JP4703471B2 - エチルセルローズ水性分散液で被覆した放出制御製剤 - Google Patents
エチルセルローズ水性分散液で被覆した放出制御製剤 Download PDFInfo
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Description
ヒドロモルホンビーズは、ヒドロモルホンHClを水に溶出した溶液に、(登録商標名)Opadry Y-5-1442 ライトピンク(米国ペンシルベニア、ウエストポイントのコロロン社からの市販品であり、ヒドロオキシプロピルメチルセルロース、ヒドロオキシプロピルセルローズ、二酸化チタン、ポリエチレングリコール、D&C Red No.30 アルミニュームレーキとを含有する)20%w/wを加えて約1時間混和し、ついでワルスター(Wurster)の挿入装置を使ってニューパリエル(Nu-Pariel)18/20ビーズに噴霧して製造した。その結果コートされたビーズをOpadry Y-5-1442 ライトピンク (15%w/w)でオーバーコートした。生成した製品の処方は下表1に記載された通りである:
実施例2では、60℃/85%RHでの硬化によって達成された安定な初期溶出が湿度を加えずに硬化時間を長くしても達成できるかどうかを確定するため、ヒドロモルホンHClビーズを実施例1に従って製造した。ビーズは(登録商標名)Aquacoatでコートした後、さらに(登録商標名)Opadry Y-5-1442 ライトピンクでオーバーコートした。コートされた製品は下表12に掲載の組成を有した:
実施例3では、高温だけではエチルセルローズフィルムの完全な凝結を確保できないという前提に立って、AquacoatでコートされたヒドロモルホンHClを別の手段で安定化することを試みた。可塑剤とAquacoatを混合(及び結合)する標準的時間は、FMCの奨励では30分である。実施例3では、可塑剤(クエン酸トリエチル)とエチルセルローズの重合体分散(Aquacoat)とを接触させる時間を24時間に延長した。
ヒドロモルホンビーズは、ヒドロモルホンHClを水に溶出した溶液に、(登録商標名)Opadryを加えて約1時間混合し、ついでワルスターの挿入装置を使ってニューパリエル18/20ビーズに噴霧して製造した。次いで、得られたコート済みビーズをOpadry Y-5-1442 ライトピンク(15%w/w)でオーバーコートした。ついでそのビーズを下表15に従って重量が15%増になるまでAquacoatの水性分散液でコートした:
可塑化エチルセルローズの放出制御フィルムを安定化する方法としての高温(60℃)−高湿硬化法の有効性を試験するため、実施例5−7ではAquacoatの負荷レベルを変えて実施した。
実施例1の方法に従ってヒドロモルホンHClとOpadry Y-5-1442 ライトピンク(20%w/w)との分散液をニューパリエル18/20ビーズ上に噴霧することによりヒドロモルホンHClビーズを作成した。ついで、これらのビーズを更に Opadry Y-5-1442 ライトピンク(15%w/w)でコートし、更に重量10%増を基準に(登録商標名)Sureleaseでコートした。コートされたビーズの処方を表26に掲げる:
次の実施例はこの発明に従いモルヒネビーズの安定化を説明するものである。硫酸モルヒネとHPMC(Opadry 透明 Y-5-7095)との分散液をワルスターの挿入装置を用いて流動床造粒機内の18/20メッシュ・ニューパリエルビーズに60℃で適用した。ついでHPMCの紫色の分散液(Opadry 薄紫 YS-1-4729)をオーバーコート剤として同一温度で適用した。ついでビーズをAquacoatと可塑剤としてのクエン酸トリエチルにより入口温度60℃で重量増5%までオーバーコートした。次に、ビーズを60℃/100%RHに設定したオーブン中で3日間硬化した。ついでビーズを流動床造粒機内で60℃で乾燥した後、それにHPMCの紫色のオーバーコート剤をワルスターの挿入装置を使って適用した。
第2の実験は実施例11に記述したようにモルヒネを使って行ったが、薬品効果を遅らせるAquzcoat層を15%の重量増になるまで適用して徐放性モルヒネ製品を開発した。最終処方を表31に掲げる:
放出制御ヒドロモルホン
HCl 8mg調合−1日1回製剤
実施例15−17では次のように準備した:
1.薬剤の装填:ヒドロモルホンビーズは、ヒドロモルホンHClを水に溶出した溶液に、Opadry Y-5-1442 ライトピンク(米国ペンシルベニア、ウエストポイントのコロロン社からの市販品であり、ヒドロオキシプロピルメチルセルローズ、ヒドロオキシプロピルセルローズ、二酸化チタン、ポリエチレングリコール、D&C Red No.30 アルミニュームレーキとを含有する)を加え且つ20%w/wの分散液を得るため約1時間混合して製造した。ついでこの分散液をワルスターの挿入装置を使ってニューパリエル18/20メッシュビーズに噴霧した。
実施例15:ビーズは全て5%Aquacoatコーティングを有する
実施例16:10%Aquacoatコーティングを有するビーズ75%と即放性ビーズ25%
実施例17:15%Aquacoatコーティングを有するビーズ75%と即放性ビーズ25%
実施例15−17のAquacoatでコートされたヒドロモルホンビーズについては初期時および28日後に溶出試験を行った。その結果を下表40−42に掲げる:
実施例18−20においては12個の検体について1回投与6通り無作為交差試験(1週間洗出し)を行い即放性製剤の等価用量で得られる結果と比較した。血液サンプルは血漿濃度を決めるため投与後直ぐ、0.25,0.5,0.75,1,1.5,2,2.5,3,3.5,4,6,8,10,12,18,24,30,36および48時間後に採取した。比較例18Aはヒドロモルホン即放性製剤8mg(Knoll社から市販されている(登録商標名)Dilaudid 4mg錠剤2錠)である。実施例18は実施例15のカプセル被包されたヒドロモルホンビーズの投与量8mgである。実施例19は実施例16のカプセル被包されたヒドロモルホンビーズの投与量8mgである。実施例20は実施例17のカプセル被包されたヒドロモルホンビーズの投与量8mgである。
実施例21では、5%w/wの制御放出コーティングを有しそのコーティング剤のうち穿孔剤として7%のHPMCを包含する硫酸モルヒネ制御放出ビーズを次のように製造する。
実施例21では、5%w/wの制御放出コーティングを有し(そのコーティング剤の重量に対して穿孔剤として5%のHPMCを包含する)硫酸モルヒネ制御放出ビーズを次のように製造する。
実施例23では、5%w/wの制御放出コーティングを有し(そのコーティング剤の重量に対して穿孔剤として3%のHPMCを包含する)硫酸モルヒネ制御放出ビーズを次のように製造する。
ヒトへの生物学的利用能の調査は、実施例21および22で製造された30mg硫酸モルヒネ制御放出カプセルと参照標準サンプル、(商標名)MS Contin 30mg錠(1日2回投与用として市販)とを比較して行われた。調査は正常な男性志願者を使い用量は絶食条件下で投与し洗い流し期間を1週間とした3通り交差調査とした。15人の志願者で調査を完了した。
実施例24のデータから明かになったことは、(ビーズがAquacoatの5%コーティング剤(HPMC分散比--95:5)でコートされる)実施例22のカプセルによって1日1回投与が適切であると思われる血液プロフィールが与えられたことである。しかし、そのデータの指摘するところによれば、穿孔剤(HPMC)の量をわずか減らせば1日1回製品についてさらに良好な用量処方を得ることができたであろう。それ故、ヒトへの生物学的利用能の調査は、実施例22のカプセルおよび参照用のMSコンチン30mgとともに3%の穿孔剤を包含する実施例23で製造されたカプセルを使用して行われた。同じ調査で食物と共に投与する効果も検討された。得られた結果の要約を表52に提示する:
制御放出アセトアミノフェン(APAP)の制御放出錠剤はこの発明に従い次のように作る。先ず、(商標名)コムパプ コアース U(Compap coarse U)を約555.6mgの重量の錠剤核に圧縮して即放性を有するAPAPの核を作る。Compap coarse Lは、結合剤、崩壊剤および潤滑剤を含む薬剤等級の粘性物質と共に約90%のAPAPを含んでおり、ミズーリ州、センルイスのMallinckrodt社より市販されている直接圧縮可能物質である。APAP錠剤の核にはAPAP約500mgが含まれている。Compap coarse Lは7/16"球状、標準凹形のキャップ、平板治具を備えた回転式錠剤プレスを用いて圧縮される。核は理論的重み555.6mgおよび硬度約8〜9kgで圧縮した。
実施例28では穿孔剤の量を増やすことにより実施例26の制御放出APAP製剤の放出速度を上げる。この実施例では即放性APAP錠剤コアーを実施例26に従って準備する。その後、即放性APAP錠剤コアーに穿孔剤として60%のHPMCを含んでいるエチルセルロースの水性分散液からなる制御放出コーティングを施す。
Claims (12)
- 硬化されコーティングされた基質を含む制御放出剤型であって、
該基質は鎮痛剤を有効量含有する即放性圧縮コアを含み、
該即放性圧縮コアは、可塑化されたエチルセルローズの水性分散液を含む制御放出性コートでコーティングされており、
前記制御放出性コートでコーティングされた即放性圧縮コアは相対湿度60〜100%で48〜72時間硬化され、
該剤型は、少なくとも24時間に亘って持続的放出作用を与える、
制御放出剤型。 - 前記即放性圧縮コアは錠剤である、請求項1に記載する制御放出剤型。
- 前記即放性圧縮コアは、2〜25%の重量増となる量の制御放出性コートでコーティングされている、請求項1又は2に記載する制御放出剤型。
- 前記鎮痛剤はヒドロモルホン塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はモルヒネ塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はオキシコドン塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はジヒドロコデイン塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はコデイン塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はジヒドロモルヒネ塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はブプレノルフィン塩である、請求項1又は3に記載する制御放出剤型。
- 前記鎮痛剤はアセトアミノフェンである、請求項1又は3に記載する制御放出剤型。
- 前記制御放出性コートはヒドロキシプロピルメチルセルローズを含む、請求項1又は3に記載する制御放出剤型。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/081,618 | 1993-06-23 | ||
US08/081,618 US5472712A (en) | 1991-12-24 | 1993-06-23 | Controlled-release formulations coated with aqueous dispersions of ethylcellulose |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP14201294A Division JP4505059B2 (ja) | 1993-06-23 | 1994-06-23 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
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JP2006188540A JP2006188540A (ja) | 2006-07-20 |
JP4703471B2 true JP4703471B2 (ja) | 2011-06-15 |
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Application Number | Title | Priority Date | Filing Date |
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JP14201294A Expired - Lifetime JP4505059B2 (ja) | 1993-06-23 | 1994-06-23 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
JP2006108991A Expired - Fee Related JP4703470B2 (ja) | 1993-06-23 | 2006-04-11 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
JP2006109017A Expired - Fee Related JP4703471B2 (ja) | 1993-06-23 | 2006-04-11 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
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Application Number | Title | Priority Date | Filing Date |
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JP14201294A Expired - Lifetime JP4505059B2 (ja) | 1993-06-23 | 1994-06-23 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
JP2006108991A Expired - Fee Related JP4703470B2 (ja) | 1993-06-23 | 2006-04-11 | エチルセルローズ水性分散液で被覆した放出制御製剤 |
Country Status (14)
Country | Link |
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US (1) | US5472712A (ja) |
EP (9) | EP1477162B1 (ja) |
JP (3) | JP4505059B2 (ja) |
AT (3) | ATE409024T1 (ja) |
AU (2) | AU680491B2 (ja) |
CA (1) | CA2125904C (ja) |
DE (3) | DE69431089T2 (ja) |
DK (3) | DK1419766T3 (ja) |
ES (3) | ES2315599T3 (ja) |
FI (1) | FI121620B (ja) |
HK (1) | HK1048432A1 (ja) |
NO (1) | NO314566B1 (ja) |
PT (2) | PT630646E (ja) |
SI (2) | SI1477162T1 (ja) |
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Publication number | Priority date | Publication date | Assignee | Title |
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US5472712A (en) * | 1991-12-24 | 1995-12-05 | Euroceltique, S.A. | Controlled-release formulations coated with aqueous dispersions of ethylcellulose |
US5580578A (en) * | 1992-01-27 | 1996-12-03 | Euro-Celtique, S.A. | Controlled release formulations coated with aqueous dispersions of acrylic polymers |
US5968551A (en) | 1991-12-24 | 1999-10-19 | Purdue Pharma L.P. | Orally administrable opioid formulations having extended duration of effect |
US5478577A (en) * | 1993-11-23 | 1995-12-26 | Euroceltique, S.A. | Method of treating pain by administering 24 hour oral opioid formulations exhibiting rapid rate of initial rise of plasma drug level |
US5958459A (en) * | 1991-12-24 | 1999-09-28 | Purdue Pharma L.P. | Opioid formulations having extended controlled released |
US5681585A (en) * | 1991-12-24 | 1997-10-28 | Euro-Celtique, S.A. | Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer |
US7070806B2 (en) * | 1992-01-27 | 2006-07-04 | Purdue Pharma Lp | Controlled release formulations coated with aqueous dispersions of acrylic polymers |
NZ260408A (en) | 1993-05-10 | 1996-05-28 | Euro Celtique Sa | Controlled release preparation comprising tramadol |
US7740881B1 (en) | 1993-07-01 | 2010-06-22 | Purdue Pharma Lp | Method of treating humans with opioid formulations having extended controlled release |
IL110014A (en) * | 1993-07-01 | 1999-11-30 | Euro Celtique Sa | Solid controlled-release oral dosage forms of opioid analgesics |
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