JP2820239B2 - 制御放出パウダー及びその製法 - Google Patents

制御放出パウダー及びその製法

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JP2820239B2
JP2820239B2 JP60242585A JP24258585A JP2820239B2 JP 2820239 B2 JP2820239 B2 JP 2820239B2 JP 60242585 A JP60242585 A JP 60242585A JP 24258585 A JP24258585 A JP 24258585A JP 2820239 B2 JP2820239 B2 JP 2820239B2
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theophylline
polymer
controlled release
powder
active ingredient
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JPS61109711A (ja
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ジエームズ ゲイガン エドワーズ
テイ スパークス ランドル
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エラン コーポレーション ピー エル シー
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    • A61K9/5107—Excipients; Inactive ingredients
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Description

【発明の詳細な説明】 この発明は、制御放出製剤及び、特に、別々になって
いるマイクロ粒子、即ち離散マイクロ粒子からなってい
る持続放出すなわち徐放性（Sustained release）パウ
ダーに関する。 制御放出又は徐放性ペレット剤の多くのタイプのもの
は、経口用カプセルに詰められたものが知られている。
これらのペレット剤はマクロ粒子ということができ、必
ず400μｍよりも大きな平均サイズを有している。その
ようなペレット剤は、例えば日本特許出願番号特願昭59
−68974号（特開昭59−219219号）、特願昭59−81019号
（特開昭59−205314号）、特願昭59−269582号（特開昭
60−156612号）及び特願昭59−270584号（特開昭60−15
6617号）の主題である。 徐放性ペレット剤は簡単には液剤として製剤化できな
い。徐放性の液剤は、老人用剤及び小児用剤用に望まれ
ている。 いろいろな製法が、溶媒蒸発エマルジョン技術を用い
て微小球（micro−sheres）を製造するのに知られてい
る。公知のマイクロカプセル化技術を一般に相交換のた
め、すなわち液体を固体に変えるように使用する。ある
いはまた、そのような技術は、活性物質を保護する、す
なわち、胃を刺激するという性質をマスクするために、
アスピリンを被覆するようなことのために使用しうる。 徐放性の液剤には、イオン交換樹脂を含有するものが
知られている。そのような徐放性の液剤においては、活
性成分はイオン交換樹脂に可逆的なコンプレックスの形
態で結合し、生体内（in vivo）でそれから置換され
る。そのような徐放性の液剤は、例えば仏国特許明細書
第2,278,325号に記載がある。 公知のものに比して改良された性質を有し、容易に液
状の形態に製剤化できるが、また錠剤のような他の徐放
性の形態にも製剤化できるような別々になっているマイ
クロ粒子の制御放出パウダーを提供することが、この発
明の目的である。 したがって、この発明は、セルロースアセテートブチ
レートポリマーと緊密に混合されたテオフィリンを活性
成分とそて、１日２回の投与に適する制御放出のために
十分な量でマトリックス中に均一に分布して含む、平均
粒径0.1〜125μｍの、粒子表面が上記ポリマーで完全に
覆われてはいない、口内での咀しゃく運動によって有意
な崩壊もしくは破砕を受けない、離散性マイクロマトリ
ックス粒子からなるパウダーであって、食品または医薬
品中に用いることができる、制御放出性で且つテオフィ
リンの味を遮蔽した上記パウダー提供する。 好ましくは、上記粒子は、５〜100μｍの平均サイズ
を持っている。 出願人は、この発明に記載されたパウダーのマイクロ
粒子に対して「ファルマソーム（Pharmasomes）」とい
う語を作り出し、そのことばをこれ以降この明細書で使
用する。 この発明に記載された制御放出パウダーは、このあと
に示されているように活性成分を徐々に放出することを
許容することができる。 そのパウダーは、液体のビヒクルに分散又は懸濁され
ることができ、使用する時間の間その徐放性を保持して
いる。そのような分散剤又は懸濁剤は化学的にも、溶解
速度の点でも安定である。 この発明は、また次の工程からなるこの発明に従った
制御放出パウダーを調製するための工程をも提供する。 ａ）溶媒のポリマー又はポリマー類の溶液を形成する； ｂ）活性成分（テオフィリン）を上記ポリマー溶液に溶
解又は分散させ、均一な混合物を形成する。；そして ｃ）その混合物から溶媒を除去し、0.1から125μｍの範
囲の平均サイズを有するマイクロ粒子を得る。 特に好ましい溶媒としては、アセトン、又はメタノー
ルとメチレンクロライドの混合物が含まれる。 溶媒中のポリマーの濃度は、普通は75重量％より少な
いであろう。普通にはその濃度は10−30重量％の範囲で
あろう。 もし活性成分がポリマー溶液に溶解しないなら、その
活性成分の粒子サイズは10μｍよりも小さいまでに小さ
くされる。粒子サイズを小さくすることは粉砕するこ
と、例えばボールミル又はジェットミルで粉砕すること
によりなされうる。 活性成分は、もちろん、液体であってよい。 薬とポリマーとの比率は、広い範囲で0.1:10から10:1
の範囲というような範囲で変わりうる。 ポリマー溶液中の活性成分の均一な混合物は、速くて
連続した混合によって達成されうる。 溶媒の除去及び所望のサイズの粒子の形成は多くの方
法で行うことができる。 1.噴霧乾燥（spray drying） 溶媒中の活性成分とポリマーの混合物は慣用の方法で
ホットエアーの流れの中へスプレーされる。これは溶媒
を蒸発に導き、パウダーは、噴霧乾燥（spray drying v
essed）容器内に集められる。 粒子のサイズは多くの方法で、例えば、噴霧乾燥容器
の入口及び出口の温度、スプレーの導入の速度、スプレ
ーノズルのサイズ又は活性成分とポリマーの濃度の比率
を事前に選択することにより制御しうる。 2.連続液相（external liquid phase）の利用 活性成分とポリマーの混合物、それは溶液又は懸濁物
のかたちであるものであるが、それは液体の連続相中に
注ぎ込まれる。その液体連続相は活性成分／ポリマー混
合物と非混和性又は部分的に非混和性であることろの溶
媒からなっている。 連続液相の選択は選ばれた活性成分とポリマーの個々
の組み合わせによって決定される。連続液相として適し
た液体には、水、水性溶液、例えば、糖溶液、有機溶
媒、鉱油、植物油、不揮発油（fixed oils）、シロップ
又はシリコーン類がある。その水性溶液は増粘剤、キサ
ンタンガムのようなものを、それらの粘度を増加させる
ため、含有していてもよい。オイルはマグネシウムステ
アレートのような物質を加えることにより、より粘ちょ
うになしうる。連続液相はまた異なったpHの溶液、例え
ば、緩衝液からなっていてよい。 連続液相とポリマー混合物との比率は少なくとも2:1
でありうる。 活性成分／ポリマー混合物を連続液相に加えることに
引き続き、得られた二相混合物は、例えば、迅速な混合
により、乳化させる。その形成されたエマルジョンは安
定なものであっても不安定なものであってもよい。活性
成分／ポリマーの小球がそれによってエマルジョン中に
形成される。 溶媒は多くの方法で除去しうる。もし溶媒が揮発性で
あるならば、それは障害なく除去することができる。例
えば、もし溶媒がアセトンであるなら、それは普通には
その混合ステップの間に蒸発によって蒸発される。形成
された粒子は次に過又は遠心分離して得られる。 溶媒はまた二相混合物を混合する間加熱することによ
っても除去することができる。例えば溶媒はロータリー
フィルムエバポレーター上で除去しうる。溶媒はまた減
圧下に加熱しながら又は加熱せずに除去しうる。マイク
ロウェーブ乾燥はまた減圧しながら又は減圧せずに使用
されうる。溶媒除去の別の方法は凍結乾燥によるもので
ある。 マイクロ粒子を得た後、それらは普通には適当な溶媒
を用いて繰り返し洗浄し、次に乾燥される。 例えば、使用された溶媒がアセトンで連続液相が鉱油
の時、次にはマイクロ粒子はヘキサンで繰り返し洗浄さ
れ、45℃で乾燥されるであろう。 商業的規模ではその混合物の乳化は、１個のインライ
ンミキサー又は複数のミキサーでもって乳化することに
よりなされうる。 粒子サイズは多くの方法で制御されうる。例えば、粒
子サイズは混合の速度、連続相の粘度、非連続相の粘
度、活性成分の粒子サイズ又は溶媒の揮発性によって制
御されうる。 3.溶媒除去のための他の方法は、相分離法（Phase sepa
ration）界面ポリマー沈積法（interfacial polymer de
position）又はコアセルベーション法（coacervation）
を包含している。 活性成分又はそれぞれの活性成分と一緒に使用される
任意の賦形剤はしばしば、次の投薬で活性な役割を有す
る。例えば、賦形剤は水の粒子中への移動を容易にする
ような界面活性剤、例えば、ナトリウムラウリルサルフ
ェートと又は商標トゥイーン（Tween）として販売され
ている界面活性剤であってよい。賦形剤はまた、例えば
グリコースまた１つまたはそれ以上のアミノ酸のような
活性なトランスポート剤であってよい。 賦形剤はアルカリ性の媒質に少ししか溶解しない薬物
を溶解することを促進するような１つまたはそれ以上の
有機酸からなっていてよい。そのような酸には、例え
ば、アスコルビン酸、クエン酸、フマール酸、リンゴ
酸、コハク酸及び酒石酸がある。同様に、賦形剤は酸性
媒質に少ししか溶解しない薬物を溶解することを促進す
るような１つまたはそれ以上の塩基性物質からなってい
てよい。そのような塩基性物質には炭酸ナトリウム、ク
エン酸ナトリウム及び重炭酸ナトリウムがある。 この発明に従ったマイクロ粒子は、広範な種々のかた
ちに製剤化しうる。この発明に記載された医薬製剤とは
丸剤及び錠剤、例えば、コーティング錠剤、発泡錠剤、
咀しゃく錠剤、即ちチュウアブル錠剤、湿製錠剤及び溶
解性錠剤（melt tablets）を包含している。この発明に
記載された粒子は、錠剤に圧縮されうるし、任意に粒子
中に生起するような実質的な変質なしに被覆されうる。
さらには、粒子のマイクロ微粒子の性質のゆえにそれら
はどんな咀しゃく作用によっても意味のある崩壊をうけ
る又は破砕をうけることは起こりえない。 この発明に記載された粒子はまた軟ゼラチンカプセル
であっても硬ゼラチンカプセルであってもよいところの
カプセル中に詰めることもできる。 他の固体の投与形態は、ペッサリー、直腸坐薬、膣用
錠剤及び膣用挿入薬を包含している。 パウダーは局所投与に適した形態、例えば、クリーム
剤又は軟こう剤のようなもの及び経皮投与（transderma
l delivery）に適した形態、例えば、経皮貼付剤（tran
sdermal patches）の形態に製剤化されることができ
る。 この発明に記載されたマイクロ微粒子パウダーは、ま
た泡洙剤、ゲル剤、パスタ剤、ガム、粘奬剤及びゼリー
剤の形態に使用されうる。 この発明に記載されたマイクロ粒子を入れる他の適し
た製剤は吸入剤、乳剤、子宮用デバイス（intrauterine
devices）、貼剤、生体分解性傷用包帯剤及び他の局所
包帯剤を包含している。 この発明に記載されたマイクロ微粒子パウダーは、経
口、局所又は非経口の投与のための液体のような製剤化
に適している。こうして、それらは、点鼻剤、懸濁剤、
シロップ剤、浸剤及び注射することのできる溶液として
使用するための液体形態に製剤化できる。パウダーはま
た経鼻用スプレー剤として製剤化できる。注射すること
のできる溶液とは静脈内、皮下及び筋肉内に注射するこ
とのできる溶液を包含している。 この発明に記載された経口用懸濁剤及びシロップ剤
は、老人用及び小児用医薬における用途に特に適してい
る。形成された液体は良好な口中感を有している。さら
に、ポリマーが活性成分を実質的に被覆しているので、
そのコーティングはどんな好ましくない味をもマスクし
ている。 良好な口中感を有するという特色は、咀しゃく錠剤及
び発泡錠剤にまた適用される。パウダーのマイクロ微粒
子の性質ゆえに顆粒状の感覚をおぼえることはない。 この発明に従った好適な小児科用液剤は、懸濁剤又は
シロップ剤である。 液体製剤は良好な貯蔵寿命を有し、30日間まで化学的
にも溶解速度の点でも安定性を示す。その貯蔵寿命は５
年間程の長さであると見積もられる。 この発明に記載された液体製剤において、5ml当り1g
までの活性成分の濃度を達成することができる。 今まで多くの薬は、例えば、鎮痛剤、それは４〜６時
間ごとの投与方法を必要としているものであるが、液体
の形態では安定ではなかった。この発明に記載された液
剤は、テオフィリンのための毎日二回の投与の可能性を
提供する。 この発明に記載されたパウダーの味をマスクするとい
う特徴は小児薬の領域で非常に重要なことである。しか
しながら、この特徴は、獣医薬においても同様に重要で
ある。 この発明に従ったパウダーは、動物用飼料及び飼料添
加物のプレミックス中において使用することができる。 この発明に従った適した獣医用調製物は、家畜用飼
料、大型丸剤、飲薬及び洗浄剤を包含する。 この発明に従った制御放出パウダーの各々の粒子は、
下記実施例１において詳述されているようにして調製さ
れテオフィリンを含有する「ファルマソーム（Pharmaso
mes）」の電子顕微鏡写真から作られたハーフトーンの
図面である添付図面第１図において描かれているよう
に、それによって均一に分散された活性成分と任意に１
つまたはそれ以上の賦形剤とを持っている本当のマイク
ロマトリックス構造を示している。そのテオフィリンは
「ファルマソーム（Pharmasome）」の高分子材料のすみ
からすみまで脈管系を形成するか又は迷路を形成してい
ることを観察することができる。第２図はテオフィリン
が24時間水に溶解されることによって溶出された後の
「ファルマソーム（Pharmasomes）」の電子顕微鏡写真
から作られたハーフトーン図である。そこには高分子材
料のマトリックス構造が残っている。 粒子のマイクロマトリックスの性質は、またそれらの
溶解特性によって示すことができる。例えば下記に示さ
れた実施例１を参照してみると、粒子の表面に近いとこ
ろにある活性成分と考えられるところの活性成分の最初
の激しい溶出のあと、次式に従って溶解率（Ｄ）は時間
（ｔ）の平方根に直接比例していることがわかる： 溶解速度はある与えられた時間における粒子マトリッ
クス中に残留している活性成分の量に依存している。理
論的には活性成分の一番最後の分子は決して溶出しな
い。溶解率は無限時間後において100％になることが想
定される。 この発明に記載された粒子はまたピクノメーターで測
定された粒子の絶対密度から計算することのできる多孔
性の程度を有している。この発明に従った粒子の溶解速
度は上記粒子の多孔性の程度に関連することもまたわか
る。 本発明によるマイクロ粒子においては、上記したよう
に、また、添付図面の第１図及び第２図において示した
ように、その活性成分がポリマー材料全体にわたって均
一に分布されており、それに反して、マイクロカプセル
においては、その活性成分がポリマーコーチングによっ
てカプセル化されているということで、本発明によるマ
イクロ粒子は、マイクロカプセルと区別され得る。 この発明はさらに次の実施例によって詳細に説明され
よう。実施例において、種々の医薬製剤の溶解速度は、
米国薬局方XX（U.S.Pharmacopoeia XX）のパドル法（Pa
ddle Method）により37℃、75r.p.m.で、酵素を除いて
腸液に模された液900mlあたり200mgの試料を用いて測定
される。 実施例１ テオフィリン（theophylline）を含有するマイクロ粒子
の調製 テオフィリンをモータ駆動式ボールミル中で粉砕し、
次に、30μｍ網目の篩を通して篩分けする。 セルロースアセテートブチレート（CAB）をアセトン
に溶解して、CABの濃度15w/v％のアセトン溶液を与え
る。 ヘキサン（20ml）を、絶えず攪拌しながら一定量のそ
のCAB溶液（100g）に加える。 次いで、篩過されたテオフィリンの一部（10g）を、
テオフィリンの均一な分散液に確実にするために激しく
かきまぜることを続けながらポリマー溶液中に加える。
この生成物は引き続いた乳化工程のための不連続相（in
ternal phase）を構成している。 マグネシウムステアレートを重質の鉱油（heavy mine
ral oil）米国薬局方（U.S.Phamacopoeia）に溶解し、
1.5w/v％の濃度とする。この溶液は連続用（extermal p
hase）として使用された。連続相の150mlを600mlの背の
高いビーカー中へデカンテーションし、上記で調整され
た不連続相をその中へ加えた。乳化はシルバーソンミキ
サー（Silverson mixer）（Silversonは商標である）を
用いて１分間フルスピードで行われ、次いで所望の粒子
サイズが得られるのに要求されるようなスピードにおと
すことにより行われた。 連続相中の粒子のサスペンジョンが次にロータリーエ
バポレーター中に導入し、アセトンを減圧下で除去し
た。サスペンジョンは今や単に連続相中に懸濁されたポ
リマー被覆されたテオフィリンは「ファルマソーム（Ph
armasomes）」だけからなっている。顕微鏡検査で粒子
サイズは10〜180μｍの範囲であることがわかった。 粒子を遠心分離し、連続相をデカンテーションした。
粒子を次に外液層を除去するためにヘプタンで繰返し洗
浄した。最終生成物を次にろ過し、45℃で２時間乾燥し
た。粒子を次に50,90,125及び180μｍのメッシュサイズ
で篩分けした。粒子の大部分は90μｍの篩で保持され
た。 その粒子の90〜125μｍ分画の溶解速度を上記で示し
たようにU.S.薬局XX（U.S.Phamacopoeia XX）のパドル
法（Paddle Method）を用いて測定し。 その結果は次のとおりである。時間（ｈ） 溶解百分率（％） 0.5 42 １ 57 ２ 62 ３ 65 ４ 69 ５ 73 ６ 78 ７ 85 ８ 91 ９ 95 10 97 その粒子はテオフィリンの普通は苦い味を完全にマス
タしている無味のものであることがわかった。 実施例２ テオフィリンシロップ剤の調製 実施例１に従って調製された粒子を、5mlのシロップ
あたり200mgのテオフィリンを含有するテオフィリンシ
ロップ剤を得るように糖の水溶液（66％）中に懸濁す
る。経口的に投与された時、普通には苦いところのテオ
フィリンの味を完全にマスクしていた。 薬物学的データ テオフィリンの血漿レベルのプロフィルを、表１及び
表２にリストアップされたデータに従って２人の被検者
に対して得られた平均値から得た。図面３は、表１及び
表２に示された値に基づき実施例２に従って調製された
シロップ剤についての血漿レベル（mcg/ml）対投与後の
時間（hours）のグラフである。 10時間後の血漿レベルは、１時間後の血漿レベルと大
きな違いがないことが、添付された図面３及び表１及び
表２から観察された。従って、そのグラフは、10時間以
上にわたり血漿レベルの変動が最小であるような持続性
の吸収層であることを示している。普通には、テオフィ
リン（迅速性又は中程度の放出性のもの）は２時間でピ
ークを示す。テオフィリンの明らかにされている生物的
な半減期は、４〜９時間の範囲であるとされてきた。普
通には７時間まででピーク時の血漿レベルの1/2が期待
され、10時間まででピーク時の血漿レベルの約1/3が期
待されよう。 これらの結果は、実施例２に従って調製されたシロッ
プ剤が、全く完全に12時間の間隔、すなわち毎日２回の
投薬を可能としていることを示している。このことは、
従来の非徐放性のあるいは速効性のテオフィリンの投薬
頻度の半分である。 実施例３ テオフィリン懸濁剤 テオフィリン マイクロ粒子「ファルマソーム（Phar
masomes）」（実施例１に従って調製された）を次から
なる液体ビヒクルに懸濁した： 70％ソルビトール溶液 89.9重量％ グリセリン 10.0重量％ ポリソルベート−80 （Polysorbate−80） 0.1重量％ （商標） 5mlあたり200mgのテオフィリンを含有する懸濁剤とし
た。 その懸濁剤のサンプルを室温で保存し、サスペンジョ
ン中の「ファルマソーム（Pharmasomes）」の安定性を
決定するため間隔をおいてテストした。 調製時には、テオフィリンの分析含有量は、188.4mg/
5mlであり、15週間後には、それは薬物のどんな化学的
な変質もないことを示し、190.5mg/5mlであった。 溶解速度もまた15週間以上にわたってテストされ、そ
の結果を第３表及び第４図に要約する。 そこにおけるデータはその懸濁剤は調製後少くとも15
週間はその効能及び溶解特性を保持していることを示し
ている。 薬物学的データ 実施例３に従って調製された懸濁剤を720mg（18ml）
の１回投与し、対して従来のシロップ剤〔ソモフィリン
（Somophylline）〕は０時間目と６時間目にそれぞれ36
0mgづつ計２回投与することにより、バイオアベイラビ
リティーの研究について６人の被検者を用いテストし
た。その結果を第４表及び第５図に要約する。第５図に
おいて、曲線（ａ）は実施例３の懸濁剤を表わし、曲線
（ｂ）は対照として用いられたソモフィリン（Somophyl
line）シロップ剤を表わす。 そのデータは明らかに実施例３のテオフィリン懸濁剤
はわずかにその対照よりもバイオアベイラビリティーが
低い（87％）けれども、ピークまでの時間及び意味のあ
る血液レベルの期間は毎日２回の投薬法でよいことを示
している。なお、テオフィリンについての通常の生活規
制の投薬は、１日当り４回である。 実施例４及び実施例５ テオフィリン マイクロ粒子「ファルマソーム（Phar
masomes）」を実施例１に従って調製し、二つのフラク
ションにふるいわけした。 実施例４−90ミクロンより小さい平均粒子サイズを有す
るマイクロ粒子 実施例５−90ミクロンより大きい平均粒子サイズを有す
るマイクロ粒子 「ファルマソーム（Pharmasomes）を次のものからな
るビヒクルに懸濁した。重量％ 70％ソルビトール溶液 85.3 アビセル RC 591 （Avicel RC 591）（商標） 0.7 カリウム ソルベート 0.3 二酸化チタン25％（70％ソルビトール中の）シメチコン
2.7 （Simethicone）（商標）10％乳剤 0.01 グリセリン 10.8 クエン酸 0.3 ラウリル硫酸ナトリウム 0.04 5mlあたり300mgのテオフィリンを含有する懸濁剤とし
た。 薬物学的データ 実施例４及び実施例５のシロップ剤を690mg（11.5m
l）の１回投与をするのに、対して従来のシロップ剤
〔ソモフィリン（Somophylline）〕は０時間目と６時間
目にそれぞれ320mgづつ計２回投与することにより、４
人の被検者を用いバイオアベイラビリティーについてテ
ストした。その結果を第５表及び第６図に要約した。第
６図の曲線（ａ）は実施例４の懸濁剤を表わし、曲線
（ｂ）は実施例５の懸濁剤を表わし、曲線（ｃ）は対照
として用いられたソモフィリン（Somophylline）シロッ
プ剤を表わす。 この結果は第７図に示されているように実施例３に対
する研究結果を確かめており、その第７図において曲線
（ａ）は実施例３の懸濁剤を表わし、曲線（ｂ）は実施
例４の懸濁剤を表わし、曲線（ｃ）は実施例５の懸濁剤
を表わしている。
【図面の簡単な説明】 第１図は、テオフィリンを含有するファルマソームの電
子顕微鏡から作られたハーフトーンの図である。 第２図は、テオフィリンが24時間水に溶解されることに
よって溶出された後のファルマソームの電子顕微鏡写真
から作られたハーフトーンの図である。 第３図は、第１表及び第２表に示された値に基づく、実
施例２のシロップ剤についての血漿レベル（mcg/ml）対
投与後の時間（hors）の測定結果を示す図である。 第４図は、実施例３について行われた15週間にわたる溶
解速度の試験結果を示す図である。 第５図は、実施例３について行われた、バイオアベイラ
ビリティの試験結果を示す図である。 第６図は、実施例４及び５のシロップ剤と対照シロップ
（ソモフィリン）のバイオアベイラビリティの試験結果
を示す図である。
フロントページの続き (72)発明者 ランドル テイ スパークス アメリカ合衆国 ジヨージア州 ゲニス ビル ピネブロツク ドライヴ 2620 (56)参考文献 特開 昭55−69509（ＪＰ，Ａ) 特開 昭59−205313（ＪＰ，Ａ) 特開 昭61−10（ＪＰ，Ａ) 特開 昭55−110105（ＪＰ，Ａ) 特開 昭57−149217（ＪＰ，Ａ) 特開 昭57−112321（ＪＰ，Ａ) 特開 昭57−34854（ＪＰ，Ａ) 特開 昭57−108010（ＪＰ，Ａ) 特開 昭51−79716（ＪＰ，Ａ) 特開 昭52−41214（ＪＰ，Ａ) 特開 昭49−94821（ＪＰ，Ａ) 特開 昭57−21314（ＪＰ，Ａ) 特開 昭56−122311（ＪＰ，Ａ) 特表 昭58−501128（ＪＰ，Ａ) 特公 昭46−29036（ＪＰ，Ｂ１) 特公 昭46−11839（ＪＰ，Ｂ１) 仲井 花野著「新製剤学」第１版 （1982−11−25）南山堂 Ｐ．259〜263

Claims (1)

  1. (57)【特許請求の範囲】 １．セルロースアセテートブチレートポリマーと緊密に
    混合されたテオフィリンを活性成分として、１日２回の
    投与に適する制御放出のために十分な量でマトリックス
    中に均一に分布して含む、平均粒径0.1〜125μｍの、粒
    子表面が上記ポリマーで完全に覆われてはいない、口内
    での咀しゃく運動によって有意な崩壊もしくは破砕を受
    けない、離散性マイクロマトリックス粒子からなるパウ
    ダーであって、食品または医薬品中に用いることができ
    る、制御放出性で且つテオフィリンの味を遮蔽した上記
    パウダー。 ２．セルロースアセテートブチレートポリマーと該ポリ
    マーと緊密に混合されたテオフィリンを活性成分とし
    て、１日２回の投与に適する制御放出のために十分な量
    でマトリックス中に均一に分布して含む、平均粒径0.1
    〜125μｍの、粒子表面が上記ポリマーで完全に覆われ
    ていない、口内での咀しゃく運動によって有意な崩壊も
    しくは破砕を受けない、離散性マイクロマトリックス粒
    子からなるパウダーであって、食品または医薬品中に用
    いることができる、制御放出性で且つテオフィリンの味
    を遮蔽した上記パウダー、の医薬有効量を含んでなるテ
    オフィリン製剤。 ３．錠剤、カプセル剤または座剤である、請求項２のテ
    オフィリン製剤。 ４．チュウアブル錠剤または溶融錠剤（melt tablet）
    である、請求項２または３のテオフィリン製剤。 ５．経口投与用液剤である、請求項２のテオフィリン製
    剤。 ６．ドロップ、懸濁剤、シロップ、注入剤または溶液剤
    である、請求項２のテオフィリン製剤。
JP60242585A 1984-10-30 1985-10-29 制御放出パウダー及びその製法 Expired - Lifetime JP2820239B2 (ja)

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FR2572282B1 (fr) 1989-03-31
CH669728A5 (ja) 1989-04-14
IT8567913A0 (it) 1985-10-29
HK44091A (en) 1991-06-14
AU4916185A (en) 1986-05-08
IE58110B1 (en) 1993-07-14
ZA858300B (en) 1986-07-30
BE903540A (fr) 1986-02-17
US4952402A (en) 1990-08-28
DK495585A (da) 1986-05-01
JPS61109711A (ja) 1986-05-28
AU579415B2 (en) 1988-11-24
SE8505099L (sv) 1986-05-01
NL193582B (nl) 1999-11-01
CA1268051A (en) 1990-04-24
US4940588A (en) 1990-07-10
GB8526591D0 (en) 1985-12-04
DK495585D0 (da) 1985-10-29
GB2166651B (en) 1988-11-16
DK175329B1 (da) 2004-08-23
US5354556A (en) 1994-10-11
NL193582C (nl) 2000-03-02
IT1185831B (it) 1987-11-18
BE903541Q (fr) 1986-02-17
DE3538429C2 (de) 1996-10-24
DE3538429A1 (de) 1986-04-30
GB2166651A (en) 1986-05-14
NL8502951A (nl) 1986-05-16
FR2572282A1 (fr) 1986-05-02
SE8505099D0 (sv) 1985-10-29

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