JP5674641B2 - 噴霧凝固工程の適用下での中間粉末製剤および最終固体剤形の製造方法 - Google Patents
噴霧凝固工程の適用下での中間粉末製剤および最終固体剤形の製造方法 Download PDFInfo
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- JP5674641B2 JP5674641B2 JP2011507837A JP2011507837A JP5674641B2 JP 5674641 B2 JP5674641 B2 JP 5674641B2 JP 2011507837 A JP2011507837 A JP 2011507837A JP 2011507837 A JP2011507837 A JP 2011507837A JP 5674641 B2 JP5674641 B2 JP 5674641B2
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- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
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- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
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Description
i)周囲温度において液体形態である、特に粘性液体稠度を有する(例えば、油など)か、または周囲温度においてワックス状の稠度を有する少なくとも1つの第1の成分、特に、周囲温度において固体または半固体であって15℃〜40℃の温度範囲で溶融が始まる成分を提供する工程と、
ii)周囲温度よりも高い温度から前記第1の成分の分解温度よりも低い温度までの範囲、特に周囲温度よりも高い温度から120℃までの範囲、より具体的には40℃よりも高い温度から120℃までの範囲、さらにより具体的には50℃〜120℃の範囲、またさらに具体的には55℃〜120℃の範囲の融点または溶融範囲を有する少なくとも1つの第2の成分を提供する工程と、
iii)前記第2の成分の融点または溶融範囲よりも高い温度から前記第1の成分の分解温度よりも低い温度までの範囲、特に、前記第2の成分の融点または溶融範囲よりも高い温度から120℃までの範囲の温度に混合物を攪拌および加熱するか、あるいは混合物をその温度で保持することによって、前記少なくとも1つの第1の成分および前記少なくとも1つの第2の成分を含む均一な液体混合物を形成する工程と、
iv)混合物をその移動中にその液体形態で保持するように適合された少なくとも1つの移動装置によって、前記液体混合物を少なくとも1つの噴霧凝固装置に移動させる工程と、
v)前記混合物を噴霧凝固させる工程と、
vi)噴霧凝固において得られた粉末を単離する工程と
を含む、粉末の製造方法によって解決された。
a)少なくとも1つの医薬有効成分(成分a)を提供する工程と、
b)本発明に従う上記の噴霧凝固法に従って粉末(成分b)を提供する工程と、
c)少なくとも1つの第3の成分(成分c)を提供する工程と、
d)成分aおよびbおよびcを含む混合物を形成する工程と、
e)前記混合物を固体剤形に変形させる工程と
を含む、固体剤形(特に、錠剤)の製造方法によって解決された。
a)本発明に従う上記の噴霧凝固法に従って粉末(成分a)を提供する工程であって、第1の成分、特に第1の液体成分が医薬有効成分であり、少なくとも1つの第2の成分が上記で定義した通りである工程と、
b)少なくとも1つの第3の成分(成分b)を提供する工程と、
c)成分a)およびb)を含む混合物を形成する工程と、
d)前記混合物を固体剤形に変形させる工程と
を含む、固体剤形の製造方法も含む。
鎮痛および抗炎症薬(NSAID、フェンタニル、インドメタシン、イブプロフェン、ケトプロフェン、ナブメトン、パラセタモール、ピロキシカム、トラマドール、タペンタドール(tapentadol)、COX−2阻害薬(セレコキシブおよびロフェコキシブなど))と、
抗不整脈薬(プロカインアミド、キニジン、ベラパミル)と、
抗菌薬および抗原虫薬(アモキシシリン、アンピシリン、ベンザチンペニシリン、ベンジルペニシリン、セファクロル、セファドロキシル、セフプロジル、セフロキシムアキセチル、セファレキシン、クロラムフェニコール、クロロキン、シプロフロキサシン、クラリスロマイシン、クラブラン酸、クリンダマイシン、ドキシサイクリン(doxyxycline)、エリスロマイシン、フルクロキサシリンナトリウム、ハロファントリン、イソニアジド、カナマイシン硫酸塩、リンコマイシン、メフロキン、ミノサイクリン、ナフシリンナトリウム、ナリジクス酸、ネオマイシン、ノルフロキサシン、オフロキサシン、オキサシリン、フェノキシメチル−ペニシリンカリウム、ピリメタミン−スルファドキシン(sulfadoxime)、ストレプトマイシン)と、
抗凝固薬(ワルファリン)と、
抗うつ薬(アミトリプチリン、アモキサピン、ブトリプチリン、クロミプラミン、デシプラミン、ドチエピン、ドキセピン、フルオキセチン、レボキセチン、アミネプチン、セレギリン、ゲピロン、イミプラミン、炭酸リチウム、ミアンセリン、ミルナシプラン、ノルトリプチリン、パロキセチン、セルトラリン、3−[2−[3,4−ジヒドロベンゾフロ[3,2−c]ピリジン−2(1H)−イル]エチル]−2−メチル−4H−ピリド[1,2−a]ピリミジン−4−オン)と、
抗糖尿病薬(グリベンクラミド、メトホルミン)と、
抗てんかん薬(カルバマゼピン、クロナゼパム、エトスクシミド、ガバペンチン、ラモトリギン、レベチラセタム、フェノバルビトン、フェニトイン、プリミドン、チアガビン、トピラマート、バルプロミド、ビガバトリン)と、
抗真菌薬(アンホテリシン、クロトリマゾール、エコナゾール、フルコナゾール、フルシトシン、グリセオフルビン、イトラコナゾール、ケトコナゾール、ミコナゾール硝酸塩、ニスタチン、テルビナフィン、ボリコナゾール)と、
抗ヒスタミン薬(アステミゾール、シンナリジン、シプロヘプタジン、デカルボエトキシロラタジン(decarboethoxyloratadine)、フェキソフェナジン、フルナリジン、レボカバスチン、ロラタジン、ノルアステミゾール(norastemizole)、オキサトミド、プロメタジン、テルフェナジン)と、
降圧薬(カプトプリル、エナラプリル、ケタンセリン、リシノプリル、ミノキシジル、プラゾシン、ラミプリル、レセルピン、テラゾシン)と、
抗ムスカリン薬(アトロピン硫酸塩、ヒヨスチン)と、
抗悪性腫瘍薬および代謝拮抗薬(白金化合物(シスプラチン、カルボプラチンなど)、タキサン、(パクリタキセル、ドセタキセルなど)、テカン(tecan)(カンプトテシン、イリノテカン、トポテカンなど)、ビンカアルカロイド(ビンブラスチン、ビンデシン(vindecine)、ビンクリスチン、ビノレルビンなど)、ヌクレオシド誘導体および葉酸拮抗薬(5−フルオロウラシル、カペシタビン、ゲムシタビン、メルカプトプリン、チオグアニン、クラドリビン、メトトレキセートなど)、アルキル化剤(ナイトロジェンマスタード、例えばシクロホスファミド、クロランブシル、クロルメチン、イホスファミド、メルファラン、またはニトロソ尿素、例えばカルムスチン、ロムスチン、または他のアルキル化剤、例えばブスルファン、ダカルバジン、プロカルバジン、チオテパなど)、抗生物質(ダウノルビシン、ドキソルビシン、イダルビシン、エピルビシン、ブレオマイシン、ダクチノマイシン、マイトマイシンなど)、HER2抗体(トラスツズマブなど)、ポドフィロトキシン誘導体(エトポシド、テニポシドなど)、ファルネシルトランスフェラーゼ阻害薬、アントラキノン(anthrachinon)誘導体(ミトキサントロンなど)、hdm2拮抗薬、HDAC阻害薬、cMet阻害薬)と、
抗片頭痛薬(アルニジタン(alniditan)、ナラトリプタン、スマトリプタン)と、
抗パーキンソン病薬(ブロモクリプチンメシル酸塩(bromocryptine mesylate)、レボドパ、セレギリン)と、
抗精神病薬、催眠薬および鎮静薬(アルプラゾラム、ブスピロン、クロルジアゼポキシド、クロルプロマジン、クロザピン、ジアゼパム、フルペンチキソール、フルフェナジン、フルラゼパム、9−ヒドロキシリスペリドン、ロラゼパム、マザペルチン(mazapertine)、オランザピン、オキサゼパム、ピモジド、ピパンペロン、ピラセタム、プロマジン、リスペリドン、セルホテル(selfotel)、セロクエル、セルチンドール、スルピリド、テマゼパム、チオチキセン、トリアゾラム、トリフルペリドール、ジプラシドン、ゾルピデム)と、
抗卒中薬(ルベルゾール(lubeluzole)、ルベルゾールオキシド、リルゾール、アプチガネル、エリプロジル(eliprodil)、レマセミド(remacemide))と、
鎮咳薬(デキストロメトルファン、レボドロプロピジン(laevodropropizine)と、
抗ウイルス薬(アシクロビル、ガンシクロビル(ganciclovir)、ロビリド、チビラピン、ジドブジン、ラミブジン、ジドブジン+ラミブジン、ジダノシン、ザルシタビン、スタブジン、アバカビル、ロピナビル、アンプレナビル、ネビラピン、エファビレンツ、デラビルジン、インジナビル、ネルフィナビル、リトナビル、サキナビル、アデホビル、ヒドロキシ尿素、エトラビリン、ダルナビル、リルピビリン(rilpivirine))と、
β−アドレナリン受容体遮断薬(アテノロール、カルベジロール、メトプロロール、ネビボロール、プロパノロール(propanolol))と、
強心剤(cardiac inotropic agent)(アムリノン、ジギトキシン、ジゴキシン、ミルリノン)と、
副腎皮質ステロイド薬(ジプロピオン酸ベクロメタゾン、ベタメタゾン、ブデソニド、デキサメタゾン、ヒドロコルチゾン、メチルプレドニゾロン、プレドニゾロン、プレドニゾン、トリアムシノロン)と、
消毒薬(クロルヘキシジン)と、
利尿薬(アセタゾラミド、フルセミド、ヒドロクロロチアジド、イソソルビド)と、
酵素と、
精油(アネトール、アニス油、キャラウェー、カルダモン、カッシア油、シネオール、桂皮油、クローブ油、コリアンダー油、脱メントール化ミント油、ディル油、ユーカリ油、オイゲノール、ショウガ、レモン油、カラシ油、橙花油、ナツメグ油、オレンジ油、ペパーミント、セージ、スペアミント、テルピネオール、タイム)と、
胃腸薬(シメチジン、シサプリド、クレボプリド、ジフェノキシラート、ドンペリドン、ファモチジン、ランソプラゾール、ロペラミド、酸化ロペラミド、メサラジン、メトクロプラミド、モサプリド、ニザチジン、ノルシサプリド(norcisapride)、オルサラジン、オメプラゾール、パントプラゾール、ペルプラゾール(perprazole)、プルカロプリド(prucalopride)、ラベプラゾール、ラニチジン、リドグレル、スルファサラジン)と、
止血薬(アミノカプロン酸)と、
脂質調節剤(アトルバスタチン、ロバスタチン、プラバスタチン、プロブコール、シンバスタチン)と、
局所麻酔薬(ベンゾカイン、リグノカイン)と、
オピオイド鎮痛薬(ブプレノルフィン、コデイン、デキストロモラミド、ジヒドロコデイン、ヒドロコドン、オキシコドン、モルヒネ)と、
副交感神経刺激薬および抗認知症薬(ATT−082、エプタスチグミン(eptastigmine)、ガランタミン、メトリホナート、ミラメリン(milameline)、ネオスチグミン、フィゾスチグミン、タクリン、ドネペジル、リバスチグミン、サブコメリン(sabcomeline)、タルサクリジン(talsaclidine)、キサノメリン、メマンチン、ラザベミド)と、
ペプチドおよびタンパク質(抗体、ベカプレルミン、シクロスポリン、エリスロポエチン、免疫グロブリン、インスリン(insuline))と、
性ホルモン(エストロゲン、結合型エストロゲン、エチニルエストラジオール、メストラノール、エストラジオール、エストリオール、エストロン、プロゲストーゲン、酢酸クロルマジノン、酢酸シプロテロン、17−脱アセチルノルゲスチメート、デソゲストレル、ジエノゲスト、ジドロゲステロン、二酢酸エチノジオール、ゲストデン、3−ケトデソゲストレル、レボノルゲストレル、リネストレノール、酢酸メドロキシ−プロゲステロン、メゲストロール、ノルエチンドロン、酢酸ノルエチンドロン、ノルエチステロン、酢酸ノルエチステロン、ノルエチノドレル、ノルゲスチメート、ノルゲストレル、ノルゲストリエノン、プロゲステロン、酢酸キンゲスタノール)と、
刺激薬(シルデナフィル)と、
血管拡張薬(アムロジピン、ブフロメジル、亜硝酸アミル、ジルチアゼム、ジピリダモール、三硝酸グリセリン、二硝酸イソソルビド、リドフラジン、モルシドミン、ニカルジピン、ニフェジピン、オクスペンチフィリン(oxpentifylline)、四硝酸ペンタエリトリトール)と、
これらのN−オキシド、これらの薬学的に許容可能な酸または塩基付加塩、これらの溶媒和物、およびこれらの立体化学的異性体が包含される。
−メチルセルロースなどのアルキルセルロース、
−ヒドロキシアルキルセルロース、例えば、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロースおよびヒドロキシブチルセルロース、
−ヒドロキシエチルメチルセルロースおよびヒドロキシプロピルメチルセルロースなどのヒドロキシアルキルアルキルセルロース、
−カルボキシメチルセルロースなどのカルボキシアルキルセルロース、
−カルボキシメチルセルロースナトリウムなどのカルボキシアルキルセルロースのアルカリ金属塩、
−カルボキシメチルエチルセルロースなどのカルボキシアルキルアルキルセルロース、
−カルボキシアルキルセルロースエステル、
−アルギン酸、そのアルカリ金属およびアンモニウム塩、カラゲナン、ガラクトマンナン、トラガカント、寒天、アラビアガム(gummi arabicum)、グァーガム、キサンタンガム、デンプン、ペクチン(ナトリウムカルボキシメチルアミロペクチンなど)、キチン誘導体(キトサンなど)、ポリフルクタン、イヌリンなどのその他の天然、半合成、または合成多糖類、
−ポリアクリル酸およびその塩、
−ポリメタクリル酸およびその塩、メタクリラートコポリマー、
−ポリビニルアルコール、
−ポリビニルピロリドン、ポリビニルピロリドンと酢酸ビニルとのコポリマー、
−ポリビニルアルコールおよびポリビニルピロリドンの組み合わせ、
−ポリエチレンオキシドおよびポリプロピレンオキシド、ならびにエチレンオキシドおよびプロピレンオキシドのコポリマーなどのポリアルキレンオキシドである。
a)本発明の上記噴霧凝固法に従って粉末(成分a)を提供する工程と、
b)工程a)の前記粉末と共に、少なくとも1つの第1の(特に、固体の)医薬有効成分(成分b)を提供し、そして/あるいは少なくとも1つの第2の医薬有効成分(特に、第1の成分の形態)を提供する工程と、
c)少なくとも1つの第3の成分(成分c)を提供する工程と、
d)そこから混合物を形成する工程と、
e)前記混合物を溶融押出する工程と、
f)押出生成物を捕集する工程と、
g)押出生成物を固体剤形、特に錠剤に圧縮する工程と、
を含む、固体剤形、特に錠剤の製造方法に関する。
a)周囲温度において液体形態である、特に粘性液体稠度を有する(例えば、油など)か、または周囲温度においてワックス状の稠度を有する少なくとも1つの第1の成分、特に、周囲温度において固体または半固体であって15℃〜40℃の温度範囲で溶融が始まる成分を提供する工程と、周囲温度よりも高い温度から前記第1の成分の分解温度よりも低い温度までの範囲、特に周囲温度よりも高い温度から120℃までの範囲、より具体的には40℃よりも高い温度から120℃までの範囲、さらにより具体的には50℃〜120℃の範囲、またさらに具体的には、55℃〜120℃または90℃を超えない範囲の融点または溶融範囲を有する少なくとも1つの第2の成分を提供する工程と、前記第2の成分の融点または溶融範囲よりも高い温度から前記第1の成分の分解温度よりも低い温度までの範囲、特に、前記第2の成分の融点または溶融範囲よりも高い温度から120℃まで、より好ましくは90℃を超えない範囲の温度に混合物を攪拌および加熱するか、あるいは混合物をその温度で保持することによって、前記少なくとも1つの第1の成分および前記少なくとも1つの第2の成分を含む均一な液体混合物を形成する工程と、混合物をその移動中にその液体形態で保持するように適合された少なくとも1つの移動装置によって、液体混合物を少なくとも1つの噴霧凝固装置に移動させる工程と、前記混合物を噴霧凝固させる工程と、噴霧凝固において得られた粉末を単離する工程とを含む方法に従って、粉末(成分a)を提供する工程と、
b)少なくとも1つの医薬有効成分(成分b)を提供する工程と、
c)少なくとも1つの第3の成分(成分c)を提供する工程と、
d)成分aおよびbおよびcを含む混合物を形成する工程と、
e)前記混合物を溶融押出する工程と、
f)特に少なくとも1つのストランドの形態または前記少なくとも1つのストランドの切断によって得られる個片の形態の押出生成物を捕集する工程と、
g)特に少なくとも1つのストランドの形態または前記少なくとも1つのストランドの切断によって得られる個片の形態の前記押出生成物に錠剤プレスを受けさせる工程と、
h)打抜き工程/圧縮工程の後に錠剤プレスから錠剤(単数または複数)を捕集する工程と
を含む、錠剤の製造方法にも関するということが導き出され得る。
以下の組成を有する噴霧凝固粉末の製造:
DL−α−トコフェロール(ビタミンE) 4.00重量%
ポリエチレングリコール6000(PEG6000) 96.00重量%
ビタミンEおよびPEG6000の必要量を検量した。Chromalox Micro Therm温度制御システムが取り付けられたミキサーを有する適切なサイズのステンレス鋼供給タンクを窒素でパージした。供給タンク内にPEG6000をゆっくり添加した。部分的に溶融したら、ミキサーにより攪拌して、溶融を促進した。PEG6000を完全に添加し、溶融させたら、80℃の溶融温度を保持した。タンクを窒素により連続的にパージした。溶融PEG6000にビタミンEを添加した。噴霧凝固を開始する前に、混合を少なくとも10分間続けた。噴霧凝固法全体を通して攪拌を続けた。
供給ラインのための熱制御装置を90℃に設定し、少なくとも30分間予熱した。
装置:Niro−PSD−2(登録商標)(2.0mmのオリフィス直径を有する2流体ノズル)
噴霧ガス:窒素(80℃)
噴霧ガス圧 1.0バール
工程ガス:窒素、流速425CMH
供給速度:9kg/時
出口温度:10℃
冷却器温度:0℃。
生成物ドラム内のサイクロンから噴霧凝固粉末を捕集した(密封する前に窒素で最低5分間パージした)。
ビタミンEを含有する粉末の製造
目的は、少量のビタミンEを粉末ブレンド中に分配することであった。粉末ブレンドは、タペンタドールHCl、ポリエチレンオキシド7M、ヒドロキシプロピルメチルセルロースおよびポリエチレングリコール6000で構成した。
少量の液体(ビタミンEなど)を粉末中に取り込む1つの方法は、まず液体を固体キャリアに吸収し、次に残りの固体賦形剤とブレンドすることである。希釈が重要である場合には、幾何学的に実施することができ、例えば、ビタミンE含有キャリアは、1つまたは複数の固体粉末と混合され(特定の希釈を得るために)、得られたブレンドは、同じまたは他の固体粉末と再度希釈される。まず、ビタミンEを賦形剤の1つ、すなわち粉末ブレンドの主成分であるポリエチレンオキシドPEO7Mに吸収することを試みた。9部のPEO上に1部のビタミンEを被覆することを試みた。PEO7M上へのビタミンEの分配は上手くいかなかった。
US2タイプのNeusilinはビタミンEの分配が著しく悪く、非常に大きい塊が形成された。
ビタミンE被覆Neusilin ULF2(1:1 w:w)を75μmのふるいにかけ、1gの被覆キャリアをまず不活性賦形剤としての24gのポリ(エチレンオキシド)(PEO)7Mとブレンドした(=1/25希釈工程)(プレミックス)。次に、2.5gのこのプレミックスを47.5gのPEO7Mと再度ブレンドして(=1/20希釈工程)(最終混合物)、1/500希釈比とした。Turbulaミキサーを用いてブレンドを製造した。
ブレンド品質を改善するために、Neusilin塊は回避されなければならない。これには、造粒機内での塊の形成、および製造後の凝集傾向の防止が含まれる。従って、Neusilinの比率を増大させて、キャリア/ビタミンE混合物の安定化を試みた。塊形成の防止を助けるために、neusilin上でまとめて秤量する代わりに、シリンジによりビタミンEを添加した。さらに、PEO中の被覆キャリアの即時希釈の選択を試みた。さらに、ふるい分けの必要性を評価した。このために、Neusilinの単一のバッチを被覆し、4つの画分に分割し、そのうちの2つはさらに処理しなかったが、1つはふるいにかけ(500μmのふるい)、2つの画分はプレミックスを生じるために使用し、この場合も1つのプレミックスはふるいにかけた(被覆キャリアを500μmのふるいにかけ(75μmのふるいに比べてより製造規模に適合される)、次にPEOで希釈した(1/25希釈))。ビタミンEの加熱(40℃)は、シリンジの充填を可能にするために粘度を十分に低下させることが必要であると分かった。以前はビタミンEが造粒機の壁に付着し得ることにより、ボウルの排出後に塊を生じたので、シリンジを使用することによって、塊の形成が大幅に低減された。
NeusilinにおけるビタミンEの分配をさらに改善して凝集体形成を最小限にするために、ビタミンEと混和性の溶媒を選択して、濃い油性ビタミンEの粘度を大きく変更した。この実験では、用量シリンジの充填の前に、2.77gのビタミンEを2.22gのエタノール96°と混合した。混合は、250mlのボウルを用いてMi−Pro内で行った。ビタミンE/エタノール溶液を、7.1gのNeusilin UFL2および約100mgの酸化鉄を含有するボウル内に注入した。前の実験について示したように、単一の被覆バッチから4つの画分を作った。2つの画分は未処理の被覆キャリアであり、そのうち1つだけを500μmのふるいにかけ、2つの画分をさらにプレミックスに希釈して、この場合も1つはふるいにかけた(被覆キャリアを500μmのふるいにかけ、次にPEOで希釈した)。プレミックスは、1部の被覆Neusilinと19部のPEO7Mとで構成し、プレミックスに1/20の希釈係数を与えた。250mbarの真空下で、全ての画分を30℃で一晩乾燥させた。
ビタミンEおよびPEG6000の噴霧凝固
PEG6000を秤量し、オフラインの加熱プレート上で溶融した。実験が行われるほんの少し前に、適切な量のビタミンEを添加し、PEG6000と機械的に混合した。混合物を約75〜80℃に加熱し、加熱供給ラインによってMobile Minor噴霧乾燥器の噴霧ノズルに移した。100℃に予熱したN2を用いて混合物を2流体ノズルから噴霧した。冷却ガスもN2であり、11〜13℃の入口温度および20〜26℃の範囲の出口温度を有した。噴霧の後、噴霧乾燥器のサイクロン内に粒子を捕集した。
安定性試験
ビタミンEをキャリアに吸収することによって製造される粉末、または噴霧凝固によって製造される(実施例3に従って製造される)粉末をガラス瓶に入れ、種々の条件(5℃および30℃/75%相対湿度)下で貯蔵した。「活性」ビタミンE(抗酸化活性をまだ有するビタミンE)の濃度はHPLCアッセイによって決定し、粉末の外観は視覚的に検査した。
第1の工程工程では、Mi−Pro(0.25Lのボウル、インペラ速度200〜400rpm、チョッパー速度500〜650rpmで45分間)において、全てのneusilinをビタミンE/EtOH混合物で被覆した。ボウルを空にした後、Pro−C−epT(0.25Lのボウル中、250rpmのインペラ速度で12分間)において、5gの被覆neusilinを70gのPEO7Mとブレンドすることにより画分1を作った。次にこれを空にしたら、4.5gの被覆Neusilinおよび63.0gのPEO7Mを用いて画分2を作った(0.25Lのボウル中、250rpmのインペラ速度で16分間)。画分1および2は同じ相対組成を有するが、画分2(=Neusilin粉末1)は300mbarbの真空下25℃で16時間の後乾燥を行ったが、画分1(=Neusilin粉末2)は行わなかった点が異なる。
ブレンド均一性(BU)
粉末ブレンド組成物1:
タペンタドールHCl 58.24mg
ポリエチレンオキシドWSR303
ヒドロキシプロピルメチルセルロース
ポリエチレングリコール6000
ポリエチレングリコール6000およびαトコフェロールの噴霧凝固粉末(噴霧凝固粉末中4.56%のビタミンE) 13.16mg
粉末の全重量 400mg
タペンタドールHCl 291.20mg
ポリエチレンオキシドWSR303
ヒドロキシプロピルメチルセルロース
ポリエチレングリコール6000
ポリエチレングリコール6000およびαトコフェロールの噴霧凝固粉末(噴霧凝固粉末中4.56%のビタミンE) 15.35mg
粉末の全重量 700mg
錠剤の含量均一性(CU)
粉末ブレンド組成物3:
タペンタドールHCl 58.24mg
ポリエチレンオキシドWSR303
ヒドロキシプロピルメチルセルロース
ポリエチレングリコール6000
ポリエチレングリコール6000およびαトコフェロールの噴霧凝固粉末(噴霧凝固粉末中4%のビタミンE) 15.00mg
粉末の全重量 400mg
タペンタドールHCl 291.20mg
ポリエチレンオキシドWSR303
ヒドロキシプロピルメチルセルロース
ポリエチレングリコール6000
ポリエチレングリコール6000およびαトコフェロールの噴霧凝固粉末(噴霧凝固粉末中4%のビタミンE) 17.50mg
粉末の全重量 700mg
Claims (14)
- i) − 周囲温度において液体形態であるか、あるいは
− 周囲温度において固体または半固体であって15℃〜40℃の温度範囲において溶融が始まる、
少なくとも1つの第1の成分を提供する工程と、
ii)周囲温度よりも高い融点または溶融範囲を有し、ポリアルキレングリコールを含むか、あるいはポリアルキレングリコールからなる少なくとも1つの第2の成分を提供する工程と、
iii)前記第2の成分の融点または溶融範囲よりも高い温度から120℃までの範囲の温度に混合物を攪拌および加熱するか、あるいは混合物をその温度で保持することによって、前記少なくとも1つの第1の成分および前記少なくとも1つの第2の成分を含む均一な液体混合物を形成する工程と、
iv)混合物をその移動中にその液体形態で保持するように適合された少なくとも1つの移動装置によって、前記液体混合物を少なくとも1つの噴霧凝固装置に移動させる工程と、
v)前記混合物を噴霧凝固させる工程と、
vi)噴霧凝固において得られた粉末を単離する工程と
を含み、この際、上記少なくとも1つの第1の成分がトコフェロールおよび/またはトコフェロールエステルを含むか、あるいはこれらからなり、そして工程iii)で形成される均一な液体混合物が、92重量%〜99.9重量%の前記少なくとも1つの第2の成分と、0.1重量%〜8重量%の前記少なくとも1つの第1の成分とを含む、固体剤形の製造用粉末の製造方法。 - 前記少なくとも1つの第2の成分が、ポリエチレングリコールを含むか、あるいはこれらからなる、請求項1に記載の方法。
- 前記ポリエチレングリコールが、ポリエチレングリコール6000である請求項2に記載の方法。
- 前記移動装置が少なくとも1つの供給ラインおよび少なくとも1つのポンプを含み、少なくとも前記供給ラインが、加熱可能であるように適合された、請求項1〜3のいずれか一項に記載の方法。
- 前記第2の成分の融点または溶融範囲が、40℃よりも高い温度から120℃までの範囲である、請求項1〜4のいずれか一項に記載の方法。
- 請求項1〜5のいずれか一項に記載の方法によって入手可能な粉末。
- 92重量%〜99.9重量%の前記少なくとも1つの第2の成分としてのポリアルキレングリコールと、0.1重量%〜8重量%の前記少なくとも1つの第1の成分としてのトコフェロールとを含むか、あるいはこれらからなる請求項6に記載の粉末。
- 40μm〜300μmの範囲の粒径分布d50を有する、請求項6または7に記載の粉末。
- 少なくとも1つの医薬有効成分を含有する固体剤形を製造するための、請求項6〜8のいずれか一項に記載の粉末の使用。
- 前記固体剤形が、少なくとも1つの医薬有効成分、少なくとも1つのポリ(アルキレンオキシド)、少なくとも1つのセルロースエーテル誘導体、少なくとも1つのポリアルキレングリコール、およびトコフェロールおよび/またはトコフェロールエステルを含む、請求項9に記載の使用。
- 前記トコフェロールおよび/またはトコフェロールエステルが、固体剤形の全重量を基準として1重量%未満の量で存在する、請求項10に記載の使用。
- a)請求項1〜5のいずれか一項に記載の方法に従って粉末(成分a)を提供する工程と、
b)少なくとも1つの医薬有効成分(成分b)を提供する工程と、
c)少なくとも1つの第3の成分(成分c)を提供する工程と、
d)成分a、bおよびcを含む混合物を形成する工程と、
e)前記混合物を固体剤形に変形させる工程と
を含む、固体剤形の製造方法。 - 前記少なくとも1つの第3の成分(成分c)が、ポリ(アルキレンオキシド)、ポリ(ビニルアルコール)、ヒドロキシメチルセルロース、ヒドロキシエチルセルロース、ヒドロキシプロピルセルロース、ヒドロキシプロピルメチルセルロースおよびカルボキシメチルセルロースからなる群から選択される、請求項12に記載の方法。
- a)請求項1〜5のいずれか一項に記載の方法に従って粉末(成分a)を提供する工程と、
b)少なくとも1つの医薬有効成分(成分b)を提供する工程と、
c)少なくとも1つの第3の成分(成分c)を提供する工程と、
d)成分a、bおよびcを含む混合物を形成する工程と、
e)前記混合物を溶融押出する工程と、
f)前記押出生成物を捕集する工程と、
g)前記押出生成物を錠剤に圧縮する工程と
を含む、請求項12または13のいずれか一項に記載の錠剤の製造方法。
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