性剤溶解プロファイルを比較した。
統計学的類似性については、完成品5mg及び10mg COSFの活性剤溶解プロファイルは、同等の保存サンプルと統計学的に類似ではない。完成品20mg COSFサンプルの活性剤溶解プロファイルは、保存された20mg COSFサンプルと統計学的に類似である。
媒体の選択が溶解速度にどのように影響を及ぼすかを決定するために、5mg、10mg及び20mgのCOSFを作製し、PION技術を用いて試験した(保存期間無し)。PION技術に使用したパラメーターは上記の表3に示す。よって、各フィルム中の活性剤の溶解は、0.1N HCL、水酸化ナトリウムでpH6.8に調整した第一リン酸カリウムの0.05モル溶液、又は水のいずれかの槽の中で試験する。
図20は、種々の媒体中の5mg、10mg及び20mgのCOSFの活性剤溶解プロファイルを示す。図21は、図20の一次微分曲線である。PION技術の高い識別能をもってしても、選択した媒体は溶解に影響を及ぼさず、種々の媒体中に溶解した同じ強度のサンプルは統計学的に同等である。従来の溶解では、明確な溶解度の問題がなければ、活性剤溶解プロファイルは一般にこの高度な情報を提供しない。
活性剤の放出に対する付加的賦形剤の影響を評価するように実験を計画した。特異度は、医薬品に含まれるいずれの賦形剤によっても活性剤の定量化の干渉が無いことを保証するための方法開発の一側面である。よって、以下のサンプルの活性剤溶解プロファイルをPION技術により測定し、図22に表した:
・5mg COSF完成品(図22では「公称5mg」として示す);
・乾燥前のフィルム組成物の液体混合物;
・プラセボ、すなわち、活性剤以外の全ての賦形剤を含むフィルム;及び
・2倍量の賦形剤を含む5mg COSF完成品(図22では「5mg w/2プラセボ」として示す)。
図22に示されるように、プラセボ、すなわち、活性剤を含まないフィルムは、いくらかの干渉を示す−約20%応答。従って、賦形剤及びフィルム剤形は単独で活性剤溶解プロファイルに影響を及ぼす。図23は、図22の一次微分曲線である。
液体混合物中の活性剤は、水和、膨潤、及びその後の活性剤の放出を必要とするフィルム中の活性剤よりも速く溶解すると想定されていた。しかしながら、意外にも、フィルムは液体混合物よりも速い溶解プロファイルを有していたことが判明した。これらの結果に基づけば、基材に水分を吸収する乾燥フィルムは活性剤の放出及び溶解を促進すると考えられる。
製造中、具体的には、20mgのクロバザムを含有する口腔用フィルムの乾燥段階で使用する基板を変更する実験を行った。特に、1016μm(40ミル)のギャップ、比較評価のための種々の基板を使用し、COSF 20mg製剤を用いてコーティングした。コーティング基板を80℃で15分間乾燥させた。乾燥したコーティング基板を評価し、結果を表12に示す。
乾燥フィルムサンプルは全て、乾燥後に基板から外すことができた。しかしながら、フィルムの端がガラス基板に強く接着すること、及びポリエチレンテレフタレートコロナ処理基板では接着はあまり大きくないことが認められた。最良の性能の基板は、ポリエチレンテレフタレート(無処理)であった。
液体混合物(乾燥前)及び口腔用フィルム(COSF)におけるクロバザムの溶解度を評価するための実験を行った。10mg及び20mgのクロバザムを含有する口腔用薄膜フィルムを作製し、次いで、1.5mlの水に溶解させた。他の2つのサンプルも評価し、1つは水中の活性剤(口腔用フィルム用組成物に賦形剤を加えないもの)であり、もう1つはフィルム形成(すなわち、乾燥)前に試験したフィルム用の液体混合物であった。表13に評価の結果を示す。
上記の表に示されるように、各試験サンプルにおいて約1%〜約2%のクロバザムが溶解したが、98%を超えるものが分散したままであった。湿潤質量サンプル、すなわち、フィルムの液体混合組成物は、その後1.5mlの水で水和されたフィルムのサンプルよりも溶解した活性剤が少なかった。これはこのフィルム形成方法の乾燥工程が製剤中の活性剤の可溶化を高めるためである。溶解度は乾燥工程及びフィルムの大きさ(例えば厚さ)の関数である。例えば、10mgのフィルムは20mgのフィルムよりも溶解パーセントが高いが、これは10mgのフィルムの方が薄く、それにより、乾燥工程中に単位面積当たりの熱曝露が大きいからである。溶解度は又、口腔用フィルムの味覚プロファイルにも比例する。
Claims (45)
- 各単位用量において所望の量の活性剤を送達するための口腔用フィルムであって、
a)水溶性ポリマー基材、水膨潤性ポリマー基材、又は水溶性且つ水膨潤性ポリマー基材;
b)約160ミクロン未満の平均粒径D90を有する活性剤;及び
c)甘味剤、着香剤、調味料、充填剤、可塑剤、色素、顔料、浸透促進剤、緩衝剤、保存剤、二酸化ケイ素、粘着防止剤、及びこれらの任意の組合せからなる群から選択される添加剤
を含み、
前記フィルムを媒体に入れた際に、約3分後に約2%を超える前記活性剤が前記媒体に溶解する、フィルム。 - 前記活性剤が約120ミクロン未満の平均粒径D90を有する、請求項1に記載のフィルム。
- 前記活性剤が約100ミクロン未満の平均粒径D90を有する、請求項2に記載のフィルム。
- 前記活性剤が約30ミクロン未満の平均粒径D50を有する、請求項2に記載のフィルム。
- 前記活性剤が約20ミクロン未満の平均粒径D50を有する、請求項4に記載のフィルム。
- 前記活性剤が約10ミクロン未満の平均粒径D10を有する、請求項2に記載のフィルム。
- 前記活性剤が約5ミクロン未満の平均粒径D10を有する、請求項6に記載のフィルム。
- 前記各単位用量が約0.5mg〜約100mgの前記活性剤を含有する、請求項1に記載のフィルム。
- 前記活性剤がクロバザムである、請求項8に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約3分後に約10%を超える前記活性剤が溶解する、請求項1に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約5分後に約40%を超える前記活性剤が溶解する、請求項1に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約5分後に約50%を超える前記活性剤が溶解する、請求項1に記載のフィルム。
- 各単位用量において所望の量の活性剤を送達するための口腔用フィルムであって、
d)水溶性ポリマー基材、水膨潤性ポリマー基材、又は水溶性且つ水膨潤性ポリマー基材;
e)クロバザムであって、約160ミクロン未満の平均粒径D90を有する活性剤;及び
f)甘味剤、着香剤、調味料、充填剤、可塑剤、色素、顔料、浸透促進剤、緩衝剤、保存剤、二酸化ケイ素、粘着防止剤、及びこれらの任意の組合せからなる群から選択される添加剤
を含み、
前記フィルムを媒体に入れた際に、約3分後に約20%を超える前記活性剤が前記媒体に溶解する、フィルム。 - 前記活性剤が約120ミクロン未満の平均粒径D90を有する、請求項13に記載のフィルム。
- 前記活性剤が約100ミクロン未満の平均粒径D90を有する、請求項14に記載のフィルム。
- 前記活性剤が約30ミクロン未満の平均粒径D50を有する、請求項13に記載のフィルム。
- 前記活性剤が約20ミクロン未満の平均粒径D50を有する、請求項16に記載のフィルム。
- 前記活性剤が約10ミクロン未満の平均粒径D10を有する、請求項14に記載のフィルム。
- 前記活性剤が約5ミクロン未満の平均粒径D10を有する、請求項18に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約3分後に約30%を超える活性剤が溶解する、請求項13に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約5分後に約55%を超える活性剤が溶解する、請求項13に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約1.5分後に約5%を超える活性剤が溶解する、請求項13に記載のフィルム。
- 前記各単位用量が約2mg〜約20mgのクロバザムを含有する、請求項13に記載のフィルム。
- 前記各単位用量が約5mgのクロバザムを含有する、請求項23に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約1分後に約30%を超える活性剤が溶解する、請求項24に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約2分後に約80%を超える活性剤が溶解する、請求項24に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約2.5分後に約95%を超える活性剤が溶解する、請求項24に記載のフィルム。
- 前記各単位用量が約10mgのクロバザムを含有する、請求項23に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約1.5分後に約50%を超える活性剤が溶解する、請求項28に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約2.5分後に約70%を超える活性剤が溶解する、請求項28に記載のフィルム。
- 前記各単位用量が約20mgのクロバザムを含有する、請求項23に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約1.5分後に約2%を超える活性剤が溶解する、請求項31に記載のフィルム。
- 前記フィルムを媒体に入れた際に、約3.5分後に約40%を超える活性剤が溶解する、請求項31に記載のフィルム。
- スクラロース、ステビア、アセスルファムカリウム、サッカリン、フルクトース、アスパルテーム、及びこれらの任意の組合せからなる群から選択される甘味剤を含む、請求項13に記載のフィルム。
- 前記甘味剤が組成物の約0.5〜約5質量%で存在する、請求項34に記載のフィルム。
- 果実香料である着香剤を含む、請求項13に記載のフィルム。
- 前記果実香料がベリー香料である、請求項36に記載のフィルム。
- 前記ベリー香料が約0.1〜約15質量%で存在する、請求項37に記載のフィルム。
- 口腔用フィルムにおいて活性剤の総量の約10質量%未満が溶解する、請求項13に記載のフィルム。
- 試験溶解前に、フィルムが以下の条件:0か月を超えて約36か月まで、約20℃〜約60℃、相対湿度(RH)最大約75%、及びこれらの任意の組合せのうち1以上の下で保存される、請求項1〜39のいずれか一項に記載のフィルム。
- 前記媒体が浸漬状態を提供する任意の溶媒である、請求項1〜40のいずれか一項に記載のフィルム。
- 前記媒体が、希塩酸、1.2〜7.5の生理的pH範囲の緩衝剤、人工胃腸液、水、界面活性剤、及びこれらの任意の組合せからなる群から選択される、請求項41に記載のフィルム。
- 請求項2〜12、39及び40のいずれか1以上を更に含む、請求項1に記載のフィルム。
- 請求項14〜42のいずれか1以上を更に含む、請求項13に記載のフィルム。
- ヒトにおいて癲癇及び/又は発作を処置する方法であって、前記ヒトに請求項1〜44のいずれか一項に記載の口腔用フィルムの各単位用量を投与することを含む、方法。
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WO2020051317A1 (en) | 2020-03-12 |
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CA3110997A1 (en) | 2020-03-12 |
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