JP7475468B2 - 皮膜形成エアゾール組成物及びエアゾール型皮膜形成外用製剤 - Google Patents
皮膜形成エアゾール組成物及びエアゾール型皮膜形成外用製剤 Download PDFInfo
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- JP7475468B2 JP7475468B2 JP2022550528A JP2022550528A JP7475468B2 JP 7475468 B2 JP7475468 B2 JP 7475468B2 JP 2022550528 A JP2022550528 A JP 2022550528A JP 2022550528 A JP2022550528 A JP 2022550528A JP 7475468 B2 JP7475468 B2 JP 7475468B2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K8/00—Cosmetics or similar toiletry preparations
- A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
- A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
- A61K8/81—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions involving only carbon-to-carbon unsaturated bonds
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Birds (AREA)
- Inorganic Chemistry (AREA)
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- Cosmetics (AREA)
Description
前記皮膜形成剤として、ガラス転移温度が20℃以下のアクリル酸アルキル・酢酸ビニル共重合体のエマルション及びガラス転移温度が20℃以下のアクリル酸アルキル共重合体(アクリル酸アルキル・酢酸ビニル共重合体を除く)のエマルションが含有されており、かつ、
前記溶剤として、沸点が30~100℃の有機溶剤が含有されているものである。
1/Tg=Σ(Wi/Tgi)
より求め、摂氏換算することができる。前記式中、Tgは求める共重合体のガラス転移温度(K)を示し、Wiは、各モノマーの質量分率を示し、Tgiは対応するモノマーの単独重合体のガラス転移温度(K)を示す。単独重合体のTgは、「POLYMER HANDBOOK」(第4版;John Wiley&Sons,Inc.発行)等の刊行物に記載されている数値を採用すればよい。
(1)アクリル酸アルキル・酢酸ビニル共重合体1:商品名:ビニゾール2140L、大同化成工業株式会社製、医薬部外品原料規格:アクリル酸アルキル・酢酸ビニル共重合体エマルション、INCI名:Acrylates/VA Copolymer、不揮発分:45質量%、Tg:-9℃
(2)アクリル酸アルキル・酢酸ビニル共重合体2:商品名:ビニゾール2140LH、大同化成工業株式会社製、医薬部外品原料規格:アクリル酸アルキル・酢酸ビニル共重合体エマルション、INCI名:Acrylates/VA Copolymer、不揮発分:45質量%、Tg:26℃
(3)アクリル酸アルキル共重合体1:商品名:ビニゾール1086WP、大同化成工業株式会社製、医薬部外品原料規格:アクリル酸アルキル共重合体エマルション(2)、INCI名:Ammonium Acrylates Copolymer、不揮発分:40質量%、Tg:10℃
(4)アクリル酸アルキル共重合体2:商品名:ビニゾール1089HT、大同化成工業株式会社製、組成:アクリル酸アルキル共重合体エマルション、INCI名:Ammonium Acrylates Copolymer、不揮発分:35質量%、Tg:50℃
(5)酢酸ビニル樹脂:商品名:Kollicoat SR30D、BASFジャパン株式会社製、不揮発分:30質量%
(6)スチレン-イソプレン-スチレンブロック共重合体:商品名:SIS5002、JSR株式会社製、不揮発分:100質量%
(7)シリコーン系粘着基剤:商品名:Bio-PSA 7-4102、デュポン・東レ・スペシャルティ・マテリアル株式会社製、不揮発分:60質量%
[溶剤]
(8)エタノール:沸点78.3℃
(9)酢酸エチル:沸点77.1℃
(10)アセトン:沸点56.5℃
(11)ジエチルエーテル:沸点34.6℃
[噴射剤]
(12)ジメチルエーテル:沸点-23.6℃。
試験者の前腕に皮膜形成エアゾール組成物を約1秒間噴霧し、乾燥して、乾燥後の厚みが約0.03mmの皮膜を形成した。その後、皮膜を形成した前腕を約40℃の水浴下に浸し、皮膜を指でこすり取ったときに、除去できるか否かを以下の評価基準に沿って評価した。
A:容易に除去できた
B:除去できたが時間がかかった
C:除去が困難で、一部残ってしまった。
試験者の前腕に皮膜形成エアゾール組成物を約1秒間噴霧し、乾燥して、乾燥後の厚みが約0.03mmの皮膜を形成した。その後、皮膜を形成した前腕を常温の水浴下に浸し、皮膜を指でこすり取ったときに、皮膜が皮膚から剥がれるか否かを以下の評価基準に沿って評価した。
A:皮膜が皮膚から剥がれなかった
B:皮膜が皮膚から剥がれた。
予め重量を測定した約7cm×7cmの合皮(藤久株式会社製)上に皮膜形成エアゾール組成物を約1秒間噴霧し、乾燥して、乾燥後の厚みが約0.03mmの皮膜を形成し、形成した皮膜の重量を測定した。その後、皮膜の上に予め重量を測定した約7cm×7cmの織布(目付:約95g/m2)を積層し、約80kgの荷重を約30秒間織布全体にかけた後、織布を剥離し、織布へ移行した皮膜の重量を測定した。得られた測定値から、織布へ移行した皮膜の割合[質量%]を算出した。
プラスチックフィルム(藤森工業株式会社製)上に皮膜形成エアゾール組成物を約1秒間噴霧し、乾燥後の厚みが約0.03mmとなる皮膜を形成した後、10秒間隔で皮膜を指で触り、乾燥しているか否かを評価した。3人の試験者が同じ評価を行い、乾燥が確認できた時間(秒)の平均値を求めた。なお、皮膜の速乾性として好ましい結果(乾燥時間)は、60秒以内である。
表1に示す溶剤と皮膜形成剤を同表に示す組成となるように混合して原液を調製した後、得られた原液をエアゾール用耐圧容器内(容量:100ml)に充填し、エアゾール用バルブを取り付けた後、同表に示す噴射剤を同表に示す組成となるように圧入し、アクチュエーターを取り付けて、皮膜形成エアゾール組成物が充填されたエアゾール製品を得た。
溶剤、皮膜形成剤及び噴射剤の組成が表2に示す組成となるようにしたこと以外は実施例1と同様の方法で皮膜形成エアゾール組成物が充填されたエアゾール製品を得た。得られた皮膜形成エアゾール組成物について、皮膜の速乾性を評価した。得られた結果を表2に示す。
溶剤、皮膜形成剤及び噴射剤の組成が表3に示す組成となるようにしたこと以外は実施例1と同様の方法で皮膜形成エアゾール組成物が充填されたエアゾール製品を得た。得られた皮膜形成エアゾール組成物について、皮膜の速乾性を評価した。得られた結果を表3に示す。
溶剤、皮膜形成剤及び噴射剤の組成が表4に示す組成となるようにしたこと以外は実施例1と同様の方法で皮膜形成エアゾール組成物が充填されたエアゾール製品を得た。得られた皮膜形成エアゾール組成物について、皮膜の除去性及び皮膜の耐水性を評価し、実施例10~11の皮膜形成エアゾール組成物についてはべたつきも評価した。得られた結果を表4に示す。
溶剤、皮膜形成剤及び噴射剤の組成が表5に示す組成となるようにしたこと以外は実施例1と同様の方法で皮膜形成エアゾール組成物が充填されたエアゾール製品を得た。得られた皮膜形成エアゾール組成物について、皮膜の除去性、皮膜の耐水性、べたつき、及び皮膜の速乾性を評価した。得られた結果を表5に示す。
表6に示す溶剤と薬効成分とその他成分を同表に示す組成となるように混合し、得られた溶液に同表に示す皮膜形成剤を同表に示す組成となるように加えて混合して原液を調製した後、得られた原液をエアゾール用耐圧容器内(容量:100ml)に充填し、エアゾール用バルブを取り付けた後、同表に示す噴射剤を同表に示す組成となるように圧入し、アクチュエーターを取り付けて、エアゾ-ル型皮膜形成外用製剤が充填されたエアゾール製品を得た。得られたエアゾ-ル型皮膜形成外用製剤について、皮膜の除去性、皮膜の耐水性、べたつき、及び皮膜の速乾性を評価した。得られた結果を表6に示す。
Claims (7)
- 皮膜形成剤及び溶剤を含有する原液と、噴射剤とを含有する皮膜形成エアゾール組成物であって、
前記皮膜形成剤として、ガラス転移温度が20℃以下のアクリル酸アルキル・酢酸ビニル共重合体のエマルション及びガラス転移温度が20℃以下のアクリル酸アルキル共重合体(アクリル酸アルキル・酢酸ビニル共重合体を除く)のエマルションが含有されており、かつ、
前記溶剤として、沸点が30~100℃の有機溶剤が含有されている、
皮膜形成エアゾール組成物。 - 前記アクリル酸アルキル・酢酸ビニル共重合体と前記アクリル酸アルキル共重合体の含有比(アクリル酸アルキル・酢酸ビニル共重合体の質量:前記アクリル酸アルキル共重合体の質量)が不揮発分換算で1:0.5~1:9である、請求項1に記載の皮膜形成エアゾール組成物。
- 前記有機溶剤が、エタノール、酢酸エチル、アセトン及びジエチルエーテルからなる群から選択される少なくとも1種である、請求項1又は2に記載の皮膜形成エアゾール組成物。
- 前記有機溶剤が、エタノール、酢酸エチル及びアセトンからなる群から選択される少なくとも2種である、請求項1~3のうちのいずれか一項に記載の皮膜形成エアゾール組成物。
- 前記原液中の前記皮膜形成剤の含有量が、不揮発分換算で5~25質量%である、請求項1~4のうちのいずれか一項に記載の皮膜形成エアゾール組成物。
- 前記原液と前記噴射剤の配合比(原液の質量:噴射剤の質量)が5:95~25:75である、請求項1~5のうちのいずれか一項に記載の皮膜形成エアゾール組成物。
- 請求項1~6のうちのいずれか一項に記載の皮膜形成エアゾール組成物に、薬効成分を配合してなる、エアゾ-ル型皮膜形成外用製剤。
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