JP4972553B2 - マイクロエマルジョン及びサブミクロンエマルジョンの製造法及び組成物 - Google Patents
マイクロエマルジョン及びサブミクロンエマルジョンの製造法及び組成物 Download PDFInfo
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- JP4972553B2 JP4972553B2 JP2007528524A JP2007528524A JP4972553B2 JP 4972553 B2 JP4972553 B2 JP 4972553B2 JP 2007528524 A JP2007528524 A JP 2007528524A JP 2007528524 A JP2007528524 A JP 2007528524A JP 4972553 B2 JP4972553 B2 JP 4972553B2
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- surfactant
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- 238000004448 titration Methods 0.000 description 1
- 229960001017 tolmetin Drugs 0.000 description 1
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- 239000003204 tranquilizing agent Substances 0.000 description 1
- 230000002936 tranquilizing effect Effects 0.000 description 1
- 238000012546 transfer Methods 0.000 description 1
- 229960003741 tranylcypromine Drugs 0.000 description 1
- 229960003991 trazodone Drugs 0.000 description 1
- PHLBKPHSAVXXEF-UHFFFAOYSA-N trazodone Chemical compound ClC1=CC=CC(N2CCN(CCCN3C(N4C=CC=CC4=N3)=O)CC2)=C1 PHLBKPHSAVXXEF-UHFFFAOYSA-N 0.000 description 1
- 150000003626 triacylglycerols Chemical class 0.000 description 1
- 229960005294 triamcinolone Drugs 0.000 description 1
- GFNANZIMVAIWHM-OBYCQNJPSA-N triamcinolone Chemical compound O=C1C=C[C@]2(C)[C@@]3(F)[C@@H](O)C[C@](C)([C@@]([C@H](O)C4)(O)C(=O)CO)[C@@H]4[C@@H]3CCC2=C1 GFNANZIMVAIWHM-OBYCQNJPSA-N 0.000 description 1
- JOFWLTCLBGQGBO-UHFFFAOYSA-N triazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1Cl JOFWLTCLBGQGBO-UHFFFAOYSA-N 0.000 description 1
- 229960003386 triazolam Drugs 0.000 description 1
- HFFLGKNGCAIQMO-UHFFFAOYSA-N trichloroacetaldehyde Chemical compound ClC(Cl)(Cl)C=O HFFLGKNGCAIQMO-UHFFFAOYSA-N 0.000 description 1
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- QDWJJTJNXAKQKD-UHFFFAOYSA-N trihexyphenidyl hydrochloride Chemical compound Cl.C1CCCCC1C(C=1C=CC=CC=1)(O)CCN1CCCCC1 QDWJJTJNXAKQKD-UHFFFAOYSA-N 0.000 description 1
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- ZSCDBOWYZJWBIY-UHFFFAOYSA-N trimipramine Chemical compound C1CC2=CC=CC=C2N(CC(CN(C)C)C)C2=CC=CC=C21 ZSCDBOWYZJWBIY-UHFFFAOYSA-N 0.000 description 1
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- CBEQULMOCCWAQT-WOJGMQOQSA-N triprolidine Chemical compound C1=CC(C)=CC=C1C(\C=1N=CC=CC=1)=C/CN1CCCC1 CBEQULMOCCWAQT-WOJGMQOQSA-N 0.000 description 1
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- 235000019155 vitamin A Nutrition 0.000 description 1
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
- A61K8/06—Emulsions
- A61K8/062—Oil-in-water emulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
- A61K8/04—Dispersions; Emulsions
- A61K8/06—Emulsions
- A61K8/068—Microemulsions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
- A61Q19/00—Preparations for care of the skin
Description
本発明は、皮膚科学の分野における美容的及び治療的用途に有用なマイクロエマルジョン及びサブミクロンエマルジョンの処方方法に関する。特に本発明は、処方物の物理的状態を破壊することが既知である成分を含有する、安定マイクロエマルジョン及びサブミクロンエマルジョンの処方方法に関する。本発明はまた、これらの方法から生じる美容用及び治療用マイクロエマルジョン組成物及びサブミクロンエマルジョン組成物に関する。マイクロエマルジョン及びサブミクロンエマルジョンを用いる美容的及び医学的処置の方法は、適切な処置における処方方法から生じる組成物の使用と同様に、本発明に包含される。
粒子のサイズは皮膚の障壁を通過する粒子の能力、つまり、対象となる患者の局所的又は全身的な病状の治療のために薬学的活性成分を送達する粒子の能力にとって重大である。粒子が小さく(特に100nmより小さく)なると、未精製物質と比較した場合、その総容積に比例して粒子の曝露表面積のパーセンテージは増大し、その潜在的効力は増大する。
険を低減すると考えられるプロセスのためのエネルギーの要求を低減するのが望ましい。
リコールは、処方物を分解又は不安定化する潜在能力を有するため、マイクロエマルジョン技術においては望ましくないと報告されている添加剤である。国際公開特許第WO94/08603(SMITHKLINE BEECHAM CORPORATION)は、プロピレングリコール及びその他のポリヒドロキシルアルコール補助界面活性剤によりもたらされる加工処理及び安定性における問題のため、これらを使用しないことを教示する。
少なくとも1つの薬学的活性成分の皮膚送達のための水中油型(O/W)マイクロエマルジョン又はサブミクロンエマルジョン組成物の製造方法であって、
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び1つ又は複数の親油性界面活性剤を含む第1の成分と、水及び少なくとも1つの親水性界面活性剤を含む第2の成分とを均質になるように混合し、
b)工程a)の混合物を、継続的に混合しながら、40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の範囲で相集合温度に加熱して水中油型マイクロエマルジョン又はサブミクロンエマルジョンを生成させ、
c)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却し、
d)2℃と前記相集合温度との間の温度で上記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は、必要に応じて予備混合され、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物、界面活性剤及び水から成る群から選択される少なくとも1つの構成成分を含むが、第3の成分が水を含む場合には、非界面活性剤両親媒性型化合物及び/又は界面活性剤も含む、
工程を含む方法を提供する。
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び1つ又は複数の親油性界面活性剤を含む第1の成分を40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度に加熱し、均質になるように混合し、
b)水及び少なくとも1つの親水性界面活性剤を含む第2の成分を40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度に加熱し、均質になるように混合し、
c)前記第2の成分を、継続的に混合しながら、40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度で前記第1の成分に添加し、マイクロエマルジョン又はサブミクロンエマルジョンを相集合温度で生成させ、
d)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却し、
e)室温と前記相集合温度との間の温度で前記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は予備混合され、必要に応じて、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物、界
面活性剤及び水から成る群から選択される少なくとも1つの構成成分を含むが、該第3の成分が水を含む場合には、非界面活性剤両親媒性型化合物及び/又は界面活性剤も含む、工程を含む。
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び1つ又は複数の親油性界面活性剤を含む第1の成分と、水及び少なくとも1つの親水性界面活性剤を含む第2の成分とを均質になるように混合し、
b)工程a)の混合物を、継続的に混合しながら、40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の範囲で相集合温度に加熱して水中油型マイクロエマルジョン又はサブミクロンエマルジョンを生成させ、
c)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却し、
d)2℃と前記相集合温度との間の温度で前記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は、必要に応じて予備混合され、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物、界面活性剤及び水から成る群から選択される少なくとも1つの構成成分を含むが、第3の成分が水を含む場合には、非界面活性剤両親媒性型化合物及び/又は界面活性剤も含む、
工程を含む方法によって製造される。
度を好ましくは約60℃より低くするように迅速に添加され、それによりマイクロエマルジョン又はサブミクロンエマルジョンを固定する。
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び1つ又は複数の親油性界面活性剤を含む第1の成分を、40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度に加熱し、均質になるように混合し、
b)水及び少なくとも1つの親水性界面活性剤を含む第2の成分を40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度に加熱し、均質になるように混合し、
c)前記第2の成分を、継続的に混合しながら、40〜99℃、好ましくは45〜95℃、より好ましくは65〜85℃の温度で前記第1の成分に添加し、マイクロエマルジョン又はサブミクロンエマルジョンを相集合温度で生成させ、
d)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却し、
e)室温と前記相集合温度との間の温度で前記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は予備混合され、必要に応じて、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物、界面活性剤及び水から成る群から選択される少なくとも1つの構成成分を含むが、第3の成分が水を含む場合には、非界面活性剤両親媒性型化合物及び/又は界面活性剤も含む、
工程を含む方法によって製造される。
しい放出特性によって決まる。薬学的活性成分は、好ましくは、水に不溶性であるか、或いは難溶性なものである。好ましくは薬学的活性成分は、コルチコステロイド、デソニド、クロベタゾール、ベタメタゾン、ビタミンDアナログ及びビタミンAアナログから成る群から選択される1つ又は複数の水不溶性化合物である。
性型化合物及び/又は界面活性剤も含み、前記第3の成分は、温度誘導性相集合プロセスによる、動物油、鉱油又は植物油、シラン、シリコーン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、並びに水及び少なくとも1つの親水性界面活性剤を含む水相全体で乳化される親油性界面活性剤を少なくとも1つ含む油相により形成されるマイクロエマルジョン又はサブミクロンエマルジョンの生成後に、前記組成物中に組み入れられる。
薬学的活性成分の皮膚送達のために伝統的に製造される組成物では、油相及び水相が共に混合される前に、薬学的活性成分、並びに、例えば活性成分のための溶媒、或いは溶媒、エモリエント又は浸透促進剤として作用するポリオールなどの任意の非界面活性剤両親媒性型化合物を、薬学的活性成分が溶解可能な相に添加することは慣用的である。これは、一方の相中で他の相がエマルジョン又は分散体となる生成物を生じる。理論に制限されることなく、第3の成分を添加することにより、本明細書の序文で論じた利点を有するマイクロエマルジョン又はサブミクロンエマルジョンが形成され得ることが明らかになった。これは、ポリオール及び/又はアルコールを含む溶媒中以外で、不溶性傾向の薬学的活性成分を用いることが望ましい特に有用な現象である。相集合が達成される温度を有効に下げることにより、温度への曝露により分解される活性成分は、従来技術の処方物より良好に保存される。従って、本発明の処方物の保存寿命は、従来技術の組成物と比較して、延長され得ると考えられる。
この用語の範囲に入る化合物としては、プロピレングリコール、ジクロロベンジルアルコール、フェノキシエタノール、トランスクトールP、パンテノールなどのアルコール、グリセリンのようなポリオール、種々の分子量のポリエチレングリコールなどのアルコキシル化アルコール、メチルピロリジンなどの複素環式化合物、及びジメチルスルホキシドなどの非プロトン性溶媒が挙げられる。好ましい非界面活性剤両親媒性型化合物は、フェノキシエタノール及びプロピレングリコールである。フェノキシエタノールは最大2%w/wの量で存在し得るし、プロピレングリコールは望ましくは最大50%w/wの量で、より好ましくは最大30%w/wの量で、更に好ましくは最大25%w/wの量で存在する。
剤及び麻酔剤。
ルなどの天然及び合成のプロスタグランジンのような体液剤。
リン酸ラウレス)及びエトキシル化オレイルアルコール(リン酸オレス)に基づくものが挙げられる。概して、界面活性剤のエトキシル化度が高いほど、そのHLBは高く、マイクロエマルジョン又はサブミクロンエマルジョンが生成する温度は高く、その結果生じる処方物の粒子サイズは大きい。エトキシル化は、界面活性剤の炭素鎖長よりも、マイクロエマルジョン又はサブミクロンエマルジョンとして集合する組成物の能力により大きな影響を及ぼす。
.0:1.0である。即ち総親水性:総親油性比は、好ましくは3.0:2.0〜1:1である。
[実施例1]
[実施例2]
[実施例3]
[実施例4]
ソルビタン:セチルアルコールの界面活性剤比を示す。
[実施例5]
[実施例6]
℃に加熱する。全構成成分が完全に溶解するまで、混合を継続する。この成分の温度を、冷却させるか、又は水浴中で30℃に冷却する。
[実施例7]
全に溶解されるまで、混合物を最大50℃まで加熱する。
[実施例8]
プロセスのスケジュールを示す。スケジュールは、残った水相の迅速な添加直後の、伝導率測定により決定される相の反転が起きるまでの水相の緩徐添加を示す。
[実施例10]
E208/2/1 − 4.0:5.0:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 81℃に加熱
E208/2/2 − 4.5:4.5:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 82℃に加熱
E208/2/3 − 5.5:3.5:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 94℃に加熱
E208/2/4 − 5.0:4.0:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 84℃に加熱
E208/2/5 − 4.5:4.5:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 92℃に加熱
E208/2/6 − 4.5:4.5:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を1回で添加 − 78℃に加熱
E208/2/7 − 5.0:4.0:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を2回に分けて(70/30 熱:冷)添加、プロピレングリコールを添加時に攪拌 − 74℃に加熱
E208/2/8 − 5.0:4.0:1.0比のセテアレス−20:ラウリン酸ソルビタン:セチルアルコール、全水相を2回に分けて(70/30 熱:冷)添加、プロピレングリコールを添加時に撹拌しない − 74℃に加熱。
ポイントが、界面活性剤系中の親水性界面活性剤の相対的な割合を減少することにより低減され得るという傾向を実証する。水相が2つのアリコートに分割されると、集合温度も低下する。水相の分割は、親水性界面活性剤の相対的な割合を低減し、マイクロエマルジョンの集合温度を下げるのと同じ作用を有すると仮定される。
[実施例11]
[実施例12A]
1.成分1の調製:項目2〜項目8を混合容器に添加する。60℃に加熱し、撹拌して混合する。温度を保持した後、プロピオン酸クロベタゾールを添加する。溶解するまで撹拌し、成分2添加のための調製に備えて温度を80〜85℃に上げる。
2.成分2の調製:項目9〜項目13を混合容器に添加し、透明溶液が生成するまで撹拌しながら80〜85℃*に加熱する。
3.乳化:成分1を十分に(空気を混入せずに)撹拌し、成分2を添加する。最初に遅い速度で成分2を添加する。成分2添加中、高粘度の期間があり、完全な混合を達成するために短時間の撹拌速度の増大が必要となる。
4.均質化:エマルジョンを40℃に撹拌冷却する(適度に迅速な速度で冷却)。平均粒子サイズが>2.5μmであるか又は最大粒子サイズが>15μmである場合、エマルジョンを均質化する。エマルジョンを25℃に撹拌冷却する。
1.成分1の調製:項目1〜項目6を混合容器に添加する。60〜80℃に加熱し、撹拌して混合する。温度を保持した後、成分2Aを添加する。
2.成分2の調製:室温で項目7(水)を、項目9(クエン酸無水物)及び項目10(クエン酸カリウム一水和物)を適切なサイズの容器に添加する。十分に撹拌し、項目8(セトマクロゴール1000BP)の全てを添加する。セトマクロゴールが完全に溶解するまで最大50℃に加熱する(50℃を上回るとセトマクロゴールは融解、凝集し、大きい塊を形成する)。
3.成分2の分離:成分2の重量測定を行い、
成分2A − 70%の成分2を含有
成分2B − 30%の成分2を含有
に分割し、成分2Bを20〜30℃(できれば20〜25℃)に冷却する。
4.成分2Aの添加:成分2Aを混合容器に添加する。成分2Aは、熱い場合、又は予め調製され、室温に冷却されていた場合には、セトマクロゴールを溶解した直後に添加してもよい。
5.混合容器を十分に撹拌しながら少なくとも80〜85℃に加熱し(成分1+成分2)、<100μS/cmであると考えられる伝導率を測定する場合には10分間保持し、そうでない場合は温度を上げる。混合容器を徐々に73.0℃に冷却する。目標温度(73.0℃)に近づいたら、冷却速度が1℃/分以上にならないようにすべきである。これは、エマルジョンの最大透明度に対応するはずである。それは、Δ伝導率が大きな負の値からほぼ一定のゼロまで変化する点でもある。
6.成分2Bの添加:混合容器が73.0℃に達したら、成分2Bをポンプで送り込み(25℃で)、直ちに混合溶液を冷却し始める。成分2Bの添加は、90秒以内に完了すべきである。混合物の温度は、成分2Bの添加完了時に約60℃であるべきである。
7.成分3の添加:混合容器を35〜40℃に撹拌冷却する。成分3は、項目11〜項目13を適切な容器中に添加し、クロベタゾールが溶解されるまで加熱することにより、
予め調製される必要がある。クロベタゾール溶解後、成分3を<30℃に冷却し、少なくとも5〜10分を要する速度で混合容器に添加する。
8.混合容器を25〜30℃(25℃が好ましい)に撹拌冷却する。重量測定を行う。ベースエマルジョンは、充填前に20〜25℃に保持すべきである。ベースエマルジョンは、撹拌せずに少なくとも48時間均質なままである必要がある。
[実施例13]
研究者の固定化した世界的な評価:クリア(0)又はほぼクリア(1)、並びに
紅斑;0又は1、並びに
硬結/丘疹形成;0又は1、並びに
ISGA;2等級の最小の改善。
[実施例15]
・項目1及び項目2を混合する。完全に溶解するまで撹拌する。
・項目3、項目4、項目5及び項目6を添加する。60℃に加熱して、溶解するまで撹拌する。
・別のビーカー中で、項目7、項目8、項目9及び項目10を混合する。溶解するまで撹拌する。
・撹拌しながら、70%の水相を温かく透明な油相に添加する。温度及び伝導率を記録しながら、連続的に撹拌、加熱する。
・集合温度(約74℃)をちょうど超えるまで、加熱及び撹拌を続ける。エマルジョンの加熱をやめ、冷却撹拌器上に置く。
・撹拌を続けて、残りの水相を伝導率が最大になる温度(約70〜72℃)で添加する。
・30℃に撹拌冷却する。水をつぎ足し、蒸発による損失を算出する。
・pHを調べて、pH4に調整する(必要に応じて)。
Claims (25)
- 少なくとも1つの薬学的活性成分の皮膚送達のための水中油型(O/W)マイクロエマルジョン又はサブミクロンエマルジョン組成物の製造方法であって、
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物及びアルコキシル化アルコールから成る群のうちの少なくとも1つ、並びに1つ又は複数のHLB数が10未満の界面活性剤を含む第1の成分と、水及び少なくとも1つのHLB数が10より大きい界面活性剤を含む第2の成分とを均質になるように混合する工程、
b)工程a)の混合物を、継続的に混合しながら、40〜99℃の範囲で相集合温度に加熱して水中油型マイクロエマルジョン又はサブミクロンエマルジョンを生成させる工程、c)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却する工程、
d)2℃と前記相集合温度との間の温度で前記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は、必要に応じて予備混合され、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物および水に不溶性又は難溶性の薬学的活性成分を含む、工程
を含む方法。 - 工程b)において、工程a)の混合物を45〜95℃の範囲で相集合温度に加熱する、請求項1に記載の方法。
- 工程b)において、工程a)の混合物を65〜85℃の範囲で相集合温度に加熱する、請求項1又は2に記載の方法。
- 前記第2の成分が2つのアリコートで添加される、請求項1〜3のいずれかに記載の方法。
- 前記アリコートが、それぞれ第2の成分の約70質量%及び30質量%である、請求項4に記載の方法。
- 前記第2のアリコートが、前記マイクロエマルジョン又はサブミクロンエマルジョンが
生成された後、第1のアリコートの温度より実質的に低い温度で、組成物の全体温度を約60℃より低くするように迅速に添加され、それにより前記マイクロエマルジョン又はサブミクロンエマルジョンの構造が固定される、請求項4又は5に記載の方法。 - 前記第1の成分中に閉塞剤が存在する、請求項1〜6のいずれかに記載の方法。
- 前記閉塞剤がワセリンである、請求項7に記載の方法。
- 前記薬学的活性成分がコルチコステロイド、デソニド、クロベタゾール、ベタメタゾン、ビタミンDアナログ及びビタミンAアナログから選択される1つ又は複数の水不溶性化合物である、請求項1〜8のいずれかに記載の方法。
- 少なくとも1つの薬学的活性成分の皮膚送達のための水中油型(O/W)マイクロエマルジョン又はサブミクロンエマルジョン組成物の製造方法であって、
a)動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び1つ又は複数のHLB数が10未満の界面活性剤を含む第1の成分を、40〜99℃の温度に加熱し、均質になるように混合する工程、
b)水及び少なくとも1つのHLB数が10より大きい界面活性剤を含む第2の成分を40〜99℃の温度に加熱し、均質になるように混合する工程、
c)前記第2の成分を、継続的に混合しながら、40〜99℃の温度で前記第1の成分に添加し、マイクロエマルジョン又はサブミクロンエマルジョンを相集合温度で生成させる工程、
d)前記マイクロエマルジョン又はサブミクロンエマルジョンを冷却する工程、
e)室温と前記相集合温度との間の温度で前記マイクロエマルジョン又はサブミクロンエマルジョンに第3の成分を添加する工程であって、該第3の成分は予備混合され、必要に応じて、構成成分が溶解するまで加熱されており、非界面活性剤両親媒性型化合物および水に不溶性又は難溶性の薬学的活性成分を含む、工程
を含む、方法。 - 工程a)の前記温度が45〜95℃である、請求項10に記載の方法。
- 工程a)の前記温度が65〜85℃である、請求項10又は11に記載の方法。
- 工程b)の前記温度が45〜95℃である、請求項10〜12のいずれかに記載の方法。
- 工程b)の前記温度が65〜85℃である、請求項10〜13のいずれかに記載の方法。
- 工程c)の前記温度が45〜95℃である、請求項10〜14のいずれかに記載の方法。
- 工程c)の前記温度が65〜85℃である、請求項10〜15のいずれかに記載の方法。
- 水相全体に分散した油相及び水に不溶性又は難溶性の薬学的活性成分を含む少なくとも1つの薬学的活性成分の皮膚送達のための水中油型マイクロエマルジョン又はサブミクロンエマルジョン組成物であって、該油相が動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物又はアルコキシル化アルコールから成る群のうちの少なくとも1つ、及び少なくとも1つのHLB数が10未満の界面活性剤を含み、前記水相が少なくとも1つのHLB数が10より大きい界面活性剤、水、及び非界面活性剤両親媒性化合物を含み、該少なくとも1つのHLB数が10より大きい界面活性剤と該少なくとも1つのHLB数が10未満の界面活性剤の重量比が約9.0:1.0〜2.0:3.0であり、
前記非界面活性剤両親媒性化合物がマイクロエマルジョン又はサブミクロンエマルジョンの形成後に組成物に加えられることを特徴とする、組成物。 - 前記界面活性剤の総HLB数が8.0〜15.0である、請求項17に記載の組成物。
- 前記界面活性剤の総HLB数が10〜12である、請求項18に記載の組成物。
- 前記界面活性剤の総HLB数が9.7〜11.8である、請求項18又は19に記載の組成物。
- 前記油相中に閉塞剤が含まれる、請求項17〜20のいずれかに記載の組成物。
- 前記閉塞剤がワセリンである、請求項21に記載の組成物。
- 前記薬学的活性成分がコルチコステロイド、デソニド、クロベタゾール、ベタメタゾン、ビタミンDアナログ及びビタミンAアナログから選択される1つ又は複数の水不溶性化合物である、請求項17〜22のいずれかに記載の組成物。
- 前記薬学的活性成分が前記水相中に存在する、請求項17〜23のいずれかに記載の組成物。
- 水相全体に分散した油相及び水に不溶性又は難溶性の薬学的活性成分を含むことを特徴とする、患者の皮膚状態の医学的又は美容的処置のための水中油型マイクロエマルジョン又はサブミクロンエマルジョン組成物であって、
前記油相が動物油、鉱油又は植物油、シラン、シロキサン、エステル、脂肪酸、脂肪、ハロゲン化合物及びアルコキシル化アルコールから成る群のうちの少なくとも1つ、並びに少なくとも1つのHLB数が10未満の界面活性剤を含み、
前記水相が少なくとも1つのHLB数が10より大きい界面活性剤、水及び非界面活性剤両親媒性型化合物を含み、
前記少なくとも1つのHLB数が10より大きい界面活性剤と前記少なくとも1つのHLB数が10未満の界面活性剤の重量比が約9.0:1.0〜2.0:3.0であり、
前記非界面活性剤両親媒性化合物がマイクロエマルジョン又はサブミクロンエマルジョンの形成後に組成物に加えられることを特徴とする、
組成物。
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ES2429040T5 (es) | 2017-06-13 |
RU2007111706A (ru) | 2008-10-10 |
EP1796636B2 (en) | 2016-12-14 |
EP1796636A4 (en) | 2011-03-02 |
AU2005279704A1 (en) | 2006-03-09 |
KR101243526B1 (ko) | 2013-03-20 |
CA2578594A1 (en) | 2006-03-09 |
PL1796636T5 (pl) | 2017-10-31 |
EP1796636A1 (en) | 2007-06-20 |
KR20070069155A (ko) | 2007-07-02 |
WO2006024095A8 (en) | 2007-04-19 |
TW200624124A (en) | 2006-07-16 |
IL181632A (en) | 2015-01-29 |
RU2381023C2 (ru) | 2010-02-10 |
AR051197A1 (es) | 2006-12-27 |
AU2005279704B2 (en) | 2010-05-13 |
HK1110198A1 (en) | 2008-07-11 |
WO2006024095A1 (en) | 2006-03-09 |
CA2578594C (en) | 2012-04-17 |
TWI397427B (zh) | 2013-06-01 |
US20060057168A1 (en) | 2006-03-16 |
EP2438910A1 (en) | 2012-04-11 |
IL181632A0 (en) | 2007-07-04 |
PL1796636T3 (pl) | 2014-01-31 |
BRPI0514806A (pt) | 2008-06-24 |
US8460641B2 (en) | 2013-06-11 |
EP1796636B1 (en) | 2013-08-14 |
ES2429040T3 (es) | 2013-11-12 |
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