JP4933538B2 - 無線周波識別標識を用いた経口薬服薬履行監視 - Google Patents
無線周波識別標識を用いた経口薬服薬履行監視 Download PDFInfo
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- JP4933538B2 JP4933538B2 JP2008512470A JP2008512470A JP4933538B2 JP 4933538 B2 JP4933538 B2 JP 4933538B2 JP 2008512470 A JP2008512470 A JP 2008512470A JP 2008512470 A JP2008512470 A JP 2008512470A JP 4933538 B2 JP4933538 B2 JP 4933538B2
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Description
本発明は、上述の課題を、少なくとも一部、解決するものである。
より明確には、本発明は、経口ドラッグデリバリーに有用な装置であって、次のものを含む。
(a)胃腸系で分散するように設計されたカプセル、タブレットまたはピル;
(b)カプセル、タブレットまたはピルの中に配置されたRFID標識(ただしRFID標識はアンテナを含む。);
(c)カプセル、タブレットまたはピルが胃腸系で分散する前にRFID標識が問合せを受けた場合は、カプセル、タブレットまたはピルが胃腸系で分散されていないと判定するために、RFID標識の応答が十分に変更されまたは減じられるように、そしてカプセル、タブレットまたはピルが胃腸系において分散した後にRFID標識が問合せを受けた場合は、カプセル、タブレットまたはピルが胃腸系において分散したと判定するためにRFID標識の応答が十分に検出できるように、その物体がRFID標識から分離するように、RFID標識のアンテナ特徴を変更するために、RFID標識のアンテナの中に、その上に、またはそれに隣接して配置された、磁石、強磁性物体、フェライト物体および電磁遮蔽物体からなる群から選ばれる物体。
(a)胃腸系で分散するように設計されたタブレット、ピルまたはカプセル;
(b)タブレット、ピルまたはカプセルの中に位置するRFID標識(ただし、そのRFID標識はスイッチを含み、タブレット、ピルまたはカプセルが胃腸系において分散する前にRFID標識が問合せを受けた場合は、カプセルが胃腸系において分散していないことをRFID標識の応答が示すように、そしてタブレット、ピルまたはカプセルが胃腸系において分散した後にRFID標識が問合せを受けた場合は、タブレット、ピルまたはカプセルが胃腸系において分散したことをRFID標識の応答が示すように、そのスイッチは胃腸系における状態に応じてついたり切れたりする。)
(a)胃腸系において分散するように設計されたカプセル、タブレットまたはピル;
(b)カプセルの中に配置された第一の非耐衝突性RFID標識;
(c)カプセルの中に配置された第二の非耐衝突性RFID標識
を含み、
カプセル、タブレットまたはピルが胃腸系において分散する前にRFID標識がRFID読取り機によって問合せを受けた場合は、RFID標識の応答が衝突するように、そしてカプセルの分散性物質が胃腸系において分散し、それによって第一および第二の非耐衝突性標識が互いから分離するのを可能にした後は、カプセルが胃腸系において分散したと判定するためにRFID標識の応答が互いとは十分に異なるようになっていることを特徴とする装置である。
しかしながら、下部カプセル部分13aが胃または腸管において分散する限り、RFID標識が金箔12aから分離するので、上部カプセル部分が非常に分散しやすいものであることは、図7に示される実施態様においては決定的ではない。図1に示されるように上部カプセル部分11aの内側に金箔12aを配置することが好ましいが、金箔12aは上部カプセル部分11aの外側に配置することもできる。金はRFID標識14aのアンテナ18aを遮蔽するのに好ましい物質であるが、電磁波を遮蔽するのに効果的でありかつ摂取用に承認されているいかなる金属または他の物質(例えば、鉄およびニッケルは、米国食品薬品局(FDA)によって摂取用に安全なものとして一般に認識されるものとして目録に載せられている。)も使用することができる。
(a)胃腸系において分散するように設計された薬のタブレット、ピルまたはカプセル;
(b)タブレット、ピルまたはカプセルの中に配置されたRFID標識(ただし、そのRFID標識はスイッチを含み、タブレット、ピルまたはカプセルが胃腸系において分散する前にRFID標識が問合せを受けた場合は、カプセルが胃腸系において分散していないことをRFID標識の応答が示すように、そしてタブレット、ピルまたはカプセルが胃腸系において分散した後にRFID標識が問合せを受けた場合は、タブレット、ピルまたはカプセルが胃腸系において分散したことをRPBD標識の応答が示すように、そのスイッチは胃腸系における状態に応じてついたり切れたりする。)
RFID標識が能動的RFID標識である場合は、スイッチは、好ましくは、タブレット、ピルまたはカプセルが胃腸系において分散した後にRFID標識を作動させる(用語「問合せを受ける」とは、本発明の全体を通じて、そのような能動的RFID標識からの信号を読み取ることを含む。)。限定するものではないが、その代わりに、スイッチはRFID標識の論理機能を変えるために使用することもできる。
(a)胃腸系において分散するように設計されたカプセル、タブレットまたはピル;
(b)カプセルの中に配置された第一の非耐衝突性RFID標識;
(c)カプセルの中に配置された第二の非耐衝突性RFID標識
を含み、
カプセル、タブレットまたはピルが胃腸系において分散する前にRFID標識がRFID読取り機によって問合せを受ける場合は、RFID標識の応答が衝突するように、そしてカプセルの分散性物質が胃腸系において分散し、それによって第一および第二の非耐衝突性標識が互いから分離することを可能にした後、カプセルが胃腸系において分散したと判定するために、RFID標識の応答が互いとは十分に異なるようになっている。
(実質的に図1に示されるように)一連の6つの独自にコード化されたガラスでカプセル化された動物永久識別RFID標識(ストールティング社、イリノイ州ウッドデール)をフェライト環(ナショナル・マグネティックス・グループ(National Magnetics Group)、ペンシルベニア州ベスレヘム(Bethlehem))で覆い、そして食品用乳糖からなる模擬薬製剤と一緒にゼラチンカプセルの中に入れる。カプセルは各々、携帯用RFID読取り機(Allflex ISO Compatible RF/ID Portable Reader Model No.930002−001)で問合せを受けるが、読取り機は「標識は見つからない」と示す。カプセルを、米国薬局方模擬胃液900mLを含む一連の1リットルビーカーに、摂氏37度で撹拌しながら入れる。カプセルは分散し、各RFID標識から約10センチメートルの距離に保持された読取り機は、次の時刻、すなわち1.50、1.80、1.85、1.87、1.88および1.95分に「標識が見つかった」と応答する。
(3つのフェライト環が使用されること以外は、実質的に図1に示されるように)一連の6つの独自にコード化されたガラスでカプセル化された動物永久識別RFID標識(ストールティング社、イリノイ州ウッドデール)をフェライト環(ナショナル・マグネティックス・グループ、ペンシルベニア州ベスレヘム)で覆い、そして食品用乳糖からなる模擬薬製剤と一緒にゼラチンカプセルの中に入れる。カプセルは各々、携帯用RFID読取り機(Allflex ISO Compatible RF/ID Portable Reader Model No.930002−001)で問合せを受けるが、読取り機は「標識は見つからない」と示す。カプセルを、米国薬局方模擬胃液900mLを含む一連の1リットルビーカーに、摂氏37度で撹拌しながら入れる。カプセルは分散し、各RFID標識から約10センチメートルの距離に保持された読取り機は、次の時刻、すなわち1.58、2.22、2.33、3.25、3.50および7.92分に「標識が見つかった」と応答する。
(実質的に図1に示されるように)一連の独自にコード化されたガラスでカプセル化された動物永久識別RFID標識(ストールティング社、イリノイ州ウッドデール)を一対のフェライト環(ナショナル・マグネティックス・グループ、ペンシルベニア州ベスレヘム)で覆い、そして食品用乳糖からなる模擬薬製剤と一緒にゼラチンカプセルの中に入れる。4匹の健康な大人のビーグル犬に、RFID標識およびフェライト環を含む一つのカプセルを経口的に服用させる。RFID標識から無線信号を読み取るために、受信機(ストールティング社、イリノイ州ウッドデール)を、犬の腹部の皮膚からの約2cm以内に手動で保持する。カプセルが溶解しフェライトスリーブが解放された後にRFID標識が最初に読み取られるまでの時間は、最初の読み取りが成功裡に達成されるまで、1分間隔で測定する。その後の信号は、RFID標識およびフェライト環が胃腸(GI)管を通過し、収集した糞便から回収されるまで、その1、2、4、8および24時間後に読み取る。RFID標識およびフェライト環がGI管を通り抜け、それが糞便のなかに出現するまでの時間も、各収集間隔(例えば0〜24および24〜48時間)において監視される。初期の実験における犬は、服用する前も後も、飼料に自由に接近できる。一晩(約16時間)絶食した、そのすぐ後の実験における犬は、その後、服用してから4時間後に飼料に自由に接近できるようにした。
2つのストールティング社製コンパニオンアニマル永久識別受動的RFID標識(Allflex ISO Compliant FDX−Bトランスポンダー;12mm 移植可能)を、図23に示されるような並列型で一緒に、ゼラチンカプセルの中に配置する。カプセルの残りは薬組成物で充填される。カプセルは、携帯用RFID読取り機(Allflex ISO Compatible RF/ID Portable Reader Model No.930002−001)で問合せを受けるが、読取り機は、0cmの読み取り距離でさえ、「標識は見つからない」と示す。カプセルは、摂氏37度の1リットルビーカー中の米国薬局方模擬胃液900mLの中に、撹拌しながら、入れられる。カプセルは約2分後に分散し、そして1リットルビーカーから約10センチメートルの距離に保持された読取り機は、「標識が見つかった」と応答する。同一の6つの実験が行なわれ、約10cmの読み取り距離で次の時間(分:秒)で読み取りに成功する。1:45、2:02、1:45、2:10、1:45および1:49。
433MHz受動的RFID標識が、実質的に図7に示されるように、薬製剤を含む、金箔で改質されたゼラチンカプセルの中に配置される。カプセルは、携帯用RFID読取り機(Intermec IP3 Intellitag Portabe Reader)で問合せを受けるが、読取り機は「標識は見つからなかった」と示す。カプセルは、摂氏37度の1リットルビーカー中の米国薬局方模擬胃液900mLの中に、撹拌しながら、入れられる。カプセルは約2分後に分散し、そして1リットルビーカーから約10センチメートルの距離に保持された読取り機は、「標識が見つかった」と応答する。
伝導率スイッチを有する433MHz能動的RFID標識が、(RFID標識が電池で電力供給され、アンテナが誘電体中に螺旋状に巻かれている以外は)実質的に図15に示されるように、薬製剤を含む大きなゼラチンカプセルの中に配置される。カプセルは、撹拌しながら、摂氏37度の米国薬局方模擬胃液40リットルを含む50リットルポリエチレンタンクの中央に置かれたプラスチック針金網かごの中に入れられる。受信ダイポールアンテナは、タンクの底に配置される。別の受信ダイポールアンテナは、タンクの外に配置される。ゼラチンカプセルは模擬胃液の中で分散し、伝導率スイッチはRFID標識を作動させ、RFID標識はその後その433MHzの信号を送信する。タンク中のアンテナによって受信された信号強度は約5ナノワットである。タンクに接して保持されたタンクの外のアンテナによって受信された信号強度は、約0.1ナノワットである。タンクから70センチメートル離れて保持されたタンクの外のアンテナによって受信された信号強度は、約0.01ナノワットである。タンクとアンテナとの間に保持された腕は、アンテナによって受信された信号強度をわずかに(2〜3dB)減少させる。
Claims (11)
- 経口ドラッグデリバリーに有用な装置であって、
(a)胃腸系において分散するカプセル、タブレットまたはピル;
(b)カプセル、タブレットまたはピルの中に配置されたRFID標識(そのRFID標識はアンテナを含む。);
(c)磁石、強磁性物体、フェライト物体および電磁遮蔽物体からなる群から選ばれた物体
を含み、
該物体は、RFID標識のアンテナの共鳴振動数を変更しまたはアンテナからの有効な信号強度を減じるために、RFID標識のアンテナの中に、その上に、またはそれに隣接して配置され、
カプセル、タブレットまたはピルが胃腸系において分散する前にRFID標識が問合せを受けた場合は、RFID標識の応答がカプセル、タブレットまたはピルが胃腸系において分散していないと判定するのに十分変更されまたは減じられるように、そしてカプセル、タブレットまたはピルが胃腸系において分散した後にRFID標識が問合せを受けた場合は、RFID標識の応答がカプセル、タブレットまたはピルが胃腸系において分散したと判定するのに十分検出できるように該物体がRFID標識から分離するように、該物体が配置されていることを特徴とする装置。 - 要素(c)の物体は胃腸系において分解することを特徴とする請求項1に記載の装置。
- 要素(c)の物体は胃腸系においてRFID標識から分離することを特徴とする請求項1に記載の装置。
- RFID標識が能動的RFID標識および受動的RFID標識からなる群から選ばれることを特徴とする請求項1に記載の装置。
- タブレット、ピルまたはカプセルの中に配置された薬製剤をさらに含むことを特徴とする請求項4に記載の装置。
- 経口ドラッグデリバリーに有用な装置であって、
(a)胃腸系において分散するように設計されたタブレット、ピルまたはカプセル;
(b)タブレット、ピルまたはカプセルの中に配置されたRFID標識
を含み、
RFID標識はスイッチを含み、
タブレット、ピルまたはカプセルが胃腸系において分散する前にRFID標識が問合せを受けた場合は、タブレット、ピルまたはカプセルが胃腸系において分散していないことをRFID標識の応答が示すように、そしてタブレット、ピルまたはカプセルが胃腸系において分散した後にRFID標識が問合せを受けた場合は、タブレット、ピルまたはカプセルが胃腸系において分散したことをRFID標識の応答が示すように、RFID標識が胃の酸性の状態、胃腸系の電解質溶液、または胃腸系における温度の変化に曝露されたときにスイッチが作動しまたは切れることを特徴とする装置。 - RFID標識が能動的RFID標識および受動的RFID標識からなる群から選ばれることを特徴とする請求項6に記載の装置。
- タブレット、ピルまたはカプセルの中に配置された薬製剤をさらに含むことを特徴とする請求項7に記載の装置。
- 経口ドラッグデリバリーに有用な装置であって、
(a)胃腸系において分散するように設計されたカプセル、タブレットまたはピル;
(b)カプセル、タブレットまたはピルの中に配置された第一の非耐衝突性RFID標識;
(c)カプセル、タブレットまたはピルの中に配置された第二の非耐衝突性RFID標識
を含み、
カプセル、タブレットまたはピルが胃腸系において分散する前にRFID標識がRFID読取り機によって問合せを受けた場合は、RFID標識の応答が衝突するように、そしてカプセル、タブレットまたはピルの分散性物質が胃腸系において分散し、それによって第一および第二の非耐衝突性標識が互いから分離することを可能にした後は、カプセル、タブレットまたはピルが胃腸系において分散したと判定するために、RFID標識の応答が衝突しないようになっていることを特徴とする装置。 - RFID標識が能動的RFID標識および受動的RFID標識からなる群から選ばれることを特徴とする請求項9に記載の装置。
- タブレット、ピルまたはカプセルの中に配置された薬製剤をさらに含むことを特徴とする請求項10に記載の装置。
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EP1885343A2 (en) | 2008-02-13 |
CN101217945A (zh) | 2008-07-09 |
TW200706180A (en) | 2007-02-16 |
EP1885343B1 (en) | 2011-10-05 |
WO2006127355A2 (en) | 2006-11-30 |
DK1885343T3 (da) | 2012-01-16 |
CN101217945B (zh) | 2012-07-11 |
ATE526952T1 (de) | 2011-10-15 |
CA2609007A1 (en) | 2006-11-30 |
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