JP2017500990A - 口を介する連続的薬物送達のためのデバイスおよび方法 - Google Patents
口を介する連続的薬物送達のためのデバイスおよび方法 Download PDFInfo
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- JP2017500990A JP2017500990A JP2016552470A JP2016552470A JP2017500990A JP 2017500990 A JP2017500990 A JP 2017500990A JP 2016552470 A JP2016552470 A JP 2016552470A JP 2016552470 A JP2016552470 A JP 2016552470A JP 2017500990 A JP2017500990 A JP 2017500990A
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- levodopa
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Abstract
Description
本発明は、固体形態における薬物または薬物が溶解もしくは懸濁された流体を継続的に投与するために、口の中に係留される薬物送達デバイスを特徴とする。
本発明は、経口経路指定を介した連続または半連続薬物投与のためのデバイスおよび方法に関する。本発明の目的は、薬物の短生理学半減期(例えば、8時間、6時間、4時間、2時間、1時間、30分、20分、または10分より短い)および/または現在1日あたり複数回投薬されている薬物の狭治療濃度域を伴う、薬物に関連するいくつかの問題を解決することである。すなわち、1日あたり数回または夜間に投薬されなければならない薬物を服用することは、不便であって、薬物の薬物動態および有効性は、準最適であり得、かつ副作用が、頻度および/または重症度において増加し得る。連続または半連続投与は、特に、レボドパ(LD)、抗癲癇薬(例えば、オキスカルバゼピン、トピラマート、ラモトリジン、ガバペンチン、カルバマゼピン、バルプロ酸、レベチラセタム、プレガバリン)、および睡眠薬(例えば、ザレプロン)等の短半減期および/または狭治療濃度域を伴う薬物に有益である。口内における連続または半連続注入は、器官または流体、例えば、血液または血漿中の薬物の濃度により少ない変動をもたらすことができる。薬物の便宜的な自動投与はまた、特に、薬剤を夜間に服用しなければならない患者および認知症を伴う患者にとって、その薬物投薬計画への患者コンプライアンスを増加させることができる。
(略語および定義)
(薬剤および疾患)
本発明のデバイスおよび方法を用いて治療され得る、例示的疾患/病状と、対応する薬物ならびに1日用量および平均投与率の例示的範囲は、以下に列挙される。
不整脈:キニジン(300〜2,000mg/日、12.5〜83mg/時間)
糖尿病:経口インスリン
(薬物送達デバイス)
(ポンプ)
(周囲圧力および吸引から影響を受けないポンプ設計)
(周囲温度から影響を受けないポンプ設計および方法)
(ポンプ自動停止/始動安全特徴)
(濃縮された薬物製剤)
(レボドパ製剤)
(レボドパプロドラッグ製剤)
(ヒドラジン形成を最小限にするレボドパ/カルビドパ製剤)
(ポンプ駆動懸濁液分離)
本発明は、以下の懸濁液流増進要素のうちの1つまたはそれを上回るものの使用による、口腔内薬物送達デバイス内のポンプ駆動懸濁液分離の減少または排除を含む。
(経口液不浸透性薬物リザーバ)
(使用方法および疾患治療方法)
(PDの治療)
1.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 経口液不浸透性薬物リザーバであって、その体積は、0.1mL〜5mLである、薬物リザーバと、
を備える、デバイス。
6.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 経口液不浸透性薬物リザーバであって、その体積は、0.1mL〜5mLである、薬物リザーバと、
を備える、デバイス。
11.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 経口液不浸透性薬物リザーバであって、その体積は、0.1mL〜5mLである、薬物リザーバと、
を備える、デバイス。
20.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 経口液不浸透性薬物リザーバであって、その体積は、0.1mL〜5mLである、薬物リザーバと、
を備える、デバイス。
23.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 圧力不変機械ポンプと、
を備える、デバイス。
29.患者の口内に着脱可能に挿入され、薬物を含む医薬品組成物の連続または半連続口腔内投与のために構成される、薬物送達デバイスであって、
(i) 該薬物送達デバイスを該患者の口の表面に着脱可能に固着するための締結具と、
(ii) 機械ポンプと、
を備える、デバイス。
194.該方法は、約0.25mL/時間〜約0.5mL/時間の範囲内の率における経口投与を含む、項目191または192に記載の方法。
195.該方法は、約0.5mL/時間〜約0.75mL/時間の範囲内の率における経口投与を含む、項目191または192に記載の方法。
196.該方法は、約0.75mL/時間〜約1.0mL/時間の範囲内の率における経口投与を含む、項目191または192に記載の方法。
213.患者におけるパーキンソン病を治療するための方法であって、
(a)項目1−122のいずれか一項に記載の薬物送達デバイスを該患者の口の中に挿入するステップであって、該デバイスは、レボドパまたはレボドパプロドラッグ薬物リザーバを含む、ステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿中LD濃度が、該投与中の少なくとも8時間の周期の間、継続的に維持されるように、少なくとも8時間の周期の間、10〜125mg/時間の範囲内の毎時率において、該患者の口の中に該レボドパまたはレボドパプロドラッグを投与するステップと、
を含む、方法。
214.患者におけるパーキンソン病を治療するための方法であって、
(a)項目126−144のいずれか一項に記載の医薬品組成物を含む、薬物送達デバイスを該患者の口の中に挿入するステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿中LD濃度が、該投与中の少なくとも8時間の周期の間、継続的に維持されるように、少なくとも8時間の周期の間、10〜125mg/時間の範囲内の毎時率において、該患者の口の中に該レボドパまたはレボドパプロドラッグを投与するステップと、
を含む、方法。
(実施例)
めのう乳鉢および乳棒を使用して摩砕された0.256gCD(OChemカタログ番号821C497、ロット番号90630A1)および0.988gLD(JSTARからのAjinomoto Lot R059K008)に、次いで、1.25g水が添加され、再び、10分間、めのう乳鉢内で摩砕された。白色懸濁液が、産生され、流体は、ガラスピペット(約1mmID先端および使い捨てゴム吸引器)を用いてピペット操作のために十分であった。1.8gをバイアルに移送し、沈降を観察した。4時間後、事実上粒子がないが、若干のみ、光散乱する、水層が、認められ、沈降を示した。
0.267g CD(OChemカタログ番号821C497、ロット番号90630A1)および1.000g LD(JSTARからのAjinomoto Lot R059K008)が、めのう乳鉢内に置かれ、乳棒を使用して摩砕され、次いで、1.25gプロピレングリコール>99.5%(Sigma Aldrich W294004−1kg−K Lot MKBP3539V)が、添加された。これらは、10分間、乳棒を使用して、めのう乳鉢内で摩砕された。白色懸濁液が、産生され、実施例17の水性懸濁液より粘性であったが、依然として、ガラスピペット(約1mmID先端および使い捨てゴム吸引器)を用いた低速ピペット操作のために十分な流体であった。懸濁液は、実施例17の水性懸濁液より均質に見える。移送された1.5gをバイアルに移送し、沈降を観察した。4時間後、容易に可視である沈降の指標はなく、懸濁液は、均一のままであるように見えた。
LDEE溶液の味は、最初は、若干甘くかつ苦みがあるが、対象を悩ませるものではなかった。
シネメット(R)25/100におけるものに類似する組成物の、それぞれ20mgLDおよび5mgCDを含有する、64個の錠剤が、16覚醒時間の間、15分毎に、錠剤を1日1.28gLDを要求するPD患者の口内に投与するために、Ca2+架橋結合アルギン酸塩の33cm長および0.5cm幅リボン(錠剤間に0.5cm中心間距離を伴う)に糊着されることができる。
LDおよびCD粒子を含有するシートが、巻装され、リボンが崩壊し、そのLDおよびCD粒子を放出するであろう口の中に継続的に給送されるであろうようなリボンに注型およびスライスされ得る。注型された混合物は、アルギン酸カルシウムと混合された、平均および中央径1μm〜20μmのLDおよびCD粒子を含有するであろう。随意に、注型されたシートはまた、Ca2+濃度が低い唾液による湿潤に応じて、アルギン酸塩の架橋結合Ca2+イオンが、Na+交換され、ポリマーが、膨隆し、ヒドロゲルを形成し、そこで、酸および炭酸塩の反応が、CO2を産生し、崩壊を加速させるガスを発生させるであろうように、アルギン酸カルシウム封入クエン酸粒子およびアルギン酸カルシウム封入重炭酸ナトリウム粒子を含有し得る。
ほぼニュートン性の懸濁液は、流体の粘度が剪断によって実質的に影響されない、薬物粒子の流体懸濁液である。LDおよびCDの水性ニュートン性懸濁液が、薬物粉末と、水、ナトリウムカルボキシメチルセルロース(NaCMC)等の低分子量親水性ポリマー懸濁剤、およびポリソルベート80(P80)等の界面活性剤を組み合わせることによって、生成されることができる。広範囲の成分濃度が、使用され得るが、一実施例は、約50%LD、約12.5%CD、約2%NaCMC、および約0.2%P80を含有し得る。製剤中で使用され得る、他の親水性ポリマーとして、ヒドロキシプロピルセルロース(HPC)、ヒドロキシプロピルメチルセルロース(HPMC)、ヒドロキシエチルセルロース(HEC)、ポリビニルピロリドン(PVP)、ポリビニルアルコール(PVA)、およびセルロース、澱粉、他の炭水化物、キチン等の他の中性、負電荷、または正電荷誘導体、ならびに短鎖アルコール、カルボキシ酸、アミン、または他の化合物の中性または荷電ポリマーが挙げられる。製剤中で使用され得る他の界面活性剤として、種々のポリソルベート、ラウリル硫酸ナトリウムおよび他の荷電脂肪酸誘導体、脂肪酸、ブロックコポリマー等が挙げられる。懸濁液は、他の賦形剤を含み、流動能力、香味、および外観を向上させてもよい。
ずり減粘懸濁液は、流体の粘度が剪断力の増加に伴って減少する、薬物粒子の流体懸濁液である。そのような懸濁液は、典型的には、ゼラチン、カルボマー、およびセクション2.1に列挙されるポリマーの高分子量の変種等の比較的に高分子量の親水性ポリマーとともに製剤化される。水性ずり減粘懸濁液の実施例は、約30%LD、7.5%CD、0.5%カーボポール934P、および0.2%ポリソルベート80を含有し得る。
いくつかの超高濃度懸濁液は、粒子間の潤滑性液体からの圧搾に起因する剪断の増加に伴って、濃密化される。そのような懸濁液は、デバイスが外れ、患者がそれを咬合しようとする場合等、あまりに多くの剪断力がそこに印加される場合、懸濁液の流動が中断されるであろうという点において、潜在的に有利であり得る。そのような製剤の実施例は、水中の濃密懸濁液として、約60%LD、15%CD、および0.2%ポリソルベート80を含有するものであり得る。
ポリエチレングリコール(PEG)は、種々の平均分子量範囲において利用可能であって、約1000を下回る分子量を伴うものは、室温で液体である。液体PEG懸濁液の実施例は、PEG−300中に懸濁された約40%LDおよび10%CDであろう。PEG−400およびPEG−600等の他の容易に利用可能なPEGグレードもまた、使用され得る。
懸濁液が、約50gのプロピレングリコールを約40gのLD粉末および約10gのCD粉末に添加することによって、調製され得る。成分は、濃密懸濁液を形成するために、へらまたは他の混合器具を使用して混成される。
懸濁液が、60gのグリセリンを32gのLD粉末および8gのCD粉末に添加することによって、調製され得る。成分は、濃密懸濁液を形成するために、へらまたは他の混合器具を使用して混成される。
低親水性/親油性平衡(HLB)界面活性剤の有無にかかわらず、大豆油、ごま油、オリーブ油、コーン油、中鎖トリグリセリド(MCT)油等の種々の液体トリグリセリドが、LDおよびCD粉末の懸濁液を形成するために使用されることができる。例えば、懸濁液は、49.5gのMCT油および0.5gのソルビタンモノオレエートを組み合わせ、混合し、均一に分散させることによって、調製され得る。液体は、次いで、40gのLD粉末および10gのCD粉末に添加され、撹拌器具または高剪断ミキサを使用して混成され、均一懸濁液を形成し得る。
低粘度グレードの鉱油等の非消化性油もまた、セクション3.4に説明されるものと同様に、懸濁流体として使用され得る。非消化性とは、そのような油が毒性であることを暗示するものではない。すなわち、消化性ではなく、食料として吸収されるにすぎない。例えば、鉱油は、便秘薬として、はるかに高用量で使用される。
水性ナノ懸濁液は、32%LD、8%CD、およびポリソルベート80等の約2%の界面活性剤を含有し得る。ナノ懸濁液は、原料を組み合わせ、懸濁液を形成し、次いで、マイクロフルイダイザー、媒体粉砕機、または他の高エネルギー粒子サイズ減少デバイスを通して懸濁液を通過させることによって、調製されるであろう。種々の他の界面活性剤も、潜在的に、他のポリソルベート、ソルビタンエステル、ポリエチレングリコール脂肪酸エステル、他のエーテル、または親水性ポリマー、レシチン等を伴うアルカンおよびアルケンのエステルを含む、製剤中で使用され得る。
非水性ナノ懸濁液は、低HLB界面活性剤の有無にかかわらず、最大32%LDおよび最大8%CDと、低粘度トリグリセリド油を組み合わせることによって、調製され得る。結果として生じる懸濁液は、次いで、マイクロフルイダイザー、媒体粉砕機、または薬物粒子のサイズをサブミクロン範囲に減少させるための他のデバイスを通して通過させることによって処理されるであろう。
カカオバターは、ココア豆から抽出される食用油である。油は、室温で固体であるが、体温で液体となるような約34℃〜36.5℃の典型的溶融範囲を有する。懸濁液は、40gのLDおよび10gのCD中に約50gのカカオバターを約40℃で溶融させ、次いで、撹拌させることによって、調製されることができる。懸濁液は、次いで、デバイスまたは容器の中に入れられることができ、冷却に応じて、固化するであろう。
懸濁液は、40gのLDおよび10gのCD中に約40℃でバター(冷蔵されているとき、固体のままであって、約32℃〜約35℃で溶融する、油中水乳剤)を溶融させ、次いで、撹拌することによって、調製されることができる。懸濁液は、次いで、薬物リザーバの中に置かれることができ、冷蔵庫内に入れることによって、固化するであろう。
成分脂肪酸鎖の鎖長および飽和度の2つの要因が、トリグリセリド油の溶融範囲に影響を及ぼす。ココナッツおよびパーム油等の飽和中鎖長油ならびに飽和および不飽和脂肪酸鎖の混合物を含有する長鎖長油は、室温または若干それを下回って固体であるが、体温では液体であることができる。トリステアリン等の飽和油もまた、標的溶融範囲を得るために、異なる比率において、オリーブ油または大豆油等の不飽和油と組み合わせられることができる。カカオバターと同様に、そのような低溶融範囲油または油の混合物は、貯蔵の間は固体であるが、いったん患者の口の中に挿入されると、流体になる、LDおよびCDの懸濁液を製剤化するために使用されることができる。
鉱油およびパラフィンワックスは、正しい比率で組み合わせられ、室温で固体または半固体であるが、体温では液体である、材料を形成することができる。そのような混合物は、感温懸濁液の基礎としての役割を果たし得る。ワセリンは、室温で半固体であるが、約体温で溶融する、高および低溶融炭化水素の周知の混合物である。非消化性とは、そのような油が毒性であることを暗示するものではない。すなわち、消化性ではなく、食料として吸収されるにすぎない。
PEGの溶融範囲は、分子量の増加に伴って増加する。PEG−600は、20°〜25℃の溶融範囲を有する一方、PEG−1000は、35°〜40℃の溶融範囲を有する。2つを組み合わせことは、室温〜体温の間の溶融範囲を伴う材料をもたらすことができる。
標準的懸濁液製剤の代替は、製剤化される薬物物質が、本質的に、1度に1つ放出される、小ビーズの中にパッケージ化される、微粒子状製剤である。ビーズは、次いで、本質的に、デバイス内およびそこからのその移動を促進するための潤滑剤として作用するであろう、非溶媒液体中に製剤化され得る。
噴霧乾燥は、比較的に均一形状および直径の粒子を生成するために使用されることができる、別の技法である。APIおよび賦形剤の懸濁液は、高圧で、噴霧ノズルを通して、加熱された空気流動が液滴を粒子に急速に乾燥させる、チャンバの中に押進される。
ワースターコーティングは、粒子上に均一コーティングを形成するために使用される、底部噴霧流動床コーティング方法論である。医薬品ワースターコーティング用途では、糖類球体等のシード粒子から開始し、コーティングをそれに塗布することが典型的である。シード粒子を利用する必要性は、本方法論を使用して得られ得る薬物装填量を限定する。
造粒は、液体の添加の有無にかかわらず、粉末が圧密化され、硬質集合体を形成するプロセスである。集合体は、次いで、種々のプロセスによってミル粉砕され、潜在的に、より均一サイズのより小さい集合体を形成することができる。
微粒子を生成するために使用される方法論にかかわらず、デバイスからの薬物粒子の放出は、植物油または鉱油等の非溶媒流体中の懸濁液として製剤化することによって補助され得る。プロピレングリコール、低分子量PEG、およびグリセロール等の極性溶媒もまた、これらの流体の中への粒子の溶解が著しく生じない場合、本目的のために使用され得る。
LD/CDは、粘性水性懸濁液として製剤化されることができる。懸濁液は、約0.6gLD/mL、0.15gCD/mL、および0.34gスクロース/mLを含有することができる。懸濁液は、二峰性粒子サイズ分布を伴うLDおよび/またはCDを含有することができ、より大きいものは、約5μmおよび1μmにおいてピークに達し、より大きい薬物粒子の重量は、より小さいものの重量の1.5倍を超える。粘度は、200ポアズを上回ることができる。懸濁液は、随意に、潤滑剤を含有してもよい。
LD/CDは、固体丸剤として製剤化される。合計48個の丸剤が、合計約0.75gLD、0.19gCD、および0.19gの分散剤を含有するように調製される。各丸剤は、実質的に球状かつ平滑であって、重量23.4mg、体積約0.016mL、および直径約0.31cmを伴う。丸剤は、ダイ内における圧縮によって作製され、経口崩壊する。丸剤は、図20Aおよび20Bのデバイスの上行渦巻内に置かれ、単一列の丸剤を形成し、その縁は、実質的に間隙を伴わずに、相互に接触し得る。チャネル内の丸剤を囲繞する容積は、食用植物油で充填される。丸剤および油は、流動に対するその抵抗が丸剤および油のものを約10倍上回る、エラストマープランジャによって、推進剤から分離される。0.25mLの冷蔵された液体推進剤1,1,1,2テトラフルオロエタンが、中心シリンダの中に置かれ、デバイスは、シールされる。
(他の実施形態)
より特定すれば、本願明細書は、以下の項目に関する構成を記載する。
(項目1)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 自動停止/始動装置と、
を備える、デバイス。
(項目2)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 吸引誘発流制限器と、
を備える、デバイス。
(項目3)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 温度誘発流制限器と、
を備える、デバイス。
(項目4)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 耐咬合構造支持体と、
を備える、デバイス。
(項目5)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 圧力不変機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
を備える、デバイス。
(項目6)
薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 上記薬物送達デバイスを上記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
を備える、デバイス。
(項目7)
上記薬物送達デバイスは、37℃および13psiaの一定圧力において、約4時間〜約168時間の期間にわたって、約0.015mL/時間〜約1.25mL/時間の平均体積流量を送達するように構成され、上記平均率は、4時間またはそれを上回る期間にわたって、±20%または±10%/時間未満だけ変動する、項目1〜6のいずれか一項に記載のデバイス。
(項目8)
上記ポンプは、ばね駆動ポンプまたは推進剤駆動ポンプである、項目1〜7のいずれか一項に記載のデバイス。
(項目9)
上記薬物リザーバは、レボドパまたはレボドパプロドラッグの懸濁液と、懸濁液流増進要素とを備える、項目1−8のいずれか一項に記載の薬物送達デバイス。
(項目10)
上記薬物リザーバは、4cm、3cm、2cm、1cm、0.5cm、または0.2cm未満の長さの管、チャネル、またはオリフィスと流体連通し、上記医薬品組成物の剪断粘度は、約50、500、5,000、または50,000cPを上回り、上記デバイスは、上記管、チャネル、またはオリフィスを介して、上記薬物を投与するように構成される、項目1−9のいずれか一項に記載のデバイス。
(項目11)
上記薬物リザーバは、レボドパまたはレボドパプロドラッグを固体薬物として含む、項目1−10のいずれか一項に記載のデバイス。
(項目12)
上記薬物リザーバは、非水性液体中に懸濁されたレボドパまたはレボドパプロドラッグを含む、項目1−10のいずれか一項に記載のデバイス。
(項目13)
連続または頻回断続口腔内送達に好適なレボドパまたはレボドパプロドラッグを含有する懸濁液を含む、医薬品組成物であって、上記懸濁液は、37℃で上記レボドパまたはレボドパプロドラッグの固体粒子を含み、上記レボドパまたはレボドパプロドラッグの濃度は、約2Mを上回り、粘度は、約100ポアズを上回り、上記懸濁液は、6ヶ月またはそれを上回る間、沈殿した固体レボドパまたはレボドパプロドラッグがないままである、医薬品組成物。
(項目14)
上記懸濁液は、非水性分散媒、油、または食用油を含む、項目13に記載の医薬品組成物。
(項目15)
500mgを上回るレボドパ/mLまたは500mgを上回るレボドパおよびカルビドパ/mLの油中懸濁液を含む、連続または半連続口腔内投与のための医薬品組成物。
(項目16)
上記懸濁液は、感温懸濁液を含む、項目13〜15のいずれか一項に記載の医薬品組成物。
(項目17)
上記懸濁液は、約25℃で少なくとも6ヶ月間貯蔵されるとき、上記懸濁流体中に実質的に均一な固体薬物濃度を維持する、項目13〜16のいずれか一項に記載の医薬品組成物。
(項目18)
上記医薬品組成物は、50ポアズ〜500ポアズの剪断粘度を有する、項目17に記載の医薬品組成物。
(項目19)
上記懸濁液は、(i)約25℃で少なくとも6ヶ月間貯蔵されるとき、上記懸濁流体中に非均一固体薬物濃度を維持し、続いて、(ii)上記医薬品組成物が、約60秒の期間の間、手で振盪されると、実質的に均一な固体薬物濃度が、達成される、項目13〜16のいずれか一項に記載の医薬品組成物。
(項目20)
上記医薬品組成物は、0.1ポアズ〜50ポアズの粘度を有する、項目19に記載の医薬品組成物。
(項目21)
上記デバイスは、項目13〜20のいずれか一項に記載の医薬品組成物を含む、項目1〜12のいずれか一項に記載のデバイス。
(項目22)
患者におけるパーキンソン病を治療するための方法であって、約4時間〜約168時間の期間の間、10〜125mgのレボドパまたはレボドパプロドラッグ/時間の率における、上記患者の中への項目13〜20のいずれか一項に記載の医薬品組成物の連続または半連続投与を含み、上記レボドパまたはレボドパプロドラッグは、上記送達期間の間、30分毎に少なくとも1回、上記患者に投与される、方法。
(項目23)
患者におけるパーキンソン病を治療するための方法であって、
(a)項目1〜12または21のいずれか一項に記載の薬物送達デバイスを上記患者の口の中に挿入するステップであって、上記デバイスは、レボドパまたはレボドパプロドラッグを含む薬物リザーバを有する、ステップと、
(b)少なくとも4時間の送達期間の間、10〜125mg/時間の範囲内の平均毎時流量において、上記患者の口の中に上記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)ステップ(b)に続いて、上記薬物送達デバイスを上記患者の口から除去するステップと、
を含む、方法。
(項目24)
患者におけるパーキンソン病を治療するための方法であって、
(a)項目1〜12または21のいずれか一項に記載の薬物送達デバイスを上記患者の口の中に挿入するステップと、
(b)少なくとも4時間の送達期間の間、10〜125mg/時間の範囲内の平均毎時流量において、上記患者の口の中に上記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)ステップ(b)に続いて、上記薬物送達デバイスを上記患者の口から除去するステップと、
を含む、方法。
(項目25)
患者におけるパーキンソン病を治療するための方法であって、
(a)項目1〜12または21のいずれか一項に記載の薬物送達デバイスを上記患者の口の中に挿入するステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿LD濃度が、上記投与の間で少なくとも8時間の期間の間、継続的に維持されるように、少なくとも8時間の期間の間、10〜125mg/時間の範囲内の毎時流量において、上記患者の口の中に上記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)上記薬物送達デバイスを上記口から除去するステップと、
を含む、方法。
(項目26)
患者におけるパーキンソン病を治療するための方法であって、
(a)項目13〜20のいずれか一項に記載の医薬品組成物を含有する薬物送達デバイスを上記患者の口の中に挿入するステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿LD濃度が、上記投与の間で少なくとも8時間の期間の間、継続的に維持されるように、少なくとも8時間の周期の間、10〜125mg/時間の範囲内の毎時流量において、上記患者の口の中に上記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)上記薬物送達デバイスを上記口から除去するステップと、
を含む、方法。
(項目27)
上記血漿中のレボドパの変動指数は、上記送達周期の間、1.0、0.75、0.50、0.25、または0.15未満またはそれに等しい、項目22〜26のいずれか一項に記載の方法。
(項目28)
50mg/mL〜500mg/mLの濃度において、流体中にカルビドパの懸濁液を含み、ヒドラジンの濃度は、3ヶ月の期間の間、25℃で貯蔵後、1ppm未満である、安定した不溶融性医薬品組成物。
Claims (28)
- 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 自動停止/始動装置と、
を備える、デバイス。 - 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 吸引誘発流制限器と、
を備える、デバイス。 - 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 温度誘発流制限器と、
を備える、デバイス。 - 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 電気または機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
(iv) 耐咬合構造支持体と、
を備える、デバイス。 - 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 圧力不変機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
を備える、デバイス。 - 薬物を含む医薬品組成物の連続または半連続口腔内投与のために、患者の口内に着脱可能に挿入されるように構成される、薬物送達デバイスであって、
(i) 前記薬物送達デバイスを前記患者の口の表面に着脱可能に固着するための締結具と、
(ii) 機械ポンプと、
(iii) 0.1mL〜5mLの容積を有し、レボドパまたはレボドパプロドラッグを懸濁液として、または固体として含む医薬品組成物を含む、経口液不浸透性薬物リザーバと、
を備える、デバイス。 - 前記薬物送達デバイスは、37℃および13psiaの一定圧力において、約4時間〜約168時間の期間にわたって、約0.015mL/時間〜約1.25mL/時間の平均体積流量を送達するように構成され、前記平均率は、4時間またはそれを上回る期間にわたって、±20%または±10%/時間未満だけ変動する、請求項1〜6のいずれか一項に記載のデバイス。
- 前記ポンプは、ばね駆動ポンプまたは推進剤駆動ポンプである、請求項1〜7のいずれか一項に記載のデバイス。
- 前記薬物リザーバは、レボドパまたはレボドパプロドラッグの懸濁液と、懸濁液流増進要素とを備える、請求項1−8のいずれか一項に記載の薬物送達デバイス。
- 前記薬物リザーバは、4cm、3cm、2cm、1cm、0.5cm、または0.2cm未満の長さの管、チャネル、またはオリフィスと流体連通し、前記医薬品組成物の剪断粘度は、約50、500、5,000、または50,000cPを上回り、前記デバイスは、前記管、チャネル、またはオリフィスを介して、前記薬物を投与するように構成される、請求項1−9のいずれか一項に記載のデバイス。
- 前記薬物リザーバは、レボドパまたはレボドパプロドラッグを固体薬物として含む、請求項1−10のいずれか一項に記載のデバイス。
- 前記薬物リザーバは、非水性液体中に懸濁されたレボドパまたはレボドパプロドラッグを含む、請求項1−10のいずれか一項に記載のデバイス。
- 連続または頻回断続口腔内送達に好適なレボドパまたはレボドパプロドラッグを含有する懸濁液を含む、医薬品組成物であって、前記懸濁液は、37℃で前記レボドパまたはレボドパプロドラッグの固体粒子を含み、前記レボドパまたはレボドパプロドラッグの濃度は、約2Mを上回り、粘度は、約100ポアズを上回り、前記懸濁液は、6ヶ月またはそれを上回る間、沈殿した固体レボドパまたはレボドパプロドラッグがないままである、医薬品組成物。
- 前記懸濁液は、非水性分散媒、油、または食用油を含む、請求項13に記載の医薬品組成物。
- 500mgを上回るレボドパ/mLまたは500mgを上回るレボドパおよびカルビドパ/mLの油中懸濁液を含む、連続または半連続口腔内投与のための医薬品組成物。
- 前記懸濁液は、感温懸濁液を含む、請求項13〜15のいずれか一項に記載の医薬品組成物。
- 前記懸濁液は、約25℃で少なくとも6ヶ月間貯蔵されるとき、前記懸濁流体中に実質的に均一な固体薬物濃度を維持する、請求項13〜16のいずれか一項に記載の医薬品組成物。
- 前記医薬品組成物は、50ポアズ〜500ポアズの剪断粘度を有する、請求項17に記載の医薬品組成物。
- 前記懸濁液は、(i)約25℃で少なくとも6ヶ月間貯蔵されるとき、前記懸濁流体中に非均一固体薬物濃度を維持し、続いて、(ii)前記医薬品組成物が、約60秒の期間の間、手で振盪されると、実質的に均一な固体薬物濃度が、達成される、請求項13〜16のいずれか一項に記載の医薬品組成物。
- 前記医薬品組成物は、0.1ポアズ〜50ポアズの粘度を有する、請求項19に記載の医薬品組成物。
- 前記デバイスは、請求項13〜20のいずれか一項に記載の医薬品組成物を含む、請求項1〜12のいずれか一項に記載のデバイス。
- 患者におけるパーキンソン病を治療するための方法であって、約4時間〜約168時間の期間の間、10〜125mgのレボドパまたはレボドパプロドラッグ/時間の率における、前記患者の中への請求項13〜20のいずれか一項に記載の医薬品組成物の連続または半連続投与を含み、前記レボドパまたはレボドパプロドラッグは、前記送達期間の間、30分毎に少なくとも1回、前記患者に投与される、方法。
- 患者におけるパーキンソン病を治療するための方法であって、
(a)請求項1〜12または21のいずれか一項に記載の薬物送達デバイスを前記患者の口の中に挿入するステップであって、前記デバイスは、レボドパまたはレボドパプロドラッグを含む薬物リザーバを有する、ステップと、
(b)少なくとも4時間の送達期間の間、10〜125mg/時間の範囲内の平均毎時流量において、前記患者の口の中に前記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)ステップ(b)に続いて、前記薬物送達デバイスを前記患者の口から除去するステップと、
を含む、方法。 - 患者におけるパーキンソン病を治療するための方法であって、
(a)請求項1〜12または21のいずれか一項に記載の薬物送達デバイスを前記患者の口の中に挿入するステップと、
(b)少なくとも4時間の送達期間の間、10〜125mg/時間の範囲内の平均毎時流量において、前記患者の口の中に前記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)ステップ(b)に続いて、前記薬物送達デバイスを前記患者の口から除去するステップと、
を含む、方法。 - 患者におけるパーキンソン病を治療するための方法であって、
(a)請求項1〜12または21のいずれか一項に記載の薬物送達デバイスを前記患者の口の中に挿入するステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿LD濃度が、前記投与の間で少なくとも8時間の期間の間、継続的に維持されるように、少なくとも8時間の期間の間、10〜125mg/時間の範囲内の毎時流量において、前記患者の口の中に前記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)前記薬物送達デバイスを前記口から除去するステップと、
を含む、方法。 - 患者におけるパーキンソン病を治療するための方法であって、
(a)請求項13〜20のいずれか一項に記載の医薬品組成物を含有する薬物送達デバイスを前記患者の口の中に挿入するステップと、
(b)1,200ng/mLを上回り、かつ2,500ng/mL未満の循環血漿LD濃度が、前記投与の間で少なくとも8時間の期間の間、継続的に維持されるように、少なくとも8時間の周期の間、10〜125mg/時間の範囲内の毎時流量において、前記患者の口の中に前記レボドパまたはレボドパプロドラッグを投与するステップと、
(c)前記薬物送達デバイスを前記口から除去するステップと、
を含む、方法。 - 前記血漿中のレボドパの変動指数は、前記送達周期の間、1.0、0.75、0.50、0.25、または0.15未満またはそれに等しい、請求項22〜26のいずれか一項に記載の方法。
- 50mg/mL〜500mg/mLの濃度において、流体中にカルビドパの懸濁液を含み、ヒドラジンの濃度は、3ヶ月の期間の間、25℃で貯蔵後、1ppm未満である、安定した不溶融性医薬品組成物。
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JP2021511117A (ja) * | 2018-01-09 | 2021-05-06 | イー2バイオ ライフ サイエンシーズ、エルエルシー | 口腔粘膜炎及び他の口腔病態に対する局所的処置を向上させるための方法及び装置 |
US11585042B2 (en) | 2020-09-30 | 2023-02-21 | Haier Us Appliance Solutions, Inc. | Dryer appliance with additive dispenser |
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JP2022130379A (ja) | 2022-09-06 |
JP6807371B2 (ja) | 2021-01-06 |
CN113384373B (zh) | 2022-10-21 |
CA2929410A1 (en) | 2015-05-14 |
KR102457026B1 (ko) | 2022-10-21 |
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JP6538063B2 (ja) | 2019-07-03 |
AU2014346855A1 (en) | 2016-05-19 |
BR112016009874A2 (pt) | 2017-08-01 |
EP3065808B1 (en) | 2023-08-30 |
JP2019063574A (ja) | 2019-04-25 |
JP7137234B2 (ja) | 2022-09-14 |
KR20160084422A (ko) | 2016-07-13 |
CN105873631A (zh) | 2016-08-17 |
WO2015069773A1 (en) | 2015-05-14 |
EP3065808C0 (en) | 2023-08-30 |
CN113384373A (zh) | 2021-09-14 |
AU2014346855A2 (en) | 2016-06-23 |
ES2957768T3 (es) | 2024-01-25 |
EP3065808A1 (en) | 2016-09-14 |
AU2014346855B2 (en) | 2019-07-18 |
WO2015069773A8 (en) | 2016-05-26 |
IL245347A0 (en) | 2016-06-30 |
JP2020203914A (ja) | 2020-12-24 |
CA2929410C (en) | 2021-11-09 |
EP3065808A4 (en) | 2017-08-16 |
US20160278899A1 (en) | 2016-09-29 |
US20210267739A1 (en) | 2021-09-02 |
CN105873631B (zh) | 2021-06-18 |
BR112016009874B1 (pt) | 2022-10-11 |
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