JP2017019785A - 微小突起アレイを使用した副甲状腺ホルモンの経皮送達のための方法及びデバイス - Google Patents
微小突起アレイを使用した副甲状腺ホルモンの経皮送達のための方法及びデバイス Download PDFInfo
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Abstract
【解決手段】薬剤送達システムは、それぞれPTHを含む微小突起のアレイを有する。
【選択図】図1
Description
[0001] 本出願は、2010年5月4日に出願され参照により本明細書に組み込まれる米国仮特許出願第61/331,226号に対する優先権を主張する。
[0051] 本明細書で使用する「ある」及び「その」という単数形は、明白に他の記述がない限り複数の指示対象を含むことに留意されたい。したがって、例えば「ポリマー」に言及した場合、それは単一のポリマー、さらに2つ以上の同じポリマー又は異なるポリマーを含み、「賦形剤」に言及した場合、それは単一の賦形剤、さらに2つ以上の同じ賦形剤又は異なる賦形剤を含み、以下同様となる。
[0060] 上述したように、本明細書では、微小突起のアレイを使用して副甲状腺ホルモン(PTH)を経皮投与する方法及び薬剤送達システムが提供される。上記方法及び関連する薬剤送達システムは、特に達成される薬物動態学的プロファイルに関して、特にCmaxへのその急速な立ち上がり及びその後の急速な排出に関して、皮下投与より幾つかの予想外の利点を提供し、したがってパルス状送達プロファイルが可能になる。次に、上記方法、例示的な微小突起アレイ、及び関連する形態を以下でさらに詳細に説明する。
[0061] 本方法で使用する微小突起アレイの一般的形態は、米国特許公開US2008/0269685号に詳細に記載されており、その全内容は参照により本明細書に明示的に組み込むものとし、以下でさらに詳細に説明する。特に図3、図4、図5A、図5B、図5C及び図6を参照されたい。
[0090] 本発明の微小隆起アレイの調製に使用されるPTH含有配合物は、以上で全体的に説明されている。本明細書でドラッグ・イン・チップ又はDIT配合物と呼ぶこともある薬剤含有配合物は、最終的な微小突起アレイ製品に治療有効量を提供するのに十分な量のPTHを含有する。一般的に、PTHの量は投与量単位につき約10〜500μg、又は投与量単位につき約10〜250μg、又は投与量単位につき約10〜100μgの範囲である。
[0095] 1つ又は複数の実施形態では、微小突起アレイが最終的な経皮送達システム又は製品の一部を形成する。製品は通常、本明細書で提供される実施形態のうち任意の1つ又は複数の実施形態による微小隆起アレイ、及びアレイ支持部材(本明細書では微小突起保持部材とも呼ぶ)を有する。アレイ支持部材(又は微小突起保持部材)は通常、微小隆起の反対側の表面で微小隆起アレイの基部に取り付けられるか、又は取り付け可能である。このような例示的微小突起保持部材の1つは、実施例10で説明するようなプランジャーである。
[0102] 本明細書で説明する微小突起アレイを使用して、健康な被験者にhPTH(1−34)を経皮的に投与した。比較対照として、健康な被験者グループへのhPTH(1−34)の皮下投与も実施した。この研究の詳細を実施例11に提供し、その結果のデータを図3〜図8及び表1に提示し、次に説明する。
[0116] 本明細書で説明する方法、キット、微小突起アレイ及び関連するデバイスは、PTHでの治療に対して受容的な任意の症状の治療に使用することができる。例えば、PTHを含有する微小突起アレイを使用して、骨粗鬆症、オステオペニア、歯周病、及び特に歯槽骨の喪失に伴う歯周病の治療にPTHを送達することができる。PTHを含有する微小突起アレイは、骨折の治癒、骨折の治癒速度の改善に、及び危険性がある人の骨折の危険を低減するために使用することも想定される。
アレイ注型の全体的プロセス
[0121] 金型ホルダに清浄な金型を入れる。次に金型をペトリ皿に入れ、少量、例えば200μLの配合物を金型に載せる。本明細書で説明するような例示的配合物を適用する。先端をトリミングした全量ピペットを使用して、配合物を金型上に手作業で広げる。次に、市販の振動機器を使用して配合物に例えば5秒間にわたって渦を発生させる。配合物を含む金型を、1気圧で約1分間、圧力容器に入れる。圧力を解放し、金型を32℃で約1時間、保温器に入れる。次に、例えば両面接着テープを使用してアレイを金型から取り出し、任意選択でバッキング部に取り付ける。
2層アレイを注型する全体的プロセス
[0122] 実施例1の乾燥工程の後、同様の手順を使用して金型上に追加の層を注型する。例示的な組成物、例えばエタノールとイソプロピルアルコールとの3:1の混合物中に20重量%のEudragit(登録商標)EPOを75μL含む組成物を金型に注型する。追加の層は、例えばガラスのスライドを使用して広げることができる。追加の層を含む金型を圧力容器に入れ、1気圧で2分間加圧する。圧力を解放し、さらに5分間、妨害せずに圧力容器内で金型を乾燥させる。再び金型を保温器内で1時間、32℃で乾燥させ、次に金型から取り出す。
2層アレイの注型
[0123] 2層ある微小突起アレイは通常、下記の工程で調製される。
溶媒を注型したhPTH(1−34)を含有する微小突起アレイ
[0126] 微小突起アレイは、上述した一般的手順に従い調製した。下表は、水溶性マトリックス成分と有効作用物質との相対量、さらに結果となる例示的注型溶液の固形物含有率を提供する。
マイクロニードルアレイの「バッキング」又は上層を注型するためのポリマー溶液
[0128] 微小隆起の上部を、又はアレイの基部に近い層を有し、水不溶性ポリマー/hPTH先端層上に配置されたアレイには、異なるポリマー配合物を使用した。バッキング層(この実施形態では、基部に近い微小隆起の上部、及び基部自体を有する)は、1つ又は複数の水不溶性ポリマーを含む。ポリマー溶液は通常、約15〜30重量%のポリマー濃度範囲でポリマーを室温にて溶媒又は溶媒混合物に溶解させることによって調製した。
3層あるマイクロニードルアレイの注型
[0131] 3層あるマイクロニードルアレイは以下のように調製する。
アレイから薬剤物質を徐放するためのアレイの注型
[0135] アレイから薬剤物質を徐放するマイクロニードルアレイは、下記の工程で調製される。
マイクロニードル注型配合物で作成した乾燥膜中のhPTH(1−34)の安定性
[0141] 乾燥形態のhPTH(1−34フラグメント)の安定性を評価するために、マイクロニードルアレイを注型するものと同様のプロセス条件を使用して、マイクロニードル注型配合物の乾燥膜を調製した。約200μLの液体配合物をエッペンドルフ型試験管に入れた。試験管の内壁に配合物を広げて薄膜にし、次に32℃で30分間乾燥してから、真空、室温でさらに一晩乾燥させた。エッペンドルフ型試験管内の乾燥膜を多弁型の袋にパッケージ化し、様々な温度で様々な期間保存した。逆相HPLC(rp−HPLC)とサイズ排除HPLC(sec−HPLC)の両方でhPTH(1−34)の純度を分析した。配合物の詳細が以下の表8−1に示されている。
ヒト副甲状腺ホルモン(hPTH(1−34))を含む2層微小突起アレイの調製
[0145] 以下のような第I相臨床試験に使用するために、治療有効量のhPTH(1−34)(32μg)を含む微小突起アレイを以下のように調製した。
H-Ser-Val-Ser-Glu-Ile-Gln-Leu-Met-His-Asn-Leu-Gly-Lys-His-Leu-Asn-Ser-Met-Glu-Arg-Val-Glu-Trp-Leu-Arg-Lys-Lys-Leu-Gln-Asp-Val-His-Asn-Phe-OH(配列番号:1)
ヒト副甲状腺ホルモン(HPTH(1−34))を含む微小突起アレイを含む送達デバイスの調製
[0151] アプリケータアレイアセンブリとも呼ばれ、実施例9により調製された微小突起アレイ、及び図1〜図2に関して説明したようなアプリケータを備える送達システムは、以下のように組み立てられた。微小突起アレイ(実施例9)がある微小突起保持部材を調製して、パッケージ化し、別個にアプリケータアセンブリ(すなわち、微小突起保持部材がない図1〜図2のようなアプリケータ)をパッケージ化した。患者に使用する前にアプリケータアレイアセンブリを組み立てるために、2つの別個のパッケージを1つの箱入りユニットにして各臨床現場に提供した(臨床データについては以下の実施例11を参照)。
インビボ検査:微小突起アレイデバイスによる健康な被験者へのヒト副甲状腺ホルモンhPTH(1−34)の投与
[0155] 16人の健康な女性ボランティアで、オープンラベルで1回分投与の無作為化シーケンスの3way cross-over studyを実施し、皮下投与した(SC)FORTEO(テリパラチド)20μgに対して、実施例9及び10で説明したTDS(「MicroCor(登録商標)」)を使用して送達した32μgのhPTH(1−34)及び64μgのhPTH(1−34)(32μgのhPTH(1−34)×2)の薬物動態学を(追加の二次終点とともに)明らかにした。実施例9及び10で説明したシステムは、この実施例では一般的に「MicroCor(登録商標)hPTH(1−34)」と、又は簡略化のために本明細書では「MicroCor(登録商標)」と呼ぶ。
Claims (17)
- 1回分投与量のPTHを哺乳類の対象に経皮投与する方法であって、
ほぼ平面の基部から延在する複数の微小隆起を有する微小隆起アレイを対象の皮膚部位に適用する工程であって、各微小隆起は、前記基部から遠い端部及び前記基部に近い上部を含み、少なくとも前記端部は水溶性ポリマーマトリックス中に副甲状腺ホルモン(PTH)を含む工程と、
前記複数の微小隆起の全部又は一部を前記皮膚に挿入する工程と、
前記アレイを前記皮膚部位上に15分以内維持し、それにより前記複数の微小隆起の前記端部の少なくとも一部が前記微小隆起アレイから分離する工程と、
を含み、
それにより約10分以内という最大PTH血漿中濃度(Tmax)の平均時間を達成する、方法。 - 前記PTHは、ヒト副甲状腺ホルモン(1−34)である、請求項1に記載の方法。
- 前記水溶性ポリマーマトリックスは、デキストラン及びソルビトールを含む、請求項1又は2に記載の方法。
- 前記水溶性マトリックスは、ヒスチジン及びヒスチジン塩酸塩をさらに含む、請求項3に記載の方法。
- 前記基部は、水不溶性ポリマーで構成される、請求項1〜4のいずれか1項に記載の方法。
- 各微小隆起の前記上部は、水不溶性ポリマーで構成される、請求項5に記載の方法。
- 前記水不溶性ポリマーは、ポリ(乳酸−コ−グリコール酸)を含む、請求項5又は6に記載の方法。
- 各微小隆起の前記端部及び前記上部は、同じ水溶性ポリマーで構成される、請求項1〜5のいずれか1項に記載の方法。
- 各微小隆起の前記基部及び前記上部は、同じ水溶性ポリマーで構成される、請求項1〜7のいずれか1項に記載の方法。
- PTHの前記投与量の少なくとも約80%は、前記複数の微小隆起の各微小隆起の前記端部にある、請求項8に記載の方法。
- 前記適用する工程と挿入する工程は、腹部の皮膚部位で起こる、請求項1〜10のいずれか1項又は複数項に記載の方法。
- 前記方法は、約45分未満という消失半減期を達成するのに効果的である、請求項1〜11のいずれか1項に記載の方法。
- 前記方法は、皮下注射により送達される同じ投与量又はより低い投与量のPTHで達成される消失半減期より少なくとも約20%短い消失半減期を達成するのに効果的である、請求項1〜11のいずれか1項に記載の方法。
- ほぼ平面の基部から延在する複数の微小隆起で構成された微小隆起アレイであって、各微小隆起は前記基部から遠い端部及び前記基部に近い上部を含み、各微小隆起の前記端部は水溶性ポリマーマトリックス中にPTHを含み、前記アレイは治療有効量のPTHを含む微小隆起アレイを備え、さらに、
前記微小隆起アレイを挿入可能又は取り付け可能であるアプリケータアセンブリを備える、キット。 - 前記微小隆起アレイは、前記アプリケータアセンブリに挿入可能な保持部材に固定される、請求項14に記載のキット。
- 前記保持部材に固定された前記微小隆起アレイは、前記キットの第1のパッケージに含まれ、前記アプリケータアセンブリは、前記キットの第2のパッケージに含まれる、請求項15に記載のキット。
- 前記アプリケータは、前記微小隆起アレイを挿入することができるハウジングと、エネルギー貯蔵要素とをさらに備える、請求項14〜16のいずれか1項に記載のキット。
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JP2016135849A Active JP6279662B2 (ja) | 2010-05-04 | 2016-07-08 | 微小突起アレイを使用した副甲状腺ホルモンの経皮送達のための方法及びデバイス |
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US11213663B2 (en) | 2017-02-27 | 2022-01-04 | Quadmedicine | Microneedle and method of manufacturing the same |
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WO2011140274A3 (en) | 2012-04-05 |
JP6279662B2 (ja) | 2018-02-14 |
AU2011248108B2 (en) | 2016-05-26 |
US9687641B2 (en) | 2017-06-27 |
JP2013527853A (ja) | 2013-07-04 |
EP2566501B1 (en) | 2019-03-13 |
EP2566501A2 (en) | 2013-03-13 |
ES2719595T3 (es) | 2019-07-11 |
AU2011248108A1 (en) | 2012-12-13 |
EP2566501A4 (en) | 2014-04-16 |
US20230027289A1 (en) | 2023-01-26 |
US20200405630A1 (en) | 2020-12-31 |
US20170281535A1 (en) | 2017-10-05 |
JP6327852B2 (ja) | 2018-05-23 |
CA2798145C (en) | 2022-10-18 |
CA2798145A1 (en) | 2011-11-10 |
US11419816B2 (en) | 2022-08-23 |
US20110276028A1 (en) | 2011-11-10 |
WO2011140274A2 (en) | 2011-11-10 |
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