TW202320880A - 微針貼附劑 - Google Patents
微針貼附劑 Download PDFInfo
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- TW202320880A TW202320880A TW111131362A TW111131362A TW202320880A TW 202320880 A TW202320880 A TW 202320880A TW 111131362 A TW111131362 A TW 111131362A TW 111131362 A TW111131362 A TW 111131362A TW 202320880 A TW202320880 A TW 202320880A
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- microneedle
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Abstract
本發明之一例之微針貼附劑具備支持體、設置於支持體之主面的黏著劑層、及至少一部分位於黏著劑層內之微針陣列,黏著劑層包含水溶性高分子及水,於環境溫度為25℃及頻率為1 Hz之測定條件下,黏著劑層之損耗正切為0.20~0.41。
Description
本發明之一態樣係關於一種微針貼附劑。
於專利文獻1中,記載有一種附微細針之貼附劑。該貼附劑於黏著層之內部具備可自該黏著層向貼合面側頂出之一根以上之微細針構件。
於專利文獻2中,記載有一種貼附劑,其具備:支持體;黏著劑層,其設置於支持體之一面,且包含活性成分;及微針陣列,其具有設置於基板上之微針。微針自黏著劑層之中露出而刺入皮膚後,由於彈性而向遠離該皮膚之方向移動。
先前技術文獻
專利文獻
專利文獻1:日本專利特開2007-1938號公報
專利文獻2:日本專利特開2015-151380號公報
[發明所欲解決之問題]
期望一種自皮膚剝離時微針陣列不會殘留於皮膚上之微針貼附劑。
[解決問題之技術手段]
本發明之一態樣之微針貼附劑具備支持體、設置於支持體之主面的黏著劑層、及至少一部分位於黏著劑層內之微針陣列,黏著劑層包含水溶性高分子及水,於環境溫度為25℃及頻率為1 Hz之測定條件下,黏著劑層之損耗正切為0.20~0.41。
於此種態樣中,覆蓋微針之至少一部分的黏著劑層之損耗正切設定為上述數值範圍內。藉由使黏著劑層具有此種構成,能夠於不在皮膚上殘留微針陣列之情況下將應用於該皮膚之微針貼附劑剝離。
[發明之效果]
根據本發明之一態樣,能夠提供一種自皮膚剝離時微針陣列不會殘留於皮膚上之微針貼附劑。
以下,參照隨附圖式對本發明中之實施方式詳細地進行說明。於圖式之說明中,對相同或同等之要素標註相同符號,省略重複說明。
圖1係實施方式之微針貼附劑10之立體圖。微針貼附劑10係用作敷劑、貼劑等之製劑。於一例中,微針貼附劑10具備:支持體12;黏著劑層14,其形成於支持體12之大致整個主面;剝離片材16,其可剝離地貼附於黏著劑層14之作用面;及微針陣列20,其嵌埋於黏著劑層14內。所謂黏著劑層14之作用面,係指使用微針貼附劑10時與使用者之皮膚接觸之面。
微針貼附劑10之尺寸亦可根據使用者之症狀、年齡、體重、性別等而進行設定。例如,微針貼附劑10之面積可為1~500 cm
2,亦可為10~400 cm
2。藉由將其面積設為1 cm
2以上,而易於維持活性成分之充足之皮膚透過性。藉由將其面積設為500 cm
2以下,而易於使用微針貼附劑10。
支持體12係片狀之構件。支持體12亦可具有伸縮性。支持體12之材質亦可考慮物理性質(厚度、伸長率、拉伸強度、貼附作業性等)、貼附時之觸感、皮膚之密閉性、活性成分向支持體12之移行等而進行選擇。例如,其材質亦可為織布、不織布、樹脂膜、發泡片材、或紙。作為織布之例,可例舉編織布。於使用織布、不織布、或樹脂膜作為支持體12之情形時,作為其等之素材,例如可例舉:聚乙烯、聚丙烯、聚丁烯等聚烯烴;聚對苯二甲酸乙二酯(PET)等聚酯;嫘縈;聚胺酯;及棉。該等素材可單獨使用一種,亦可組合使用兩種以上。支持體12可具有單層構造,亦可具有多層構造。支持體12亦可為片狀之多孔質材料或片狀之發泡體。
作為編織布之例,可例舉包含聚酯系、尼龍系、聚丙烯系、嫘縈系等之材料中之一種或組合其等中之兩種以上而成之編織布。例如,亦可使用與活性成分之相互作用較少之包含聚酯系之聚對苯二甲酸乙二酯的編織布。
於支持體12為編織布或不織布之情形時,若於支持體12延展含有水之黏著劑組合物,則存在黏著劑組合物通過支持體12之網眼而滲出至支持體之背面側之虞。考慮到該點,編織布或不織布之單位面積重量可為50~150 g/m
2,亦可為75~125 g/m
2。藉由將單位面積重量設為此種範圍,往往能夠於黏著劑組合物不通過支持體12之間隙而滲出至支持體12之背面側之情況下延展該黏著劑組合物。並且,能夠維持支持體12與黏著劑層14之間的抓固性。
關於支持體12之伸縮性,於縱方向及橫方向中之至少一者上,50%模數(50%伸長時負荷)亦可為0.5~10 N/50 mm。此處,所謂「縱方向」,係指製造編織布之步驟中之行進方向,所謂「橫方向」,係指與縱方向正交之方向,即寬度方向。模數之測定方法係基於JIS L 1018: 1999。
支持體12之厚度例如亦可於5~1000 μm之範圍內進行設定。將其厚度設為5 μm以上,係為了使微針貼附劑10之使用變得容易。將其厚度設為1000 μm以下,係為了防止支持體12之硬度對微針貼附劑10之附著性造成影響。
黏著劑層14係具有能夠貼附於人之皮膚之黏著性的層。於一例中,黏著劑層14含有水溶性高分子及水。黏著劑層14亦可進而包含活性成分(生理活性物質)。所謂「黏著劑層包含活性成分」,其概念包括如下兩種態樣:黏著劑層14於其中含有活性成分之態樣、以及活性成分附著於黏著劑層14之作用面之態樣。
水溶性高分子係指具有親水基之高分子。作為親水基,例如可例舉:羥基、羧基、胺基等。藉由使黏著劑層14含有水溶性高分子,能夠更加長時間地保持微針貼附劑10中之水分。
水溶性高分子亦可為聚丙烯酸或聚丙烯酸中和物(有時會將該等稱作「水溶性丙烯酸聚合物」)。藉由使黏著劑層14包含聚丙烯酸或聚丙烯酸中和物,能夠提供具有優異附著性之黏著劑層14。
水溶性丙烯酸聚合物係使具有發揮水溶性之官能基(親水基)之含有丙烯醯基之化合物聚合而獲得之聚合物。黏著劑層14藉由含有水及水溶性丙烯酸聚合物而發揮附著性。水溶性丙烯酸聚合物例如為使聚丙烯酸或其中和物、具有親水基之丙烯酸酯、或者具有親水基之丙烯醯胺等具有丙烯醯基之化合物聚合而獲得之聚合物。水溶性丙烯酸聚合物可為由具有一種丙烯醯基之化合物所獲得之均聚物,亦可為由具有兩種以上之丙烯醯基之化合物所獲得之共聚物。
親水基為陽離子性親水基、陰離子性親水基、或非離子性親水基均可。作為陽離子性親水基之例,可例舉四級銨基。作為陰離子性親水基之例,可例舉:羧基、磺基、及磷酸基。作為非離子性親水基之例,可例舉:羥基、及胺基。
於黏著劑層14中包含聚丙烯酸作為水溶性高分子之情形時,其含量以黏著劑層14之總質量為基準,可調整為0.1~5質量%,亦可調整為0.5~4質量%。藉由將聚丙烯酸之含量設為0.1質量%以上,黏著劑層14之成型性及保型性呈進一步提昇之趨勢。藉由將聚丙烯酸之含量設為5質量%以下,呈現如下趨勢:黏著劑層14之硬度不易變高,對皮膚之密接性進一步變高。若增加黏著劑層14中之聚丙烯酸之含量,則損耗正切呈增加趨勢。
聚丙烯酸中和物為聚丙烯酸完全中和物、聚丙烯酸部分中和物、該等之混合物均可。作為聚丙烯酸中和物,可例舉聚丙烯酸鹽,例如可使用鈉鹽、鉀鹽、鈣鹽、銨鹽等。
作為聚丙烯酸中和物,亦可使用初始附著力、經時性附著力均變高之聚丙烯酸部分中和物。聚丙烯酸部分中和物係於一個聚合物鏈中,以任意比率存在來自丙烯酸之結構單元及來自丙烯酸鹽之結構單元之組合物。作為聚丙烯酸部分中和物,亦可使用一個聚合物鏈中之羧基中之20~80莫耳%經過中和者。
於黏著劑層14中包含聚丙烯酸中和物作為水溶性高分子之情形時,其含量以黏著劑層14之總質量為基準,可調整為1~10質量%,亦可調整為2~7質量%。藉由將聚丙烯酸中和物之含量設為1質量%以上,可充分獲得聚丙烯酸中和物之附著力。藉由將聚丙烯酸中和物之含量設為7質量%以下,黏著劑層14之成型性及保型性提昇。若增加黏著劑層14中之聚丙烯酸中和物之含量,則損耗正切呈減少趨勢。於併用聚丙烯酸及聚丙烯酸中和物(較佳為聚丙烯酸部分中和物)作為水溶性高分子之情形時,各者之較佳含量亦如上所述。
於具有親水基之丙烯酸酯中,丙烯酸酯部分亦可為丙烯酸烷基酯。該烷基部分可為碳數為1~10之烷基,亦可為碳數為1~8之烷基。於具有親水基之丙烯酸酯中,親水基亦可存在於該烷基部分。
黏著劑層14中亦可包含除了水溶性丙烯酸聚合物以外之成分作為水溶性高分子。例如,黏著劑層14亦可包含:明膠、聚乙烯醇、聚乙烯吡咯啶酮、海藻酸鈉、玻尿酸鈉、羥丙基纖維素、羧甲基纖維素鈉(carmellose sodium)、甲基纖維素、角叉菜膠、葡甘露聚醣、瓊脂、瓜爾膠、三仙膠、結冷膠、果膠、或刺槐豆膠。該等可單獨使用一種,亦可組合使用兩種以上。例如,亦可使用羧甲基纖維素鈉、明膠、或聚乙烯醇。該等成分亦可與水溶性丙烯酸聚合物組合使用。
於黏著劑層14包含除了水溶性丙烯酸聚合物以外之水溶性高分子之情形時,其含量以黏著劑層14之總質量為基準,可調整為0.1~30質量%,可調整為3~18質量%,亦可調整為3~10質量%。若除了水溶性丙烯酸聚合物以外之水溶性高分子之含量為3質量%以上,則黏著劑層14之凝集力呈容易變高之趨勢。若其含量為10質量%以下,則黏著劑層14中所包含之活性成分呈容易均勻分散之趨勢。若增加黏著劑層14中之除了水溶性丙烯酸聚合物以外之水溶性高分子之含量,則損耗正切呈減少趨勢。
藉由使黏著劑層14含有水,活性成分之皮膚透過性提昇,活性成分之作用得以更加有效地發揮。水之含量以黏著劑層14之總質量為基準,可為10~90質量%,可為15~88質量%,亦可為18~85質量%。
黏著劑層14亦可含有丙烯酸甲酯-丙烯酸2-乙基己酯共聚物樹脂。關於先前之貼附劑,若黏著劑層14之重量較小,則水含量容易下降,附著力容易下降。藉由使黏著劑層14包含丙烯酸甲酯-丙烯酸2-乙基己酯共聚物樹脂,即使於黏著劑層14之質量相對較小之情形時,亦會呈現如下趨勢:經過較長時間後亦容易維持足夠之附著力。
黏著劑層14亦可進而包含增溶劑、交聯劑、保濕劑、清涼劑、穩定劑、填充劑、防腐劑、螯合劑、無機粉體、著色料、著香料、或pH值調整劑等作為其他成分。
增溶劑係用以使活性成分溶解。作為增溶劑,例如可例舉:克羅米通;N-甲基吡咯啶酮;聚乙二醇(PEG)、聚丁二醇等聚伸烷基二醇;肉豆蔻酸異丙酯、己二酸二乙酯等脂肪酸酯;聚乙二醇單硬脂酸酯等氧伸烷基脂肪酸酯;聚氧伸烷基山梨醇酐脂肪酸酯等脂肪酸酯;聚氧乙烯氫化蓖麻油;聚山梨糖醇酯80等界面活性劑。該等增溶劑可單獨使用一種,亦可組合使用兩種以上。增溶劑之含量以黏著劑層14之總質量為基準,亦可調整為0.1~10質量%。
交聯劑係用以使黏著劑層14牢固並維持保水性。作為交聯劑之例,可例舉:胺基樹脂、酚樹脂、環氧樹脂、醇酸樹脂、不飽和聚酯等熱固性樹脂、異氰酸酯化合物、封端異氰酸酯化合物、有機系交聯劑、硫酸鉀鋁(明礬)、矽酸鋁、硫酸鎂、以及金屬或金屬化合物等無機系交聯劑。交聯劑之含量以黏著劑層14之總質量為基準,可為0.01~10質量%,可為0.01~6.5質量%,可為0.01~3質量%,可為0.05~2質量%,亦可為0.1~1質量%。若增加黏著劑層14中之交聯劑之含量,則損耗正切呈減少趨勢。
保濕劑係用以抑制水分隨著時間推移自黏著劑層14蒸發。作為保濕劑,例如可例舉甘油、山梨糖醇、乙二醇、1,2-丙二醇、聚乙二醇、1,3-丙二醇、及1,4-丁二醇等多元醇,亦可例舉玻尿酸、膠原蛋白、腦醯胺、脲、及肝素。該等保濕劑可單獨使用一種,亦可組合使用兩種以上。保濕劑之含量以黏著劑層14之總質量為基準,可調整為0.1~70質量%,亦可調整為3~70質量%。
藉由使黏著劑層14含有多元醇,呈現如下趨勢:黏著劑層14變得更加柔軟,微針貼附劑10之附著性進一步提昇。若增加黏著劑層14中之多元醇之含量,則損耗正切呈增加趨勢。
於黏著劑層14中包含甘油作為多元醇之情形時,甘油之含量以黏著劑層14之總質量為基準,可為5~50質量,可為10~40質量%,亦可為15~35質量%。若甘油之含量為5質量%以上,則能夠於微針貼附劑10之使用中進一步延緩黏著劑層14之乾燥,易於更加長時間地維持微針貼附劑10之附著力。若甘油之含量為50質量%以下,則甘油不易自黏著劑層14分離,黏著劑層14之表面更不易變得黏膩。若增加黏著劑層14中之甘油之含量,則損耗正切呈增加趨勢。
作為清涼劑,例如可例舉:瑞香草酚、l-薄荷腦、dl-薄荷腦、l-異洋薄荷醇、薄荷油等。作為清涼劑,亦可使用l-薄荷腦。清涼劑之含量以黏著劑層14之總質量為基準,亦可調整為0.5~3質量%。
作為穩定劑,例如可例舉:氧苯酮、二丁基羥基甲苯(BHT)、乙二胺四乙酸鈉、UV吸收劑(例如,二苯甲醯甲烷衍生物)等。穩定劑之含量以黏著劑層14之總質量為基準,亦可調整為0.01~3質量%。
作為填充劑之例,可例舉:碳酸鈣、碳酸鎂、矽酸鹽(例如,矽酸鋁、矽酸鎂等)、矽酸、硫酸鋇、硫酸鈣、鋅酸鈣、氧化鋅、氧化鈦等。填充劑之含量以黏著劑層14之總質量為基準,可為0.01~10質量%,亦可為3~9質量%。若增加黏著劑層14中之填充劑之含量,則損耗正切呈減少趨勢。
作為防腐劑之例,可例舉:對羥苯甲酸甲酯、對羥苯甲酸乙酯、對羥苯甲酸丙酯、及對羥苯甲酸丁酯等。
作為螯合劑之例,可例舉:乙二胺四乙酸鹽、焦磷酸鹽、六偏磷酸鹽、及葡萄糖酸等。螯合劑之含量以黏著劑層14之總質量為基準,可為0.01~1質量%,可為0.05~0.5質量%,亦可為0.1~0.3質量%。若增加黏著劑層14中之螯合劑之含量,則損耗正切呈增加趨勢。
作為pH值調整劑之例,可例舉:乙酸、乳酸、草酸、檸檬酸、酒石酸等有機酸;鹽酸、硫酸、硝酸、磷酸等無機酸;以及該有機酸及該無機酸之藥學上容許之鹽。pH值調整劑之含量以黏著劑層14之總質量為基準,可為0.01~1質量%,可為0.05~0.5質量%,亦可為0.1~0.3質量%。藉由利用黏著劑層14中之pH值調整劑,呈現如下趨勢:當黏著劑層14之pH值減少時損耗正切減少,當黏著劑層14之pH值增加時損耗正切增加。
作為無機粉體、著色料、及著香料,可使用通常用於微針貼附劑10之組合物。
構成微針貼附劑10之黏著劑層14,即,製造微針貼附劑10,物性變化(例如交聯反應)收斂後之黏著劑層14之損耗正切(tanδ)可為0.20~0.41。物性變化收斂所需之時間因黏著劑層14之組成而異,例如可藉由損耗正切或凝膠強度之經時變化之收斂來確認。於本發明中,損耗正切(tanδ)係藉由動態黏彈性測定所獲得之值。具體而言,將含有水溶性高分子及水之黏著劑層14自微針貼附劑10剝離,藉由兩個板夾著該剝離之黏著劑層14,測定對單個板賦予週期性地振動的應變時之應力變化。動態黏彈性測定係依據JIS K7244-10:2005(ISO 6721-10:1999)。損耗正切係根據下述式(1)而獲得。
損耗正切(tanδ)=損耗彈性模數(G")/儲存彈性模數(G') (1)
動態黏彈性測定例如使用旋轉式流變儀,於環境溫度為25℃及頻率為1 Hz之測定條件下實施。損耗正切之上述數值範圍0.20~0.41係由該測定條件下之測定值而獲得。該損耗正切可藉由對水溶性高分子或水之含量加以變更而調整為所需值。
於第1例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、3.5~7質量%之羧甲基纖維素鈉、2質量%以上且未達5質量%之聚丙烯酸部分中和物、及0.22~1質量%之交聯劑。所謂水溶性高分子之總量,係指一種以上之水溶性高分子之質量%之總和。
於第2例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、3.5~6質量%之羧甲基纖維素鈉、3~4.58質量%之聚丙烯酸部分中和物、及0.24~1質量%之交聯劑。
於第3例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、0.5質量%以上且未達3.5質量%之羧甲基纖維素鈉、1質量%以上且未達5質量%之聚丙烯酸部分中和物、及1~9質量%之交聯劑。
於第4例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、1質量%以上且未達3.5質量%之羧甲基纖維素鈉、2~4.58質量%之聚丙烯酸部分中和物、及1~6.24質量%之交聯劑。
於第5例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、0.5質量%以上且未達3.5質量%之羧甲基纖維素鈉、5~10質量%之聚丙烯酸部分中和物、及0.18~0.7質量%之交聯劑。
於第6例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、1質量%以上且未達3.5質量%之羧甲基纖維素鈉、5~8質量%之聚丙烯酸部分中和物、及0.2~0.5質量%之交聯劑。
於第7例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、3.5~7質量%之羧甲基纖維素鈉、2質量%以上且未達5質量%之聚丙烯酸部分中和物、0.22~1質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~2。
於第8例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、3.5~6質量%之羧甲基纖維素鈉、3~4.58質量%之聚丙烯酸部分中和物、0.24~1質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~1.67。
於第9例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、0.5質量%以上且未達3.5質量%之羧甲基纖維素鈉、1質量%以上且未達5質量%之聚丙烯酸部分中和物、1~9質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~2。
於第10例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、1質量%以上且未達3.5質量%之羧甲基纖維素鈉、2~4.58質量%之聚丙烯酸部分中和物、1~6.24質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~1.67。
於第11例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11~20質量%之水溶性高分子、0.5質量%以上且未達3.5質量%之羧甲基纖維素鈉、5~10質量%之聚丙烯酸部分中和物、0.18~0.7質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~2。
於第12例中,損耗正切為0.20~0.41之黏著劑層包含:總量為11.5~18.5質量%之水溶性高分子、1質量%以上且未達3.5質量%之羧甲基纖維素鈉、5~8質量%之聚丙烯酸部分中和物、0.2~0.5質量%之交聯劑、0.1~5質量%之聚丙烯酸、1~6質量%之聚乙烯醇、及0.01~1質量%之乙二胺四乙酸二鈉,且乙二胺四乙酸二鈉相對於交聯劑之比率為0.04~1.67。
於本發明中,所謂環境溫度,係指進行測定或試驗之作業環境之溫度。於一例中,環境溫度係指作業空間之溫度、以及測定機器之中至少與黏著劑層接觸之部分之溫度兩者。作業空間為室內或室外均可,因此,作業空間之溫度為室溫或外部大氣溫度均可。
活性成分例如亦可自由抗氧化劑、自由基捕捉劑、保濕劑、脫色素劑、脂肪調節劑、紫外線反射劑、濕潤劑、抗菌劑、抗過敏藥、抗痤瘡藥、抗老化藥、抗皺藥、殺菌劑、鎮痛劑、止咳藥、止癢藥、局部麻醉藥、防禿劑、育髮輔助劑、育髮抑制劑、抗頭屑劑、抗組織胺劑、角質溶解劑、消炎藥、解熱劑、治療用藥、抗感染藥、消炎劑、止吐藥、抗膽鹼作用藥、血管收縮藥、血管擴張藥、外傷癒合助劑、肽、多肽、蛋白質、防體臭劑、止汗劑、皮膚軟化劑、皮膚保濕液、柔軟劑、護髮素、毛髮軟化劑、毛髮保濕劑、美黑劑、美白劑、抗真菌劑、脫毛劑、外用鎮痛藥、對抗刺激劑、痔瘡藥、殺蟲劑、毒長春籐治療用藥、毒漆樹治療用藥、灼傷治療用藥、抗尿布疹藥、汗疹藥、化妝水、維生素、胺基酸、胺基酸衍生物、草藥萃取物、視黃醇、類黃酮、感覺標記物、皮膚調理劑、頭髮脫色劑、螯合劑、細胞代謝回轉強化劑、著色劑、防曬劑、麻醉藥、免疫活化劑、營養藥、水分吸收劑、皮脂吸收劑、美肌成分、及該等之混合物所組成之群中進行選擇。
活性成分例如亦可包含萃取物或酊劑等之類的植物調合液以治療局部皮膚病。作為萃取物或酊劑之例,可例舉:橡木樹皮之萃取液、胡桃之萃取液、山金車之酊劑、金縷梅之萃取物、長葉車前草之萃取物、三色堇之萃取物、百里香或鼠尾草之萃取物;聖約翰草之酊劑、金光菊之萃取物、甘菊花之萃取物、或金盞花之酊劑;用以修復嚴重疲勞及受損之皮膚的例如樺木葉之萃取物、蕁麻之萃取物、款冬(coldsfoot)之萃取物、康福利草之酊劑、問荊之萃取物、或蘆薈之萃取物;七葉樹及假葉樹之萃取物、山金車、金盞花、及辣椒之萃取物。
作為活性成分,胺基酸不僅可包含由其鹽、酯、或醯基衍生物之水解所獲得之胺基酸,還可包含由各種蛋白質之水解所獲得之胺基酸。作為此種胺基酸藥品之例,例如可例舉:烷基醯胺烷基胺、麩胺酸硬脂基乙醯酯、辛醯蠶絲胺基酸、辛醯膠原胺基酸等兩性胺基酸;辛醯角蛋白胺基酸;辛醯豌豆胺基酸;椰油基二甲基銨羥丙基蠶絲胺基酸;玉米蛋白胺基酸;半胱胺酸(cysteine);麩胺酸;甘胺酸;人髮角蛋白胺基酸;例如天冬胺酸、蘇胺酸、絲胺酸、麩胺酸、脯胺酸、甘胺酸、丙胺酸、半胱胺酸(half cystine)、纈胺酸、甲硫胺酸、異白胺酸、白胺酸、酪胺酸、苯丙胺酸、氧化半胱胺酸(cysteic acid)、離胺酸、組胺酸、精胺酸、半胱胺酸(cysteine)、色胺酸、瓜胺酸等人髮胺基酸;離胺酸;蠶絲胺基酸;小麥胺基酸;及其等之混合物。
作為活性成分,肽、多肽、及蛋白質包含例如碳原子數至少為約10之長鏈、及例如具有至少為1000之高分子量之聚合物,其等係藉由胺基酸之自縮合而形成。作為此種蛋白質之例,可例舉:膠原蛋白;去氧核糖核酸酶;碘化玉米蛋白;角蛋白;乳蛋白;蛋白酶;血清蛋白;絲蛋白;甜杏仁蛋白;小麥麥芽蛋白;小麥蛋白;小麥蛋白、角蛋白蛋白質之α及β螺旋;例如中間絲蛋白、硫含量高之蛋白質、硫含量極高之蛋白質、中間絲相關蛋白、高酪胺酸蛋白、高甘胺酸-酪胺酸蛋白、毛透明蛋白、及其等之混合物等人髮蛋白質。
作為抗皺成分之例,可例舉:玻尿酸、玻尿酸鈉、視黃醇(維生素A)、水飛薊賓肽類(HTC膠原蛋白、棕櫚醯五肽-3、六胜肽)、胺基酸類、羥基脯胺酸、托可維A酸、熊果酸、維生素C衍生物、輔酶Q10、蝦紅素、富勒烯、多酚類、α-硫辛酸、大豆萃取物、聚三葡萄糖、活性型異黃酮、糖類、多糖類、甘油、甘油衍生物等。抗皺成分亦可為該等組合物中之至少兩種之混合。
作為維生素之例,可例舉:維生素B複合體;包含硫胺素、菸鹼酸、生物素、泛酸、膽鹼、核黃素、維生素B6、維生素B12、吡哆醇、肌醇、肉鹼之例如維生素A棕櫚酸酯等維生素A、C、D、E、K及其等之衍生物;以及例如泛醇(原維生素B5)及泛醇三乙酸酯等原維生素;以及該等之混合物。
作為抗菌物質之例,可例舉:枯草桿菌素、紅黴素、新黴素、四環素、氯四環素、苄索氯銨、苯酚、及該等之混合物。
作為皮膚軟化劑及肌膚保濕劑之例,可例舉:礦物油、羊毛脂、植物油、異硬脂酸異硬脂酯、月桂酸甘油酯、甲基葡萄糖10環氧乙烷、甲基葡萄糖20環氧乙烷、聚葡萄胺糖、及該等之混合物。
作為護髮素之例,不僅可例舉鯨蠟醇、硬脂醇、氫化聚癸烯、及該等之混合物之類的脂溶性化合物,還可例舉山萮醯胺丙基PG-二甲基氯化銨、三鯨蠟基氯化銨、氫化牛脂醯胺乙基羥乙基甲基銨甲基硫酸鹽、及該等之混合物等四級化合物。
作為防曬劑之例,可例舉:丁基甲氧基二苯甲醯基甲烷、甲氧基肉桂酸辛酯、氧苯酮、奧克立林、水楊酸辛酯、苯基苯并咪唑磺酸、胺基苯甲酸乙基羥丙基酯、鄰胺苯甲酸薄荷酯、胺基苯甲酸、辛諾賽、甲氧基肉桂酸二乙醇胺、胺基苯甲酸甘油、二氧化鈦、氧化鋅、氧苯酮、帕地馬酯O、紅凡士林、及其混合物。作為美黑劑之例,可例舉二羥基丙酮。
作為皮膚美白劑之例,可例舉:對苯二酚及其衍生物、鄰苯二酚及其衍生物、抗壞血酸及其衍生物、土耳其鞣酸及其衍生物、麴酸及其衍生物、傳明酸及其衍生物、間苯二酚衍生物、胎盤萃取物、熊果苷、油溶性甘草萃取物、以及該等之混合物。
作為消炎鎮痛藥之例,可例舉:乙醯胺酚、水楊酸甲酯、水楊酸單乙二醇酯、阿斯匹靈、甲芬那酸、氟芬那酸、吲哚美辛、雙氯芬酸、阿氯芬酸、雙氯芬酸鈉、布洛芬、酮洛芬、萘普生、普拉洛芬、非諾洛芬、舒林酸、芬氯酸、環氯茚酸、氟比洛芬、芬替酸、丁苯羥酸、匹洛西卡、保泰松、羥布宗、氯非宗、噴他佐辛、噻吡唑、及鹽酸噻拉米特。作為可與微針貼附劑10一起使用之類固醇性消炎鎮痛藥之例,可例舉:氫化可體松、潑尼松龍、地塞米松、曲安奈德、氟輕鬆、乙酸氫化可體松、乙酸潑尼松龍、甲基潑尼松龍、乙酸地塞米松、倍他米松、戊酸倍他米松、氟美松、氟米龍、及二丙酸倍氯米松。
作為抗組織胺藥之例,可例舉:鹽酸苯海拉明、水楊酸苯海拉明、苯海拉明、鹽酸氯苯那敏、馬來酸氯苯那敏、鹽酸氮異丙嗪、鹽酸曲吡那敏、鹽酸普敏太定、及鹽酸甲地嗪。作為可與微針貼附劑10一起使用之局部麻醉藥之例,可例舉:鹽酸狄布卡因、狄布卡因、鹽酸利多卡因、利多卡因、苯唑卡因、對丁胺基苯甲酸2-(二乙基胺基)乙基酯鹽酸鹽、鹽酸普魯卡因、四卡因、鹽酸四卡因、鹽酸氯普魯卡因、鹽酸羥普魯卡因、甲哌卡因、鹽酸古柯鹼、鹽酸哌羅卡因、達克羅寧、及鹽酸達克羅寧。
作為殺菌藥及消毒劑之例,可例舉:硫柳汞、苯酚、瑞香草酚、氯化苄烷銨、苄索氯銨、洛赫西定、普維酮碘、西吡氯銨、丁香油酚、及溴化三甲基銨。作為可與微針貼附劑10一起使用之血管收縮藥之例,可例舉:硝酸萘甲唑啉、鹽酸四氫唑啉、鹽酸羥甲唑啉、鹽酸去氧腎上腺素、及鹽酸曲馬唑啉。作為可與微針貼附劑10一起使用之止血藥之例,可例舉:凝血酶、維生素K1、硫酸魚精蛋白、胺基己酸、傳明酸、卡巴克絡、卡巴克絡磺酸鈉、芸香苷、及橙皮苷。
作為化學治療藥之例,可例舉:磺醯胺、磺胺噻唑、磺胺嘧啶、磺胺米隆、磺胺異㗁唑、磺胺索嘧啶、磺胺甲基噻唑、及呋喃西林。作為可與微針貼附劑10一起使用之抗生物質之例,可例舉:青黴素、二甲氧苯青黴素、苯唑西林、頭孢噻吩、頭孢胺苄、紅黴素、林可黴素、四環素、氯四環素、氧四環素、美他環素、氯黴素、康黴素、鏈黴素、慶大黴素、枯草桿菌素、及環絲胺酸。
作為抗病毒藥之例,可例舉:蛋白酶抑制劑、胸苷激酶抑制劑、糖或糖蛋白合成抑制劑、構成蛋白合成抑制劑、附著及吸附抑制劑,以及例如阿昔洛韋、噴昔洛韋、伐昔洛韋、及更昔洛韋等核苷類似物。
作為生髮或育髮藥之例,可例舉:敏樂定、卡普氯銨、十五酸甘油酯、維生素E乙酸酯、吡羅克酮乙醇胺、甘草酸、異丙基甲基苯酚、檜木醇、當藥萃取液、腦醯胺及前驅物、菸鹼醯胺及辣椒酊。
作為美容活性成分之例,可例舉:D-α-生育酚、DL-α-生育酚、D-α-生育酚乙酸酯、DL-α-生育酚乙酸酯、棕櫚酸抗壞血酸酯、維生素F及維生素F甘油酯、維生素D、維生素D2、維生素D3、視黃醇、視黃醇酯、棕櫚酸視黃醇酯、丙酸視黃醇酯、β-胡蘿蔔素、輔酶Q10、D-泛醇、金合歡醇、乙酸法尼酯;必需脂肪酸中所富含之荷荷芭油及黑醋栗油;5-正辛醯基水楊酸及其酯、水楊酸及其酯;例如檸檬酸、乳酸、羥乙酸等α-羥酸之烷基酯;積雪草酸、羥基積雪草酸、積雪草苷、雷公根之總萃取物、β-甘草次酸、α-甜沒藥醇、例如2-油醯基胺基-1,3-十八烷等腦醯胺;植烷三醇、聚不飽和必需脂肪酸中所富含之來源於海洋之磷脂、乙氧基喹啉;迷迭香之萃取物、香脂之萃取物、檞皮酮、乾燥微細藻類之萃取物、例如類固醇系消炎藥等消炎藥、以及例如激素或者利用脂肪及/或蛋白質之合成所獲得之化合物之類的生物化學刺激劑。
維生素C促進膠原蛋白(結締組織)合成、脂質(脂肪)及碳水化合物之代謝、以及神經傳導物質之合成。維生素C還能有助於維持最佳之免疫系統。維生素C對廣範圍之癌細胞,尤其是對黑色素瘤有毒。酪胺酸氧化酶之活動亦因維生素C之存在而受到阻礙,上述酪胺酸氧化酶催化向黑色素及其他色素變化之酪胺酸之好氧性活動。發現維生素C在催化對較多病毒及細菌之感染的免疫反應上有效。除了上述較多應用以外,膠原蛋白合成及外傷治療亦需要維生素C。微針貼附劑10可包含維生素C,維生素E,以及例如保濕劑、膠原蛋白合成促進劑及擦洗洗面乳之類的其他成分之組合。
皮膚調理劑成分可包含:礦物油、凡士林、植物油(例如大豆油或馬來醯化大豆油等)、矽靈、二甲矽氧多元醇、陽離子性單體及聚合物(例如瓜爾膠羥丙基三甲基氯化銨及二硬脂基二甲基氯化銨等)、以及其混合物。保濕劑例如亦可為山梨糖醇、甘油、1,2-丙二醇、乙二醇、聚乙二醇、聚丙烯乙二醇、1,3-丁二醇、己二醇、異戊二醇、木糖醇、果糖、及其混合物等多元醇。
美肌成分亦可包含:茶萃取物(例如唐津茶萃取物、嬉野茶萃取物、靜岡茶萃取物等)、酒糟萃取物(例如純米大吟釀酒糟萃取物、大吟釀酒糟萃取物、純米吟釀酒糟萃取物、吟釀酒糟萃取物等)、柑橘類萃取物(例如元寇萃取物、醋橘萃取物、溫州蜜柑萃取物等)、海藻萃取物(例如海苔萃取物等)、及植物萃取物(例如蘆筍萃取物等)、以及其混合物。
該等活性成分可單獨使用,亦可併用兩種以上。只要為藥學上可容許之鹽即可,當然亦包含無機鹽或有機鹽之任一形態之活性成分。亦可將活性成分直接塗抹於皮膚,其後將後述之微針陣列20抵於皮膚之相同部分。於此情形時,藉由拉伸皮膚之效果及於皮膚上之ODT(密封包袋療法)效果,能夠促進活性成分向皮膚之滲透。
黏著劑層14之質量例如可為500 g/m
2以上,亦可為700 g/m
2以上。黏著劑層14之質量例如可為2000 g/m
2以下,亦可為1500 g/m
2以下。黏著劑層14之質量亦可為700~1500 g/m
2,於此情形時,能夠提高服貼感,並且在更長時間內維持附著性。藉由如上所述地設定黏著劑層14之質量,能夠減小微針貼附劑10整體之厚度,其結果是,微針貼附劑10易於追隨皮膚且不易剝離。
剝離片材16係於使用微針貼附劑10前保護黏著劑層14之片狀構件。
亦可於剝離片材16跨及其全長或全寬地形成弱化部16a。弱化部16a係為了易於將剝離片材16斷開而設置。於圖1之例中,弱化部16a為直線狀之縫線孔,但弱化部16a之態樣並不限定於此。例如,弱化部16a可為薄壁,可為半切口,亦可為其他形態。弱化部16a亦可呈波形或鋸齒形等。
作為剝離片材16,可使用聚丙烯(例如,未延伸聚丙烯或延伸聚丙烯等)、聚對苯二甲酸乙二酯、聚對苯二甲酸丁二酯、聚乙烯、聚酯、聚胺酯、聚氯乙烯、聚苯乙烯等塑膠膜,可使用對合成樹脂、合成紙、或合成纖維進行矽加工所獲得之矽加工紙,亦可使用於鋁箔或牛皮紙層壓聚乙烯等所獲得之層壓加工紙等。剝離片材16可為無色,亦可為至少一部分著色。
微針陣列20係用以穿刺或按壓皮膚之器具。雖然圖1之例示出一個微針陣列20,但亦可將複數個微針陣列20嵌埋於黏著劑層14。於使用複數個微針陣列20之情形時,其等可形狀及尺寸統一,亦可形狀及尺寸中之至少一者互不相同。
於一例中,微針陣列20之至少一部分被黏著劑層14掩埋(即,微針陣列20之至少一部分位於黏著劑層14內)。例如,亦可各微針22之至少一部分位於黏著劑層14內。亦可微針陣列20之整體被黏著劑層14掩埋(即,亦可各微針22之整體位於黏著劑層14內)。
圖2係表示微針陣列20之一例之放大立體圖。於一例中,微針陣列20具備基板21、及設置於該基板21上之至少一個微針22。
作為微針陣列20(基板21及微針22)之材料,例如亦可使用矽、二氧化矽、陶瓷、金屬(不鏽鋼、鈦、鎳、鉬、鉻、鈷等)、合成或天然之樹脂素材等。或者,考慮到微針22之抗原性及材料之單價,可使用聚乳酸、聚乙交酯、聚乳酸-共聚-聚乙交酯、聚三葡萄糖、己內酯、聚胺酯、聚酸酐等生物降解性聚合物,亦可使用作為非分解性聚合物之聚乙烯、聚丙烯、聚醯胺、聚對苯二甲酸乙二酯、環烯烴共聚物、聚碳酸酯、聚甲基丙烯酸、聚甲基丙烯酸甲酯、硬質氯乙烯、乙烯乙酸乙烯酯、聚四氟乙烯、四氟乙烯-乙烯共聚物、聚甲醛、丙烯腈-丁二烯-苯乙烯共聚物等合成或天然之樹脂素材。或者,亦可使用作為多糖類之玻尿酸、玻尿酸鈉、聚三葡萄糖、葡聚糖、糊精或硫酸軟骨素、纖維素衍生物等。考慮到微針22於皮膚上折斷之可能性,亦可採用生物降解性樹脂,例如亦可使用聚乳酸。聚乳酸中存在聚L-乳酸、聚D-乳酸等聚乳酸均聚物、聚L/D-乳酸共聚物、及該等之混合物等,使用該等中之任一者均可。聚乳酸之平均分子量越大,其強度越強,例如亦可使用平均分子量為40000~100000之聚乳酸。基板21及微針22可藉由相同素材進行製作,亦可藉由互不相同之素材進行製作。
基板21係用以支持微針22之基座。於本發明中,將豎立有微針22之面稱作基板21之主面,將該主面之相反側稱作基板21之背面。於圖1之例中,基板21之背面與支持體12之主面接觸。基板21之尺寸可考慮黏著劑層14之尺寸而決定。於圖1之例中,基板21之面積比黏著劑層14之面積小。於另一例中,亦可基板21與黏著劑層14面積相同。或者,亦可基板21之面積比黏著劑層14之面積大,於此情形時,基板21之一部分露出。基板21之面積可為0.5 cm
2~300 cm
2,可為1 cm
2~100 cm
2,亦可為1 cm
2~50 cm
2。或者,基板21之面積可為0.5 cm
2~10 cm
2、0.5 cm
2~5 cm
2、1 cm
2~5 cm
2、0.5 cm
2~3 cm
2、或1 cm
2~3 cm
2。亦可藉由連結數個該基板21而形成所需大小之基板。基板21之厚度之下限為5 μm或20 μm均可,其厚度之上限為1000 μm或300 μm均可。
微針22係自基板21之主面豎立之微小之構造物。微針22呈從與基板21連接之底部向頂端部變細之錐形。本說明書中之「微針」之概念不僅包含廣義上之針狀構造物、及包含針狀之構造物,而且亦包含頂端不尖之形狀。
微針22之密度之下限例如亦可為0.05根/cm
2、1根/cm
2、100根/cm
2、200根/cm
2、300根/cm
2、或400根/cm
2。另一方面,其密度之上限例如亦可為10000根/cm
2、5000根/cm
2、2000根/cm
2、或850根/cm
2。密度之下限係由可投予1 mg活性成分的針之根數、及所需面積所換算出之值。密度之上限係考慮過針之形狀後之極限值。
微針22之長度之下限為20 μm或50 μm均可,其上限為1000 μm或600 μm或500 μm均可。所謂微針22之長度,係指自與基板21連接之底部至頂端之距離。將微針22之長度設為20 μm以上係為了確實地進行活性成分之經皮吸收。藉由將微針22之長度設為600 μm以下,能夠避免微針22接觸到神經,從而減少產生疼痛之可能性,並且避免出血之可能性。若微針之長度為500 μm以下,則能夠高效率地投予應該進入皮內之量之活性成分,例如亦能於不使基底膜穿孔之情況下投予活性成分。於一例中,微針22之長度被選擇為於正常使用中不會貫通皮膚之角質層,但亦有一部分微針22貫通角質層之可能。即,表皮被微針22拉伸而變薄,活性成分滲透至該易於滲透之表皮,但亦有活性成分之一部分從形成於角質之孔進入皮膚內之可能。
於圖2之例中,微針22為立體形狀。例如,微針22可為圓錐,亦可為四角錐等任意角錐。微針22亦可不為錐體,例如亦可頂端部平坦或帶弧度。平坦或帶弧度之頂端部既存在藉由刻意地進行加工而獲得之情形,又存在雖然未進行此種加工但結果仍舊獲得之情形。於頂端部平坦之情形時,其平坦部之面積可為20~600 μm
2,亦可為50~250 μm
2。於頂端部帶弧度之情形時,頂端部之曲率半徑可為2~100 μm,亦可為5~30 μm。
作為具有立體形狀之微針22的微針陣列20之製法,可例舉:使用矽基板之濕式蝕刻加工或乾式蝕刻加工、使用金屬或樹脂之精密機械加工(放電加工、雷射加工、切割加工、加熱壓花加工、射出成型加工等)、以及機械切削加工。藉由該等加工法,基板21與微針22一體成型。作為使微針22中空之方法,可例舉於製作微針22後藉由雷射加工等進行二次加工之方法。
可於微針22中包含活性成分,亦可於微針22之表面上形成包含活性成分之塗層。
微針22亦可為平面形狀。例如,微針22可為三角形,亦可為菱形等其他形狀。平面形狀之微針22係藉由對基板21進行沖裁而形成微針22,並將該微針22自基板21提昇而成。因此,基板21與微針22厚度相同。若基板21為金屬,則可藉由藥液對該片材進行沖裁而形成多個微針22,藉由立起該微針22而形成微針陣列20。若基板21為非金屬,則藉由雷射對該基板21進行沖裁而形成多個微針22,與金屬片材之情形同樣地立起該微針22即可。於如上所述使用蝕刻之情形時,各微針22之周圍會產生空隙。
不論微針22為立體形狀還是平面形狀,微針22之頂端所朝向之方向(微針22之頂端方向)均可與基板21之面垂直,亦可為相對於該面呈銳角之方向(即,微針22之傾斜角度大於0度且未達90度)。
接下來,對微針貼附劑10之製造方法之一例進行說明。首先,於剝離片材16上使黏著劑組合物延展,藉此形成黏著劑層14。繼而,以各微針22之至少一部分埋於黏著劑層14內之方式將微針陣列20配置於黏著劑層14上。繼而,以支持體12之主面與基板21之背面接觸之方式將支持體12置於黏著劑層14及微針陣列20之上。其結果是,黏著劑層14及微針22被支持體12與剝離片材16夾住。
微針貼附劑10亦可存放於包裝袋之內部。藉由此種存放方法,能夠抑制黏著劑層14之水含量之下降,並且減少污物等向黏著劑層14之附著。微針貼附劑10亦可以被摺疊了複數次的狀態存放於包裝袋中。於此情形時,能節約存放微針貼附劑10所需之空間,因此能夠減少包裝袋所使用之材料。
以上,基於本發明之實施方式詳細地進行說明。然而,本發明並不限定於上述例。可於不脫離本發明之主旨之範圍內進行各種變化。
於上述例中,微針貼附劑10呈大致矩形,但微針貼附劑亦可具有其他形狀。例如微針貼附劑可為正方形、圓、橢圓、新月形、彎玉形、其他多邊形等任意形狀。於上述例中,微針陣列20之形狀為大致矩形,但微針陣列亦可具有其他形狀。例如微針陣列可為正方形、圓、橢圓、新月形、其他多邊形等任意形狀。微針陣列之形狀可與微針貼附劑之形狀相同,亦可不同。
[附記]
本發明包含以下所示之態樣。
(附記1)
一種微針貼附劑,其具備:
支持體;
黏著劑層,其設置於上述支持體之主面;及
微針陣列,其至少一部分位於上述黏著劑層內;
上述黏著劑層包含水溶性高分子及水,
於環境溫度為25℃及頻率為1 Hz之測定條件下,上述黏著劑層之損耗正切為0.20~0.41。
(附記2)
如附記1所記載之微針貼附劑,其中
上述水溶性高分子包含聚丙烯酸及聚丙烯酸部分中和物中之至少一種。
(附記3)
如附記1或2所記載之微針貼附劑,其中
上述黏著劑層進而包含多元醇。
(附記4)
如附記3所記載之微針貼附劑,其中
上述多元醇為甘油。
(附記5)
如附記1至4中任一項所記載之微針貼附劑,其中
上述損耗正切為0.202~0.404。
(附記6)
如附記1至5中任一項所記載之微針貼附劑,其中
上述損耗正切為0.208~0.385。
根據附記1,覆蓋微針之至少一部分的黏著劑層之損耗正切被設定為上述數值範圍內。藉由使黏著劑層具有此種構成,能夠於不在皮膚上殘留微針陣列之情況下將應用於該皮膚之微針貼附劑剝離。
[實施例]
以下,具體地對實施例進行說明,但本發明並不限定於其等。
根據下述表1中所示之組成(單位:質量%)製備6種黏著劑組合物。使用6種黏著劑組合物之各者,藉由上述所例示之製造方法而製作微針貼附劑。微針貼附劑設為面積為15 cm
2之大致矩形。黏著劑層之質量為1000 g/m
2。關於微針陣列,於厚度為700 μm且面積為1.4 cm
2之圓形基板上,以640根/cm
2之密度設置長度為500 μm之微針。作為支持體,使用單位面積重量為100 g/m
2之PET製不織布。以掩埋微針整體之方式形成黏著劑層。以下,將6種微針貼附劑設為實施例1、2及比較例1~4而加以區別。
[表1]
比較例1 | 實施例1 | 實施例2 | 比較例2 | 比較例3 | 比較例4 | ||
組成 | 聚丙烯酸 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 4.58 | 4.58 | 4.58 | 4.58 | 4.58 | 4.58 | |
甘油 | 15.00 | 15.00 | 15.00 | 15.00 | 15.00 | 35.00 | |
水 | 59.66 | 65.66 | 69.31 | 70.81 | 71.81 | 51.66 | |
乙二胺四乙酸二鈉 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | |
羧甲基纖維素鈉 | 1.00 | 1.00 | 3.50 | 2.00 | 1.00 | 1.00 | |
聚乙烯醇 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | |
酒石酸 | 0.25 | 0.25 | 0.10 | 0.10 | 0.10 | 0.25 | |
明礬 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | |
矽酸鋁 | 12.00 | 6.00 | 0 | 0 | 0 | 0 | |
其他 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | |
總和 | 100 | 100 | 100 | 100 | 100 | 100 | |
評價 | 損耗正切 | 0.197 | 0.208 | 0.385 | 0.430 | 0.460 | 0.496 |
90°剝離試驗得分 | - | 1 | 1 | 0 | 0 | 0 | |
剝離官能試驗得分 | - | 1 | 1 | 0 | 0.4 | 0.4 |
自製造起14天,於環境溫度25℃及相對濕度50%之條件下將微針貼附劑存放於包裝材料中,藉此使6種微針貼附劑各者之交聯反應充分收斂。繼而,自各微針貼附劑剝離黏著劑層,使用流變儀「HAAKE MARS」(Thermo Fisher Scientific股份有限公司製造)於以下之測定條件下進行該黏著劑層之動態黏彈性測定。繼而,由所測定出之儲存彈性模數(G')及損耗彈性模數(G"),根據上述(1)算出損耗正切(tanδ)。
[測定條件]
・試樣部:直徑為20 mm之平板
・間隙間隔:1 mm
・試樣量:0.8~1.2 g
・環境溫度:25℃(該環境溫度對應於作業空間之溫度、以及流變儀中與黏著劑層接觸之部分之溫度兩者)
・頻率:1 Hz
・變形:1%
對除比較例1以外之5種微針貼附劑之各者進行90°剝離試驗。於比較例1中,黏著劑層之附著性較低,微針貼附劑容易從貼附對象脫落,因此,將該比較例1從評價中排除。將微針貼附劑貼附於PTFE(Polytetrafluorethylene,聚四氟乙烯)板,15分鐘後,使用自動立體測圖儀於環境溫度25℃及剝離速度50 mm/min之條件下進行90°剝離試驗。對除比較例1以外之5種微針貼附劑之各者進行3次該試驗。將試驗時微針陣列未從微針貼附劑脫落之情形時之得分設為「1」,將脫落之情形時之得分設為「0」,獲得3次得分之平均值作為最終得分。
對除比較例1以外之5種微針貼附劑之各者進行剝離官能試驗。將微針貼附劑貼附於5名受驗者之上臂部,15分鐘後,將微針貼附劑自皮膚剝離。該剝離時,藉由目視確認微針陣列是否從微針貼附劑脫落。將試驗時微針陣列未從微針貼附劑脫落之情形時之得分設為「1」,將脫落之情形時之得分設為「0」,獲得5人之得分之平均值作為最終得分。
上述表1亦示出所算出之損耗正切及兩種試驗之結果。實施例1、2之90°剝離試驗得分及剝離官能試驗得分均為1,表示微針陣列一次都未從微針貼附劑脫落。比較例2之90°剝離試驗得分及剝離官能試驗得分均為0,表示所有微針貼附劑均微針陣列脫落。比較例3、4中之剝離官能試驗得分為0.4,表示5人中有3人微針陣列從微針貼附劑脫落。
藉由與上述6種黏著劑組合物同樣之方法,根據下述表2~表6中所示之組成(單位:質量%)進而製備38種黏著劑組合物,使用各黏著劑組合物製作微針貼附劑。以下,將38種微針貼附劑設為實施例3~18及比較例5~26而加以區別。對追加之38種微針貼附劑之各者,亦與上述6種微針貼附劑同樣地,算出黏著劑層之損耗正切,實施90°剝離試驗及剝離官能試驗。其中,將下述比較例從評價中排除:未能製作出微針貼附劑之比較例;以及黏著劑層之附著性較低,微針貼附劑容易從貼附對象脫落之比較例。關於比較例12,由於90°剝離試驗之得分為「0」,故省略剝離官能試驗。
[表2]
比較例5 | 比較例6 | 實施例1 | 實施例3 | 比較例7 | ||
組成 | 聚丙烯酸 | 0.10 | 5.00 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 1.00 | 5.00 | 4.58 | 4.58 | 10 | |
甘油 | 35.00 | 10.00 | 15.00 | 40.00 | 35.00 | |
水 | 54.71 | 75.70 | 65.66 | 39.81 | 41.39 | |
乙二胺四乙酸二鈉 | 0.25 | 1.00 | 0.25 | 0.25 | 0.25 | |
羧甲基纖維素鈉 | 3.50 | 0.10 | 1.00 | 6.00 | 6.00 | |
聚乙烯醇 | 4.00 | 0.10 | 4.00 | 6.00 | 4.00 | |
酒石酸 | 0.10 | 1.00 | 0.25 | 0.10 | 0.10 | |
明礬 | 0.24 | 1.00 | 0.24 | 0.24 | 0.24 | |
矽酸鋁 | 0 | 0 | 6.00 | 0 | 0 | |
其他 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | |
總和 | 100 | 100 | 100 | 100 | 100 | |
水溶性高分子 | 8.60 | 10.20 | 11.50 | 18.50 | 21.92 | |
交聯劑 | 0.24 | 1.00 | 6.24 | 0.24 | 0.24 | |
EDTA/交聯劑 | 1.04 | 1.00 | 0.04 | 1.04 | 1.04 | |
評價 | 損耗正切(tanδ) | 0.659 | 0.121 | 0.208 | 0.355 | 0.182 |
90°剝離試驗得分 | 0 | - | 1 | 1 | - | |
剝離官能試驗得分 | 0 | - | 1 | 1 | - |
[表3]
實施例2 | 實施例3 | 實施例4 | 實施例5 | 實施例6 | 實施例7 | 實施例8 | 比較例3 | 比較例8 | 比較例9 | 比較例10 | 比較例11 | 比較例12 | 比較例13 | 比較例14 | 比較例15 | 比較例16 | 比較例17 | ||
組成 | 聚丙烯酸 | 1.92 | 1.92 | 5.00 | 0.10 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 0.10 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 4.58 | 4.58 | 4.58 | 4.58 | 3.00 | 4.58 | 4.58 | 4.58 | 4.58 | 1.00 | 1.00 | 6.00 | 4.58 | 4.58 | 4.58 | 4.58 | 4.58 | 4.58 | |
甘油 | 15.00 | 40.00 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | 15.00 | 35.00 | 35.00 | 40.00 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | |
水 | 69.31 | 39.81 | 45.33 | 51.22 | 48.39 | 47.80 | 48.65 | 71.81 | 44.81 | 50.39 | 45.77 | 44.63 | 49.55 | 49.78 | 49.45 | 48.70 | 48.60 | 45.80 | |
乙二胺四乙酸二鈉 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 1.00 | 0.15 | 0.25 | 0.25 | 0.25 | 0.01 | 0.25 | 0.25 | 0.01 | 0.25 | 1.00 | 1.00 | 1.00 | |
羧甲基纖維素鈉 | 3.50 | 6.00 | 3.50 | 3.50 | 6.00 | 3.50 | 3.50 | 1.00 | 8.00 | 6.00 | 6.00 | 6.00 | 3.50 | 3.50 | 3.50 | 3.50 | 3.50 | 3.50 | |
聚乙烯醇 | 4.00 | 6.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 6.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | |
酒石酸 | 0.10 | 0.10 | 1.00 | 0.01 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.01 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | 0.10 | |
明礬 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 1.00 | 1.00 | 0.24 | 0.24 | 0.24 | 0.01 | 1.00 | 0 | 0.01 | 0.10 | 0.10 | 0.20 | 3.00 | |
矽酸鋁 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
其他 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | |
總和 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
水溶性高分子 | 14.00 | 18.50 | 17.08 | 12.18 | 14.92 | 14.00 | 14.00 | 11.50 | 18.50 | 12.92 | 13.10 | 17.92 | 14.00 | 14.00 | 14.00 | 14.00 | 14.00 | 14.00 | |
交聯劑 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 1.00 | 1.00 | 0.24 | 0.24 | 0.24 | 0.01 | 1.00 | 0 | 0.01 | 0.10 | 0.10 | 0.20 | 3.00 | |
EDTA/交聯劑 | 1.04 | 1.04 | 1.04 | 1.04 | 1.04 | 1.00 | 0.15 | 1.04 | 1.04 | 1.04 | 1.00 | 0.25 | - | 1.00 | 2.50 | 10.00 | 5.00 | 0.33 | |
評價 | 損耗正切(tanδ) | 0.385 | 0.355 | 0.329 | 0.400 | 0.402 | 0.209 | 0.202 | 0.460 | 0.181 | 0.620 | 0.627 | 0.170 | 0.591 | 0.504 | 0.642 | 0.622 | 0.624 | 0.090 |
90°剝離試驗得分 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | - | 0 | 0 | - | 0 | 0 | 0 | 0 | 0 | - | |
剝離官能試驗得分 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0.4 | - | 0 | 0.4 | - | - | 0 | 0 | 0 | 0 | - |
[表4]
實施例9 | 實施例10 | 實施例1 | 比較例17 | 比較例18 | 比較例19 | 比較例20 | 比較例1 | 比較例2 | 比較例3 | 比較例4 | ||
組成 | 聚丙烯酸 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 4.58 | 2.00 | 4.58 | 4.58 | 4.58 | 0.50 | 7.00 | 4.58 | 4.58 | 4.58 | 4.58 | |
甘油 | 35.00 | 35.00 | 15.00 | 35.00 | 35.00 | 35.00 | 35.00 | 15.00 | 15.00 | 15.00 | 35.00 | |
水 | 50.15 | 43.84 | 65.66 | 45.80 | 50.56 | 45.34 | 38.84 | 59.66 | 70.81 | 71.81 | 51.66 | |
乙二胺四乙酸二鈉 | 1.00 | 0.25 | 0.25 | 1.00 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | |
羧甲基纖維素鈉 | 1.00 | 3.40 | 1.00 | 3.50 | 0.10 | 3.40 | 3.40 | 1.00 | 2.00 | 1.00 | 1.00 | |
聚乙烯醇 | 4.00 | 6.00 | 4.00 | 4.00 | 6.00 | 6.00 | 6.00 | 4.00 | 4.00 | 4.00 | 4.00 | |
酒石酸 | 0.25 | 0.25 | 0.25 | 0.10 | 0.25 | 0.25 | 0.25 | 0.25 | 0.10 | 0.10 | 0.25 | |
明礬 | 1.00 | 0.24 | 0.24 | 3.00 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | |
矽酸鋁 | 0 | 6.00 | 6.00 | 0 | 0 | 6.00 | 6.00 | 12.00 | 0 | 0 | 0 | |
其他 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | |
總和 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
水溶性高分子 | 11.50 | 13.32 | 11.50 | 14.00 | 12.60 | 11.82 | 18.32 | 11.50 | 12.50 | 11.50 | 11.50 | |
交聯劑 | 1.00 | 6.24 | 6.24 | 3.00 | 0.24 | 6.24 | 6.24 | 12.24 | 0.24 | 0.24 | 0.24 | |
EDTA/交聯劑 | 1.00 | 0.04 | 0.04 | 0.33 | 1.04 | 0.04 | 0.04 | 0.02 | 1.04 | 1.04 | 1.04 | |
評價 | 損耗正切(tanδ) | 0.217 | 0.276 | 0.208 | 0.090 | 0.493 | 0.425 | 0.176 | 0.197 | 0.430 | 0.460 | 0.496 |
90°剝離試驗得分 | 1 | 1 | 1 | - | 0 | 0 | - | - | 0 | 0 | 0 | |
剝離官能試驗得分 | 1 | 1 | 1 | - | 0 | 0 | - | - | 0 | 0.4 | 0.4 |
[表5]
實施例11 | 實施例12 | 實施例13 | 實施例14 | 比較例21 | 比較例22 | 比較例3 | 比較例4 | 比較例2 | 比較例23 | 比較例24 | 比較例25 | 比較例26 | ||
組成 | 聚丙烯酸 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 6.00 | 8.00 | 5.00 | 6.00 | 6.00 | 6.00 | 4.58 | 4.58 | 4.58 | 11.00 | 6.00 | 6.00 | 8.00 | |
甘油 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | 35.00 | 15.00 | 35.00 | 15.00 | 35.00 | 35.00 | 35.00 | 35.00 | |
水 | 50.28 | 48.24 | 48.84 | 49.98 | 51.28 | 44.74 | 71.81 | 51.66 | 70.81 | 45.24 | 50.43 | 50.33 | 47.48 | |
乙二胺四乙酸二鈉 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | |
羧甲基纖維素鈉 | 1.00 | 1.00 | 3.40 | 1.00 | 0.10 | 6.50 | 1.00 | 1.00 | 2.00 | 1.00 | 1.00 | 1.00 | 1.00 | |
聚乙烯醇 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | 4.00 | |
酒石酸 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.25 | 0.10 | 0.25 | 0.10 | 0.25 | 0.25 | 0.25 | 0.25 | |
明礬 | 0.20 | 0.24 | 0.24 | 0.50 | 0.10 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 0.05 | 0.15 | 1.00 | |
矽酸鋁 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
其他 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | 1.10 | |
總和 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | 100 | |
水溶性高分子 | 12.92 | 14.92 | 14.32 | 12.92 | 12.02 | 18.42 | 11.50 | 11.50 | 12.50 | 17.92 | 12.92 | 12.92 | 14.92 | |
交聯劑 | 0.20 | 0.24 | 0.24 | 0.50 | 0.10 | 0.24 | 0.24 | 0.24 | 0.24 | 0.24 | 0.05 | 0.15 | 1.00 | |
EDTA/交聯劑 | 1.25 | 1.04 | 1.04 | 0.50 | 2.50 | 1.04 | 1.04 | 1.04 | 1.04 | 1.04 | 5.00 | 1.67 | 0.25 | |
評價 | 損耗正切(tanδ) | 0.400 | 0.274 | 0.390 | 0.220 | 0.532 | 0.161 | 0.460 | 0.496 | 0.430 | 0.192 | 0.543 | 0.498 | 0.093 |
90°剝離試驗得分 | 1 | 1 | 1 | 1 | 0 | - | 0 | 0 | 0 | - | 0 | 0 | - | |
剝離官能試驗得分 | 1 | 1 | 1 | 1 | 0 | - | 0.4 | 0.4 | 0 | - | 0 | 0 | - |
[表6]
實施例15 | 實施例16 | 實施例17 | 實施例18 | ||
組成 | 聚丙烯酸 | 1.92 | 1.92 | 1.92 | 1.92 |
聚丙烯酸部分中和物 | 4.58 | 4.58 | 4.58 | 4.58 | |
甘油 | 15.00 | 0 | 0 | 35.00 | |
水 | 68.55 | 47.80 | 50.31 | 49.41 | |
乙二胺四乙酸二鈉 | 0.25 | 1.00 | 0.25 | 0.25 | |
羧甲基纖維素鈉 | 3.50 | 3.50 | 3.50 | 3.50 | |
聚乙烯醇 | 4.00 | 4.00 | 4.00 | 4.00 | |
酒石酸 | 0.10 | 0.10 | 0.10 | 0 | |
明礬 | 0 | 1.00 | 0.24 | 0.24 | |
其他 | 1.10 | 1.10 | 0.10 | 1.10 | |
矽酸鋁鎂 | 1.00 | 0 | 0 | 0 | |
聚乙二醇 | 0 | 35.00 | 0 | 0 | |
聚山梨糖醇酯80 | 0 | 0 | 35.00 | 0 | |
總和 | 100 | 100 | 100 | 100 | |
水溶性高分子 | 14.00 | 14.00 | 14.00 | 14.00 | |
交聯劑 | 1.00 | 1.00 | 0.24 | 0.24 | |
EDTA/交聯劑 | 0.25 | 1.00 | 1.04 | 1.04 | |
評價 | 損耗正切(tanδ) | 0.314 | 0.404 | 0.333 | 0.358 |
90°剝離試驗得分 | 1 | 1 | 1 | 1 | |
剝離官能試驗得分 | 1 | 1 | 1 | 1 |
表2~表5於進而包含「水溶性高分子」、「交聯劑」、及「EDTA/交聯劑」3列之方面與表1不同。「水溶性高分子」一列表示聚丙烯酸、聚丙烯酸部分中和物、羧甲基纖維素鈉、及聚乙烯醇之質量%之總和。即,「水溶性高分子」一列表示水溶性高分子之總量。「交聯劑」一列表示明礬及矽酸鋁之質量%之總和。「EDTA/交聯劑」一列表示乙二胺四乙酸二鈉相對於交聯劑之比率。表1中所示之實施例1、2及比較例1~4視需要亦於表2~表5中重新示出。
表2與上述第1~第12例相關。表2表示,若水溶性高分子之總量脫離11~20質量%之範圍,則損耗正切會脫離0.20~0.41之範圍。
表3與上述第1、第2、第7、及第8例相關。表3表示,若羧甲基纖維素鈉之量脫離3.5~7質量%之範圍,或者聚丙烯酸部分中和物之量脫離2質量%以上且未達5質量%之範圍,或者交聯劑之量脫離0.22~1質量%之範圍,則損耗正切會脫離0.20~0.41之範圍。
表4與上述第3、第4、第9、及第10例相關。表4表示,若羧甲基纖維素鈉之量脫離0.5質量%以上且未達3.5質量%之範圍,或者聚丙烯酸部分中和物之量脫離1質量%以上且未達5質量%之範圍,或者交聯劑之量脫離1~9質量%之範圍,則損耗正切會脫離0.20~0.41之範圍。
表5與上述第5、第6、第11、及第12例相關。表5表示,若羧甲基纖維素鈉之量脫離0.5質量%以上且未達3.5質量%之範圍,或者聚丙烯酸部分中和物之量脫離5~10質量%之範圍,或者交聯劑之量脫離0.18~0.7質量%之範圍,則損耗正切會脫離0.20~0.41之範圍。
表6與表2~表5同樣地,包含「水溶性高分子」、「交聯劑」、及「EDTA/交聯劑」3列。其中,表6中之「交聯劑」一列表示明礬、矽酸鋁、及矽酸鋁鎂之質量%之總和。實施例15表示,即使不使用明礬,亦能將損耗正切設定為0.20~0.41之範圍。實施例16、17表示,即使不使用甘油,亦能將損耗正切設定為0.20~0.41之範圍。實施例18表示,即使不使用酒石酸,亦能將損耗正切設定為0.20~0.41之範圍。
10:微針貼附劑
12:支持體
14:黏著劑層
16:剝離片材
16a:弱化部
20:微針陣列
21:基板
22:微針
圖1係實施方式之微針貼附劑之立體圖。
圖2係表示圖1中所示之微針陣列之一例之放大立體圖。
10:微針貼附劑
12:支持體
14:黏著劑層
16:剝離片材
16a:弱化部
20:微針陣列
Claims (5)
- 一種微針貼附劑,其具備: 支持體; 黏著劑層,其設置於上述支持體之主面;及 微針陣列,其至少一部分位於上述黏著劑層內; 上述黏著劑層包含水溶性高分子及水, 於環境溫度為25℃及頻率為1 Hz之測定條件下,上述黏著劑層之損耗正切為0.20~0.41。
- 如請求項1之微針貼附劑,其中 上述水溶性高分子包含聚丙烯酸及聚丙烯酸部分中和物中之至少一種。
- 如請求項1或2之微針貼附劑,其中 上述黏著劑層進而包含多元醇。
- 如請求項3之微針貼附劑,其中 上述多元醇為甘油。
- 如請求項1或2之微針貼附劑,其中 上述損耗正切為0.202~0.404。
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