JP4865330B2 - 経口ドラッグデリバリーシステム - Google Patents
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Description
本発明は製剤を含んでなる剤形に関するものであって、その製剤は薬物、HVLCM、網目形成成分を含んでなり、さらにレオロジー調整剤を含んでいてもよい。製剤はまた、溶媒を包含することもできる。別の態様において、本発明は、薬物を有する製剤を含んでなる経口投与剤形に関するが、ここでこの製剤は、水性環境に曝露されたとき製剤内部に網目構造を形成し、外面を形成する。本発明の製剤は、望ましい薬物放出動態および/または濫用抑止特性を示す。
明細書を通じて使用される略号は次の通りである:
HVLCM:高粘性液体担体材料
SAIB:イソ酪酸酢酸スクロース
EL:乳酸エチル
IM(またはIPM):ミリスチン酸イソプロピル
CAB:酢酸酪酸セルロース
OC(またはOXY):オキシコドンの遊離塩基または塩
化合物の誘導体とは、その構造が元の化合物の構造に基づいている分子を指す。誘導体は置換された置換基を有する、または付加された追加の基を有する、または除去された基を有することができるが、実質的には元の化合物と同じ基本構造を共有する。化合物の誘導体には、たとえば、当該化合物の遊離塩基、塩、および水和物がある。
本明細書に記載の実施例は、例証にすぎず、決して本発明の範囲を限定するものではない。
・溶媒、たとえば、乳酸エチル(EL)もしくはトリアセチン、DMSO、炭酸プロピレン、NMP、エチルアルコール、ベンジルアルコール、グリコフロール、α-トコフェロール、Miglyol 810、イソプロピルアルコール、フタル酸ジエチル、PEG 400、クエン酸トリエチル、安息香酸ベンジル。
本発明の具体例となる製剤を調製する方法は、HVLCMとしてSAIBを使用して提示される。他のSAIB製剤は、この方法を変更することによって調製することができる。比率は、それぞれ、SAIB/乳酸エチル/ミリスチン酸イソプロピル/CAB 381-20の重量パーセント比を表す。
表1は、さまざまな製剤に関する粘性および溶解データを示す。粘性値は、26℃および37℃にて(+/−0.1から0.3℃)、Brookfield Digital Rheometer Models LV DV IIIおよびHBDVおよびCPE 52コーン(およそn=1)を用いて測定した。オキシコドンの含量は、SAIB製剤においてジェルキャップあたり9から12 mgまでとした(ロット#X03502はSAIBおよびオキシコドンのみを含有する)。
累計の薬物溶解を、EL, IPMおよびCAB 381-20BPの重量パーセントの関数として測定した。対応するin vitro溶解データを有する8個のSAIB-オキシコドン製剤を示した。非GLPおよびGLPのイヌの薬物動態(PK)研究に製剤を使用した。ロットX03511からX03518(n = 8)。
(a) 37℃にて水に浸漬する前のCAB 381-20BP含有SAIBプラセボ溶液(n = 13)について:
Z = 3359.02 - 192.26 x1 - 227.88 x2 + 1240.29 x3 : : r2 = 0.93(式4)
もう一つの相関
Ln Z = 8.47 - 0.1x1 - 0.137x2 + 0.585x3 : : r2 = 0.96(式5)
(b) 37℃にて5時間水に浸漬した後のCAB 381-20BP含有SAIBプラセボ溶液(n = 13)について:
Ln Z1 = 3.8 + 0.056x1 - 0.00911x2 + 1.02x3 : : r2 = 0.96(式6)
もう一つの相関は
Z1 = - 42327.04 + 292.95x1 + 405.64 x2 + 12173.84x3 : : r2 = 0.8 (式7)
であるが、式中、ZおよびZ1は37℃の水に5時間浸漬する前後のSAIBプラセボ溶液の粘度(cP)である。
いくつかのSAIB-オキシコドン製剤のうち1つを含有するソフトジェルキャップ1個を、スターラー機構とともに標準的なガラスビーカーに入れた(米国薬局方装置II(United States Pharmacopia Apparatus II)に記載のとおり; VK 7000 米国薬局方溶出試験器(USP II Dissolution Tester))。37℃の0.1N HCl溶液900 mlをそのビーカーにいれ、その溶液を50 rpmで2時間撹拌した。この間に、ジェルキャップは溶解し、SAIB薬物製剤は低pHの溶液に曝露され、さらに、オキシコドンの溶解が始まる。多数の1mlサンプルを採取し、オキシコドン濃度をHPLC(Perkin Elmer Series 200 LC Pump、または同等な物;UV検出器、Perkin Elmer ダイオードアレイ検出器(Diode Array Detector) 235C、または同等な物)によって測定した。この最初の溶解ステップ後、ビーカー内容物に変更を加え、リン酸ナトリウムバッファーを添加することによってpHを1から6.8に調整した。温度は37℃に維持して、薬物の溶解をさらに22時間続けた。さまざまな時点で追加の1mlサンプルを採り、オキシコドン濃度をHPLCによって測定した。媒体中に溶解したオキシコドンの累計パーセントを各期間について算出し、グラフを描いた(図7)。
本発明の重要な特徴は、旧来のエタノール抽出を用いた製剤からの薬物抽出(これまで薬物乱用者によって用いられた抽出)が、先行技術の錠剤およびカプセル製剤には有効であるのに比べて、はるかに非効率となるように、製剤を製造することができるという点である。
式中、Cum%は、全期間にわたって抽出された薬物の累計パーセントを示し、x1, x2およびx3はEL, IPMおよびCAB 381-20の重量パーセントである。図に示すように、上記のアルコール溶液によって抽出される薬物の重量パーセントは、CAB 381-20の増加に伴って減少した(製剤256-62-02, 256-62-04, 256-62-06 および 256-62-08を参照されたい)。しかしながら、よく知られているレオロジー調整剤IPMの添加が、4重量パーセントのCAB 381-20を含有する製剤に添加したとき、製剤256-62-16によって示されるように薬物のアルコール抽出に影響しないということは、明らかではなかった。これは、医薬製剤技術の常識に反する。すなわち、IPMはSAIBのレオロジー調整剤であって、SAIB製剤をゆるめて薬物抽出を促進すると予想されたが、そうではなかった。CAB含量が256-62-12のように3重量パーセントである場合、3重量パーセントのIPMの添加が、製剤256-62-04のようにIPMを含有しない製剤と対比して、アルコール溶液による薬物の抽出可能性を相当増加させることも明らかになった。したがって、CABの最適な重量パーセントに起因するのみならず、CABとIPM間の最適な比率によって、アルコールによるSAIB製剤からの薬物抽出可能性の低下をもたらすことができると結論付けられた。
別の実験を実施して、本発明の製剤が濫用抑止特性を有する度合いを判定し、具体的には水へのオキシコドンの抽出可能性を測定した。一般的に、薬物乱用者はオキシコドン錠剤を砕いてすりつぶし、水に溶解して、注射目的で水溶液中に薬物を抽出することがある。本発明の実験において、実験用剤形は、SAIB:EL:IPM:CAB比が67:26:3:4である製剤をソフトジェラチンカプセル中に含有し、さらに9mgの薬物(オキシコドン遊離塩基)を含有するSAIB-オキシコドンジェルキャップとした。対照として使用した剤形は、9mgオキシコンチン(登録商標)錠であった。それぞれの剤形を乳鉢と乳棒で破砕し、水5mlを入れてすりつぶした。次に、得られた溶液/懸濁液を、0.45ミクロンフィルターを通して濾過してフラスコに入れ、水で希釈して50mlとした。その後、オキシコドン濃度をHPLCで定量した。結果は次の通りである:対照(オキシコンチン(登録商標)錠)については、100%のオキシコドンが粉砕された錠剤から水中に抽出された。実験用SAIB製剤については、約21%のオキシコドンしか水中に抽出されなかった。このことは、薬物を効率よく水中に抽出することができないので、本製剤が、オキシコンチン(登録商標)錠と比べて、少なからぬ薬物濫用抑止特性を有することを示している。
薬物濫用のためのもう一つの可能性のある方法は、吸引可能な、または注射用溶液に溶解可能な粉末を生じることができるように、温度を下げて製剤を機械的に壊すことである。現行製剤のこうした特性を、特に温度低下と粉砕について判定するために、実験を行った。この手順において、製剤を研究用冷凍庫に入れて−80℃に8時間おいた後、ハンマーで鋭くたたいた。ある製剤は、100% SAIBを含んでなり、別の製剤はSAIBに加えて溶媒(26% EL)を含んでなり、またある製剤は、SAIB:EL:IPM:CAB比が67:26:3:4であってオキシコドン遊離塩基からなる製剤(上記)とした。最初の製剤(100% SAIB)に関する結果は、下記の通りであった:破砕されて約45秒以内に、破片が溶けて高粘性な液体の状態に戻った。製剤の放出制御マトリクス構造は保存された。2番目の製剤(SAIB + 溶媒)について:破砕されて30秒以内に、製剤塊は高粘性で粘着性に見えるようになり、破砕してばらばらの破片にはならなかった。やはり、放出制御マトリクス構造は保存された。PTI-821製剤について:破砕されて30秒以内に、製剤塊は高粘性で粘着性に見えるようになり、破砕してばらばらの破片にはならなかった。ここでもやはり、放出制御マトリクス構造は保存された。結局、温度を低下させて破砕することによる濫用の試みは、容易に濫用できる形態の薬物をもたらすことはないと思われた。図8-10を参照されたい。
図5は、9 mgオキシコドン製剤を含有する3つのSAIBソフトジェルキャップ(A, BおよびC)、およびオキシコンチン(登録商標)について、時間(時間)に対する血漿濃度(ng/ml)を示す、イヌの薬物動態研究から得られたグラフである(A=SAIB:EL:CAB; B=SAIB:EL:CAB; C=SAIB:EL:CAB, CAB=CAB 171-15)。それぞれのオキシコドン製剤を約0.75g含有する1つのジェルキャップをイヌに経口で投与した。12時間にわたって定期的に血液を採取し、オキシコドンの血漿濃度を時間の関数として測定した。
Claims (38)
- 20から90重量%のイソ酪酸酢酸スクロース(SAIB);
0.01から75重量%の、酢酸酪酸セルロース(CAB)、炭水化物重合体、炭水化物重合体を含む有機酸エステル、ヒドロゲルおよび粒子からなる一群から選択される網目形成成分、ここで、該網目形成成分は、会合、整列または凝固する能力を有し、水性環境において3次元網目構造を形成することができる;
1から75重量%の、ミリスチン酸イソプロピル、カプリル酸/カプリン酸トリグリセリド、オレイン酸エチル、フタル酸ジメチルおよび安息香酸ベンジルからなる一群から選択される、軟化剤としてのレオロジー調整剤;
0.01から75重量%の溶媒;および
オピオイド、中枢神経系(CNS)抑制薬または興奮薬である薬物;
を含む製剤を含んでなる経口投与剤形。 - SAIBが剤形重量の30%から90%までの量、含まれている、請求項1に記載の剤形。
- 網目形成成分が酢酸酪酸セルロース(CAB)を含んでなる、請求項1または2に記載の剤形。
- 網目形成成分が、ブチリル、アセチルおよびヒドロキシルを有するCABであり、ブチリル含量が17から38重量%であり、アセチル含量が13から30重量%であり、ヒドロキシル含量が0.8から1.7重量%である、請求項3に記載の剤形。
- 網目形成成分が、ブチリル、アセチルおよびヒドロキシルを有するCABであり、ブチリル含量が36から38重量%であり、アセチル含量が13.5から14.5重量%であり、ヒドロキシル含量が1.3から1.7重量%である、請求項4に記載の剤形。
- 網目形成成分が、ブチリル、アセチルおよびヒドロキシルを有するCABであり、ブチリル含量が36重量%であり、アセチル含量が15.5重量%であり、ヒドロキシル含量が0.8重量%である、請求項4に記載の剤形。
- CABが、CAB 381-20またはCAB 381-20BPである、請求項3に記載の剤形。
- 網目形成成分が重量として、剤形の20%未満の量、含まれている、請求項1〜7のいずれか一つに記載の剤形。
- 網目形成成分が重量として、剤形の1%〜8.6%の量、含まれている、請求項8に記載の剤形。
- レオロジー調整剤が、ミリスチン酸イソプロピル(IPM)、オレイン酸エチル、フタル酸ジメチルおよび安息香酸ベンジルからなる一群から選択される、請求項1〜9のいずれか一つに記載の剤形。
- レオロジー調整剤が、ミリスチン酸イソプロピル(IPM)である、請求項1〜10のいずれか一つに記載の剤形。
- レオロジー調整剤が剤形の重量として1%から10%までの量、含まれている、請求項1〜11のいずれか一つに記載の剤形。
- 溶媒がアルコール、有機酸、有機酸誘導体、有機酸エステル、またはアルコールおよび有機酸残基を含んでなる、請求項1〜12のいずれか一つに記載の剤形。
- 溶媒が乳酸エチル(EL)、トリアセチン、ジメチルスルホキシド(DMSO)、炭酸プロピレン、N-メチルピロリドン (NMP)、エチルアルコール、ベンジルアルコールおよびグリコフロールからなる一群から選択される、請求項13に記載の剤形。
- 溶媒がトリアセチンである、請求項14に記載の剤形。
- 溶媒が剤形の重量の60%未満の量、含まれている、請求項1〜15のいずれか一つに記載の剤形。
- 溶媒が剤形の重量の25%から48%までの量、含まれている、請求項16に記載の剤形。
- 製剤が安定剤を含んでなる、請求項1〜17のいずれか一つに記載の剤形。
- 安定剤が抗酸化剤である、請求項18に記載の剤形。
- 薬物が、
(a) モルヒネ、メタドン、エトルフィン、レボルファノール、フェンタニル、スフェンタニル、フェンタニル関連薬物、DAMGO、ブトルファノール、ブプレノルフィン、ナロキソン、ナルトレキソン、CTOP、ディプレノルフィン(diprenorphine)、β-フナルトレキサミン、ナロキソナジン、ナロルフィン、ペンタゾシン、ナルブフィン、ナロキソン・ベンゾイルヒドラゾン、ブレマゾシン、エチルケトシクラゾシン、U50,488、U69,593、スピラドリン、ノル-ビナルトルフィミン、ナルトリンドール、DPDPE、[D-Ala2,Glu4]デルトルフィン、DSLET、Met-エンケファリン、Leu-エンケファリン、β-エンドルフィン、ダイノルフィンA、ダイノルフィンB、α-ネオエンドルフィン、ヘロイン、ヒドロモルホン、オキシモルホン、レバロルファン、コデイン、ヒドロコドン、オキシコドン、およびナルメフェンからなる一群から選択されるオピオイド;
(b) バルビツレートおよびベンゾジアゼピン類から選択されるCNS抑制薬;または
(c)デキストロアンフェタミンおよびメチルフェニデートから選択される興奮薬;
である請求項1〜19のいずれか一つに記載の剤形。 - 薬物がオピオイドである、請求項20に記載の剤形。
- 薬物がオキシコドン、ヒドロコドン、オキシモルホンまたはヒドロモルホンである、請求項21に記載の剤形。
- 薬物がオキシコドンである、請求項22に記載の剤形。
- 薬物が0.1mgから1000mgまでの量として存在する、請求項1〜23のいずれか一つに記載の剤形。
- 薬物が5mgから50mgまでの量として存在する、請求項24に記載の剤形。
- 製剤がカプセル中に含まれている、請求項1〜25のいずれか一つに記載の剤形。
- カプセルがゼラチンカプセルである、請求項26に記載の剤形。
- カプセルがソフトゼラチンカプセルである、請求項27に記載の剤形。
- カプセルがハードゼラチンカプセルである、請求項27に記載の剤形。
- 製剤がSAIB、CAB、ミリスチン酸イソプロピル、乳酸エチルおよびオピオイドを含んでなる、請求項1に記載の剤形。
- 製剤がSAIB、CAB、ミリスチン酸イソプロピル、トリアセチンおよびオピオイドを含んでなる、請求項1に記載の剤形。
- 請求項1〜31のいずれか一つに定義された製剤を含んでなるドラッグデリバリーデバイス。
- SAIB、網目形成成分、レオロジー調整剤、および溶媒を混合して溶液を形成させること、および
薬物を溶液に添加すること
を含んでなる、請求項1〜25のいずれか一つに記載の剤形の調製方法。 - 製剤を容器またはカプセル内に入れることをさらに含む、請求項33に記載の方法。
- カプセルがゼラチンカプセルである、請求項34に記載の方法。
- カプセルがハードゼラチンカプセルである、請求項35に記載の方法。
- カプセルがソフトゼラチンカプセルである、請求項35に記載の方法。
- 薬物を被験体に送達する方法に使用する医薬の製造における請求項1〜31のいずれか一つに記載の剤形の使用であって、該方法が被験体に該剤形を経口投与することを含む、上記使用。
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