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JP2010179109A - 医薬組成物用サシェ - Google Patents

医薬組成物用サシェ Download PDF

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JP2010179109A
JP2010179109A JP2010041157A JP2010041157A JP2010179109A JP 2010179109 A JP2010179109 A JP 2010179109A JP 2010041157 A JP2010041157 A JP 2010041157A JP 2010041157 A JP2010041157 A JP 2010041157A JP 2010179109 A JP2010179109 A JP 2010179109A
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Carin Widerstrom
ウイダーストロム，カリン
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Abstract

【課題】静電気が発生しにくく、光、湿気および／または空気による分解を防ぐ、サシェを提供する。
【解決手段】紙；ポリエチレンなどの接着層；アルミニウムホイルのバリヤー層；および低密度ポリエチレンのシール層の複数層からなる。例えば、有効医薬成分が、メサラジンであるサシェに含まれた医薬組成物に関して長期保存安定性を供与する。さらに、引き裂くことが容易であり、静電気が除去されて、その内容物を完全に空にし得る。
【選択図】なし

Description

本発明は、医薬組成物用サシェに関する。
本願（ｗｒｉｔ）は、デンマーク特許出願ＰＡ ２００３ ００６１２、欧州特許出願ＥＰ ０３３８８０２３、および米国仮特許出願第６０／４６４６４９号からの優先権を主張する。
錠剤または顆粒剤のいずれかであるメサラジンを含む経口用医薬品製剤が知られている。顆粒剤は、サシェに詰めることができる。本発明の目的に関して、「サシェ」とは、顆粒剤用の包みまたはバッグを言い、また、「顆粒剤」とは、粒子、顆粒または球状化粒子を言う。
知られたサシェは、製造方法の複雑さ、または製造コストの高さという欠点をこうむる傾向がある。消費者によって受け入れられるために、サシェは、好ましくは、鋏を使用しないで容易に開封できなければならない。サシェから顆粒剤を移す際に、できるだけ物質の損失が少ないことが好ましい。一定の顆粒剤タイプとサシェとの間には静電気が発生し得る。これは、顆粒のタイプならびにサシェのタイプに左右される。静電気が存在する場合、サシェから顆粒剤を移すことが困難になりがちである。最後に、サシェ中の顆粒剤は、光、湿気および／または空気による分解に鋭敏であり得る。これもまた、サシェのタイプならびに顆粒のタイプに左右される。
本発明の態様は、これらの問題、および下記のその他の問題に取り組む。
本発明の目的のために、用語の「メサラジン」はまた、ＷＯ９７／２３１９９ １５ページ、１７行目〜６ページ、１２行目に記載されたものなど、製薬的に許容できるその塩類およびエステル類、ならびにバルサラジドなどのプロドラッグを包含する。
本発明によるサシェに保存される製剤は、粒子状物、例えば、顆粒、球状物、ペレット、粒子の形態が好ましく、顆粒の形態が好ましい。
当該サシェは、任意の医薬品製剤に使用され得るが、メサラジンなどの感受性の高い化合物を含む医薬品を保存するために特に好適である。
一態様によれば、本発明は、
ｉ）紙；
ｉｉ）接着層、好ましくはポリエチレンなどの接着剤；
ｉｉｉ）バリヤー層、好ましくはアルミニウムホイル；および
ｉｖ）シール層、好ましくは低密度ポリエチレン
の複数層を含むサシェに関する。
メサラジンは、湿気、大気および／または光に感受性が高い。したがって、メサラジンを含有する製品のためのサシェは、湿気、大気および光に対するバリヤーを提供することが好ましいと云える。前記サシェはまた、患者にとって開封が容易である必要があり、鋏などのさらなる道具を使用することがないのが好ましい。人の指によりサシェを引き裂いて開封できることを犠牲にすることなく、必要なバリヤー性を有するサシェを提供することが課題となっていた。さらに、既存のサシェは、静電気の発生をこうむりがちである。サシェは、好ましくは、製造が容易で、充填が容易で、空にすることが容易であるべきで、また患者のコンプライアンスを改善するために魅力ある外見を有するべきである。
本態様は、例えば、有効医薬成分が、メサラジンであるサシェに含まれた医薬組成物に関して長期保存安定性を供与するサシェを提供する。さらに、前記サシェは、引き裂くことが容易であり、静電気が除去されて、その内容物を完全に空にし得るサシェを提供する。本発明によるサシェと経口用製剤との組合せは、殆ど静電気を発生させない。
外側の紙ｉ）は、好ましい実施形態において、単位面積当たり１０〜１００ｇ／ｍ２、好ましくは３０〜７０ｇ／ｍ２、より好ましくは４０〜６０ｇ／ｍ２、最も好ましくは５０ｇ／ｍ２の重量を有する。
単位面積当たり１０〜１００ｇ／ｍ２の範囲外の重量を有する紙は、サシェの工業的製造においてほとんど好適とは言えない。単位面積当たり約３０〜４０ｇ／ｃｍ２以下の重量を有する紙は、サシェ用の製造装置内で破損しがちである。単位面積当たり約６０〜７０ｇ／ｃｍ２超の重量を有する紙については、材料をサシェへと形状化することが困難である。単位面積当たり約５０ｇ／ｃｍ２を超える重量により最適な結果が達成された。
一態様によれば、接着層ｉｉ）は、好ましくは単位面積当たり６〜２０ｇ／ｍ２、好ましくは９〜１８ｇ／ｍ２、より好ましくは１２〜１５ｇ／ｍ２の重量を有する。極めて薄い層が用いられる場合、通常、適切な適用範囲を達成するために高価な特殊のポリマー類の使用が必要となる。厚い層が適用される場合、本質的により高価となり、また、層の不均一性を避けることが難しい。
一態様によれば、バリヤー層ｉｉｉ）は、好ましくは６〜３０μｍ、より好ましくは７〜２５μｍ、好ましくは９〜２５μｍ、より好ましくは８〜２０μｍ、好ましくは９〜１５μｍ、より好ましくは１２μｍの厚さを有する。
前記請求項のいずれかに記載のサシェであって、前記シール層ｉｖ）は、１５〜５０μｍの厚さを有する。極めて薄い層が適用される場合、表面を完全には被覆しない傾向がある。極めて厚い層が適用される場合、完全に融着することが難しく、どんな加熱が適用されても、均一に温めることは難しい。
一態様によれば、シール層ｉｖ）は、好ましくは単位面積当たり１０〜１００ｇ／ｍ２、より好ましくは１５〜７５ｇ／ｍ２、好ましくは２０〜５０ｇ／ｍ２、より好ましくは３０〜４０ｇ／ｍ２、最も好ましくは３５ｇ／ｍ２の重量を有する。
一態様によれば、本発明は、本発明による医薬組成物用サシェの使用に関する。
前記サシェは、本発明による医薬組成物を保存するのに好適であることが証明された。
一態様によれば、本発明は、医用目的のサシェの使用に関する。
本願のサシェは、メサラジンまたは製薬的に許容できるその塩を含む医薬品製剤に特に好適である。
当該サシェは、静電気の発生が著しく低い傾向にある。これは以前に、特にメサラジン顆粒剤に伴った問題であった。このようなメサラジン製品の例として、特許出願ＰＣＴ／ＤＫ０１／００６７７により得られる顆粒剤を述べることができる。
本発明の態様によれば、それは、本願サシェ中の顆粒剤における有効成分として、メサラジンの使用に限定されず、ＷＯ００／４４３５３、１２〜１６ページに記載された成分など、他の有効成分にも関連する。
本発明の態様によれば、さらに、充填剤、崩壊剤、ｐＨ調整剤、または界面活性剤などの添加剤を、本発明による組成物に含むことができる。このような添加剤は、文献でよく知られており、多数の好適な添加剤に関して、例えば、ＷＯ００／４４３５３、１６〜２０ページを参照されたい。
幾つかの添加剤は、吸湿性である。このような添加剤の例として、ポビドンを挙げることができる。有効成分が、吸湿性添加剤と共に製剤化される場合、好適なサシェの必要性が強調される。当該サシェは、少なくとも１種の吸湿性添加剤を含む医薬品に用いるのに好適である。
サシェの材料は、以下の構成である：
クレーコート化紙 ５０ｇ／ｍ２
低密度ポリエチレン １２ｇ／ｍ２
アルミニウムホイル １２μｍ
低密度ポリエチレン ３５ｇ／ｍ２
本実施例に関して、１２ｇ／ｍ２のＰＥは、１３μｍに相当し、３５ｇ／ｍ２のＰＥは、３８μｍに相当する。この材料は、１２９ｇ／ｍ２の秤量を有した。水蒸気に対する透過性は、２４時間、２５℃、７５％ＲＨで＜０．０５ｇ／ｍ２であり、Ｏ２に対する透過性は、２４時間、１気圧、２３℃、７５％ＲＨで＜０．０５ｍｌ／ｍ２であった。
前記紙が、サシェの外側にあるように、充填／シールステーションの充填チューブをサシェで包み、次いで、シール層としての低密度ポリエチレンにより縦にシールする。サシェ底部に交差シールを形成後、サシェに顆粒剤を充填してから、上部で再度シールし、最後に切断する。
全ての引用文献は、参照としてそれら全体を援用する。

Claims (16)

  1. ｉ）紙；
    ｉｉ）接着層；
    ｉｉｉ）バリヤー層；および
    ｉｖ）シール層
    の複数層を含む医薬組成物用サシェ。
  2. 前記バリヤー層が、アルミニウムホイルであり、前記接着層が、好ましくはポリエチレンであり、かつ前記シール層が、好ましくは低密度ポリエチレンである請求項１に記載のサシェ。
  3. 前記紙ｉ）が、単位面積当たり１０〜１００ｇ／ｍ２の重量を有する請求項１または２に記載のサシェ。
  4. 前記紙ｉ）が、単位面積当たり３０〜７０ｇ／ｍ２の重量を有する請求項３に記載のサシェ。
  5. 前記紙ｉ）が、単位面積当たり４０〜６０ｇ／ｍ２の重量を有する請求項４に記載のサシェ。
  6. 前記接着層ｉｉ）が、単位面積当たり６〜２０ｇ／ｍ２の重量を有する前記請求項のいずれかに記載のサシェ。
  7. 前記接着層ｉｉ）が、単位面積当たり９〜１８ｇ／ｍ２の重量を有する請求項６に記載のサシェ。
  8. 前記接着層ｉｉ）が、単位面積当たり１２〜１５ｇ／ｍ２の重量を有する請求項７に記載のサシェ。
  9. 前記シール層ｉｖ）が、１５〜５０μｍの厚さを有する前記請求項のいずれかに記載のサシェ。
  10. 前記シール層ｉｖ）が、単位面積当たり１０〜１００ｇ／ｍ２、より好ましくは１５〜７５ｇ／ｍ２、好ましくは２０〜５０ｇ／ｍ２、より好ましくは３０〜４０ｇ／ｍ２、最も好ましくは３５ｇ／ｍ２の重量を有する前記請求項のいずれかに記載のサシェ。
  11. 前記バリヤー層ｉｉｉ）が、６〜３０μｍ、より好ましくは７〜２５μｍ、好ましくは９〜２５μｍ、より好ましくは８〜２０μｍ、好ましくは９〜１５μｍ、より好ましくは１２μｍの厚さを有する前記請求項のいずれかに記載のサシェ。
  12. 医薬品製剤を含有する前記請求項のいずれかに記載のサシェ。
  13. 前記医薬品製剤が、メサラジンまたは製薬的に許容できるその塩を含む請求項１２に記載のサシェ。
  14. ５５重量％を超えるメサラジンまたは製薬的に許容できるその塩を含む顆粒形態の経口用医薬品製剤を含有する請求項１２または１３に記載のサシェ。
  15. 医薬組成物用の前記請求項のいずれかに記載のサシェの使用。
  16. 医用目的の請求項１から１４のいずれかに記載のサシェの使用。
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MXPA05011308A (es) 2005-12-12
US20070043004A1 (en) 2007-02-22
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US8858992B2 (en) 2014-10-14
US20150209297A1 (en) 2015-07-30
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PT1615648E (pt) 2014-08-26
CA2520026C (en) 2010-02-23
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