JP5706326B2 - 安定したユニラメラ組成物およびその製造方法 - Google Patents
安定したユニラメラ組成物およびその製造方法 Download PDFInfo
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- JP5706326B2 JP5706326B2 JP2011530105A JP2011530105A JP5706326B2 JP 5706326 B2 JP5706326 B2 JP 5706326B2 JP 2011530105 A JP2011530105 A JP 2011530105A JP 2011530105 A JP2011530105 A JP 2011530105A JP 5706326 B2 JP5706326 B2 JP 5706326B2
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- liposome
- formulation
- suspension
- liposome suspension
- oil
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Description
一般に、本発明は加えられた活性成分のあるなしにかかわらず、安定な半透明ないし透明のユニラメラリポソーム懸濁液(unilamellar liposomal suspension)の、化粧品、治療薬、または診断薬の用途のための組成物およびその製造方法に関する。
「リポソーム溶液」という用語は、外部相組成物中に懸濁される前の、リポソーム粒子または小胞を含む水溶液をいう。
表2は実施例1に記載された工程で作られたリポソーム懸濁液について示す。
表3は実施例1に記載された工程で作られたリポソーム懸濁液について示す。
表4は実施例1に記載された工程であって、以下に示すいくつかの変更を加えて作られたリポソーム懸濁液について示す。図3および4は周囲温度条件下での2.5月の貯蔵期間の後の、異なる保存条件での表4の2つのリポソーム懸濁液の、得られたユニモーダルの粒度分布を示している。図3のリポソーム溶液はマイクロフルイダイザーに4回通した。図4のリポソーム溶液はマイクロフルイダイザーに2回通した。図3はフェノキシエタノール、プロピレングリコール、クロルフェネシン、およびメチルイソチアゾリノンを使う、パラオキシ安息香酸エステル類を含まない懸濁液について、約87ナノメートルの平均粒径と約38から約187ナノメートルの間の粒径範囲を示している。図4はメチルパラベン、プロピルパラベンおよびエチルパラベンを含む様々なパラオキシ安息香酸エステル類と組み合わせてフェノキシエタノールを使用する懸濁液について、約141ナノメートルから約518ナノメートルの間の粒径範囲と約247ナノメートルの平均粒径を示している。図5は少なくとも19カ月周囲室温条件のもとでの、表4によるリポソーム懸濁液のユニモーダルの粒度分布の維持を示している。特に、図5は約157ナノメートルの平均粒径と約54ナノメートルと約521ナノメートルの間の粒径範囲によって特徴付けられたユニモーダルの粒度分布を示している。
表5は実施例1に記載された一般的な方法で、以下に記載するようにいくつかの成分を変えて形成されたリポソーム懸濁液について示す。図6はリポソーム溶液をマイクロフルイダイザーに2回通し、周囲温度条件下での2.5カ月の貯蔵の後の結果として起こる表5のユニモーダル粒度分布を表示する。
表6は実施例1記載された一般的な方法で、以下に記載するようにいくつかの成分を変えて形成されたリポソーム懸濁液について示す。図7は、周囲温度条件下での2.5カ月の貯蔵の後の結果として起こる表6のユニモーダル粒度分布を表示する。
Claims (21)
- 以下を含む安定した透明ないし半透明のユニラメラリポソーム懸濁液;
a. 25%から70%のリポソーム製剤、および
b. 30%から75%の外部相、ここで該リポソーム製剤は外部相組成物中に懸濁されている、
該リポソーム製剤はユニモーダルサイズ分布を有し、50ナノメートルから290ナノメートルの間の平均粒径を有する複数のユニラメラリポソーム粒子を含み、
該リポソーム製剤は油溶性組成物と水溶性組成物から構成される水性のリポソーム溶液から形成され、該油溶性組成物はリポソーム溶液の重量に基づいて5%から33%の間の量で存在し、該水溶性組成物はリポソーム溶液の重量に基づいて67%から95%の間の量で存在し、
該油溶性組成物は、i)ブチレングリコール、プロピレングリコール、ヘキシレングリコール、およびポリエチレングリコール、並びにそれらの混合物から成る群から選択されるカップリング試薬、ii)少なくとも1つのリン脂質、iii)リポソーム懸濁液の重量に基づいて0.02%から1%の量で存在し、スフィンゴリピド、セラミド、ステロール、およびそれらの混合物からなる群から選択される少なくとも1つの剛性エンハンサー、およびiv)酸化防止剤を含み;
該外部相組成物は増粘剤、高密度化薬剤、ゲラント剤、ガムおよびそれらの混合物から成る群から選択される粘度促進物質を含み、0.95g/ccから1.25g/ccの間の密度を有し、21℃で10秒−1のせん断速度において2.5cPから40,000cPの間の粘度を有し;
該リポソーム懸濁液は1.30から1.45の屈折率を有し、目視または後方散乱の動態学的分析により測定される時、4℃から50℃の温度で少なくとも30日間、または21℃の温度で少なくとも180日間の期間、ニートの形態で安定であり、
該リポソーム懸濁液はEDTA、安息香酸ナトリウム、およびクエン酸、ソルビン酸、安息香酸、およびイソプロピルメチルフェノールを含まない。 - 該カップリング試薬がブチレングリコールである、請求項1に記載のリポソーム懸濁液。
- 該剛性エンハンサーが、セラミド、スフィンゴシンおよびフィトスフィンゴシンから成る群から選ばれた少なくとも1つの成分、および少なくとも1つのフィトステロールを含む、少なくとも2つの剛性エンハンサーを含む請求項1に記載のリポソーム懸濁液。
- 該少なくとも1つのリン脂質が異なった脂肪アシル部位を有するグリセロリン脂質またはスフィンゴミエリンを含む、請求項1に記載のリポソーム懸濁液。
- 該少なくとも1つのリン脂質が、リン脂質製剤の重量に基づいて80%から95%の間の量のホスファチジルコリンを含むリン脂質製剤を含む、請求項1−4のいずれか1項記載のリポソーム懸濁液。
- 該油溶性組成物がブチレングリコール、セラミドIIIB、β−シトステロール、およびトコフェロールを含む、特許請求の範囲1−4のいずれか1項記載のリポソーム懸濁液。
- 該酸化防止剤が、トコフェロール、トコフェロールの誘導体、アルファトコフェロール、トコフェリル酢酸、コハク酸トコフェロール、アスコルビン酸、アスコルビン酸の誘導体、テトラヘキシルデシルアスコルビン酸、ブチル化ヒドロキシルトルエン、ブチル化ヒドロキシアニソール、およびそれらの混合物からなる群から選択される、請求項1−4のいずれか1項記載のリポソーム懸濁液。
- 該外部相が、リポソーム懸濁液の35%から75%の間の量のグリセリンを含む、請求項1−4のいずれか1項記載のリポソーム懸濁液。
- 該油溶性組成物が、レシチン製剤、ブチレングリコール、セラミドIIIB、およびβ−シトステロールを含み、リポソーム懸濁液が1.30から1.45の間の屈折率を有する、請求項8に記載のリポソーム懸濁液。
- 以下を含む、請求項1に記載の安定な透明ないし半透明のユニラメラリポソーム懸濁液を調製するための方法;
a. i)ブチレングリコール、プロピレングリコール、ヘキシレングリコール、およびポリエチレングリコール、並びにそれらの混合物から成る群から選択されるカップリング試薬、ii)少なくとも1つのリン脂質、iii)リポソーム懸濁液の重量に基づいて0.02%から1%の量のスフィンゴリピド、セラミド、ステロール、およびそれらの混合物からなる群から選択される少なくとも1つの剛性エンハンサー、およびiv)酸化防止剤を含む油溶性組成物を調製すること、
b. 水溶性組成物を調製すること、
c. リポソーム懸濁液の重量に基づいて67%から95%の間の量の該水溶性組成物と、リポソーム懸濁液の重量に基づいて5%から33%の間の量の該油溶性組成物とを組み合わせ、マルチラメラ、多胞体リポソーム製剤を形成すること、
d. 高圧力ミクロ流動化、押し出し、高速剪断、混合、超音波処理物、または均質化処理により該マルチラメラ、多胞体リポソーム製剤をユニラメラリポソーム製剤に変換すること、ここでユニラメラリポソーム製剤粒子はユニモーダルサイズ分布を有し、50ナノメートルから290ナノメートルの間の平均粒径を有する、および
e. 該ユニラメラリポソーム製剤を、増粘剤、高密度化薬剤、ゲラント剤、ガムおよびそれらの混合物から成る群から選択される粘度促進物質を含む外部相組成物に加え、
1.05g/ccから1.25g/ccの間の密度を有し、21℃で10秒−1のせん断速度において2.5cPから40,000cPの間の粘度を有する外部相組成物を与え、1.30から1.45の屈折率を有し、4℃から50℃の温度で少なくとも30日間、または21℃の温度で少なくとも180日間の期間、ニートの形態で安定である該リポソーム懸濁液を形成すること。 - 該カップリング試薬がブチレングリコールである、請求項10に記載の方法。
- 該剛性エンハンサーがスフィンゴリピド、フィトステロール、コレステロール、およびそれらの混合物からなる群から選択される請求項10に記載の方法。
- 該剛性エンハンサーが、セラミド、スフィンゴシンおよびフィトスフィンゴシンから成る群から選ばれた少なくとも1つの成分、および少なくとも1つのフィトステロールを含む、少なくとも2つの剛性エンハンサーを含む、請求項12に記載の方法。
- 該少なくとも1つのリン脂質が異なった脂肪アシル部位を有するグリセロリン脂質またはスフィンゴミエリンを含む、請求項10から13のいずれか1項に記載の方法。
- 該少なくとも1つのリン脂質が、リン脂質製剤の重量に基づいて80%から95%の間の量のホスファチジルコリンを含むリン脂質製剤を含む、請求項10から13のいずれか1項に記載の方法。
- 該油溶性組成物がブチレングリコール、セラミドIIIB、β−シトステロール、およびトコフェロールを含む、請求項10から13のいずれか1項に記載の方法。
- 該酸化防止剤が、トコフェロール、トコフェロールの誘導体、アルファトコフェロール、トコフェリル酢酸、コハク酸トコフェロール、アスコルビン酸、アスコルビン酸の誘導体、テトラヘキシルデシルアスコルビン酸、ブチル化ヒドロキシルトルエン、ブチル化ヒドロキシアニソール、およびそれらの混合物からなる群から選択される、請求項10から13のいずれか1項に記載の方法。
- 該リポソーム溶液の外部相組成物に対する重量比は、0.002〜0.54である。請求項10から13のいずれか1項に記載の方法。
- 該リポソーム懸濁液は、リポソーム懸濁液の35%から75%の間の濃度でグリセリンを含む、請求項10から13のいずれか1項に記載の方法。
- 該ユニラメラリポソーム製剤が外部相組成物中に懸濁される前に凍結乾燥される、請求項10から13のいずれか1項に記載の方法。
- 以下を含む、請求項1に記載のリポソーム懸濁液を含む化粧品配合物を調製するための方法;
a. i)ブチレングリコール、プロピレングリコール、ヘキシレングリコール、およびポリエチレングリコール、並びにそれらの混合物から成る群から選択されるカップリング試薬、ii)少なくとも1つのリン脂質、iii)リポソーム懸濁液の重量に基づいて0.02%から1%の量のスフィンゴリピド、セラミド、ステロール、およびそれらの混合物からなる群から選択される少なくとも1つの剛性エンハンサー、およびiv)酸化防止剤を含む油溶性組成物を調製すること、
b. 水溶性組成物を調製すること、
c. リポソーム懸濁液の重量に基づいて67%から95%の間の量の該水溶性組成物と、リポソーム懸濁液の重量に基づいて5%から33%の間の量の該油溶性組成物とを組み合わせ、マルチラメラ、多胞体リポソーム製剤を形成すること、
d. 高圧力ミクロ流動化、押し出し、高速剪断、混合、超音波処理物、または均質化処理により該マルチラメラ、多胞体リポソーム製剤をユニラメラリポソーム製剤に変換すること、ここでユニラメラリポソーム製剤粒子はユニモーダルサイズ分布を有し、50ナノメートルから290ナノメートルの間の平均粒径を有する、
e. 該ユニラメラリポソーム製剤を、増粘剤、高密度化薬剤、ゲラント剤、ガムおよびそれらの混合物から成る群から選択される粘度促進物質を含む外部相組成物に加え、
1.05g/ccから1.25g/ccの間の密度を有し、21℃で10秒−1のせん断速度において2.5cPから40,000cPの間の粘度を有する外部相組成物を与え、1.30から1.45の屈折率を有し、4℃から50℃の温度で少なくとも30日間、または21℃の温度で少なくとも180日間の期間、ニートの形態で安定である該リポソーム懸濁液を形成すること、および
f. クリーム、ローション、ゲル、セラム、トニック、エマルション、ペースト、またはスプレーの形で化粧品配合物を形成するために化粧品的に適当なマトリツクスに該リポソーム懸濁液を組み合わせること。
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WO2010039490A2 (en) | 2010-04-08 |
KR20110073495A (ko) | 2011-06-29 |
CN102170853B (zh) | 2016-07-06 |
TW201018498A (en) | 2010-05-16 |
HK1160385A1 (zh) | 2012-08-17 |
CN102170853A (zh) | 2011-08-31 |
KR101705912B1 (ko) | 2017-02-10 |
WO2010039490A3 (en) | 2011-03-24 |
US20100086573A1 (en) | 2010-04-08 |
US9445975B2 (en) | 2016-09-20 |
TWI537009B (zh) | 2016-06-11 |
JP2012504620A (ja) | 2012-02-23 |
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