JP6948994B2 - 個別化された医薬品の生産のためのシステムおよび方法 - Google Patents
個別化された医薬品の生産のためのシステムおよび方法 Download PDFInfo
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Description
例:心筋梗塞後の個別化されたポリピルの利用
2. アスピリン、ベーター−ブロッカー、スタチン、ACE阻害薬(終生の治療)。
● 個別の遺伝子型に基づいた医薬物質の最適選択−−より良好な治療、より少ない有害な医薬物質の作用
● 1つの錠剤が5つの異なる医薬物質を伴う−−薬物療法に対するより良好な固守。
クロピドグレルは、抗血小板物質医薬物質である。主としてこれは、経皮的冠動脈インターベンションの後にステント血栓症のディセーブルのために使用される。これは、プロドラッグの形式であり、したがって、それが働くためにはCYP2C19によって活性化される必要がある。CYP2C19の代謝活性が非常に高い者(UM)は、通常のクロピドグレル用量を服用した場合に出血のリスクがより高くなるため、それらの者については半分の用量が適切である。それとは逆に、代謝活性欠損者(PM)および中間的な代謝活性を有する者(IM)は、クロピドグレルを活性化する能力があまりない障害性の酵素を有している。それらの者のステント血栓症のリスクはより高い。それらの者は、CYP2C19によって代謝されない代替医薬物質(たとえば、プラスグレル)を服用する必要がある。
いくつかのベーター−ブロッカー、特にメトプロロールおよびカルベジロールに対する反応は、CYP2D6酵素によって影響を受ける。CYP2D6の代謝活性欠損者は、心筋梗塞の引き金となり得る徐脈の可能性を増加させる。CYP2D6のPMには、CYP2D6酵素に依存しないベーター−ブロッカーまたはアテノロールを、より低い用量で使用する必要がある(PMID 18784654)。
スタチンの主な有害作用はミオパシーである。アトルバスタチンおよび、特にシンバスタチンは、SLCO1B1遺伝子内における遺伝子多型によって影響を受ける。2%の者はマイナー・ホモ接合体であり、一般的なホモ接合体と比較して17倍高いミオパシーの可能性を有し、一方、ヘテロ接合体は、4乃至5倍高いミオパシーの可能性を有する。より高い可能性を伴う患者は、ほかのスタチン(ロスバスタチン、フルバスタチン)を服用すれば、これらのリスクを最小化することができる。
3つのSNPが、ペリンドプリル反応に影響を与えることが研究によって示された。25%の者が、3またはそれより多くの変異体アレルを保有しており、ペリンドプリルを用いた治療の恩典が得られない。それらの者がほかの医薬物質を服用すれば、心臓脈管系疾患を防止するより高い恩典を有し得る可能性がある。発明者らの経済的分析から、クロピドグレル治療に先行する遺伝子型決定がコスト効果的であることが明らかにされた。ほかの医薬物質および治療の選択に影響を及ぼす追加のSNPのための遺伝子型決定のコストは、実質的により高いものとはならず、むしろ患者および健康管理負担者のための恩典が実質的により高いものとなる。
100 システム
102 コンピュータ
104 プロセッサ
106 コンピュータ可読メモリ、データベース、メモリ
108 データベース
110 患者情報
112 外部の測定デバイス
114 参照情報
118 データベース
120 表示器
130 電子医療記録(EMR)
140 医薬物質生産デバイス
150 データベース
210 入力ブロック
220 ブロック
230 出力ブロック
300 組み合わせ医薬物質、デバイス、医薬物質生産デバイス、医薬物質組み合わせデバイス
302 コントローラ
310 カートリッジ
310a 医薬物質カートリッジ、第1の医薬物質
310b 医薬物質カートリッジ、第2の医薬物質
310c 医薬物質カートリッジ、第3の医薬物質
312 ディスペンサ
314 バルブ
320 コンベア
330 医薬物質キャリア、キャリア、カプセル
340 キャリア・シーラ
350 検証段
360 スキャナ
400 カプセル
410 半分のカプセルのシェル
430 第2の半分のカプセルのシェル
500 医薬物質生産デバイス
510a 医薬物質カートリッジ
510b 医薬物質カートリッジ
510c 医薬物質カートリッジ
512a 計量分配チャンネル
512b 計量分配チャンネル
512c 計量分配チャンネル
514a バルブ
514b バルブ
514c バルブ
520 チャンネル
530 医薬物質キャリア
620a カプラ
620b カプラ
620c カプラ
630a マシン可読表示
630b マシン可読表示
630c マシン可読表示
710a 医薬物質
710b 医薬物質
710c 医薬物質
730 棒状食品
735 キャップ
737 シール
745 ボトル
800 システム
810 粉体医薬物質、粉体医薬物質の供給源
820 エーロゾル作成要素
840 医薬物質生産デバイス
850 表面荷電ステーション
860 放出デバイス
870 パッケージング材料
890 電荷キャリア表面
890a あらかじめ決定済みのエリア、荷電された表面
900 パッチ
904 コンピュータ
930 医薬物質、医薬品
Claims (12)
- 個別の患者についての個別化された医薬品を生産するためのシステムであって、
患者情報を種々の医薬物質の最適投薬量と関係付ける複数のカテゴリの情報をストアするべく構成されたデータベースと、
前記患者情報を受け取り、前記受け取った患者情報を前記データベース内にストアされている前記情報と比較して前記患者のための最適な医薬物質の選択、組み合わせ、および投薬量を予測すべく構成されたコンピュータ・プロセッサと、
前記プロセッサと通信し、前記予測された最適な医薬物質の選択、組み合わせ、および投薬量に基づいて医薬品を生産する医薬物質生産デバイスとを包含し、前記医薬物質生産デバイスが、
それぞれがマイクロタブレットの形態でバルク量の医薬物質を保持すべく構成されている複数の医薬物質容器であって、各マイクロタブレットは等しいサイズに設定された用量の特定の医薬物資を含み、異なる医薬物質が相互作用を伴うことなく近接させることを可能にするべく形成されている複数の医薬物質容器と、
複数の医薬物質ディスペンサであって、それぞれが前記医薬物質容器のうちの1つと結合されている複数の医薬物質ディスペンサと、
ハーフカプセルシェルに摂取可能な第1及び第2の空の形態の複数の摂取医薬物質容器と、
選択された医薬物質ディスペンサによってマイクロタブレットが第1の摂取可能なオープンカプセルハーフシェルにロードされるときに、選択された医薬物質ディスペンサを通過するマイクロタブレットの数を光学式粒子カウンタにより数えることによって、医薬物質の計量分配をコントロールするように構成されたコントローラと、
前記第2の摂取可能なハーフシェルのアプリケーションにより、決定された量の選択された医薬物質を前記第1の摂取可能なオープンカプセルハーフシェルに分配した後、前記第1の摂取可能なオープンカプセルハーフシェルを閉じるためのカプセルクローザーと、
前記計量分配された医薬物質の構成を検証する検証ユニットと、を包含し、前記患者のために個別化された単一摂取パッケージ内の最適投薬量で2種類以上の医薬物質を有する組み合わせ医薬品が、選択され計量分配された医薬物質から生産され、
前記患者情報は、体重;年齢;性別;BSA(体表面積);肥満指数;除脂肪体重、体脂肪率、代謝;腎臓機能;肝臓酵素;プロテオミクス/バイオマーカー、血液化学、薬物動態;疾病に関するリスク・ファクタ;現在の薬剤;そのほかの薬剤/栄養補助食品;1つまたは複数の薬剤に対する以前の副作用の履歴;部分的または完全なゲノムSNPスクリーニング・データ;薬理ゲノミクスおよび/または遺伝薬理学プロファイルの分析;医薬物質‐医薬物質相互作用の情報;医薬物質‐食餌相互作用の情報;全体または部分的ゲノム解析;ビタミン欠乏症;ビタミンおよび微量栄養素レベル;食餌;薬物アレルギおよび/または過敏性;環境性、トキシン、またはそのほかのアレルギ履歴;前記患者の医療履歴;診断情報;エクササイズ活動;睡眠活動;組織発現プロファイリング;ホルモン・サイクル、バイオマーカー情報;放射線学的/撮影情報、人口統計学情報;患者の医療履歴;診断情報;エクササイズ活動;月毎生殖周期;睡眠活動;組織発現プロファイリング、ジオロケーション、ソシアル・ネットワーク、消費者情報、習慣、生理学的データ、脳電図(EEG)記録、挙動履歴、地理上の履歴、放射能に対する曝露を含めたトキシンおよびそのほかの環境要因に対する曝露または潜在的曝露、服薬遵守の履歴および身体測定デバイスからのパーソナリティ・テストからなるグループのうちの少なくとも1つから選択される情報を含み、それにおいて前記バイオマーカー情報は、好ましくは、前記患者の血液、尿、汗、唾液、身体組織、バイオプシー、または体液からなるグループのうちの少なくとも1つから獲得される情報を含み、
それにおいて個別の患者についての個別化された、単一摂取カプセル内の組み合わせ医薬品が、前記計量分配された医薬物質から生産されることを特徴とする、システム。 - 前記プロセッサが、さらに参照情報を受け取り、前記患者のための最適な医薬物質の選択、組み合わせ、および投薬量を、前記受け取った患者情報および参照情報に基づいて予測する特徴とする請求項1に記載のシステム。
- 外部測定デバイスを包含し、前記外部測定デバイスが、患者情報の少なくとも1つの要素を測定し、かつ前記測定した患者情報の要素を前記プロセッサに送信するべく構成される特徴とする請求項1に記載のシステム。
- 予測された最適な医薬物質の選択、組み合わせ、および投薬量が表示器に出力される特徴とする請求項1に記載のシステム。
- 前記プロセッサが、前記医薬物質生産デバイス内に収容される特徴とする請求項1に記載のシステム。
- 前記予測された最適な医薬物質の選択、組み合わせ、および投薬量が、前記患者の電子医療記録に送信される特徴とする請求項1に記載のシステム。
- 前記予測された最適な医薬物質の選択、組み合わせ、および投薬量が、薬局に送信される特徴とする請求項1に記載のシステム。
- 前記プロセッサが、前記医薬物質生産デバイスと、無線ネットワークを介して通信するべく構成される特徴とする請求項1に記載のシステム。
- 前記プロセッサが、さらに患者フィードバック情報を受け取り、前記患者のための最適な医薬物質の選択、組み合わせ、および投薬量を、前記受け取った患者情報および前記受け取った患者フィードバック情報に基づいて予測する特徴とする請求項1に記載のシステム。
- 前記医薬物質ディスペンサのそれぞれが、互いに結合される特徴とする請求項1に記載のシステム。
- さらに、連続する医薬物質ディスペンサに対して医薬物質キャリアを移動するためのコンベアを包含し、それにおいて各医薬物質ディスペンサから前記医薬物質キャリア上に各医薬物質の決定済みの量が計量分配される特徴とする請求項1に記載のシステム。
- さらに、前記医薬物質容器上に提供される識別表示をスキャンするためのスキャナを包含する特徴とする請求項1に記載のシステム。
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US20220258935A1 (en) | 2022-08-18 |
WO2012021899A3 (en) | 2012-05-10 |
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