JP2022050472A - 活性成分を含むマイクロニードルアレイ - Google Patents
活性成分を含むマイクロニードルアレイ Download PDFInfo
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- JP2022050472A JP2022050472A JP2021210143A JP2021210143A JP2022050472A JP 2022050472 A JP2022050472 A JP 2022050472A JP 2021210143 A JP2021210143 A JP 2021210143A JP 2021210143 A JP2021210143 A JP 2021210143A JP 2022050472 A JP2022050472 A JP 2022050472A
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- microneedle array
- soluble polymer
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- fluid
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0061—Methods for using microneedles
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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Abstract
Description
この出願は、2017年2月17日に出願された米国仮出願第62/460,261号の利益及び優先権を主張し、その全体が参照により本明細書に組み込まれる。
例
いくつかの実施形態では、本明細書の条項のいずれかは、独立条項のいずれか1つ、又は従属条項のいずれか1つに従属してもよい。一態様では、任意の条項(例えば、従属又は独立条項)を他の任意の1つ以上の条項(例えば、従属又は独立条項)と組み合わせてもよい。一態様では、請求項は、節、文、句、又は段落で列挙された単語の一部又はすべて(例えば、工程、操作、手段、又は構成要素)を含んでいてもよい。一態様では、請求項は、1つ以上の節、文、句又は段落で列挙された単語の一部又はすべてを含んでいてもよい。一態様では、各節、文、句、又は段落の一部の単語が削除されてもよい。一態様では、追加の単語又は要素を節、文、句、又は段落に追加してもよい。一態様では、主題技術は、本明細書で説明される構成要素、要素、機能、又は動作の一部を利用することなく実装され得る。一態様では、主題技術は、追加の構成要素、要素、機能、又は操作を利用して実装されてもよい。
Claims (48)
- ベース層、
ベース層から突出する複数のマイクロニードルであって、
各マイクロニードルは、近位部分及び遠位部分を有する細長い本体を含み、近位部分はベース層に取り付けられ、かつ各マイクロニードルは少なくとも1つの溶解性ポリマーを含む、上記マイクロニードル、並びに
細長い本体に組み込まれた活性成分であって、活性成分は、遠位部分にのみ及び少なくとも遠位部分の内部に存在する、上記活性成分
を含む、
上記マイクロニードルアレイ。 - 活性成分が神経毒を含む、請求項1に記載のマイクロニードルアレイ。
- 神経毒がボツリヌス毒素を含む、請求項2に記載のマイクロニードルアレイ。
- ボツリヌス毒素がA、B、C、D又はE型である、請求項3に記載のマイクロニードルアレイ。
- ボツリヌス毒素が、ボツリヌス毒素血清型A(BoNT/A)、ボツリヌス毒素血清型B(BoNT/B)、ボツリヌス毒素血清型C1(BoNT/C1)、ボツリヌス毒素血清型D(BoNT/D)、ボツリヌス毒素血清型E(BoNT/E)、ボツリヌス毒素血清型F(BoNT/F)、ボツリヌス毒素血清型G(BoNT/G)、ボツリヌス毒素血清型H(BoNT/H)、ボツリヌス毒素血清型X(BoNT/X)、モザイクボツリヌス毒素及び/又はその多様体からなる群から選択される、請求項3のマイクロニードルアレイ。
- 各マイクロニードルの少なくとも1つの溶解性ポリマーが第1の溶解性ポリマーを含み、遠位部分及び近位部分が両方とも第1の溶解性ポリマーを含む、請求項1~5のいずれか一項に記載のマイクロニードルアレイ。
- ベース層が第1の溶解性ポリマーを含む、請求項6に記載のマイクロニードルアレイ。
- 遠位部分が第1の溶解性ポリマーを含み、近位部分が第2の溶解性ポリマーを含み、第1の溶解性ポリマーと第2の溶解性ポリマーとが互いに異なる、請求項1~5のいずれか一項に記載のマイクロニードルアレイ。
- ベース層が第2の溶解性ポリマーを含む、請求項8に記載のマイクロニードルアレイ。
- 近位部分及びベース層が、活性成分を欠いている、請求項1~9のいずれかに記載のマイクロニードルアレイ。
- 近位部分及びベース層が、少なくとも1つの溶解性ポリマーからなる、請求項10に記載のマイクロニードルアレイ。
- 各溶解性ポリマーが、約10℃~約50℃の範囲の温度で約6.8~約7.8の範囲のpHを有するリン酸緩衝生理食塩水(PBS)に溶解するポリマー材料から独立して選択される、請求項1~11のいずれか一項に記載のマイクロニードルアレイ。
- 少なくとも1つの溶解性ポリマーが、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸、又はそれらの任意の組み合わせを含む、請求項1~12のいずれか一項に記載のマイクロニードルアレイ。
- 少なくとも1つの溶解性ポリマーが、グリコサミノグリカン、多糖類、コラーゲン、エラスチン、フィブロイン、デンプン、グルコマンナン、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸又はそれらの任意の組み合わせの少なくとも1つを含む、請求項1~13のいずれか一項に記載のマイクロニードルアレイ。
- 活性成分が、遠位部分の少なくとも1つの溶解性ポリマーのマトリックス中に分散している、請求項1~14のいずれか一項に記載のマイクロニードルアレイ。
- 各マイクロニードルが、約25ミクロン~約3000ミクロンの範囲の長さを有する、請求項1~15のいずれか一項に記載のマイクロニードルアレイ。
- 各マイクロニードルが実質的に同じ長さを有する、請求項1~16のいずれか一項に記載のマイクロニードルアレイ。
- 各マイクロニードルが円錐形又はピラミッド形の幾何学形状を有する、請求項1~17のいずれか一項に記載のマイクロニードルアレイ。
- 各マイクロニードルが約1ミクロン~約30ミクロンの範囲の先端幅を有する、請求項1~18のいずれか一項に記載のマイクロニードルアレイ。
- マイクロニードルアレイ内のマイクロニードルの密度が、約5マイクロニードル/cm2~約1000マイクロニードル/cm2の範囲である、請求項1~19のいずれか一項に記載のマイクロニードルアレイ。
- 活性成分が、遠位部分に均一に配置される、請求項1~20のいずれか一項に記載のマイクロニードルアレイ。
- 活性成分が、遠位部分に勾配で存在する、請求項1~21のいずれか一項に記載のマイクロニードルアレイ。
- マイクロニードルアレイを形成する方法であって、
複数の細長いウェルを含むマイクロニードルアレイモールドを提供することであって、細長いウェルのそれぞれは下方部分と上方部分とを含むこと、
細長いウェルのそれぞれの下方部分を、第1の溶解性ポリマー及び活性成分を含む第1の流体で充填することであって、細長いウェルのそれぞれは、部分的にのみ充填され、細長いウェルのそれぞれの上方部分は充填されないままにすること、
細長いウェルのそれぞれの下方部分を充填した後、細長いウェルのそれぞれの未充填の上方部分を第2の流体で過剰充填することであって、第2の流体は第2の溶解性ポリマーを含み、活性成分を欠いていること、及び
モールドを加熱するか、又はモールドにおける第1及び第2の流体を室温で乾燥させて、複数のマイクロニードルが突出したベース層を含むマイクロニードルアレイを形成すること
を含む、上記方法。 - キャスティングプロセスを使用して、第1の流体及び第2の流体のうちの少なくとも1つを細長いウェルのそれぞれに配置する、請求項23に記載の方法。
- 細長いウェルのそれぞれの下方部分を充填することが、細長いウェルのそれぞれの下方部分に第1の流体をキャスティングすることを含む、請求項24に記載の方法。
- 細長いウェルのそれぞれの上方部分を過剰充填することが、細長いウェルのそれぞれの上方部分に第2の流体をキャスティングすることを含む、請求項25に記載の方法。
- 細長いウェルのそれぞれの上方部分を過剰充填することが、第1の流体及び第2の流体を細長いウェルのそれぞれにキャスティングすることを含む、請求項24に記載の方法。
- 第2の流体の少なくとも一部が、モールドの過剰充填された部分又はベース部分に配置され、第2の流体が、マイクロニードルアレイのベース層を画定するモールドの過剰充填部分に配置される、請求項23~27のいずれか一項に記載の方法。
- 方法が、マイクロニードルアレイをマイクロニードルアレイモールドから分離することをさらに含む、請求項23~28のいずれか一項に記載の方法。
- 第1の流体が第2の流体よりも高い粘度を有する、請求項23~29のいずれか一項に記載の方法。
- 第1のキャスティングプロセスを利用して、細長いウェルのそれぞれの未充填の上方部分に第2の流体を過剰充填する前に、マイクロニードルアレイモールドに第1の流体を堆積させる、請求項23~30のいずれか一項に記載の方法。
- 第2のキャスティングプロセスを利用して、マイクロニードルアレイモールドにおける第1の流体上に第2の流体を堆積させる、請求項31に記載の方法。
- 活性成分が神経毒を含む、請求項23~32のいずれか一項に記載の方法。
- 神経毒がボツリヌス毒素を含む、請求項33に記載の方法。
- ボツリヌス毒素がA、B、C、D又はE型である、請求項34に記載の方法。
- 第1の溶解性ポリマー及び第2の溶解性ポリマーが同じである、請求項23~35のいずれか一項に記載の方法。
- 第1の溶解性ポリマー及び第2の溶解性ポリマーが、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸、又はそれらの任意の組み合わせの少なくとも1つを含む、請求項23~36のいずれか一項に記載の方法。
- 第1の溶解性ポリマー及び第2の溶解性ポリマーが、グリコサミノグリカン、多糖類、コラーゲン、エラスチン、フィブロイン、デンプン、グルコマンナン、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸、又はそれらの任意の組み合わせの少なくとも1つを含む、請求項23~37のいずれか一項に記載の方法。
- 被験体を処置する方法であって、
ベース層、
ベース層から突出する複数のマイクロニードルであって、各マイクロニードルは近位部分及び遠位部分を有する細長い本体を含み、近位部分はベース層に取り付けられ、各マイクロニードルは少なくとも1つの溶解性ポリマーを含む、上記マイクロニードル、及び
細長い本体に組み込まれた活性成分であって、遠位部分にのみ及び少なくとも遠位部分の内部に存在する上記活性成分
を含む、マイクロニードルアレイを提供すること、並びに
皮膚表面に複数のマイクロニードルを埋め込むために被験体の皮膚表面にマイクロニードルアレイを適用すること
を含む、上記方法。 - 複数のマイクロニードルが皮膚表面に埋め込まれている間に少なくとも1つの溶解性ポリマーが溶解して、被験体に活性成分を放出する、請求項39に記載の方法。
- 少なくとも1つの溶解性ポリマーが溶解した後、被験体の皮膚表面からベース層を取り除くことをさらに含む、請求項39又は40に記載の方法。
- 活性成分が神経毒を含む、請求項39~41のいずれか一項に記載の方法。
- 神経毒がボツリヌス毒素を含む、請求項42に記載の方法。
- マイクロニードルのそれぞれの少なくとも1つの溶解性ポリマーが第1の溶解性ポリマーを含み、遠位部分及び近位部分の両方が第1の溶解性ポリマーを含む、請求項39~43のいずれか一項に記載の方法。
- ベース層が第1の溶解性ポリマーを含む、請求項44に記載の方法。
- 少なくとも1つの溶解性ポリマーが、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸、又はそれらの任意の組み合わせを含む、請求項39~45のいずれか一項に記載の方法。
- 少なくとも1つの溶解性ポリマーが、グリコサミノグリカン、多糖類、コラーゲン、エラスチン、フィブロイン、デンプン、グルコマンナン、ヒアルロン酸、架橋ヒアルロン酸、疎水性修飾ヒアルロン酸又はそれらの任意の組み合わせの少なくとも1つを含む、請求項39~45のいずれか一項に記載の方法。
- マイクロニードルアレイを使用して、前額のしわ、目じりの小じわ、眉間のしわ、小じわ、多汗症、瘢痕、乾癬、炎症性皮膚病を処置する、請求項39~47のいずれか一項に記載の方法。
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2018
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- 2018-02-16 CA CA3053641A patent/CA3053641A1/en active Pending
- 2018-02-16 JP JP2019544653A patent/JP2020507422A/ja active Pending
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2021
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2023
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US20240050726A1 (en) | 2024-02-15 |
WO2018151832A1 (en) | 2018-08-23 |
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JP2020507422A (ja) | 2020-03-12 |
JP2024023486A (ja) | 2024-02-21 |
CA3053641A1 (en) | 2018-08-23 |
AU2018222745A1 (en) | 2019-08-29 |
KR102401856B1 (ko) | 2022-05-26 |
US11065428B2 (en) | 2021-07-20 |
US20220008702A1 (en) | 2022-01-13 |
AU2018222745B2 (en) | 2021-02-18 |
KR20190112324A (ko) | 2019-10-04 |
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