JP2013542943A - 可食性フィルムに含まれる用量サイズを分析し確立する方法 - Google Patents
可食性フィルムに含まれる用量サイズを分析し確立する方法 Download PDFInfo
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- JP2013542943A JP2013542943A JP2013536869A JP2013536869A JP2013542943A JP 2013542943 A JP2013542943 A JP 2013542943A JP 2013536869 A JP2013536869 A JP 2013536869A JP 2013536869 A JP2013536869 A JP 2013536869A JP 2013542943 A JP2013542943 A JP 2013542943A
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Abstract
る。
【選択図】なし
Description
本願は、2010年10月29日出願の米国特許出願第12/915,849号の利益を主張する。この特許出願の内容全体は、参照により本明細書に援用したものとする。
本明細書で論じられるように、流動可能なフィルム形成マトリクスが本発明の教示に従って含量で一様であるように調製される。含量の一様性は、流動可能な物質がフィルムに成形され、乾燥される際に、維持されることが望ましい。本発明の乾燥方法は、、活性物質を安全な温度、すなわち、その活性物質が実質的に分解せず、または効力低下したかもしくは実質的に不活性なものにならない温度および/または条件に維持しながらフィルム内に一様性を生じるための幾つかの因子を使用してもよい。第一に、本発明のフィルムは極めて短い熱履歴、通常わずかに分のオーダーの熱履歴を有し、その結果、合計の温度暴露ができるだけ最小にされる。フィルムは成分の凝集および移行を防止するだけでなく、その中の熱蓄積を防止するように制御して乾燥される。フィルムは下部から乾燥されてもよいし、または上部および下部の乾燥の組み合わせであってもよい。この湿ったフィルムの上面は、このフィルムの厚さを所望の最終水分含量レベル(これは、本明細書中で後述されるように、全フィルム組成物の約10重量%以下である)まで乾燥する前にスキニングを引き起こさないように乾燥されることが望ましい。
本発明のフィルム単位または用量は、少なくとも1つの水溶性ポリマーを含む。このフィルムは、所望に応じて水膨潤性または水不溶性ポリマーも含んでもよい。
本発明のフィルムに組み込んでよい活性成分には、それだけには限らないが、ブタクサ花粉、胞子、微生物、種子、洗口剤成分、香味料、香料、酵素、保存料、甘味料、着色料、スパイス、ビタミンなど、医薬活性物質および化粧用活性物質、薬物、薬剤、抗原、またはアレルゲン、ならびにそれらの組合せが含まれる。
本発明のフィルムは乾燥の前にフィルム細片またはシートに成形されてもよい。所望の成分(ポリマー、水、および活性物質ならびに所望のその他の成分を含む)が合わされて多成分マトリックスを形成した後、その組み合わせが当業界で知られているあらゆる方法、例えば、多成分マトリックスの押出、被覆、塗布、キャスティングまたは圧伸成形により、シートまたはフィルムに成形される。多層フィルムが所望される場合、これは成分の1つより多い組み合わせ(これは同じ組成または異なる組成であってもよい)を同時押出することにより達成されてもよい。多層フィルムはまた既に形成されたフィルム層に組み合わせを被覆、塗布、またはキャスティングすることにより得られてもよい。
本発明は成分の実質的に一様な分布を有する自己支持性フィルムの製造方法を使用する。自己支持性フィルムは本明細書に説明された活性物質の送達に特に有益である。フィルムの製造方法はフィルムフィルム全体にわたって分布された成分の組成一様性を維持するように設計され、これは活性物質、例えば、医薬活性物質がフィルムに混入される場合に特に必要である。医薬に関しては、フィルムはそれが個々のフィルム投与単位(それぞれの投与単位が投与される場合に適当な量の活性物質を有する)に分けられるように組成上一様であることが必須であり、その結果、規制認可が確実にし得る。
乾燥工程はまたフィルム組成物の一様性を維持することに関して寄与因子である。制御された乾燥方法は、増粘性組成物、または粘度が、例えば、ポリマーの選択により調節される組成物の不在下で、フィルム内の成分が凝集または団塊する増大された傾向を有するかもしれない場合に特に重要である。
本発明の1つの実施形態では、以下の事柄を実証するために、1つの例を行った:(i) フィルムピースの重量とそのフィルムピースの中に存在する活性物質の均一分布との間に密接な相互関連性があること;(ii)この関連性のため、乾燥プロセスの間の揮発性成分の現実のロスを考慮して流動性フィルムマトリクスがキャストされるときに、フィルムの厚さを調整することができること。従って、所望の「表示値」は、この予測および調整のプロセスによって得られ得る。厚さの調整の結果、そのフィルムの単位面積あたりの重量の変化が生じる。
本発明の別の実施形態では、以下の事柄を実証するために、1つの例を行った:(i)フィルムピースの重量とそのフィルムピースの中に存在する活性物質の均一分布との間に密接な相互関連性があること;(ii)この関連性のため、乾燥プロセスの間の揮発性成分の現実のロスを考慮して流動性フィルムマトリクスがキャストされるときに、フィルムの厚さを調整することができること。従って、所望の「表示値」は、この予測および調整のプロセスによって得られ得る。厚さの調整の結果、そのフィルムの単位面積あたりの重量の変化が生じる。
図2は、この活性薬物についての異なる細片重量でのアッセイ間で優れた線形相関があったことを示す。それゆえ、これは、製造中の揮発物のロスを考慮するための1つの方法は、キャストフィルムの厚さを調整することによってピース重量を調整することであり、キャストフィルムの厚さを調整することは、各フィルムピース(投与単位)の中に所望の量の活性物質を調整して得るための手段として使用できるということを示す。
本発明の別の実施形態では、以下の事柄を実証するために、1つの例を行った:(i)フィルムピースの重量とそのフィルムピースの中に存在する活性物質の均一分布との間に密接な相互関連性があること;(ii)この関連性のため、所望の標的アッセイを成し遂げるために、フィルムマトリクスが切断されるときに、フィルムの長さを調整することができること。従って、この予測および調整のプロセスによって所望の「表示値」を得ることができる。長さの調整により、単位用量の重量の変化が生じる。
本発明の別の実施形態では、活性物質の連続測定がオンラインで利用できれば、所望の%LCを与えるようにフィルムの厚さを調整することができるということを実証するために、1つの例を行った。
図3および4は、実施例4についての吸光度スペクトルを示す。特に、図4は、二次微分吸光度スペクトルを示す。二次微分データへと変換することにより、そのスペクトルからより多くの詳細が得られる。図4の中の矢印は二次微分ピークを示し、このピークでは、サンプルは、下地からの影響なく強い二次微分を有する。灰色のピークはより大きく、このことは、サンプル厚さが2倍になったことに起因するより高い感度を示す。
本発明の別の実施形態では、NDCガンマゲージ(「NDC」)を使用してフィルムの厚さを調整することによってフィルムにおける単位面積あたりの塗布重量およびその後の活性物質濃度を制御することができることを実証するために、1つの例を行った。感度のよいゲージを使用して一連の測定結果を得ることによって、フィルム寸法を調整することが必要であるかどうかを示す計算がなされ得る。次いで、図14に示すように、製造ロスを補うために、フィルム寸法の予測および調整が行われ得る。調整の情報を製造機械に提供するためにフィードバックループを使用することができる。
これらの結果は、図14に示すように、各フィルムピース(投与単位)の中に所望の量の活性物質を得るために、感度のよいゲージ、すなわちガンマゲージ、を使用して一連の測定値を得ることによって、フィルムの厚さを調整するための手段として、フィルム寸法を調整する必要を示す計算がなされ得る、ということを示す。
Claims (45)
- 有効成分を含む可食性フィルムの製造方法であって、前記可食性フィルムは、前記有効成分について所定の用量を有し、前記製造方法は、
a)ポリマー成分および前記ポリマー成分に一様に分散した有効成分を含む連続フィルムを調製する工程;
b)前記フィルムを分析して、前記フィルムの単位重量あたりの前記有効成分の量を決定し、前記フィルムの単位重量あたりの前記成分の前記量に基づいて、前記有効成分について前記所定の用量を送達するために必要な前記フィルムの寸法を決定する工程;
c)前記フィルムの前記寸法を、工程(b)で決定された寸法へと調整する工程、
を含む、製造方法。 - 前記有効成分は、食品、医薬品、化粧用活性物質、薬物(医薬;解毒剤;ワクチン;抗原またはアレルゲン;洗口剤成分;香味料;香料;酵素;防腐剤;甘味剤;着色料;スパイス;ビタミン;冷感剤;刺激剤)、およびこれらの組み合わせからなる群から選択される、請求項1に記載の製造方法。
- 前記ポリマー成分は、単独で、または少なくとも1つの水溶性ポリマー組み合わせてポリエチレンオキシドを含む、請求項1に記載の製造方法。
- 前記調整は前記フィルムの長さを調整することである、請求項1に記載の製造方法。
- 前記調整は前記フィルムの幅を調整することである、請求項1に記載の製造方法。
- 前記調整は前記フィルムの重量を調整することである、請求項1に記載の製造方法。
- 前記調整は前記フィルムの長さおよび幅を調整することである、請求項1に記載の製造方法。
- 前記調整は前記フィルムの厚さを調整することである、請求項1に記載の製造方法。
- 前記調整は、追加の塗膜を前記フィルムに塗布することにより、前記フィルムの重量を調整することである、請求項1に記載の製造方法。
- 前記分析はオンラインで実施される、請求項1に記載の製造方法。
- 前記分析はオフラインで実施される、請求項1に記載の製造方法。
- 前記分析はオンラインで実施され、そのあと前記フィルムの厚さが調整される、請求項1に記載の製造方法。
- 前記分析はオフラインで実施され、そのあと前記フィルムの厚さが調整される、請求項1に記載の製造方法。
- 前記分析はオフラインで実施され、そのあと前記フィルムの長さが調整される、請求項1に記載の製造方法。
- 前記分析はオフラインで実施され、そのあと前記フィルムの幅が調整される、請求項1に記載の製造方法。
- 前記分析はオフラインで実施され、そのあと前記フィルムの長さおよび幅が調整される、請求項1に記載の製造方法。
- 前記有効成分は医薬活性物質または生物活性物質である、請求項1に記載の製造方法。
- 前記調整は切断することである、請求項1に記載の製造方法。
- 前記調整は塗布することである、請求項1に記載の製造方法。
- 前記調整は塗布パラメータを変えることである、請求項1に記載の製造方法。
- 前記調整は、分析装置と塗布設備との間のフィードバック制御ループによって成し遂げられる、請求項1に記載の製造方法。
- 前記フィルムは、乾燥前に分析および調整される、請求項1に記載の製造方法。
- 前記フィルムは、乾燥後に分析および調整される、請求項1に記載の製造方法。
- 有効成分を含む可食性フィルムの製造方法であって、前記可食性フィルムは前記有効成分について所定の用量を有し、前記製造方法は、
a)ポリマー成分、水および有効成分を合わせ、前記成分の均一分布をもつマトリクスを形成する工程;
(b)前記マトリクスからフィルムを形成する工程;
(c)上面および下面を有するコンベヤー表面を準備する工程;
(d)前記フィルムを、前記表面の前記上面の上へと供給する工程;
(e)前記フィルムを分析して、前記フィルムの単位重量あたりの前記有効成分の量を決定し、前記フィルムの単位重量あたりの前記成分の前記量に基づいて、前記有効成分について前記所定の用量を送達するために必要な前記フィルムの寸法を決定する工程;ならびに
(f)前記フィルムを工程(e)で決定された寸法へと調整する工程、
を含む、製造方法。 - 前記分析はオンラインで実施される、請求項24に記載の製造方法。
- 前記分析はオフラインで実施される、請求項24に記載の製造方法。
- 前記分析はオンラインで実施され、そのあと前記フィルムの厚さが調整される、請求項24に記載の製造方法。
- 前記分析はオフラインで実施され、そのあと前記フィルムの厚さが調整される、請求項24に記載の製造方法。
- 前記有効成分は医薬活性物質または生物活性物質である、請求項24に記載の製造方法。
- 前記調整は切断することである、請求項24に記載の製造方法。
- 前記調整は塗布することである、請求項24に記載の製造方法。
- 前記製造方法は、前記フィルムを乾燥することをさらに含む、請求項24に記載の製造方法。
- 前記製造方法は、前記工程(e)の後に前記フィルムを乾燥することをさらに含む、請求項24に記載の製造方法。
- 前記製造方法は、前記工程(e)の前に前記フィルムを乾燥することをさらに含む、請求項24に記載の製造方法。
- 前記調整の後に前記フィルムを包装することを含む、請求項24に記載の製造方法。
- 前記分析は、前記製造方法の間の所定の時間に実施される、請求項24に記載の製造方法。
- 前記分析は統計的サンプリングによって実施される、請求項24に記載の製造方法。
- 前記調整は、前記フィルムを所定の寸法および/または重量へと調整するようにプログラムされたコンピューターによって制御される、請求項24に記載の製造方法。
- 前記分析する工程は、前記フィルムの単位重量あたりの前記成分の前記量に基づいて、前記フィルムを前記所定の用量を送達するのに必要な寸法および/または重量へと切断するために、前記所定の寸法および/または重量を変えることを含む、請求項24に記載の製造方法。
- 有効成分を含む可食性フィルム投与単位の製造方法であって、前記可食性フィルム投与単位は前記有効成分についての所定の%用量を有し、前記フィルム投与単位は所定の幅および長さを有し、前記製造方法は、以下の工程を含む2以上のフィルムの調製を含む、製造方法:
a)ポリマー成分および前記ポリマー成分に一様に分散した有効成分を含む第1の連続フィルムを調製し、ポリマー成分および前記ポリマー成分に一様に分散した有効成分を含む第2の連続フィルムを調製する工程であって、前記第1の連続フィルムは、切断されたときに前記可食性フィルム投与単位の前記所定の幅および長さを生成するのに有効な一定の幅および長さを有し、前記第1の連続フィルムは第1の厚さを有し、かつ前記第2の連続フィルムは前記第1のフィルムの前記一定の幅および長さを有しかつ第2の厚さを有する、工程;
b)前記2つのフィルムを分析して、前記第2の連続フィルムが前記所定の長さおよび幅を有するフィルム投与単位へと切断されるときに、前記有効成分についての所定の% 用量を有する前記可食性フィルム投与単位を調製するために必要とされる厚さを決定する工程;
c)工程b)で決定された厚さを有する連続フィルムを調製する工程;および
d)前記連続フィルムを切断して、工程b)で決定された厚さおよび所定の長さおよび幅を有するフィルム投与単位を生成する工程。 - 前記分析は、前記フィルムの%有効成分を決定することである、請求項40に記載の製造方法。
- 前記分析は、前記フィルムの%非有効成分を決定することである、請求項40に記載の製造方法。
- 前記製造方法は少なくとも3つのフィルムを含み、少なくとも1つのフィルムは薄い厚さを有し、1つのフィルムは中間の厚さを有し、1つのフィルムは厚い厚さを有する、請求項40に記載の製造方法。
- 有効成分を含む可食性フィルム投与単位の製造方法であって、前記可食性フィルム投与単位は前記有効成分についての所定の%用量を有し、前記製造方法は、
a)ポリマー成分および前記ポリマー成分に一様に分散した有効成分を含む連続フィルムを調製する工程であって、前記連続フィルムは一定の厚さを有する工程;
b)前記連続フィルムをオンラインで分析し、前記フィルム投与単位の単位重量あたりの活性物質の前記所定の%を有するフィルム投与単位を生成するのに有効な正しい乾燥前膜厚を決定する工程:
c)工程b)で決定された乾燥前厚さを有する連続フィルムを調製する工程:
d)前記フィルムを乾燥する工程;および
e)前記フィルムを切断して、前記可食性フィルム投与単位を生成する工程、
を含む、製造方法。 - 有効成分を含む可食性フィルム投与単位の製造方法であって、前記可食性フィルム投与単位は前記有効成分についての所定の%用量を有し、前記製造方法は、
a)ポリマー成分および前記ポリマー成分に一様に分散した有効成分を含む連続フィルムを調製する工程;
b)前記フィルムを乾燥する工程;
c)前記乾燥したフィルムをオフラインで分析し、前記フィルムの単位重量あたりの活性物質の%を決定する工程;
d)前記c)で得られた情報を使用して、前記所定の用量を有するフィルムを生成するのに有効な前記フィルムの幅および長さを決定する工程;および
e)前記フィルムを前記工程d)で決定された幅および長さへと切断し、可食性フィルム投与単位を生成する工程、
を含む、製造方法。
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PCT/US2011/058296 WO2012058545A2 (en) | 2010-10-29 | 2011-10-28 | Process for analyzing and establishing dosage size in an ingestible film |
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US20120107402A1 (en) * | 2010-10-29 | 2012-05-03 | Monosol Rx, Llc | Process for analyzing and establishing dosage size in an ingestible film |
EP2765999A4 (en) * | 2011-10-14 | 2015-04-01 | Purdue Research Foundation | MULTI-SHEET UNIT MAY BE INTEGRATED WITH PREDETERMINED FUNCTIONS AND COMBINATIONS |
US20170143623A1 (en) * | 2012-09-28 | 2017-05-25 | Pharmafilm S.R.L. | Orodispersible films having quick dissolution times for therapeutic and food use |
WO2014092738A1 (en) * | 2012-12-14 | 2014-06-19 | Colgate-Palmolive Company | Abradable films for use in oral care |
AU2019288476A1 (en) | 2018-06-21 | 2021-03-18 | Aquestive Therapeutics, Inc. | System and method for making personalized individual unit doses containing pharmaceutical actives |
CN111257478B (zh) * | 2020-03-24 | 2022-07-12 | 上海峰林生物科技有限公司 | 一种磷霉素氨丁三醇基因毒性杂质的分析方法 |
EP4151204A1 (de) * | 2021-09-17 | 2023-03-22 | LTS Lohmann Therapie-Systeme AG | Schnell zerfallende orale dünne filme/schäume mit hoher wirkstoffbeladung auf basis eines gemisches von polyvinylalkoholen mit unterschiedlichen molekulargewichten |
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AU2020213322B2 (en) | 2022-06-09 |
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