JP2016028078A - ポリマーフィルム中の医薬の結晶化を防止する方法 - Google Patents
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Abstract
【解決手段】ポリマーフィルム中の医薬の結晶化を防止する方法であって、該ポリマーフィルムは、溶媒、マトリクス形成ポリマー及び溶解形態で存在する少なくとも1つの医薬を含むコーティング材で基材がコーティングされる工程により形成され;前記マトリクス形成ポリマーはポリシロキサン、ポリイソブチレン及びブロックコポリマーからなる群より選択され;前記溶媒は加熱を適用する乾燥工程でコーティング材から除去され;前記乾燥工程はコーティング材中に存在する医薬の融点より10〜25℃上回る温度で15分を超えない時間、コーティング材を乾燥することを含む、医薬組成物の製造方法。
【選択図】なし
Description
を防ぐための方法に関する。本明細書中における「自発結晶化」とは、いかなる知覚可能な刺激なしでも生じる結晶化を意味する。
晶化は問題とみなされない。医薬で過飽和状態のマトリクスシステム(これは、アモルファス形態の医薬を含むシステムを包含する)は、医薬の熱力学活性およびバイオアベイラビリティーが特に高いという利点を有している。しかしながら、この利点は、過飽和マトリクスシステムは準安定性であり、医薬のバイオアベイラビリティーは、その結晶化によって非常に不利益な影響を及ぼすという不利な点と対比される。
ー混合物、および少なくとも1つの医薬を含むコーティング材でコーティングされており、かつその溶媒または溶媒混合物は熱をかけることによってそのコーティングから除去され、溶媒除去の間の最高温度はその医薬の融解温度を時々少なくとも10℃上回ることにより純粋な乾燥に必要な温度よりも高い点にある。
外側の相は自己接着性ポリシロキサンポリマーで構成されており、内側の相はポリビニルピロリドン/医薬複合体で構成されている2相のシステムを作成した。分散物で構成されているコーティング材は、外側の相のポリシロキサン接着剤がn−ヘプタン溶液中に存在しており、内側の相の医薬、ロチゴチンおよびポリビニルピロリドンは、エタノール溶液中に存在している。医薬、ロチゴチンは、97〜99℃の融解温度を有しており、コーティング材中の飽和溶解度を、室温で超える。
ロチゴチン含有コーティング材を実施例1に記載したとおりに作成し、基材上に同じ方法でコーティングした。実施例1からの逸脱として、このコーティングを表2に示される温度プロフィールにより乾燥させた。
Claims (10)
- ポリマーフィルム中の医薬の結晶化を防止する方法であって、マトリクス形成ポリマーまたはマトリクス形成ポリマー混合物、および少なくとも1つの医薬を含む、ポリマーフィルムを製造するために塗布される溶媒含有コーティング材が、コーティング材中に存在する医薬の融解温度を時々少なくとも10℃上回る温度で乾燥されることを特徴とする、方法。
- 温度が、医薬の融解温度を時々15〜25℃上回ることを特徴とする、請求項1に記載の方法。
- 乾燥温度が130℃を超えないことを特徴とする、請求項1または2に記載の方法。
- コーティングした材料を、医薬の融点を少なくとも10℃上回る温度で、少なくとも1分間、好ましくは少なくとも100秒間、より好ましくは少なくとも3分間、乾燥することを特徴とする、請求項1〜3のいずれか1項に記載の方法。
- コーティングした材料を、医薬の融点を少なくとも10℃上回る温度で、15分を超えない、好ましくは10分を超えない、より好ましくは5分を超えない時間、乾燥することを特徴とする、請求項1〜4のいずれか1項に記載の方法。
- マトリクス形成ポリマー、またはマトリクス形成ポリマー混合物の少なくとも1つのポリマーが、ポリシロキサン、ポリアクリレート、ポリイソブチレンおよびブロックコポリマーからなる群より選択されることを特徴とする、請求項1〜5のいずれか1項に記載の方法。
- マトリクス形成ポリマーが耐アミン性ポリシロキサンであることを特徴とする、請求項1〜6のいずれか1項に記載の方法。
- 溶媒が、ヘプタン、ヘキサン、シクロヘキサン、酢酸エチル、エタノール、メタノール、イソプロパノールおよびテトラヒドロフランからなる有機溶媒の群より選択されることを特徴とする、請求項1〜7のいずれか1項に記載の方法。
- 医薬が、120℃未満の融解温度、好ましくは115℃未満の融解温度、より好ましくは105℃未満の融解温度を持つことを特徴とする、請求項1〜8のいずれか1項に記載の方法。
- 医薬が、ロチゴチン及びフェンタニルを含む群より選択されることを特徴とする、請求項1〜9のいずれか1項に記載の方法。
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JP2020203839A (ja) * | 2019-06-14 | 2020-12-24 | 株式会社大石膏盛堂 | 経皮吸収型製剤の製造方法 |
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PL2350096T3 (pl) | 2008-10-02 | 2020-06-29 | Salix Pharmaceuticals, Ltd. | Sposoby leczenia encefalopatii wątrobowej |
DE102011090178A1 (de) * | 2011-12-30 | 2013-07-04 | Lts Lohmann Therapie-Systeme Ag | Transdermales therapeutisches System mit geringer Neigung zur Spontankristallisation |
TW201431570A (zh) | 2012-11-22 | 2014-08-16 | Ucb Pharma Gmbh | 用於經皮投服羅替戈汀(Rotigotine)之多天式貼片 |
CN103919755B (zh) * | 2013-01-15 | 2019-10-18 | 江苏康倍得药业股份有限公司 | 妥洛特罗透皮贴剂及其制备方法 |
US10046151B2 (en) | 2013-07-03 | 2018-08-14 | Lts Lohmann Therapie-Systeme, Ag | Transdermal therapeutic system with electronic component |
WO2015177212A1 (en) | 2014-05-20 | 2015-11-26 | Lts Lohmann Therapie-Systeme Ag | Transdermal delivery system including an interface mediator |
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