JP2013504573A - シームレスなアルギン酸塩カプセル - Google Patents
シームレスなアルギン酸塩カプセル Download PDFInfo
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- JP2013504573A JP2013504573A JP2012528838A JP2012528838A JP2013504573A JP 2013504573 A JP2013504573 A JP 2013504573A JP 2012528838 A JP2012528838 A JP 2012528838A JP 2012528838 A JP2012528838 A JP 2012528838A JP 2013504573 A JP2013504573 A JP 2013504573A
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- Prior art keywords
- alginate
- weight
- oil
- water
- gelling bath
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 229920000615 alginic acid Polymers 0.000 title claims abstract description 136
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Abstract
【選択図】なし
Description
異なるM−含量でアルギン酸塩から作られたカプセル−崩壊時間への影響
この実施例で用いられたアルギン酸塩は、Laminaria hyperboreaの茎(FM=分析していないが、典型的には0.25−0.35)、Laminaria hyperboreaの葉(FM=0.47)、及びLessonia nigrescens(FM=0.57)から分離された。アルギン酸塩溶液は、プロセス粘度を低くするように分子量低下を要したLessoniaアルギン酸塩サンプルを除いて、5%濃度にアルギン酸塩を単に溶解するだけで作られた。アルギン酸塩を溶解して8.3%溶液を調製し、3時間、85−90℃に維持した。5%濃度に希釈後、粘度を、ブルックフィールド粘度計を用いて、20rpmで、RVスピンドル2で、22℃で測定したところ、106cPであった(これは、60rpmでスピンドル#1でブルックフィールドLV粘度計を用いて測定された場合、およそ38−40cpsである)。乾燥分含量を、赤外線乾燥機(Mettler Toledo HR73)を用いて測定したところ、4.05%であった。一連のゲル浴は、0.15%NaClを含んで、異なるアルギン酸塩に対して調製された(図2参照)。アルギン酸塩溶液は、タンク中でゆっくりとした撹拌で維持され、約10L/minの連続流は、タンクからループ状に上がり、急勾配を降り、開放流となり(滝)、タンクに戻されて、再循環された。温度は、22−26℃の範囲であった。さらに60gのPolysorbate40を溶解させる前に、300gの水中の210gの無水塩化カルシウムを溶解させることで、プレ−エマルションを調製した。撹拌の間、3,900gの魚油をゆっくりと加えた。
比較例−本発明よりも低い粘度を有するアルギン酸塩で作られたアルギン酸塩カプセルは、許容不可能な低い湿潤破断強さを有するカプセル及び乾燥中の高い頻度での破損をもたらした。
この実施例におけるカプセルは、以下の変形を伴って実施例1のように作られた:プレ−エマルションを3250gのタラ肝油を用いて作り、250gの脱イオン水、175gのCaCl2 *2H2O、及び25gのPolysorbate40の組成物を有する水相に加えた。アルギン酸塩浴を、2つのアルギン酸塩サンプルの組み合わせを用いて作った。525gのRENO7029(54%のM含量)及び225gのRENO7030(53%のM含量)、並びに45gのNaClを、15,000gの全重量で脱イオン水に溶解した。溶液のpHを2MのNaOH溶液を用いて7に調節した。得られた溶液は、5%の全アルギン酸塩濃度及び61.6cPの粘度を有していた。2つのアルギン酸塩製品は、両方ともL.nigrescensの海藻から抽出されたことにより特徴付けられ、RENO7029(54%のM含量)は1%溶液において2.5cPの粘度を有し、RENO7030(53%のM含量)は1%溶液において14.6cPの粘度を有していた。3.5%水溶液中の2つのアルギン酸塩の粘度は、60rpm及びスピンドル#1において、33cpsと推定されるだろう。カプセルを一晩水中で洗浄し、15%グリセリン溶液中で25分間、可塑化した。カプセルを、環境条件での空気乾燥のために、ベンチに置いた。乾燥プロセスの間、約42%のカプセルが破裂した。これは、平均分子量が低すぎるためカプセルシェルの強度が許容不可能に低いことを示唆する。ゲル化後の湿潤カプセルの平均破断強さ(n=3)は、406gと測定され、それは非常に低い。したがって、この例は、カプセルが、各々54%及び53%のM含量並びに33cpsの粘度を有する、試験されたアルギン酸塩から作られた場合に何か起こるのかを示す。
高い機械的強度のカプセル及び許容可能な程度に低いプロセス粘度をもたらす本発明の処方
この実施例におけるカプセルは、以下の変形を伴って実施例2のように作られた。アルギン酸塩浴を、2つのアルギン酸塩サンプルの組み合わせを用いて作った。225gのRENO7035(50%のM含量)及び300gのRENO7036(53%のM含量)、並びに45gのNaClを、15,000gの全重量で脱イオン水に溶解した。得られた溶液は、3.5%の全アルギン酸塩濃度及びスピンドル#1を用いて60rpmで測定された場合、69cPの粘度を有していた(3.5%水溶液においてスピンドル#1を用いて60rpmで測定された場合、およそ76cP)。2つのアルギン酸塩製品は、両方ともL.nigrescensの海藻から抽出されたことにより特徴付けられ、RENO7035は1%溶液において4.6cPの粘度を有し、RENO7036は1%溶液において9.7cPの粘度を有していた。洗浄の間、カプセル対水の重量比は、約1:3であった。可塑剤溶液は、10%グリセリンを含有していた。乾燥の間、カプセルの破損は見られず、平均湿潤破断強さ(n=4)は、1914gと測定され、平均乾燥破断強さ(n=4)は、32,034gと測定された。
ゲル化浴におけるアルギン酸塩濃度の影響
この実施例におけるカプセルは、L.nigrescens(例えば、M及びG含量の50−62重量%の平均M含量を有する)から分離されたアルギン酸塩の混合物から作られ、60rpmでスピンドル#1を用いて3.5%水溶液において測定された場合、およそ57cPの最終粘度を有する。エマルションを、さらに2gのPolysorbate40を溶解させる前に、10gの水に7gの無水塩化カルシウムを溶解させることにより調製した。130gの魚油を、エマルションが形成されるまで、Ultra Turraxで用いる間、少しずつ加えた。エマルションの粘度は、95,000cPと測定された。
Claims (16)
- (i)アルギン酸塩シェル膜は、(a)M及びG含量の重量に基づき50重量%−62重量%の平均M含量と、(b)60rpm及びスピンドル#1でブルックフィールドLV粘度計を用いて20℃で3.5%水溶液における一価金属イオンアルギン酸塩として測定される場合、35−80cpsの粘度と、を有する、多価金属イオンアルギン酸塩を含み、
(ii)前記アルギン酸塩シェル膜は、充填マテリアルの少なくとも50重量%の量で存在する油を封入し、
(iii)乾燥されたシームレスカプセルは、37℃で、pH3の、0.1MのNaCl及びHClの溶液における20分間の前処理後、腸管緩衝液において12分間未満の崩壊時間を有し、並びに
(iv)前記乾燥されたシームレスカプセルは、少なくとも7kgの乾燥破断強さを有する、
ことを特徴とする、充填マテリアルを封入するアルギン酸塩シェル膜を含む、乾燥されたシームレスカプセル。 - 少なくとも20kgの乾燥破断強さを有する、請求項1に記載の乾燥されたシームレスカプセル。
- 前記乾燥されたシームレスカプセルは、37℃で、pH3の、0.1MのNaCl及びHClの溶液における20分間の前処理後、腸管緩衝液において10分間未満の崩壊時間を有する、
ことを特徴とする、請求項1に記載の乾燥されたシームレスカプセル。 - 前記アルギン酸塩は、M及びG含量の重量に基づき53重量%−59重量%のM含量を有する、
ことを特徴とする、請求項1に記載の乾燥されたシームレスカプセル。 - 前記充填マテリアルは、薬学的、栄養補助的、若しくは獣医学的な活性剤、又は薬学的、栄養補助的、若しくは獣医学的な活性剤に対するキャリアである、油を含む、
ことを特徴とする、請求項1に記載の乾燥されたシームレスカプセル。 - 前記油は、薬学的、栄養補助的、又は獣医学的な活性成分である、
ことを特徴とする、請求項5に記載の乾燥されたシームレスカプセル。 - 前記油は、オメガ−3−脂肪酸、その塩、エステル、又は誘導体を含む、
ことを特徴とする、請求項6に記載の乾燥されたシームレスカプセル。 - 前記カプセルは、
(a)油、水、乳化剤、水溶性多価金属塩及び酸の少なくとも50重量%の量で存在する油と、水と、乳化剤と、水溶性多価金属塩又は酸のうち少なくとも一つとを含むエマルションを調製することと、
(b)(i)50%−62%の平均M含量と、(ii)60rpm及びスピンドル#1でブルックフィールドLV粘度計を用いて20℃で3.5%水溶液において測定される場合、35−80cpsの粘度と、を有する、一価金属イオンアルギン酸塩からなる、水性ゲル化浴の3−4重量%の量で前記アルギン酸塩を含む前記水性ゲル化浴に、前記エマルションの一部を加え、前記アルギン酸塩のシェル膜に前記エマルションの前記一部を封入することと、
(c)カプセルを乾燥させることと、
を含むプロセスにより作られる、
ことを特徴とする、請求項1に記載の乾燥されたシームレスカプセル。 - (a)油、水、乳化剤、水溶性多価金属塩及び酸の少なくとも50重量%の量で存在する油と、水と、乳化剤と、水溶性多価金属塩又は酸のうち少なくとも一つとを含むエマルションを調製する工程と、
(b)(i)50%−62%の平均M含量と、(ii)60rpm及びスピンドル#1でブルックフィールドLV粘度計を用いて20℃で3.5%水溶液において測定される場合、35−80cpsの粘度と、を有する、一価金属イオンアルギン酸塩からなる、水性ゲル化浴に、前記エマルションの一部を加え、前記アルギン酸塩のシェル膜に前記エマルションの前記一部を封入する工程と、
(c)任意に、水を除去することによりカプセルを乾燥させる工程と、
を含み、前記水性ゲル化浴が、前記水性ゲル化浴の3−4重量%の量で前記アルギン酸塩を含むことを特徴とする、充填マテリアルを封入するアルギン酸塩シェル膜を含む、シームレスなアルギン酸塩カプセルを調製する方法。 - アルギン酸塩は、ゲル化浴の3.25重量%から3.75重量%の量で前記ゲル化浴中に存在する、
ことを特徴とする、請求項9に記載の方法。 - アルギン酸塩は、ゲル化浴の3.5重量%の量で前記ゲル化浴中に存在する、
ことを特徴とする、請求項10に記載の方法。 - 前記ゲル化浴はさらに、一価塩を含む、
ことを特徴とする、請求項9に記載の方法。 - 前記一価塩は、塩化ナトリウム又は塩化カリウムを含む、
ことを特徴とする、請求項12に記載の方法。 - 前記一価塩は、塩化ナトリウムである、
ことを特徴とする、請求項13に記載の方法。 - 前記一価塩は、ゲル化浴の0.1−0.5重量%の量で前記ゲル化浴中に存在する、
ことを特徴とする、請求項12に記載の方法。 - 前記一価塩は、ゲル化浴の0.3重量%の量で前記ゲル化浴中に存在する、
ことを特徴とする、請求項15に記載の方法。
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