JPH03206030A - 膨潤調節性ポリマードラツグデリバリー器具 - Google Patents

膨潤調節性ポリマードラツグデリバリー器具

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Publication number
JPH03206030A
JPH03206030A JP2300007A JP30000790A JPH03206030A JP H03206030 A JPH03206030 A JP H03206030A JP 2300007 A JP2300007 A JP 2300007A JP 30000790 A JP30000790 A JP 30000790A JP H03206030 A JPH03206030 A JP H03206030A
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Prior art keywords
swelling
polymer
release
controlled release
benefit agent
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JPH082778B2 (ja
Inventor
Gregory A Mcclelland
グレゴリー　エー．マククレランド
Gaylen M Zentner
ギヤイレン　エム．ツエントナー
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Merck and Co Inc
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Merck and Co Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。

Description

【発明の詳細な説明】 膨潤性ポリマー制御的放出ドラッグデリバリー器具は、
使用環境下における予想外の又は様々な条件、例えば酸
性レベルが器具がその薬物又は活性剤を放出する速度又
はパターンを支配してしまうという欠点を有することが
多い．例えば，胃腸管内に導入されたｐＨ感受性膨潤性
ポリマードラッグデリバリー器具の膨潤（ひいては薬物
放出）速度は器具が通過する管の特定部分の酸性度に応
じて変動する．このような変動は環境よりもむしろ投薬
量によって制御される望ましい薬物放出目標をくだいて
しまい，事実上患者にとって有害である。過剰投与又は
過少投与は、いずれか一箇所（又はいずれか特定の患者
）において望ましくない程度のポリマー膨潤又は解膨潤
が薬物を実質上多く又は少なく放出させてしまう条件が
存在する場合に起きるであろう。
膨潤性ポリマードラッグデリバリー 器具は公知であって，例えば米国特許第４，８３９，１
７７号、第４，７４７，８４７号、第４，７２３，９５
７号、第４，３　５　０，２　７　１号、第４，３　０
　９，９　９　６号および第４，６４２，２３３号明細
書で記載されているが、公知のポリマー器具では条件が
場合毎に異なる使用環境下においてポリマードラッグデ
リバリー器具の使用に伴う前記問題を解決することがで
きない．しかも，ポリマー膨潤及びそれに伴う有益剤放
出の制御用手段については以前開示されていなかった。
我々は，微孔質コーティングで被覆され又は個々のマト
リックス内に分散された緩衝剤、浸透圧剤，界面活性剤
又はそれらの組合わせのような制御的放出膨潤調節剤を
膨潤性ポリマードラッグデリバリー器具中に配合するこ
とによって、ポリマー膨潤度が望ましい一定の又は断続
的なドラッグデリバリーを達或するための長時間にわた
り調節されうろことを発見した。膨潤調節剤として機能
しかつ以下で急速放出要素と称される緩衝剤、浸透圧剤
，界面活性剤又はそれらの組合わせ自体も添加してよい
． エヤー（Ａｙｅｒ）の米国特許第４，７５５，１８０号
（エヤー’１８０）明細書では、膨潤性ポリマーではな
く緩衝剤及び浸透圧剤を用いることによる活性剤の溶解
度調節について記載している．開示された同時係属米国
特許出願第３４８，０９９号及び第３８４，１１６号明
細書では界面活性剤及び錯体形成剤を用いた活性剤の溶
解度調節について請求しているが、但しこれらの物質を
用いたポリマー膨潤性の調節については示唆していない
． 典型的な水性液体中における緩衝剤及び界面活性剤の膨
潤調節剤の効果は，各々環境液体によるポリマーのイオ
ン化状態及びポリマーの湿潤度に対する特異的影響に関
係している．浸透圧剤は、共通イオン効果のような特異
的効果、水の熱力学的活性に関する非特異的効果又は静
電シールド効果によって膨潤性に影響を与える。有効水
を分離してそれに関し競合しかつ誘引しうるポリマー鎖
の能力はそれによって修正され、膨潤性が影響を受ける
。例えば，酸性官能基を有するポリ（アクリル！！）の
ような膨潤性ポリマーは酸基の高イオン化に基づきアル
カリ性膨潤調節剤（緩衝剤）の存在下で大きな程度まで
膨潤する。
イオン化した基は互いに静電的に反発しかつ水と更に強
く相互作用しあうが、双方の効果とも容量の拡大（膨潤
）を起こす。浸透圧剤塩化ナトリウムの存在下において
、ポリ（アクリル酸）のナトリウム塩の膨潤性は抑制さ
れる６しかしながら，浸透圧剤と混合された他の膨潤性
ポリマーは浸透圧剤の浸透圧に応じた水の浸透圧抑制に
基づき高い膨潤性を示す。膨潤性ポリマーと水性環境と
の界面張力を低下させる界面活性剤はポリマー／水相互
作用（付着性増加作用）を高めて、観察される膨潤挙動
性を変える。
膨潤調節剤は調節剤を微孔質壁でコートするか又は調節
剤を個々のマトリックス中に配合することで制御的放出
形中に処方される。
次いでこれらのコートされ又はマトリックス封入された
膨潤調節剤は、有益剤の望ましい放出特性を示す程度ま
で長時間にわたりポリマー膨潤性を調節しうる量で膨潤
性ポリマー（通常、水膨潤性ポリマー）と混合される。
急速放出膨濶調節剤も場合により有益剤放出の開始相時
における膨潤性を調節するために含有させてよい。
膨潤調節剤、膨潤性ポリマー及び有益剤の組合わせは様
々なコア幾何形状（通常、錠剤、ペレット又は粒子）に
戒形されて、更に（１）有益剤の放出用に少なくとも１
つの出口手段（即ち、穴）を有した不溶性壁でコートさ
れるか、（２）使用環境下で孔を形或する浸出性添加剤
を含有しそれによって壁から有益剤を通過させうる不溶
性壁でコートされるか又は（３）非コートのままである
・コートされた形態の場合，有益剤、膨潤性ポリマー、
制御的及び急速放出膨潤調節剤並びに他の賦形剤からな
る均一な混合物がコア組成物を形成する。使用環境下に
おける双方のタイプのコーティングの場合、有益剤はコ
ーティング中の放出手段（即ち、穴）又は孔のいずれか
から放出される。コート中の穴又は孔が十分なサイズで
ある場合、膨潤性ポリマー及び制御的放出膨潤調節剤も
環境中に放出される。もう１つのコートされたバリエー
ションとしては，有益剤及び賦形剤からなる第一層並び
に膨潤性ポリマー、制御的及び急速放出膨潤調節剤及び
他の処方賦形剤の混合物からなる第二層から構威される
二層コアがある。この形態において，有益剤は膨潤性ポ
リマー又は制御的放出膨潤調節剤の同時放出なしにコア
中の穴又は孔のいずれかから実質的に放出される。半浸
透性及び微孔質コートのラミネートも開示の範囲内に属
する，微孔質壁は半浸透性壁と直接接触して二層構造を
形戊するか又は微孔質壁は場合により薬物を含有し使用
環境下で溶解する液体可溶性物質の層によって半浸透性
壁から分離されるが、その場合には微孔質及び半浸透性
壁を分離する液体層を形成する。
機能上、使用環境からの液体は制御的放出膨潤調節剤と
接触して、膨潤性ポリマーの近隣環境内に制御的に膨潤
調節剤を放出する。
ポリマー膨潤の速度及び程度、ひいてはドラッグデリバ
リーの速度はそれによって制御される。膨潤性ポリマー
は（１）コートされた器具処方において有益剤含有組威
物に対する駆動力として作用し、それによって有益剤が
コート中の穴又は孔から放出されるか、あるいは（２）
膨潤時に有益剤に対する浸透性を高める膨潤性マトリッ
クスとして作用し、その場合に有益剤が使用環境中に自
由に拡散するか又は流出する。すべての場合において，
望ましい有益剤の放出特性は制御的放出膨潤調節剤で調
節されるポリマー膨潤度の関数であり、連続的又は断続
的ボーラス双方の有益剤放出が既定時間又は部位で行わ
れる．膨潤調節剤としては緩衝剤、浸透圧剤、界面活性
剤及びそれらの組合わせがある．緩衝剤はアジピン酸、
クエン酸、リン酸ナトリウム及びカリウム、酸化マグネ
シウム等のようなＰＨに影響を与える酸及び塩基からな
る．浸透圧剤は塩化ナトリウム，炭酸カリウム、塩化カ
ルシウム、酢酸ナトリウム並びに他の有機及び無機塩の
ようなイオン強度に影響を与える水溶性塩からなる． 界面活性剤は表面及び界面張力を低下させる化合物から
なり、湿潤性を高めかつ促進させる上で役立つ。それら
は水と膨潤性ポリマーとの相互作用を促進させ，ひいて
はそれらポリマーの膨潤性を調節する上でも役立つ．通
常、界面活性剤は疎水性部分及び親水性部分からなる両
親媒性分子である．本発明で有用な界面活性剤はアニオ
ン系、カチオン系、非イオン系又は両性である．アニオ
ン系界面活性剤としては硫酸化、スルホン化又はカルボ
キシル化エステル、アミド、アルコール、エーテル，芳
香族炭化水素、脂肪族炭化水素、アシル化アミノ酸及び
ペプチドがある．リン酸アルカリ金属はアニオン系界面
活性剤のもう１つの種類である．典型的には、カチオン
系界面活性剤は一級、二級、三級又は四級アルキルアン
モニウム塩，アシル化ポリアミン及びペテロ環状アミン
の塩である．非イオン系界面活性剤は典型的にはポリオ
キシアルキレングリコール，多価アルコール又はフェノ
ールのエステル及びエーテルである．ポロキサマー及び
ボロキサミンも非イオン系界面活性剤として含まれる。
界面活性剤は界面活性剤系：それらの化学，薬学及び生
物学、Ｄ．アットウッド及びＡ．Ｔ．フロレンス、チャ
ップマン及びホール・パブ社、１９８３年（Ｓｕｒｆａ
ｃｔａｎｔ　　Ｓｙｓｔｅｍｓ，　　Ｔｈｅｉｒ　　Ｃ
ｈｅｍｉｓｔｒｙ，Ｐｈａｒｍａｃｙ　ａｎｄ　Ｂｉｏ
ｌｏｇｙ，　Ｄ．　Ａｔｔｖｏｏｄ　ａｎｄＡ＋Ｔ．Ｆ
ｌｏｒｅｎｃｅ，　Ｃｈａｐｍａｎ　ａｎｄ　Ｈａｌｌ
　Ｐｕｂ．Ｃｏ．，１９８３）で記載されている．第ｌ
図は本発明の一態様の略図である．器具本体７は薬物３
、膨潤性ポリマー６及び制御的放出ユニット５内に含有
されて制御的放出膨潤調節剤を形成する膨潤調節剤２か
らなるコア組或物を有する．急速放出膨潤調節剤４は、
微孔質非水溶性壁１の形成に適した複合コア錠剤を得る
上で要求されるような他の賦形剤中に分散される．機能
上、水は壁１内に浸透してコア区画に入り、そこで水溶
性薬物３、急速放出膨潤調節剤４及び賦形剤が溶解する
．膨潤性ポリマー６は急速放出膨潤調節剤でｖａｎされ
るような程度まで膨潤する．次いで水が制御的放出膨潤
調節ユニット５内に浸透して、膨潤調節剤２がコア環境
中に制御的速度で５から放出され，そこでポリマー６の
膨潤性が長期間にわたり調節される．膨潤調節剤４は要
素５からの膨潤調節剤放出開始時においてポリマーの膨
潤を調節させるために含有されている．膨潤度に比例し
て膨潤性ポリマーにより生じる圧力は、コアから壁を経
て環境中に薬物含有溶液を放出させるように機能する．
第２図は本発明のもう１つの態様である．器具本体１０
はコア区画成分の放出用の開口９を有した非水溶性半浸
透性壁８で被覆されている．すべての他の要素は前記の
とおりである．機能上、水は半浸透性壁８を通ってコア
内に吸収される．水は更に制御的放出膨潤調節剤ユニッ
ト５に入って、既定速度で膨潤調節剤を放出させる．そ
れによってポリマー５の膨潤性が制御される．器具の内
容物はポリマー膨潤度を反映したパターンで開口９から
放出される．第３図は本発明のもう１つの態様を表す．
器具本体１１は前記いくつかの要素を含有した二層錠剤
である．その器具は微孔質非水溶性壁１の形成に適した
錠剤を得る上で必要な賦形剤１２も含有している．第４
図は本発明のもう１つの態様の略図である。器具本体ｌ
３は前記要素からなる二層錠剤形態である。第５図は本
発明のもう１つの態様であって、その場合に器具本体工
４は一体型膨潤性ポリマーマトリックス６であり、そこ
から前記の要素が分散される。
本発明の一態様において、多数の制御的放出膨潤調節剤
は非水溶性透水性ポリマー物質に関するスプレーコーテ
ィング技術を用いて１以上のタイプの前記膨潤調節剤を
非水溶性透水性ポリマー物質でコートすることにより製
造される。コーティング用に適したポリマーの例として
は、酢酸セルロース、酪酸セルロース、プロピオン酸セ
ルロース、エチルセルロース及び混合セルロースエステ
ルのようなセルロースエステル及びエーテル、アシル化
多糖類、ポリウレタン、ポリアクリレート及びポリメタ
クリレートボリマ一並びに誘導体がある．好ましいコー
ティング厚は約１〜約１０００μ、最も好ましくは約２
０〜５００μである．格別限定されないがフタレート（
例えば、ジアルキルフタレート）、アルキル及びアリー
ルホスフェート又はグリコールエーテル及びエステルを
含めた可塑剤も柔軟性を付与するためコーティング物質
に約０．０１〜５０部／壁物質部の範囲内で加えてよい
．この態様において、ポリマーコートは少なくとも１種
の孔形成添加剤を含有している。孔形成添加剤は、使用
環境との接触で不溶性ポリマー物質から浸出され、それ
によってサイズ約１０人〜約１００μの孔約５〜９５％
を有する微孔質コーティングを形威しつるのであればい
かなる物質であってもよい。
一方、制御的放出膨潤調節剤は湿式造粒、流動層造粒、
注型，直接圧縮及び球体化［例えば・マルメリゼーショ
ン（ｍａｒｕｍｅｒｉｚａｔｉｏｎ）］のような技術で
調節剤をマトリックス形成物質と混合することによりマ
トリックス形で製造してもよい．適切なマトリックス物
質は半円体〜固体であって、使用環境からコア内に浸透
する液体に溶解もしくは侵食されるか又は膨潤調節剤の
浸出を調節する拡散媒体として機能する不溶性物質であ
る．マトリックス物質として適した物質としては、コー
ティング物質用として前記された物質，更にワックス、
ポリマーグリコール、ガム、ゴム、水溶性セルロース誘
導体，例えばヒドロキシプロビルメチルセルロース、水
溶性ポリアクリレート及びポリメタクリレート誘導体等
がある。
次いでこれらのコート又はマトリックス封入された制御
的放出膨潤調節剤は，１制御的ドラッグデリバリーにお
けるヒドロゲル”Ｎ．Ｂ．グラハム．ＮＡＴＯ　　ＡＳ
ＩシリーズＥ．コル、第１０６巻、第１７０−１９４頁
、１９８６年［“Ｈｙｄｒｏｇｅｌｓ　Ｌｎ　Ｃｏｎｔ
ｒｏｌｌｅｄＤｒｕｇ　Ｄｅｌｉｖｅｒｙ”，　Ｎ．　
Ｂ．　Ｇｒａｈａｍ，　ＮＡＴＯ　ＡＳＩＳｅｒｉｅｓ
　　Ｅ．Ｃｏｌ．Ｖｏｌ．１０６，ｐａｇｅｓ　　１７
０−１９４（１９８６）］、′医学及び薬学におけるヒ
ドロゲル”、第１．ＴＩ．ｍ巻、Ｎ．Ａ．ペパス編集、
ＣＲＣプレス，１９８７年［“Ｈ　ｙｄｒｏｇｅｌｓ　
ｉｎＭｅｄｉｃｉｎｅ　ａｎｄ　Ｐｈａｒｍａｃｙ”，
　Ｖｏｌｓ．　Ｉ　，　ｎ、■，Ｎ．Ａ．Ｐｅｐａｓｖ
　　Ｅｄ．，　　ＣＲＣ　　Ｐｒｅｓｓ（１９８７）　
］　，米国特許第３，６４０，７４１号、第３，８６５
，１０８号、第３，９　９　２，５　６　２号、第４，
００２，１７３号、第４，０１４，３　３　５号及び第
４，２　０　７，８　９　３号明細書並びに“一般ポリ
マーのハンドブック”、スコット及びラフ、ケミカル・
ラバー社発行（“Ｈａｎｄｂｏｏｋ　ｏｆ　Ｃｏｍｍｏ
ｎ　Ｐｏｌｙｍｅｒｓ”，　Ｓ　ｃｏｔｔａｎｄ　Ｒｏ
ｆｆ，　ｐｕｂｌｉｓｈｅｄ　ｂｙ　ｔｈｅ　Ｃｈａｉ
ｌｉｃａｌＲｕｂｂｅｒ　Ｃｏｍｐａｎｙ）で記載され
たヒドロゲルのような非水溶性水膨潤性ポリマーと配合
又は混合される． 現在好ましい膨潤性ポリマー物質は，有意量の水で膨潤
してそれを留めるヒドロゲルである．ポリマーヒドロゲ
ル（架橋でも又は非架橋であってもよい）は水で有意に
膨潤又は膨張し、通常２〜５０倍以上の容量増加を示す
．架橋ポリマーは膨潤するが溶解せず、非架橋ポリマー
は膨潤後に溶解するが，但し溶解は必要的結果ではない
．膨潤性ポリマーの例としては、ヒドロキシアルキル及
び／又はイオン性酸性／塩基性官能基で誘導された架橋
ポリメタクリレート及びポリアクリレートボリマ一並び
にそれらの各塩形：架橋ポリビニルーピロリドン：架橋
ポリビニルアルコール；ポリ（エチレンオキシド）；ポ
リメタクリルアミド及びポリアクリルアミド；誘導又は
修正セルロースポリマー、例えば架橋力ルボキシメチル
セルロースナトリウム，架橋ヒドロキシプロビルセルロ
ース、デンプングラフトコポリマー、架橋ヒドロキシプ
ロビルメチルセルロース、架橋デキストラン、アガロー
ス及び微結晶セルロース；カルボキシメチルアミド；高
分子電解質がある． 本発明で有用な無機及び有機化合物を含めた有益剤とし
ては、ヒト又は動物で局所又は全身効果を発揮して望ま
しい機能及び応答を示す物質がある．その例としては格
別限定されないが、アミトリプチリン，ハロペリドール
、ジアゼバム，シクロベンザプリン、カルビドバ、レボ
ドバ、アセトアミノフェン、イソプロテレノール、クロ
ルフェニラミン、ジゴキシン、チモロール、ニフェジピ
ン、ジルチアゼム，メチルドパ、エナラプリル、リシノ
プリル、フェロジビン、ヒドロクロロチアジド、シンパ
スタチン、ロバスタチン、エチニルエストラジオール，
デキサメタゾン、インドメタシン、スリンダック、ジフ
ルニサール、ラニチジン、ファモチジン、オメプラゾー
ル、ノルフロキサシン、イベルメクチン、プラビスタチ
ンがある．典型的な有益剤含有量は約０．０　５　ｎ　
ｇ〜５ｇ以上である．本発明のコートされた態様におい
て，膨潤性ポリマー、制御的放出膨潤調節剤及び有益剤
の様々な混合物を含有したコア区画はドラッグデリバリ
ー用に少なくとも１つの出口を有した壁でコートするこ
とができる．壁が微孔質性である場合には、制御的放出
膨潤調節剤を被覆する壁に関して前記されたような物質
及び方法からなる。一方、壁は液体の通過に対して浸透
性だが溶質の通過には非浸透性である半浸透性壁であっ
てもよい．その場合に，ドラッグデリバリー用の放出手
段は薬物を放出させるために適した手段及び方法により
半浸透性壁で製造される． コーティング用に適したポリマーの例としては、酢酸セ
ルロース、酪酸セルロース、プロピオン酸セルロース、
エチルセルロース及び混合セルロースエステルのような
セルロースエステル及びエーテル、アシル化多糖類、ポ
リウレタン、ポリアクリレート及びポリメタクリレート
ボリマ一並びに誘導体がある．更に、微孔質及び半浸透
性壁双方の形態に関して好ましい規格は下記である： ｌ．　可塑剤及び流動調節剤：Ｏ〜５０、好ましくは０
．０　０　１〜５０部／壁物質１００部 ２．　界面活性剤：Ｏ〜４０、好ましくは０．０　０　
１〜４０部／壁物質１００部３．　壁厚：典型的には１
〜１０００、好ましくは２０〜５００μ、但しそれより
薄くても及び厚くても本発明内に属する． 本明細書で用いられる表現“放出手段”又は穴とは、コ
アから半浸透性壁を通過して薬物を放出させるために適
した手段及び方法をいう。その表現には以下を含む：開
口、オリフィス，ボア（ｂｏｒｅ）　，穴又は製品が移
動しうる多孔質要素、薬物を通過させるために適した中
空繊維、キャピラリーチューブ、クラック等．その表現
には前制御寸法の通路を生じるように使用環境下で浸食
される生物学的浸食性物質も含む．通路を形成させるた
めに適した典型的な生物学的浸食性物質としては，浸食
性ポリ（グリコール）酸、ポリ（乳）酸繊維、ポリ（オ
ルトエステル），浸食性ゼラチン状フィラメント、ポリ
（ビニルアルコール）等がある。
非水溶性浸透性非速度制御微孔質壁は、半浸透性壁の適
用前又はその後にスプレーコーティング操作でコア組或
物に適用される。微孔質壁は半浸透性壁と直接接触して
二層構造を形或するか又は微孔質壁は場合により薬物を
含有し使用環境下で溶解する液体可溶性物質の層によっ
て半浸透性壁から分離されるが、その場合には微孔質及
び半浸透性壁を分離する液体層を形成する。
コアを被覆する速度制御壁が性質上微孔質である態様の
場合、コートは前記ポリマーから戊り、水溶性浸出性添
加剤を含有する．本発明に適した添加剤は有機又は無機
源の水溶性化合物であり、アルカリ金属及び土類塩、例
えば塩化ナトリウム及び塩化カルシウム、糖及びボリオ
ール，例えばソルビトール、スクロース、マンニトール
及びポリ（アルキレングリコール）並びに他の水溶性有
機物、例えばニコチンアミド及びトロメタミンで例示さ
れる。孔形威添加剤はポリマー及び孔形成添加剤の混合
重量中典型的にはＯ．工〜９０％で存在する． 本発明は下記実施例で更に説明される。
実施例 実施例工、２及び３において，制御的放出塩化ナトリウ
ム（Ｃ，Ｒ，ＮａＣＱ）源が浸透圧制御的放出有益剤（
Ｃ．Ｒ．Ｂ．Ａ．）デリバリー器具からの放出特性を最
適化させるためにポリアクリル酸ナトリウムヒドロゲル
ポリマー［アクア・キープＪ−５５０（Ａｑｕａ　Ｋｅ
ｅｐ”　Ｊ　　５　５　０　）　”，製鉄化学（株）社
］の膨潤性を調節（即ち、抑制）する上で制御的放出膨
潤調節剤（Ｃ．Ｒ．Ｓ．Ｍ．）として製造される。Ｃ．
Ｒ．ＮａＣｊｌは＃２０を通過して＃３０篩（開口６０
０μ）に留まる塩化ナトリウム結晶７００ｇから調製さ
れ，しかる後標準流動層スプレーコーティング装置［ユ
ニ・グラット（　Ｕ　ｎｉ−　Ｇ　ｌａｔｔ）　］によ
り微孔貿壁でコートされる。スプレー溶液は３：１ジク
ロロメタン／メタノール溶媒混合液に溶解された１００
ｇの酢酸酪酸セルロース３８１−２０である．次いで水
／メタノール溶媒混合液に溶解されたソルビトール約２
０ｇがＮ　ａ　Ｃ　Ｑの放出に影響を与える孔形成剤と
して加えられる。塩化ナトリウム結晶は様々な時間にわ
たり連続的に塩化ナトリウムを放出しうるようにコーｌ
一されるが，より厚いコートとなるに従い放出時間も長
くなる。
実施例１ 塩酸ジルチアゼムは高度に水溶性の薬物である（３７℃
で５　０　０　ｍ　ｇ　／　ｍ　Ｉ１以上の溶解度を有
する）。浸透圧ポンプＣ．Ｒ．Ｂ．Ａ．デリバリー器具
からのこの薬物の放出は約５０％ゼロ次（この場合には
薬物の飽和溶液が放出される）しかる後漸次低下する一
次放出速度（この場合には薬物の準飽和溶液が放出され
る）である．Ｃ．Ｒ．ＮａＣＱ要素の配合によって数時
間にわたりヒドロゲルポリマー区画内に塩化ナトリウム
を供給させることで、ヒドロゲルの膨潤が抑制される。
Ｃ，Ｒ．ＮａＣＱ要素中の塩化ナトリウムが枯渇すると
、即ちこれは塩酸ジルチアゼム放出の一次速度の開始時
に対応するよう時間調整してもよいが、ポリマーは実質
上水和して、塩酸ジルチアゼムの７０％以上のほぼゼロ
次放出を行うような速い速度で残留準飽和塩酸ジルチア
ゼムを薬物区画から放出させる。
このようなＣ．Ｒ．Ｂ．Ａ．器具は下記操作に従い製造
される．有益剤塩酸ジルチアゼムの制御的及び連続的放
出のための二層浸透圧器具は下記のようにして製造され
る：塩酸ジノレチアゼム３６０ｍｇをアジピン酸８５Ｉ
Ｉｌｇ、クエン酸７　０　ｍ　ｇ及び５％ｗ／ｗポリビ
ニルピロリドン２９−３２Ｋと混合し、７．１ｍｍＸ１
７．４ｍｍキャプレットパンチ装備マネスティ（Ｍａｎ
ｅｓｔｙ）打錠プレスで圧縮して、一層の薬物組成物を
得る。次いでアクア・キープＪ−５５０　　１００ｍｇ
をＣ．Ｒ．Ｎ　ａ　Ｃ　Ｑ（６〜７時間連続塩化ナトリ
ウム放出を得るためコートされている）５０ｍｇ及び急
速放出塩化ナトリウム２０ｍｇと混合する．この混合物
をマネスティプレスに加え、圧縮して、薬物区画と接触
する膨潤調節ヒドロゲルの層を形成させる．次いで得ら
れた二層コアを半浸透性壁でコートする．アセチル含有
率３９．８％の酢酸セルロース７２ｇをメタノール６０
０ｍＱ及び塩化メチレン９８０ｍｆｆｉに溶解し，しか
る後１５０μ厚コートが得られるまで流動層機械で二層
コア上にスプレーする５コートされた器具を５０℃で７
２時間乾燥し、０．０　１　５インチ（約０．０３８ｃ
ｍ）径穴を半浸透性壁から二層コアの薬物側に股けて、
薬物含有層と器具の外部とを結げる．失適皇ｌ 実施例１の操作を繰返して、二層コア錠剤を形或する．
次いで微孔質コートを下記のようにしてこれらのコアに
適用する： アセチル含有率３９．８％の酢酸セルロース７２ｇをジ
クロロメタン／メタノール溶媒混合液に溶解する．これ
に水／メタノール溶媒混合液に溶解された孔形或剤とし
てソルビトール５４ｇを加える．この溶液を市販ユニ・
プラント流動層コーティング機内でコアにスプレーする
。４００μ厚壁を錠剤コアに形成する． 失隻量互 塩酸ジルチアゼムの制御的及び連続的経口放出用の浸透
圧治療器具は下記のようにして製造される：塩酸ジルチ
アゼム３６０ｍｇをアジビン酸８　５　ｍ　ｇ　．クエ
ン酸７０ｍｇ．アクア・キープＪ　　５５０　　１００
ｍｇ及びＣ．Ｒ．　Ｎａｃｌ（６〜７時間連続塩化ナト
リウム放出を得るためコートされている）５０ｍｇと混
合する。この混合物をエタノールに溶解された５％ｗ／
ｗポリビニルピロリドン２９一３２Ｋで造粒する。得ら
れた顆粒は均一な混合物であり、これを７．１ｍｍＸ１
７．４ｍｍキャプレットパンチ装備マネスティ打錠プレ
スで打錠して、一体型コア区画を形成する。
次いでこのコア区画を実施例１で記載されたように半浸
透性コートに設けられたオリフィスのある半浸透性コー
トでコートするか又は実施例２で記載されたように微孔
質コートでコートする。
叉簾量生 本発明のもう１つの態様によれば，強力利尿剤エタクリ
ン酸ナトリウムの連続的放出のためヒドロゲルの膨潤性
を調節しうるように制御的放出要素を含有したヒドロゲ
ルマトリックスが製造される．ポリアクリル酸はアルカ
リ性ｐＨで大きな膨潤度を示すＰＨ感受性ヒドロゲルで
ある．ポリアクリル酸の近隣環境下で７以上のｐＨに維
持するため、トロメタミン遊離塩基結晶を微孔質壁でコ
ートしてポリアクリル酸の膨潤性を調節する制御的放出
要素を形成させ、しかる後ポリアクリル酸及びエタクリ
ン酸ナトリウム（薬物）と混合して、環境ｐＨから独立
した速度で利尿剤を放出する一体型器具を形成させる． Ｃ．Ｒ．　トロメタミンは，＃２０を通過して＃３０篩
（開口６００μ）に留まるトロメタミン遊離塩基結晶７
００ｇを取出して標準流動層スプレーコーティング技術
でこれらの結晶に微孔質壁を形或させることにより製造
される．スプレー溶液は３：１ジクロロメタン／メタノ
ール溶媒混合液に溶解された１００ｇの酢酸酪酸セルロ
ース３８１−２０である．これに水／メタノール溶媒混
合液に溶解されたソルビトール２０ｇをトロメタミン遊
離塩基の放出に影響を与える孔形或剤として加える．こ
の溶液を市販ユニ・グラット流動層コーティング機でト
ロメタミン遊離塩基結晶にスプレーする．トロメタミン
遊離塩基結晶を６〜８時間にわたり一定速度でトロメタ
ミン遊離塩基を放出しうるようにコートする．次いでポ
リアクリル酸２００ｍｇ．Ｃ．Ｒ．　トロメタミン５０
ｍｇ及びエタクリル酸ナトリウム５０ｍｇをポリビニル
ピロリドン２９−３２Ｋ　１５ｍｇと混合し，３７８″
（約０．９５ｃｍ）パンチ装備マネスティ打錠プレスで
打錠して、数時間にわたりエタクリン酸ナトリウムを放
出する一体型器具を得る。
去１奥４足 アミノ誘導化ヒドロゲルからの膨潤性及びそれに付随す
る薬物放出の調節のためのクエン酸のマトリックス制御
放出源（Ｃ．Ｒ．クエン酸）は下記のようにして製造さ
れる：クエン酸，２−ヒドロキシエチルメタクリレート
（ＨＥＭＡ）及びエチレングリコールジメタクリレート
をラジカル重合開始剤として作用するアゾビス（メチル
イソブチレート）８ｍ　ｍ　ｏ　Ｑ　　／　Ｈ　Ｅ　Ｍ
　Ａリットルと４：１５：１比で混合する。混合物を窒
素パージ容器中６０℃で完全重合するまで加熱して，架
橋ガラス質物を形或させる。冷却後ガラス質物を粉末に
砕き，篩分けして．＃２０１１を通過して＃３０篩に留
まる粒子をＣ．Ｒ．クエン酸源として用いる． 塩酸ジルチアゼムの制御的放出用の膨潤調節ヒドロゲル
マトリックスは下記のようにして製造される：モノマー
ＨＥＭＡ及びジメチルアミノエチルメタクリレートをア
ゾビス（メチルイソブチレート）８ｍｍｏＱ／モノマー
悲と５０　：　５０で混合する．この混合物に１０％ｗ
／ｗＣ．Ｒ．クエン酸及び２５〜５０％Ｗ　／　Ｗジル
チアゼムＨＣｆｌを加える．複合物質を１ｍｍ厚スペー
サーで分離されたシールプレート間において６０℃で重
合させてシートを形成させ、そこから８ｍｍ径ディスク
をコルク穿孔器で切断する．水性媒体中において、ディ
スクはポリマー膨潤度に比例した速度でジルチアゼムＨ
ＣＱを放出する。
胃腸管の変動的ＰＨ環境下で．Ｃ．Ｒ．クエン酸はポリ
マー膨潤度を維持し、薬物のｐＨ非依存的デリバリーを
行わせる． 叉凰銖且 本発明による薬物インドメタシンの制御的放出用錠剤は
下記のようにして製造される．第１表で示された処方の
場合には、インドメタシン、アクア・キープＪ−５５０
ポリマー及びＪ−５５０の膨潤性を調節するＣ．Ｒ．Ｎ
ａＣｕ（実施例１参照）のコア混合物が製造される。
第１表 錠剤 コア或分 Ｊ−５５０ポリマー Ｃ．Ｒ．ＮａＣ（１ インドメタシン アビセル（ＡｖＬｃａ　Ｑ　）ｐＨ ボビドン（ｐｖｐ） 重量 ２ｇ Ｉｇ ２ｇ １０１　　　　４００ｍｇ ＥｔＯＨ　６　Ｉｌ４１中６　０ｗｒｇこの混合物の湿
潤顆粒を湿潤スラリーが形或されるまでエタノール／ポ
ビドンと混合する．次いでこのスラリーを約８時間乾燥
させ、最終メッシュサイズ１８の篩に通す．錠剤コアは
、得られた顆粒から約１４０ｍｇの顆粒を取出してカー
バー（Ｃａｒｖｅｒ■）プレスで１／４”（約０．６４
ｃｍ）標準凹形バンチを用いそれらを圧縮することによ
り製造する。上記で製造された錠剤コアを透明なポリ（
ビニルクロリド）で５回浸漬コートする（錠剤は粘着を
防止するため各コート時にテフロンシ一トで端部を巻く
）．各錠剤を次のコーティングとの間に約１時間乾燥さ
せ、錠剤を５回目のコートが行われた後約８時間乾燥さ
せる。
小型ハンドドリルで３つの１ｍｍ穴をコートされた錠剤
の各面に形成する．水性環境下において、膨潤性ポリマ
ー，Ｃ．Ｒ．ＮａＣＱ及び薬物はすべてその穴から放出
される．次いで１００ｐｐｍ攪拌下３７℃でｐＨ７．５
　リン酸緩衝液１１２中への錠剤からのインドメタシン
の放出量が３２０ｎｍにおけるＵ．Ｖ．吸光度の読みか
ら調べられる。
失適量ユ 実施例５の操作がすべてそこで記載されたような条件で
繰返されるが、但し器具は目の結膜円蓋内におかれる眼
用インサートとしてデザインされ、薬物は５％ｗ／ｗ量
のチモロールである。
【図面の簡単な説明】
第１図は本発明に従い製造されたポリマードラッグデリ
バリー器具について示す。 第２図は器具が非水溶性半浸透性壁で被覆された本発明
の態様について示す６ 第３図は本発明の二層錠剤バージョンについて示す。 第４図は本発明の更にもう１つの二層錠剤態様について
示す。 第５図は器具が一体型膨潤性ポリマーマトリックスであ
る本発明の態様について示す。 ［主要部分の符号の説明］ １・・・・・・・・　　　　・　　微孔質非水溶性壁２
　・・・・・・　・　　　　　　　膨潤調節剤３・・・
・・・・・　・・・　　・・　　　水溶性薬物急速放出
膨潤調節剤 制御的放出膨潤調節ユニット 膨潤性ポリマー 器具本体 非水溶性半浸透性壁 放出用開口 器具本体 器具本体 賦形剤 器具本体 器具本体 ＦＩＧ． １ ９ Ｆ１９． ２

Claims (1)

  1. 【特許請求の範囲】 １、（ａ）使用水性環境との接触で膨潤す るポリマー； （ｂ）上記ポリマー全体に分散された多数の制御的放出
    膨潤調節剤（その各々は微孔質コーティングでコートさ
    れているか又は個々のマトリックス内に分散されている
    ）；及び （ｃ）少なくとも１種の有益剤； の組成物からなる制御的放出ドラッグデリバリー器具で
    あって、 上記制御的放出膨潤調節剤が使用環境との 上記器具の接触時に上記ポリマーの膨潤性、ひいては上
    記ドラッグデリバリー器具からの有益剤の放出速度を調
    節することを特徴とする器具。 ２、制御的放出膨潤調節剤が界面活性剤、 浸透圧剤、緩衝剤からなる群より選択される、請求項１
    記載の器具。 ３、組成物を被覆する非水溶性開口コー ティングを更に含む、請求項１記載の器具。 ４、組成物を被覆する微孔質壁を更に含 み、この微孔質壁が使用環境との上記壁の接触で孔を形
    成する浸出性添加剤を含有した不溶性コーティングから
    なる、請求項１記載の器具。 ５、緩衝剤、浸透圧剤及び界面活性剤か らなる群より選択される多数の急速放出要素を更に含み
    、この急速放出要素が制御的放出膨潤調節剤と共に分散
    されている、請求項１記載の器具。 ６、組成物が隣接微孔質及び半浸透性層 でラミネートされている、請求項１記載の器具。 ７、（ａ）賦形剤と混合された少なくとも １種の有益剤からなる第一開口層；及び （ｂ）上記第一開口層に隣接しかつ膨潤性ポリマー、制
    御的放出膨潤調節剤及び急速放出要素の混合物からなる
    第二層； からなり、上記第二層のポリマーが使用水性環境との接
    触で上記隣接第一層内に膨潤し、それによって制御的速
    度で上記第一層から有益剤を放出させることを特徴とす
    る制御的放出ドラッグデリバリー器具。 ８、ポリマー、制御的放出膨潤調節剤及 び有益剤がマトリックス基質中に混合されている、請求
    項１記載の器具。 ９、使用水性環境中に有益剤を連続的又 は断続的に放出させるための方法であって、上記環境に
    制御的放出器具を導入させ、こ の器具が（ａ）水性環境との接触で膨潤するポリマー、
    （ｂ）このポリマー全体に分散された多数の制御的放出
    膨潤調節剤（この多数の制御的放出膨潤調節剤は各々微
    孔質コーティングでコートされているか又は個々のマト
    リックス内に分散されている）及び（ｃ）少なくとも１
    種の有益剤からなり、上記ポリマーが上記水性環境との
    接触で膨潤し、それによって上記制御的放出膨潤調節剤
    により実質上決定される速度で有益剤を放出させること
    を特徴とする方法。
JP2300007A 1989-11-07 1990-11-07 膨潤調節性ポリマードラツグデリバリー器具 Expired - Fee Related JPH082778B2 (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US433,056 1989-11-07
US07/433,056 US5120548A (en) 1989-11-07 1989-11-07 Swelling modulated polymeric drug delivery device

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JPH03206030A true JPH03206030A (ja) 1991-09-09
JPH082778B2 JPH082778B2 (ja) 1996-01-17

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US (1) US5120548A (ja)
EP (1) EP0427519B1 (ja)
JP (1) JPH082778B2 (ja)
CA (1) CA2029383C (ja)
CY (1) CY1964A (ja)
DE (1) DE69011045T2 (ja)
HK (1) HK199696A (ja)

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CA2029383A1 (en) 1991-05-08
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US5120548A (en) 1992-06-09

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