TWI674115B - 貼附劑 - Google Patents

貼附劑 Download PDF

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Publication number
TWI674115B
TWI674115B TW105104139A TW105104139A TWI674115B TW I674115 B TWI674115 B TW I674115B TW 105104139 A TW105104139 A TW 105104139A TW 105104139 A TW105104139 A TW 105104139A TW I674115 B TWI674115 B TW I674115B
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TW
Taiwan
Prior art keywords
adhesive layer
patch
adhesive
mass
hydrochloride
Prior art date
Application number
TW105104139A
Other languages
English (en)
Other versions
TW201636009A (zh
Inventor
中島健太郎
Kentaro NAKASHIMA
佐藤昌宏
Masahiro Sato
古瀬靖久
Yasuhisa Kose
明
Takaaki Yoshinaga
Original Assignee
日商久光製藥股份有限公司
Hisamitsu Pharmaceutical Co., Inc.
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Application filed by 日商久光製藥股份有限公司, Hisamitsu Pharmaceutical Co., Inc. filed Critical 日商久光製藥股份有限公司
Publication of TW201636009A publication Critical patent/TW201636009A/zh
Application granted granted Critical
Publication of TWI674115B publication Critical patent/TWI674115B/zh

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    • A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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Abstract

本發明係揭示一種貼附劑，其係具有支撐體與層合於支撐體上之黏著劑層的貼附劑，支撐體係由水針不織布所構成，黏著劑層係包含SIS嵌段共聚物及流動石蠟，貼附劑係具有作為特定之基準軸方向的第1方向與和第1方向呈直角的第2方向，貼附劑之第1方向的剛軟度為18~30mm。

Description

貼附劑
本發明係關於貼附劑。
市面上販售為了緩和肩、肘及腰的疼痛而於支撐體上層合有摻合了消炎鎮痛劑等之藥物的黏著劑層之硬膏貼附劑(硬膏劑)。如此之貼附劑當中於支撐體使用了織布的貼附劑係由於伸縮性優異，容易追隨皮膚的伸縮，因此附著性優異。但，於支撐體使用了織布的貼附劑係有所謂的「硬度」(firmness)弱之傾向。因而，在將貼附劑貼附於患處時有時會因突然折彎使黏著面彼此黏住，而有難以將貼附劑進行黏貼的傾向。
另一方面，亦開發有於支撐體使用了不織布的貼附劑。與於支撐體使用了織布的貼附劑相比，於支撐體使用了不織布的貼附劑係有「硬度」的問題獲得改善的傾向，但有產生所謂的冷流(cold flow)而黏著劑層的成分容易從支撐體滲出的傾向。
[先前技術文獻] [專利文獻]
[專利文獻1]日本特開2001-328935號公報
本發明係以提供黏貼容易度優異，且黏著劑層的成分不會從支撐體滲出的貼附劑作為目的。
本發明者們係鑑於上述情事而進行努力探討。其結果，本發明者們發現藉由將由水針不織布所構成之支撐體，與包含苯乙烯-異戊二烯-苯乙烯嵌段共聚物及流動石蠟之黏著劑層進行組合，且，將貼附劑之剛軟度設為18~30mm，而解決上述課題。
亦即，本發明係提供一種貼附劑，其係具有支撐體與層合於支撐體上之黏著劑層的貼附劑，支撐體係由水針不織布所構成，黏著劑層係包含苯乙烯-異戊二烯-苯乙烯嵌段共聚物及流動石蠟，貼附劑係具有作為特定之基準軸方向的第1方向與和第1方向呈直角的第2方向，以JIS L 1085：1998所規定之45°懸臂架設法測定的貼附劑之第1方向的剛軟度為18~30mm。
於上述黏著劑層中之苯乙烯-異戊二烯-苯乙烯嵌段共聚物與流動石蠟之質量比可為1~1.65：1。上述黏著劑層亦可包含柳酸甲酯及薄荷醇。上述黏著劑層亦可包 含聚異丁烯。上述黏著劑層亦可包含萜烯樹脂。上述黏著劑層係可以黏著劑層之全質量基準計包含9~11質量%之柳酸甲酯及2.5~6.5質量%之薄荷醇，又，亦可以黏著劑層之全質量基準計包含23.7~32.5質量%之苯乙烯-異戊二烯-苯乙烯嵌段共聚物、17.9~27.5質量%之流動石蠟、9~11質量%之柳酸甲酯、3~6質量%之薄荷醇、3~12質量%之聚異丁烯及17~25質量%之萜烯樹脂。
又，上述不織布之單位面積重量可為90~110g/m2。上述不織布之寬方向的20%模數可為3~5N/50mm。上述不織布之寬方向的50%模數可為8~15N/50mm。上述不織布可由聚酯所構成。以JIS L 1085：1998所規定之45°懸臂架設法測定的貼附劑之第1方向的剛軟度可為18~27mm。
本發明之貼附劑係由於具有「硬度」因此容易黏貼。又，不易產生黏著劑層之成分的冷流。
本實施形態之貼附劑係具有支撐體與層合於支撐體上之黏著劑層。支撐體係由水針不織布所構成，黏著劑層係包含苯乙烯-異戊二烯-苯乙烯嵌段共聚物及流動石蠟。貼附劑係具有作為特定之基準軸方向的第1方向，與和第1方向呈直角的第2方向，貼附劑之第1方向的剛 軟度為18~30mm。
於本說明書中，剛軟度係意味著以JIS L 1085：1998所規定之45°懸臂架設法測定的剛軟度。亦即，剛軟度係意味著在具有45°之斜面且上面具備有刻度的表面之平滑的水平台之上，以使其短邊與刻度的基線成為一致的方式配置寬2cm之試驗片(貼附劑或支撐體)，當使試驗片往前述斜面的方向緩慢地滑動時，直到試驗片之一方的短邊之中央點與前述斜面接觸為止，試驗片所移動的距離(mm)。貼附劑之第1方向的剛軟度係意味著當使試驗片沿著第1方向在斜面緩慢地滑動時的剛軟度。
水針不織布係意味著以對纖維噴射高壓的水流使其盤繞之所謂的水流絡合法所形成之不織布。水針不織布的原料係可列舉：聚對苯二甲酸乙二酯(PET)等之聚酯、乙烯-乙酸乙烯酯共聚物(EVA)、氯乙烯、聚乙烯及聚丙烯等之聚烯烴、丁二烯-苯乙烯-甲基丙烯酸甲酯共聚合樹脂、耐隆、聚胺基甲酸酯、烷氧烷基(甲基)丙烯酸酯共聚物、聚乙烯縮醛、聚醯胺及嫘縈等之合成樹脂、木綿、羊毛、絲等之天然素材。就貼附劑之黏貼容易度的觀點而言，水針不織布較佳為由聚酯所構成之水針不織布。纖維的直徑較佳為5~15μm。
水針不織布之單位面積重量為例如50g/m2以上，較佳為70g/m2以上，更佳為90g/m2以上。若水針不織布之單位面積重量為上述下限值以上，則會變得不易產生黏著劑層之成分的滲出。水針不織布之單位面積重量為 例如200g/m2以下，較佳為150g/m2以下，更佳為125g/m2以下。若為上述上限值以下，則在貼附劑之貼附時會變得不易產生不舒適感。就貼附劑之黏貼容易度的觀點而言，水針不織布之單位面積重量特佳為90~110g/m2或100~110g/m2。
水針不織布係具有machine direction(流向或縱向)及cross direction(寬方向或橫向)。水針不織布之伸縮性，例如，流向之50%模數為200~400N/50mm，寬方向之50%模數為5~15N/50mm。伸縮性之測定係根據JIS L 1096：2010所規定的定伸長時伸長力。若水針不織布之伸縮性為上述範圍內，則變得容易追隨貼附劑之貼附部位的皮膚之伸縮。就貼附劑之黏貼容易度的觀點而言，水針不織布之伸縮性較佳係流向之20%模數為40~90N/50mm，更佳為55~75N/50mm，較佳係寬方向之20%模數為3~5N/50mm，更佳為3.6~4.4N/50mm，較佳係流向之50%模數為150~350N/50mm，更佳為220~300N/50mm，較佳係寬方向之50%模數為8~15N/50mm，更佳為11.2~11.7N/50mm。水針不織布之寬方向及流向較佳係分別與貼附劑之第1方向及第2方向一致。
水針不織布之寬方向的剛軟度較佳為18~30mm。若水針不織布之寬方向的剛軟度為上述範圍內，則在製作於由水針不織布所構成的支撐體上層合有黏著劑層的貼附劑時，可容易將貼附劑之第1方向的剛軟度設為所期望之範圍。貼附劑之第1方向的剛軟度為18~ 30mm，就貼附劑之黏貼容易度的觀點而言，較佳為18~27mm或21~27mm。
支撐體係可使用作為水針不織布而市售的製品，如此之製品係由例如Unitika股份有限公司、Kuraray Kuraflex股份有限公司、股份有限公司Yuho、Daiwabo Polytec股份有限公司及Japan Vilene股份有限公司等所販售。
黏著劑層係包含苯乙烯-異戊二烯-苯乙烯嵌段共聚物(以下，有時稱為SIS或SIS嵌段共聚物)及流動石蠟。藉由將包含此等之成分的黏著劑層與水針不織布組合，而成為可增強貼附劑之「硬度」，而使貼附劑變得容易黏貼。
可使用作為SIS嵌段共聚物而市售的製品，作為如此之製品係可列舉：CARIFLEX TR-1107、CARIFLEX TR-1111、CARIFLEX TR-1112、CARIFLEX TR-1117(以上，Shell Chemicals股份有限公司製)、JSR5000、JSR5002、JSR5100(以上，JSR股份有限公司製)及Quintac 3570C(日本ZEON股份有限公司製)。
於黏著劑層中之SIS嵌段共聚物的含量，相對於黏著劑層全質量，例如，為10質量%以上，較佳為15質量%以上，更佳為20質量%以上。具備有包含上述下限值以上的SIS嵌段共聚物之黏著劑層的貼附劑，在必要的貼附期間中貼附劑不會從皮膚剝離，且具有充分的「硬度」。於黏著劑層中之SIS嵌段共聚物的含量，相對 於黏著劑層全質量，例如，為50質量%以下，較佳為40質量%以下，更佳為30質量%以下。具備有包含上述上限值以下的SIS嵌段共聚物之黏著劑層的貼附劑，在將貼附劑剝離時無伴隨疼痛等之使用性優異。就貼附劑之黏貼容易度的觀點而言，於黏著劑層中之SIS嵌段共聚物的含量特佳為23.7~32.5%。
於黏著劑層中之流動石蠟的含量，相對於黏著劑層全質量，例如，為5質量%以上，較佳為10質量%以上，更佳為15質量%以上。具備有包含上述下限值以上的流動石蠟之黏著劑層的貼附劑係具有充分的黏著性。於黏著劑層中之流動石蠟的含量，相對於黏著劑層全質量，例如，為50質量%以下，較佳為40質量%以下，更佳為30質量%以下。具備有包含上述上限值以下的流動石蠟之黏著劑層的貼附劑係由於具備有適度的柔軟性，因此變得容易黏貼。就貼附劑之黏貼容易度的觀點而言，於黏著劑層中之流動石蠟的含量特佳為17.9~27.5質量%。
又，於黏著劑層中之SIS嵌段共聚物與流動石蠟之質量比較佳為1~1.65：1。若以該比率摻合兩者，則成為可增強貼附劑之「硬度」，而使貼附劑變得容易黏貼。又，若以該比率摻合兩者，則可將黏著劑層調整成適度的硬度，在製造時，於黏著劑層不易產生氣泡，而製造適性優異。進而，若以該比率摻合兩者，則亦變得容易防止冷流。
黏著劑層係可因應需要而包含SIS嵌段共聚物以外之黏著劑、流動石蠟以外之可塑劑，亦可包含賦黏劑、吸收促進劑、抗氧化劑、填充劑、交聯劑、防腐劑、紫外線吸收劑、界面活性劑、pH調整劑、色素及香料等之添加劑。
作為SIS嵌段共聚物以外之黏著劑係可列舉：天然橡膠、合成異戊二烯橡膠、聚異丁烯、聚乙烯醚、聚胺基甲酸酯、聚異戊二烯、聚丁二烯、苯乙烯-丁二烯共聚物及苯乙烯-異戊二烯共聚物。黏著劑層較佳為包含聚異丁烯。藉由使用聚異丁烯而成為可提昇黏著力。於黏著劑層中之聚異丁烯的含量例如1~20質量%，較佳為2~15質量%。就貼附劑之黏貼容易度的觀點而言，於黏著劑層中之聚異丁烯的含量特佳為3~12質量%。
作為流動石蠟以外之可塑劑係可列舉：聚丁烯、液狀聚異丁烯及動植物油。
作為賦黏劑係可列舉：脂環族飽和烴樹脂(荒川化學工業公司製，商品名：Alcon P-100等)、氫化松香酯(荒川化學工業公司製，商品名：KE-311、KE-100；HERCULES公司製，商品名：FORAL 105、FORAL 85等)、氫化脂環族系烴(Exon Chemical公司製，商品名：ESCOREZ 5300等)、萜烯樹脂、石油樹脂及酚樹脂。賦黏劑當中，由α-蒎烯及β-蒎烯等所構成之萜烯樹脂係由於提高黏著力之作用優異，而為佳。在將SIS嵌段共聚物及流動石蠟以1~1.65：1之比率摻合於黏著劑層的情況， 係有黏著劑層之黏著力降低的傾向。在如此之情況中，可藉由萜烯樹脂之使用，而提昇黏著力。就黏著力提昇的觀點而言，於黏著劑層中之萜烯樹脂的含量特佳為17~25質量%。
作為吸收促進劑係可列舉：肉豆蔻酸異丙酯、癸二酸二乙酯、山梨醇酐單月桂酸酯、油基磷酸鈉(oleyl phosphoric acid sodium)、月桂基硫酸鈉、辛基苯基醚、月桂基醚、山梨醇酐單月桂酸酯、月桂醯二乙醇醯胺、月桂醯肌胺酸、油醯肌胺酸糖酯、卵磷酯、甘草酸、脲、柳酸、硫代乙醇酸鈣、乳酸、乳酸酯、橄欖油、鯊烯、羊毛脂及甘油。
作為抗氧化劑係可列舉：生育酚及其酯衍生物、抗壞血酸、抗壞血酸硬脂酸酯、正二氫癒創酸(nordihydroguaiaretic acid)、二丁基羥基甲苯及丁基羥基甲氧苯。
作為填充劑係可列舉：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、亞鉛酸鈣(calcium plumbite)、氧化鋅、氧化鈦及硬脂酸鋅。
作為交聯劑係可列舉：熱硬化性樹脂(胺基樹脂、酚樹脂、環氧樹脂、醇酸樹脂及不飽和聚酯等)、異氰酸酯化合物及封端異氰酸酯化合物等之有機系交聯劑、金屬及金屬化合物等之無機系交聯劑。
作為防腐劑係可列舉：對羥基苯甲酸乙酯、 對羥基苯甲酸丙酯及對羥基苯甲酸丁酯。
作為紫外線吸收劑係可列舉：p-胺基苯甲酸衍生物、鄰胺苯甲酸(anthranilic acid)衍生物、柳酸衍生物、香豆素衍生物、胺酸系化合物、咪唑啉衍生物、吡啶衍生物及二噁烷衍生物。
於黏著劑層中所含有之藥物並無特別限定，可列舉例如：乙醯胺基酚、非那西汀(phenacetin)、邁菲那密酸(Mefenamic Acid)、二克氯吩鈉(Diclofenac Sodium)、氟芬那酸(Flufenamic Acid)、阿司匹靈、柳酸鈉、柳酸甲酯、柳酸乙二醇酯、胺基吡啉、阿氯芬酸(Alclofenac)、布洛芬(Ibuprofen)、那普洛辛(Naproxen)、氟白普洛芬(Flurbiprofen)、凱妥普洛芬(Ketoprofen)、氨芬酸鈉(Amfenac sodium)、甲嘧啶唑(Mepirizole)、吲美洒辛(Indomethacin)、匹洛西卡(Piroxicam)及非必拉克(Felbinac)等之消炎鎮痛劑；氫皮質酮、特安皮質醇、迪皮質醇及去氫皮質醇等之類固醇系抗發炎劑；鹽酸迪太贊(Diltiazem Hydrochloride)、季戊四醇四硝酸酯、異山梨醇硝酸酯、曲匹地爾(Trapidil)、尼可地爾(Nicorandil)、硝化甘油、乳酸普尼拉明(prenylamine lactate)、嗎多明(Molsidomine)、亞硝酸鋁、鹽酸妥拉唑啉(Tolazoline hydrochloride)及尼非待平(Nifedipine)等之血管擴張劑；鹽酸普卡因醯胺(Procainamide Hydrochloride)、鹽酸利度卡因(Lidocaine Hydrochloride)、鹽酸普潘奈(Propranolol Hydrochloride)、鹽酸阿普諾(Alprenolol Hydrochloride)、 阿替洛爾(Atenolol)、那杜洛(Nadolol)、酒石酸美托普洛(Metoprolol Tartrate)、阿芝嗎靈(Ajmaline)、二丙吡胺及鹽酸美克律定(Mexiletine Hydrochloride)等之抗心律不整劑(Antiarrhythmic agents)；鹽酸托屈嗪(Ecarazine hydrochloride)、吲泊胺(Indapamide)、鹽酸克氯尼定(Clonidine Hydrochloride)、鹽酸丁丙諾非(Buprenorphine Hydrochloride)、鹽酸拉倍他洛(Labetalol Hydrochloride)、卡托普利(Captopril)、乙酸胍那苄(Guanabenz acetate)、美布氨酯(mebutamate)及硫酸苄胍(Bethanidine Sulfate)等之降血壓劑；檸檬酸噴托維林(Carbetapentane Citrate)、氯哌斯汀(Cloperastine)、鞣酸奧昔拉定(oxeladin tannate)、鹽酸氯布奇諾(Kuropuchinoru Hydrochloride)、鹽酸氯苯達諾(Chlophedianol Hydrochloride)、鹽酸諾司卡賓(Noscapine Hydrochloride)、鹽酸麻黃(Ephedrine Hydrochloride)、鹽酸異丙基腎上腺素、鹽酸氯丙那林(Kuroripurenarin Hydrochloride)、鹽酸甲氧基非那明(Methoxyphenamine hydrochloride)、鹽酸丙卡特羅(Procaterol Hydrochloride)、鹽酸妥布特羅(Tulobuterol Hydrochloride)、鹽酸克侖特羅(Clenbuterol Hydrochloride)及富馬酸酮替芬(Ketotifen Fumarate)等之鎮咳去痰劑；環磷醯胺、氟尿嘧啶、替加氟(tegafur)、絲裂黴素C、鹽酸丙卡巴肼(Procarbazine Hydrochloride)、去氧氟尿苷(Doxifluridine)及雷莫司汀(Ranimustine)等之抗 惡性腫瘤劑；胺基苯甲酸乙酯、鹽酸特他卡因(Tetracaine Hydrochloride)、鹽酸普卡因(Procaine Hydrochloride)、鹽酸待布卡因(Dibucaine Hydrochloride)、鹽酸丁氧普魯卡因(Oxybuprocaine Hydrochloride)及鹽酸丙胺卡因(Propitocaine hydrochloride)等之局部麻醉劑；丙硫脲酮、甲巰咪唑、乙酸美替諾龍(methenolone acetate)、雌二醇(oestradiol)、雌三醇(estriol)及助孕素等之激素劑；鹽酸二苯安明(Diphenhydramine Hydrochloride)、馬來酸氯菲安明(Chlorpheniramine Maleate)、普美苯噻肼(promethazine)、鹽酸塞浦希他啶(Cyproheptadine Hydrochloride)及鹽酸二苯比拉林(Diphenylpyraline Hydrochloride)等之抗組織胺劑；苯甲香豆醇鉀(warfarin potassium)及鹽酸梯可匹定(Ticlopidine Hydrochloride)等之抗凝血劑；溴化甲基阿托品(atropine methyl bromide)及莨菪鹼(Scopolamine)等之抗痙攣劑；硫噴妥鈉(sodium thiopental)及戊巴比妥鈉(Pentobarbital Sodium)等之全身麻醉劑；溴滑利尿素(bromvalerylurea)、異戊巴比妥(Amobarbital)及苯巴比妥(Phenobarbital)等之催眠/鎮痛劑；二苯乙內醯脲鈉等之抗癲癇劑；甲基安非他命等之興奮劑/覺醒劑；鹽酸地芬尼多(Diphenidol Hydrochloride)及甲磺酸倍他司汀(Betahistine Mesylate)等之鎮暈劑；鹽酸氯苯噻(Chlorpromazine Hydrochloride)、沙利苯噻(Thioridazine)、美普巴邁(Meprobamate)、鹽酸伊米胺(Imipramine Hydrochloride)、氮二氮平(chlordiazepoxide) 及二氮平等之精神神經用劑；鹽酸琥珀醯膽鹼(Suxamethonium Hydrochloride)及鹽酸乙哌立松(Eperisone Hydrochloride)等之骨骼肌肉鬆弛劑；溴化新斯的明(neostigmine bromide)及氯化脂膽等之自律神經用劑；鹽酸阿曼他丁(Amantadine Hydrochloride)等之抗巴金森氏劑；氫氟甲苯噻(Hydroflumethiazide)、異山梨醇及弗西邁(Furosemide)等之利尿劑；鹽酸去甲羥麻黃(Phenylephrine Hydrochloride)等之血管收縮劑；溴化山梗菜鹼、雙嗎啉胺(dimorpholamine)及鹽酸納洛酮(Naloxone Hydrochloride)等之呼吸促進劑；溴化葡萄糖吡咯、丙谷胺(proglumide)、鹽酸西曲酸酯(Cetraxate Hydrochloride)、希美替定(Cimetidine)及螺佐呋酮(spizofurone)等之消化性潰瘍治療劑；去氧熊膽酸及柳胺酚(osalmid)等之利膽劑；優洛托品(Hexamine)、金雀花鹼(Sparteine)、地諾前列素(dinoprost)及鹽酸立托啶(Ritodrine Hydrochloride)等之泌尿生殖器及肛門用劑；柳酸、環吡酮胺(ciclopiroxolamine)及鹽酸氯康唑(Croconazole hydrochloride)等之寄生性皮膚疾患用劑；脲等之皮膚軟化劑；鈣化三醇、鹽酸硫胺(Thiamine Hydrochloride)、核黃素磷酸鈉(riboflavin sodium phosphate)、鹽酸吡哆醇(Pyridoxine Hydrochloride)、菸鹼醯胺(nicotinic acid amide)、泛醇及抗壞血酸等之維生素劑；氯化鈣、碘化鉀及碘化鈉等之無機質製劑；伊沙西雷劑(Ethamsylate)等之止血劑；硫普羅寧(Tiopronin)等之肝 臟疾患用劑；氰胺(Cyanamide)等之慣性中毒用劑；秋水仙鹼(Colchicine)、丙磺舒(Probenecid)及苯磺唑酮(Sulfinpyrazone)等之痛風治療劑；甲苯磺丁脲、氯苯磺丙脲、糖降嘧啶鈉(glymidine sodium)、格列丁唑(glybuzole)、鹽酸丁二胍(Buformin Hydrochloride)及胰島素等之糖尿病用劑；苄青黴素鉀(benzylpenicillin potassium)、丙匹西林鉀(propicillin potassium)、氯噻青黴素鈉、胺苄青黴素鈉、鹽酸巴氨西林(Bacampicillin Hydrochloride)、羧苄西林鈉(carbenicillin sodium)、西華黴素(Cephaloridine)、西福西汀鈉(Cefoxitin Sodium)、紅黴素、氯黴素、四環黴素、硫酸康絲菌素及環絲胺酸等之抗生物質；異腈、吡甲醯胺及乙硫異菸醯胺等之化學療法劑；鹽酸嗎啡、磷酸可待因(codeine phosphate)、鹽酸古柯(Cocaine Hydrochloride)、鹽酸配西汀(Pethidine Hydrochloride)及檸檬酸吩坦尼(Fentanyl Citrate)等之麻藥。
若於黏著劑層中含有高濃度之柳酸甲酯及薄荷醇(例如，1-薄荷醇)，則藉由此等藥物之作用，黏著劑層變得容易可塑化的傾向會增強，黏附劑之「硬度」會變弱，而使貼附劑變得難以黏貼。然而，本實施形態之貼附劑係如上述般「硬度」強，因此，即使於黏著劑層中高濃度包含此等之藥物，貼附劑亦容易黏貼。尤其，本實施形態之貼附劑係適合用於黏著劑層中包含以黏著劑層之全質量基準計為9~11質量%之柳酸甲酯及2.5~6.5質量%或 3~6質量%之薄荷醇的情況。
黏著劑層的厚度較佳為50~3000μm。若黏著劑層的厚度為3000μm以下，則於黏著劑層中所包含之藥劑的釋出性會成為良好，若50μm以上，則皮膚接著性會成為良好，而貼附劑不易剝離。
支撐體的厚度為例如300μm以上，較佳為400μm以上。若支撐體的厚度為上述下限值以上，則不易產生黏著劑層之成分的滲出。又，支撐體的厚度為例如1200μm以下，較佳為700μm以下。若支撐體的厚度為上述上限值以下，則貼附劑不易剝離。
支撐體的厚度及黏著劑層的厚度之合計，亦即貼附劑的厚度較佳為300~5000μm。若貼附劑的厚度為5000μm以下，則貼附劑之端部不易卡住衣類等，而貼附劑不易剝離。若貼附劑的厚度為300μm以上，則貼附劑之支撐性充分，而將貼附劑確實地貼附，且，於貼附後的貼附劑不易發生皺褶。
本實施形態之貼附劑係可為短邊4~10cm且長邊6~15cm的長方形或圓角長方形之形狀。在本實施形態之貼附劑的形狀為長方形或圓角長方形的情況，較佳係長邊方向及短邊方向分別與水針不織布之寬方向及流向一致，且與貼附劑之第1方向及第2方向一致。
本實施形態之貼附劑亦可進一步具備用以被覆黏著劑層進行保護的剝離薄膜。剝離薄膜之材質係可列舉：無延伸聚丙烯(CPP)、延伸聚丙烯(OPP)、聚對苯二甲 酸乙二酯(PET)、聚對苯二甲酸丁二酯(PBT)、聚乙烯、聚酯、聚胺基甲酸酯、聚氯乙烯及聚苯乙烯等之塑膠薄膜、在合成樹脂、合成紙及合成纖維等之矽加工而成的矽加工紙、鋁箔、牛皮紙上層疊聚乙烯等而成的層疊加工紙等。於此等之中較佳使用PET及加工紙。在貼附劑具備剝離薄膜的情況，貼附劑之剛軟度係意味著在剝離薄膜剝離後的狀態之貼附劑測定出的剛軟度。
剝離薄膜的厚度為例如10~100μm，較佳為30~90μm，更佳為40~85μm。若剝離薄膜的厚度為上述下限值以上，則容易抓取剝離薄膜，且在將剝離薄膜剝離時不易纏住黏著劑層。另一方面，若剝離薄片之厚度為上述上限值以下，則製造時之切斷成為容易，而製造適性成為良好。
本實施形態之貼附劑係可藉由該業者所周知的方法進行製造。例如，使用捏合機或混合機等之混合機，一邊加熱至120~160℃，一邊將藥物以外之黏著劑層的各成分進行混合，接著，以藥物不進行熱分解的溫度進行添加混合，而調製黏著劑層形成用之混合物。可將此混合物直接於支撐體上進行延展而形成黏著劑層，或者，於剝離薄膜上進行延展而形成黏著劑層，並於其上載放支撐體，而使黏著劑層壓著轉印於支撐體上。
實施例 貼附劑之評估試驗(1)
將表1之各成分進行加熱及捏和而得到黏著劑1。於表2記載之聚酯製不織布2~4，以使塗佈量成為210g/m2的方式塗佈黏著劑1，而得到實施例1~2及比較例1之貼附劑。貼附劑係短邊之長度為約5cm，長邊之長度為約7cm之長方形的形狀。又，不織布的寬方向與貼附劑之長邊方向為一致。針對所得到的貼附劑進行下述之評估。將結果顯示表4。
貼附劑之評估項目 (1)貼附劑之剛軟度
按照JIS L 1085：1998所規定之45°懸臂架設法，來測定貼附劑之長邊方向的剛軟度。
(2)貼附劑之黏貼容易度
於四肢健全的成人30名之肩部貼附貼附劑，將黏貼容易度以下述之3階段的基準點數化，求出其平均值。將平均值未達2的情況之評估作為○，將2以上的情況之評估作為×。
1 容易黏貼
2 普通
3 難以黏貼
(3)貼附劑之附著性
於四肢健全的成人30名之肩部貼附貼附劑，將8小時後之貼附劑的附著狀態以下述之3階段的基準點數化，求出其平均值。將平均值未達2的情況之評估作為○，將2以上的情況之評估作為×。
1 貼附劑完全未剝落，密著於皮膚的狀態
2 僅貼附劑面之端部剝離的狀態
3 貼附劑面的1/4以上剝離的狀態
(4)貼附劑之對於支撐體的滲入(滲出)
目視觀察貼附劑之對於支撐體的滲入(滲出)之有無，將無觀察到滲入(滲出)的情況之評估作為○，將雖觀察到些許滲入(滲出)但作為貼附劑之使用並無問題的情況之評估作為△，將觀察到滲入(滲出)而不適合作為貼附劑使用的情況之評估作為×。
(5)製劑適性
目視觀察黏著劑層之表面的氣泡之有無，將無氣泡的情況之評估作為○，將有氣泡的情況之評估作為×。
如由表4所示之結果得以明瞭般，貼附劑之剛軟度為18以上之實施例1及2的貼附劑係容易黏貼，附著性優異，並且未觀察到對於支撐體之黏著劑的滲入，而為優異的貼附劑。另一方面，貼附劑之剛軟度為未達 18之比較例1的貼附劑係黏貼容易度方面差。
貼附劑之評估試驗(2)
將表5之各成分進行加熱及捏和而得到黏著劑2~6。於表2記載之不織布1(聚酯製)及3，以使塗佈量成為210g/m2的方式塗佈黏著劑2~6，而得到實施例3~7及比較例2~6之貼附劑。針對所得到的貼附劑進行與評估實驗(1)相同之評估。將結果顯示表7。
如由表7所示之結果得以明瞭般，使用藉由針刺法所製造之不織布1作為支撐體的比較例2~6之貼附劑係在黏貼容易度方面差。另一方面，使用藉由水針法所製造之不織布3作為支撐體的實施例3~7之貼附劑係黏貼容易度及附著性優異。且，SIS與流動石蠟之質量比為1~1.65：1之範圍的實施例4~6之貼附劑係在對於支撐體之黏著劑的滲入難度及製造適性方面皆優異。

Claims (11)

  1. 一種貼附劑，其係具有支撐體與層合於支撐體上之黏著劑層的貼附劑，支撐體係由水針不織布所構成，黏著劑層係包含苯乙烯-異戊二烯-苯乙烯嵌段共聚物及流動石蠟，貼附劑係具有作為特定之基準軸方向的第1方向，與和第1方向呈直角的第2方向，以JIS L 1085：1998所規定之45°懸臂架設法測定的貼附劑之第1方向的剛軟度為18~30mm，於黏著劑層中之苯乙烯-異戊二烯-苯乙烯嵌段共聚物與流動石蠟之質量比為1~1.65：1。
  2. 如請求項1之貼附劑，其中，黏著劑層係包含柳酸甲酯及薄荷醇。
  3. 如請求項2之貼附劑，其中，黏著劑層係包含聚異丁烯。
  4. 如請求項3之貼附劑，其中，黏著劑層係包含萜烯樹脂。
  5. 如請求項4之貼附劑，其中，黏著劑層係以黏著劑層之全質量基準計包含9~11質量%之柳酸甲酯及2.5~6.5質量%之薄荷醇。
  6. 如請求項4之貼附劑，其中，黏著劑層係以黏著劑層之全質量基準計包含23.7~32.5質量%之苯乙烯-異戊二烯-苯乙烯嵌段共聚物、17.9~27.5質量%之流動石蠟、9~11質量%之柳酸甲酯、3~6質量%之薄荷醇、3~12質量%之聚異丁烯及17~25質量%之萜烯樹脂。
  7. 如請求項1~6中任一項之貼附劑，其中，不織布之單位面積重量為90~110g/m2。
  8. 如請求項1~6中任一項之貼附劑，其中，不織布之寬方向的20%模數為3~5N/50mm。
  9. 如請求項1~6中任一項之貼附劑，其中，不織布之寬方向的50%模數為8~15N/50mm。
  10. 如請求項1~6中任一項之貼附劑，其中，不織布係由聚酯所構成。
  11. 如請求項1~6中任一項之貼附劑，其中，以JIS L 1085：1998所規定之45°懸臂架設法測定的貼附劑之第1方向的剛軟度為18~27mm。
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US10292941B2 (en) 2019-05-21
EP3254677B1 (en) 2021-08-04

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