JP6719471B2 - 粘膜に適用するための医薬投薬形態 - Google Patents
粘膜に適用するための医薬投薬形態 Download PDFInfo
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- JP6719471B2 JP6719471B2 JP2017533916A JP2017533916A JP6719471B2 JP 6719471 B2 JP6719471 B2 JP 6719471B2 JP 2017533916 A JP2017533916 A JP 2017533916A JP 2017533916 A JP2017533916 A JP 2017533916A JP 6719471 B2 JP6719471 B2 JP 6719471B2
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- MYPYJXKWCTUITO-LYRMYLQWSA-N vancomycin Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1OC1=C2C=C3C=C1OC1=CC=C(C=C1Cl)[C@@H](O)[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@H]3C(=O)N[C@H]1C(=O)N[C@H](C(N[C@@H](C3=CC(O)=CC(O)=C3C=3C(O)=CC=C1C=3)C(O)=O)=O)[C@H](O)C1=CC=C(C(=C1)Cl)O2)=O)NC(=O)[C@@H](CC(C)C)NC)[C@H]1C[C@](C)(N)[C@H](O)[C@H](C)O1 MYPYJXKWCTUITO-LYRMYLQWSA-N 0.000 description 1
- MYPYJXKWCTUITO-UHFFFAOYSA-N vancomycin Natural products O1C(C(=C2)Cl)=CC=C2C(O)C(C(NC(C2=CC(O)=CC(O)=C2C=2C(O)=CC=C3C=2)C(O)=O)=O)NC(=O)C3NC(=O)C2NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(CC(C)C)NC)C(O)C(C=C3Cl)=CC=C3OC3=CC2=CC1=C3OC1OC(CO)C(O)C(O)C1OC1CC(C)(N)C(O)C(C)O1 MYPYJXKWCTUITO-UHFFFAOYSA-N 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 210000001835 viscera Anatomy 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
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- 238000004804 winding Methods 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
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- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- QUEDXNHFTDJVIY-UHFFFAOYSA-N γ-tocopherol Chemical class OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1 QUEDXNHFTDJVIY-UHFFFAOYSA-N 0.000 description 1
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Description
これらの研究結果は、異なる薬剤に対する粘膜の透過性は次の順、即ち、腸粘膜<結腸粘膜<頬粘膜−膣粘膜で増加することを示している(非特許文献1〜5)。
本発明に係る医薬投薬形態の好ましい実施形態では、トリガー機構は、放出機構によるシート状製剤の放出を、時間を制御しながらまたは即時作動させるように、そして/またはトリガー機構は、時間を制御しながら、またはトリガー機構の作動直後にシート状製剤を放出するように構成されている。
本発明に係る医薬投薬形態の好ましい実施形態では、特に、頬及び/または食道粘膜へ適用するための投薬形態、投薬形態の形状、または投薬形態の一部、具体的にはシェルは、嚥下可能なものである。
より少ない投与量で同等の効果が可能となること、
少ない投与量により副作用が低減されること、
適用部位と直接接触することによって効き始めが早くなること、である。
本発明に係る単層または多層製剤は、好ましくは、紙のような形態である。
本発明に適したウェーハの形状の製剤を開発及びテストするため、下記のテスト及び選択プロトコル1に基づくテスト方法が行われている。
特に、本発明に係るウェーハは、体液に少々接触しただけでは溶解せず、比較的高い伸長性と耐破壊性を有していることが既知のウェーハで認識されている。
本発明に係る使用に適した、単層製剤、特にウェーハは、特に下記のような処方である。
20% PEG400
5% HPMC
x% 活性医薬成分
100%になるまで脱塩水を加える
B 5% PVA
15% Kollicoat(登録商標)IR
x% 活性医薬成分
100%になるまで脱塩水を加える
または
C 5% PVA
15% Kollicoat(登録商標)IR
8% グリセロール85%
x% 活性医薬成分
100%になるまで脱塩水を加える
本発明に係る二層製剤、特にウェーハは、活性物質を含む粘膜付着性層と、裏打ち層と呼ばれる水不透過性層を含む。活性物質を含む粘膜付着性層は、好ましくは、セルロース誘導体、デンプン及びデンプン誘導体、ポリビニルアルコール、ポリエチレンオキサイド、ポリエチレン、ポリプロピレン、ポリアクリル酸及びポリアクリル酸誘導体、ポリビニルピロリドン、ポビドン、コポビドン、アルギン酸ナトリウム、ゼラチン、キサンタンガム、グアーガム、カラギーナン、ペクチン、デキストラン、レクチン、キトサン、プルラン、及びこれらの混合物、ポリエチレングリコール、グリセロール、ソルビトール、及びそれらの混合物などの可塑剤、及び水、エタノール、メタノール、アセトン、有機溶媒、及びそれらの混合物などの溶媒を含む粘膜付着性高分子化合物であってもよい。さらに、着色剤、香料、香味剤、防腐剤、酸化防止剤、浸透促進剤、可溶化剤、崩壊促進剤、潤滑剤、及びそれらの混合物などの添加剤を含有していてもよい。以下の群の物質、すなわち、骨格や筋肉に作用する薬剤と、神経系に作用する薬剤と、ホルモン系に作用するホルモン及び薬剤と、女性器系に作用する薬剤と、心血管系に作用する薬剤と、呼吸器系に作用する薬剤と、消化管に作用する薬剤と、利尿薬と、知覚器官に作用する薬剤と、皮膚薬と、ビタミンや微量栄養素と、ペプチド系薬剤及びタンパク質、鎮痛剤、抗感染、及び寄生虫駆除剤は、活性医薬成分として適している。
本発明に係る三層製剤、特に、ウェーハは、活性物質を含む粘膜付着性層と裏打ち層と呼ばれる水不透過性層、及び接着保護層を含む。活性物質を含む粘膜付着性層は、セルロース誘導体、デンプン及びデンプン誘導体、ポリビニルアルコール、ポリエチレンオキサイド、ポリエチレン、ポリプロピレン、ポリアクリル酸及びポリアクリル酸誘導体、ポリビニルピロリドン、ポビドン、コポビドン、アルギン酸ナトリウム、ゼラチン、キサンタンガム、グアーガム、カラギーナン、ペクチン、デキストラン、レクチン、キトサン、プルラン、及びこれらの混合物、ポリエチレングリコール、グリセロール、ソルビトール、及びそれらの混合物などの可塑剤、及び水、エタノール、メタノール、アセトン、有機溶媒、及びそれらの混合物などの溶媒、粘膜付着性高分子化合物であってもよい。さらに、着色剤、香料、香味剤、防腐剤、酸化防止剤、浸透促進剤、可溶化剤、崩壊促進剤、潤滑剤、及びそれらの混合物などの添加剤を含有していてもよい。特に、骨格や筋肉に作用する薬剤と、神経系に作用する薬剤と、ホルモン系に作用するホルモン及び薬剤と、女性器系に作用する薬剤と、心血管系に作用する薬剤と、呼吸器系に作用する薬剤と、消化管に作用する薬剤と、利尿薬と、知覚器官に作用する薬剤と、皮膚薬と、ビタミンや微量栄養素と、ペプチド系薬剤及びタンパク質、鎮痛剤、抗感染、及び寄生虫駆除剤を含む群からの物質は、活性医薬成分として適している。裏打ち層は、異なる粘度のエチルセルロースを用いることができる、様々な厚みのエチルセルロース層から形成される。さらに、着色剤、香料、香味剤、防腐剤、酸化防止剤、可溶化剤、細孔形成剤、潤滑剤、及びそれらの混合物などの添加剤を組み込んでもよい。接着性保護層は、厚みが変化してもよく、セルロース誘導体、デンプン及びデンプン誘導体、ポリビニルアルコール、ポリエチレンオキサイド、ポリエチレン、ポリプロピレン、ポリアクリル酸及びポリアクリル酸誘導体、ポリビニルピロリドン、ポビドン、コポビドン、アルギン酸ナトリウム、ゼラチン、キサンタンガム、グアーガム、カラギーナン、ペクチン、デキストラン、レクチン、キトサン、プルラン、及びこれらの混合物などの可塑剤、及び水、エタノール、メタノール、アセトン、有機溶媒、及びそれらの混合物などの溶媒を含む粘膜付着性高分子化合物から形成される。さらに、着色剤、香料、香味剤、防腐剤、酸化防止剤、浸透促進剤、可溶化剤、崩壊促進剤、細孔形成剤、潤滑剤、及びそれらの混合物などの添加剤を含有していてもよい。
ウェーハあたりの活性成分の量の算出について
具体的に、湿潤高分子膜の層厚に基づく活性成分の量は次の式にしたがって計算する。
ここで
m 質量(g)
P 密度(g/cm3)
A 面積(cm2)
h 高さ(μm)
−フルオレセインナトリウムに対しては35%
−キニーネに対しては40%
−ジクロフェナクナトリウムに対しては35%。
単層ウェーハの製造は、溶剤キャスト法によって行われる。まず、すべての成分を溶剤に溶解し、均質化し、その後、適した剥離層上に延ばし、ドクターブレードを使って所望の厚さにする。次に、その結果としてできた膜を決められた条件下で乾燥させ、適当なサイズの切片に切断する。
多層ウェーハの製造に関し、実施例3と実施例4で述べたもののように、まず、個々の層を溶剤キャスト法にて製造する。よって、層の全ての成分が溶剤に溶解され、均質化され、次にドクターブレードを使用して所望の厚さに延ばされる。次いで、個々の層は、延ばして重ねていくか、圧力または「接着」のような様々な方法で互いに接合する。その後、得られた膜を適当な大きさの断片に切断する。
1.まず、活性物質を含む粘膜付着性層用の高分子溶液を、「単層ウェーハAの製造」に従って作製し、アセトン中4%(w/v)のエチルセルロース溶液EC溶液を調製する。その後EC溶液を均一に剥離層上に所望の層厚に噴霧し、室温で15分間乾燥させる。次いで、その上に、高分子溶液を均一にドクターブレードによって延ばし、得られた二層膜は、乾燥キャビネット内で、40℃で6時間乾燥させる。試験及びさらなる使用の前に、膜は適切な大きさの断片に切断され、剥離層から取り外す。二層ウェーハは、剥離層上に格納し、アルミホイルに包む。
1.まず、活性物質を含む粘膜付着性用の高分子溶液を、「単層ウェーハAの製造」に従って作製し、アセトン中4%(w/v)のEC溶液を調製し、0.5%(w/v)HPMC溶液を、冷脱塩水中に調整する。その後EC溶液を剥離層上に所望の層厚に均一に噴霧し、室温で15分間乾燥させる。次いで、その上に、高分子溶液をドクターブレードによって均一に延ばし、得られた二層膜は、乾燥キャビネット内で、40℃で6時間乾燥させる。最後に、HPMC溶液を、ドクターブレードによって第三層としてその上に引延ばし、得られた三層膜を、再び、全ての層がしっかりと相互接続するように乾燥キャビネット中で、40℃で2時間乾燥させる。試験及びさらなる使用の前に、膜は適切な大きさの断片に切断し、剥離層から取り外す。三層ウェーハは、剥離層上に格納し、アルミホイルに包む。
−溶剤キャスティング技術で得られた膜を400mmx4mmの切片に切断する。
−得られたシート状製剤3を折り畳むかまたはロール状にする。
−シェル2であるサイズ1の硬質のゼラチンカプセルを提供する。
−硬質ゼラチンカプセル2の一部、具体的には図示の如く、上側部分を切って開口6を設ける。
−開口6を通してシート状製剤3の一端側を通す。
−カプセル2を閉じる。
2 シェル
3 シート状製剤
3a,3b シート状製剤の領域、特に第1と第2の領域
4 放出機構
5 トリガー機構
6 開口
7 シェルの内部空間
8 所定の破断点
9 層
9a,9b 活性物質含有層
9c,9d 活性物質非含有層
10 ばね要素
11 第1のチューブエレメント
12 さらなるチューブエレメント
13 第1の連結要素
14 さらなる連結要素
15 ウェーハバルーンの中央開口
16 スリット
17 被覆材またはシェル部
18 シーリング
19 ロッド
PM 移動経路
AD 投薬形態の包囲する断面積
AP シート状製剤の放出部の包囲する断面積
Claims (15)
- 粘膜に適用するための医薬投薬形態であって、
活性医薬成分を含む、少なくとも1枚のシート状製剤と、
放出機構と、
トリガー機構とを含み
前記トリガー機構は、口腔、鼻腔、消化管、直腸または膣の所定の作用部位において、前記放出機構による前記シート状製剤を放出するように構成され、
前記医薬投薬形態はさらにシェルを含み、
前記シェルは前記活性医薬成分を含む少なくとも1枚の前記シート状製剤を含み、前記シェルまたは前記トリガー機構は、前記シェルを取り巻く体液がシェルの内部空間と接触できる少なくとも1つの開口を備え、前記開口は、スリットとして形成され、そして/または前記開口は、少なくとも部分的に前記トリガー機構によって覆われているか、
又は
前記シェルは、前記シート状製剤が前記シェルから出ることを可能にするように構成された開口を前記放出機構の一部として備え、
前記シェルは、延伸機構として実現される前記放出機構の起動により延伸される前記シート状製剤を放出するための前記放出機構としてガス生成剤を含み、前記ガス生成剤は、前記シート状製剤を含む前記シェルの部分とは反対側の前記シェルの部分に配置されるか、
又は、
前記シェルは、少なくとも第1の連結部またはレバー要素を有する機械的拡張システムとして延伸機構を含み、そして/または前記シェルと、前記機械的拡張システムは、少なくとも1つのばね要素を含むか、
又は、
前記シェルは、少なくとも第1のチューブエレメントを含み、前記シェルは、少なくともさらなるチューブエレメントを備え、第2のチューブエレメントは前記第1のチューブエレメントより管径が小さく、前記第2のチューブエレメントは、少なくとも部分的に前記第1のチューブエレメント内に配置され、前記シェルは、さらにばね要素を有し、前記ばね要素は、前記ばね要素が少なくとも1つの前記第2のチューブエレメントを前記第1のチューブエレメントに対して長手方向に移動できるように配置されるか、
又は、
前記シェルは、少なくとも連結部またはレバー要素を備え、前記シェルと、前記機械的拡張システムは、少なくともさらなる連結部またはレバー要素を有し、前記第1の連結部またはレバー要素及び/または前記さらなる連結部またはレバー要素は前記シェルの自由端に配置される、
医薬投薬形態。 - 前記粘膜が、頬粘膜、鼻咽頭粘膜、又は消化管粘膜であることを特徴とする、請求項1に記載の医薬投薬形態。
- 前記消化管粘膜が、食道粘膜であることを特徴とする、請求項2に記載の医薬投薬形態。
- 前記粘膜が直腸粘膜であることを特徴とする、請求項1に記載の医薬投薬形態。
- 前記粘膜が膣粘膜であることを特徴とする、請求項1に記載の医薬投薬形態。
- 前記トリガー機構は、前記医薬投薬形態の鍵刺激との接触後に前記シート状製剤を前記放出機構によって放出するように構成されており、そして/または前記トリガー機構は前記シート状製剤を前記放出機構によって時間を制御した状態で、または即時放出するように構成されており、そして/または
前記放出機構は前記シート状製剤を前記トリガー機構の作動後に時間を制御した状態で、または即時、放出するように構成された、請求項1〜5のいずれか1項に記載の医薬投薬形態。 - 前記放出機構は延伸機構であり、前記延伸機構は、機械的拡張システム、ガス起動延伸システム、圧縮発泡、または圧縮組織を含む群から選択され、前記延伸機構の延伸により前記シェルが開口することを特徴とする、請求項1〜6のいずれか1項に記載の医薬投薬形態。
- 前記医薬投薬形態は、折り畳まれた形態の前記シート状製剤を含み、前記延伸機構の前記延伸により前記シート状製剤を展開することを特徴とする、請求項1〜7のいずれか1項に記載の医薬投薬形態。
- 前記シート状製剤は、膨張剤を備え、前記膨張剤は、スポンジであるか、又は膨張材料からなる繊維を含むことを特徴とする、請求項1〜8のいずれか1項に記載の医薬投薬形態。
- 前記第1の連結部またはレバー要素及び/または前記さらなる連結部またはレバー要素は少なくとも部分的に前記トリガー機構によって覆われ、そして/または前記少なくとも1つの第1の連結部またはレバー要素または前記少なくとも1つのさらなる連結部またはレバー要素を、前記シェルを形成するように、前記第1の連結部またはレバー要素が、それぞれの前記さらなる連結部またはレバー要素に隣接して配置されるように配置することを特徴とする、請求項1〜9のいずれか1項に記載の医薬投薬形態。
- 前記シート状製剤は、前記放出機構によって放出された後、比較的大きい表面積を提供し、比較的大きい表面積と接触し、そして/または
前記放出機構は、前記粘膜に沿って移動しながら少なくとも部分的に、前記開口を通って前記シェルを離れた前記シート状製剤を放出するように構成することを特徴とする、請求項1〜10のいずれか1項に記載の医薬投薬形態。 - 前記放出機構は、糸部材を備え、
前記糸部材は、折り畳まれた、圧潰した、ロール状に巻いた、または螺旋状に巻き上げたコンパクトな形態から、広げられ、延ばされ、開けられ、延長され、伸長され、ロール状から広げられ、あるいは長方形態に延伸した形態に、前記放出機構の起動時に延伸可能であり、
シート状製剤を支持して搬送するために、前記糸部材は一部にシート状製剤を含み、又はシート状製剤が前記糸部材の一部を形成し、
又は、
前記放出機構は、前記延伸機構と、伸長機構であり、シート状製剤を外部の動き、力、または圧力を利用することによって広げる、伸長する、巻開する、ロール状から広げる、または解くように構成される、請求項1、又は請求項11に記載の医薬投薬形態。 - 前記トリガー機構は、シート状製剤の一部である、またはシート状製剤に取り付けられた保持装置である、請求項1、請求項11、又は請求項12のいずれか1項に記載の医薬投薬形態。
- 前記保持装置は口腔に固定するように構成されており、そして/または前記医薬投薬形態(1)の投与中に手で把持されることを特徴とする、請求項13に記載の経口投与用の医薬投薬形態。
- 少なくとも前記シート状製剤の放出中に、前記シート状製剤の前記医薬投薬形態から放出された部分、及び前記医薬投薬形態は、互いに対して移動し、よって、前記医薬投薬形態の移動経路(PM)を画定し、前記医薬投薬形態の前記移動経路の方向に見た包囲断面積(AD)は、前記シート状製剤の放出部の包囲断面積(AP)より大きいことを特徴とする、請求項1〜14のいずれか1項に記載の経口投与用の医薬投薬形態。
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IL252893B (en) | 2021-03-25 |
CA2969873A1 (en) | 2016-06-30 |
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AU2015371725A1 (en) | 2017-07-06 |
BR112017013762A2 (pt) | 2018-03-13 |
CA2969873C (en) | 2024-01-16 |
KR102484222B1 (ko) | 2023-01-02 |
KR20170107449A (ko) | 2017-09-25 |
AU2015371725B2 (en) | 2021-02-11 |
US20200397708A1 (en) | 2020-12-24 |
US20180036251A1 (en) | 2018-02-08 |
IL252893A0 (en) | 2017-08-31 |
CN117085002A (zh) | 2023-11-21 |
CN107249575A (zh) | 2017-10-13 |
JP2018501878A (ja) | 2018-01-25 |
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