JP5690860B2 - 胃滞留性経口薬剤送達デバイス - Google Patents
胃滞留性経口薬剤送達デバイス Download PDFInfo
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Description
(i)1つ以上の材料を含む1つ以上の層を薬剤又は薬剤放出製剤と組み合わせて、一体化デバイスを形成する工程、
(ii)前記一体化送達デバイスを折り畳み、折り畳まれた一体化送達デバイスを形成する工程、および
(iii)前記折り畳まれた送達デバイスを少なくとも部分的に封入し、経口送達に適する形態にする工程、
を含む方法を提供する。
(i)1つ以上の材料を含む1つ以上の層を薬剤又は薬剤放出製剤と組み合わせて、前記薬剤又は薬剤放出製剤を含む一体化デバイスを形成するように構成された組み合わせ装置、
(ii)一体化デバイスを折り畳み、折り畳まれた一体化デバイスにするように構成された折り畳み装置、および
(iii)折り畳まれた一体化デバイスを封入容器内に少なくとも部分的に封入し、経口送達に適する形態のデバイスを形成するように構成された封入装置、
を備えるシステムを提供する。
(i)本発明による折り畳み装置に前記単層又は多層のシートを配置する工程、
(ii)プレスの2つの対向する面を一方を他方に対してプレスし、波状起伏がある三次元デバイスを形成する工程であって、波状起伏の形状が前記波形の表面の形状に対応する工程、および
(iii)任意に、工程(ii)で加えられたプレスの方向に垂直な2つの対向する面をプレスする工程、
を含む単層又は多層のシートを折り畳む方法も提供される。
以下の説明および特許請求の範囲で様々な用語が使用されることがあり、このような用語の意味は、本発明に従って解釈されなければならず、以下の通りである:
(a)第2の材料で製造された1つ以上のストリップを含む機能層を挟持するように、第1の材料で製造された2つの外層を組み合わせる工程であって、機能層が1つ以上の薬剤をそれぞれ機能層の1つ以上の区画および/又は層内に、又は1つ以上の区画および/又は層上に含む工程;
(b)一体化デバイスを折り畳み、折り畳まれた一体化デバイスにする工程;および
(c)折り畳まれた一体化デバイスを少なくとも部分的に封入する工程、
を含む。
−前記薬剤又は薬剤放出製剤を1つ以上の層に、又は、1つ以上の層内の1つ以上の区画に埋め込む工程(例えば、単層は、それを形成するポリマー材料の組成が異なる領域を含み、それによって層内に識別可能な領域/区画を形成してもよく、デバイスからの薬剤放出プロファイルが異なるように、これらの区画は薬剤を異なるように担持/放出してもよい);
−少なくとも2つの層内に前記薬剤又は薬剤放出製剤を閉じ込める工程(例えば、層が薬剤を収容するパウチを形成するようにする);
−少なくとも1つのポリマー膜セグメント内に前記薬剤又は薬剤放出製剤を包む工程;
−デバイスの前記1つ以上の層の少なくとも1つに又はその中に、又はキャリヤに前記薬剤又は薬剤放出製剤を付着させる工程であって、キャリヤは、(薬剤を埋め込む、閉じ込める、又は、粒子の外表面に添付させることによって)薬剤を提供する粒状物質(即ち、マトリックス)を含むナノスフェア又はマイクロスフェア、ナノカプセル又はマイクロカプセル、薬剤がコーティングされた又は含浸されたビーズ、顆粒、ペレット、および圧縮された錠剤の形態であってもよい。
(i)以下、即ち:
a)第1の材料、典型的にはポリマー材料で製造された第1の外層;
b)第1の外層上に取り付けられた第2の材料、典型的にはポリマー材料からなるフレーム;
c)フレーム内に収容された薬物放出製剤;および
d)第1の材料で製造され、フレーム上に取り付けられた第2の外層、
を含む積層デバイスを組み合わせる工程、並びに
(ii)積層デバイスを折り畳み、折り畳まれたデバイスにする工程;および
(iii)折り畳まれたデバイスを少なくとも部分的に封入し、経口投与され得る送達デバイス、好ましくは胃滞留性剤型を製造する工程、
を含む方法が提供される。
(i)濡れたときに有効な薬剤を透過させることができる第1のポリマー材料で製造され、外側境界を有する2つの第1の本質的に平面状のポリマーシート部分を調製又は提供する工程、
(ii)外側境界と内側境界を有するフレームを決定する第2のポリマー材料で製造された第2の本質的に平面状のポリマーシート部分を調製又は提供する工程であって、外側境界が第1のポリマーシート部分の外側境界と本質的に同じ形状であり、内側境界が空隙領域を決定する工程;
(iii)水性媒体と接触したとき、第3のシートから放出可能な薬剤又は薬剤放出製剤を含み、薬物を含有し放出するマトリックスを決定する第3のポリマーシートで製造された第3の本質的に平面状のポリマーシート部分を調製又は提供する工程であって、前記マトリクスが空隙領域内に嵌り合う外側境界を有する工程;
(iv)前記第3のシートが空隙領域内に配置され、2つ(第2のシート部分と第3のシート部分)が2つの第1のポリマーシート部分の間に一緒に挟持され、全ての外側境界が本質的に互いに重なり合うように4つの部分を組み合わせ、このようにして積層デバイスを得る工程;
(v)積層デバイスを折り畳んでカプセル内に嵌り合う形態にし、それを、胃液に溶解する材料で製造されたカプセル内に挿入する工程;
を含む方法に関する。
(i)薬剤又は薬剤放出製剤を全体的に平面状のアセンブリ内に組み合わせて、一体化又は積層デバイスを形成する工程であって、全体的に平面状のアセンブリが単一又は複数の層を含んでもよく、且つフレームを含んでも又はフレームからなってもよい工程;
(ii)一体化又は積層デバイスを操作して、コンパクト化された一体化デバイスにする工程であって、コンパクト化された積層剤型の投影表面積は、一体化デバイスの投影表面積より少なくとも5倍小さい工程;および
(iii)コンパクト化されたデバイスを少なくとも部分的に封入し、胃滞留性剤型を製造する工程、
を含む。
折り畳まれたデバイスをカプセルベース(即ち、封入前のカプセルの半分)の中に配置する工程;および
カプセルキャップ(即ち、カプセルの他の半分)をカプセルベースに嵌め合わせ、カプセル化され折り畳まれたた一体化送達デバイス/剤型を形成する工程、
を含む。
(i)1つ以上の材料を含む1つ以上の層を薬剤又は薬剤放出製剤と組み合わせて、一体化デバイスを形成するように構成された組み合わせ装置、
(ii)一体化デバイスを折り畳み、折り畳まれた一体化デバイスにするように構成された折り畳み装置、および
(iii)折り畳まれた一体化デバイスを外被内に少なくとも部分的に封入し、経口送達に適する形態のデバイスを形成するように構成された封入装置、
を備えるシステムを提供する。
(i)第1の材料を含む第1の外層;
(ii)前記第1の外層上に取り付けられ、第2の材料と前記薬剤又は薬剤放出製剤を含む1つ以上の機能層;
(iii)前記第1の材料を含み、前記機能層上に取り付けられた第2の外層;
を含む。
(i)第1の材料の第1の外層;
(ii)第1の遮蔽層上に取り付けられたフレーム;
(iii)フレーム内に収容された薬物放出製剤;および
(iv)フレーム上に取り付けられた第1の材料の第2の層;
を含んでもよい。
−1つ以上の層に埋め込まれている;
−少なくとも2つの層に閉じ込められている;
−少なくとも1つのポリマー膜セグメント内に包まれている;又は
−デバイスの少なくとも1つの層、ナノ粒子又はマイクロ粒子、粉末、液体又は圧縮された固体のいずれか1つに、又はそれらの中に、又は、マトリックスに又はマトリックスの中に付着されている;
および、上記の任意の組み合わせであるとき、
組み合わせ装置は薬剤又は薬剤放出製剤を組み合わせるように構成されている。
(i)一体化された剤型を取り付ける、波形の表面を有する取付治具/曲げベース;および
(ii)波状に起伏する3次元の一体化された剤型を形成するように、一体化された剤型をプレスするための、前記波形の表面に対応する隆起部を有するプレスブロック/上曲げ工具であって、波状起伏が波形の表面の形状に対応するプレスブロック/上曲げ工具、
を備える。
(i)薬剤を全体的に平面状の積層されたアセンブリ内に組み合わせて、積層デバイスを形成するための組み合わせ装置;
(ii)積層デバイスを操作してコンパクト化された積層デバイスにするように構成された操作装置であって、コンパクト化された積層デバイスの投影表面積が積層デバイスの投影表面積より少なくとも5倍小さい、操作装置;および
(iii)コンパクト化された積層デバイスを少なくとも部分的に封入して薬剤送達デバイスを製造するための封入装置;
を備える。
(i)前記シートを折り畳み装置内に配置する工程;および
(ii)第1のプレスの2つの対向する面を一方を他方に対してプレスし、波状起伏がある三次元デバイスを形成する工程であって、波状起伏の形状が前記波形の表面の形状に対応する工程;
を含む単層又は多層のシートを折り畳む方法も提供される。
Claims (20)
- 胃滞留性経口薬剤送達デバイスであって、
前記デバイスは、経口摂取用の折り畳まれた形状から、胃滞留用の展開された形状に展開されるように構成され、
前記デバイスは、機能層を挟持する2つの外層を含み;
前記機能層が、薬剤または薬剤放出製剤を含む少なくとも1つの層を含み;
前記機能層は、前記デバイスに十分に機械的強度を与え、前記デバイスが展開されるときに、胃滞留性を得るように前記展開された形状の保持を可能にし;
少なくとも1つの前記外層は穿孔を有し、
前記折り畳まれた形状において、前記デバイスは、複数の折り目を有するアコーディオン状の形状を有する、
胃滞留性経口薬剤送達デバイス。 - 前記折り畳まれた形状において、前記デバイスは、デバイス軸を有し、前記折り目は、前記デバイス軸から離れるように伸びるときに振幅がだんだん小さくなって、部分的に丸みのある断面を形成する、請求項1に記載の胃滞留性経口薬剤送達デバイス。
- 前記穿孔は、前記外層の両方に形成される、請求項1または2に記載の胃滞留性経口薬剤送達デバイス。
- 前記外層は、腸内で分解可能である、請求項1から3のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記外層及び前記機能層が組み立てられた後に、前記穿孔が作製され、前記デバイスが形成される、請求項1から4のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記穿孔は、前記外層及び前記機能層の組み立ての前に、それぞれの前記外層に作製され、前記デバイスが形成される、請求項1から4のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記穿孔は、複数の穴部(holes)を有する、請求項1から6のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記穿孔は、複数の孔部(pores)を有する、請求項1から7のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記穿孔は、1以上の:所望の寸法;所望の分布パターン;所望の形状;及び所望の穿孔量を有するように形成される、請求項1から8のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記機能層は、前記薬剤または薬剤放出製剤を担持する内部マトリックス、及び前記機械的強度を前記デバイスに与えるフレームを有する、請求項1から9のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 胃内容物内で可溶性のポリマー、及び胃内容物内ですぐには可溶性でないポリマーのうち少なくとも1つを含む、請求項1から10のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物内で可溶性のポリマーは、ヒドロゲル、非ヒドロゲル及びこれらの組み合わせからなる群から選択される、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物内で可溶性のポリマーは、ヒドロゲルであり、前記ヒドロゲルは、タンパク質、多糖類、ゼラチン、ポリデキストロース、ヒドロキシプロピルセルロース、ヒプロメロース、ヒドロキシエチルメチルセルロース、ヒドロキシエチルセルロース、メチルセルロース、ポリエチレンオキシド、ポリビニルアルコール、及びこれらの2以上の組み合わせからなる群から選択される、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物で可溶性のポリマーは、ヒドロゲルであり、前記ヒドロゲルはゼラチンである、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物で可溶性のポリマーは、ヒドロゲルであり、前記ヒドロゲルはヒドロキシプロピルセルロースである、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物で可溶性のポリマーは、ヒドロゲルであり、前記ヒドロゲルはヒプロメロースである、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物ですぐには可溶性でないポリマーは、腸溶性のポリマーまたは非腸溶性のポリマーである、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物ですぐには可溶性でないポリマーは、腸溶性のポリマーであり、前記腸溶性のポリマーは、セラック、セラセフェート、ヒプロメロースフタレート、ヒドロキシプロピルメチルセルロースアセテートサクシネート、ポリビニルアセテートフタレート、アルギン酸、カルボキシメチルセルロース、ポリメタクリレート共重合体、これらの塩、及びこれら2以上の組み合わせからなる群から選択される、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 前記胃内容物ですぐには可溶性でないポリマーは、腸溶性のポリマーであり、前記腸溶性のポリマーはポリメタクリレート共重合体である、請求項11に記載の胃滞留性経口薬剤送達デバイス。
- 可塑剤をさらに含む、請求項1から19のいずれか1項に記載の胃滞留性経口薬剤送達デバイス。
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