TW201236701A - Hydrous adhesive patch - Google Patents
Hydrous adhesive patch Download PDFInfo
- Publication number
- TW201236701A TW201236701A TW101102865A TW101102865A TW201236701A TW 201236701 A TW201236701 A TW 201236701A TW 101102865 A TW101102865 A TW 101102865A TW 101102865 A TW101102865 A TW 101102865A TW 201236701 A TW201236701 A TW 201236701A
- Authority
- TW
- Taiwan
- Prior art keywords
- formula
- aqueous
- compound
- adhesive layer
- active ingredient
- Prior art date
Links
- 239000000853 adhesive Substances 0.000 title abstract description 13
- 230000001070 adhesive effect Effects 0.000 title abstract description 13
- 150000001875 compounds Chemical class 0.000 claims abstract description 32
- 239000004480 active ingredient Substances 0.000 claims abstract description 29
- 239000012790 adhesive layer Substances 0.000 claims abstract description 28
- 150000003839 salts Chemical class 0.000 claims abstract description 27
- 239000002736 nonionic surfactant Substances 0.000 claims abstract description 26
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims abstract description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000012453 solvate Substances 0.000 claims abstract description 10
- 229960002373 loxoprofen Drugs 0.000 claims abstract description 9
- BAZQYVYVKYOAGO-UHFFFAOYSA-M loxoprofen sodium hydrate Chemical compound O.O.[Na+].C1=CC(C(C([O-])=O)C)=CC=C1CC1C(=O)CCC1 BAZQYVYVKYOAGO-UHFFFAOYSA-M 0.000 claims abstract description 9
- -1 polyoxyethylene Polymers 0.000 claims description 44
- 239000003795 chemical substances by application Substances 0.000 claims description 18
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- 239000000126 substance Substances 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 7
- 125000000962 organic group Chemical group 0.000 claims description 6
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- 230000000694 effects Effects 0.000 claims description 4
- 230000002401 inhibitory effect Effects 0.000 claims description 3
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- 241000218195 Lauraceae Species 0.000 claims 1
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- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 description 1
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Classifications
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- 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
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- 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
- A61K31/12—Ketones
- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Description
201236701 六、發明說明: 【發明所屬之技術領域】 本發明係有關一種含水系貼附劑。 【先前技術】 近年來,為了將藥物經皮投予,來取代經口投予、藉 由注射而進行之靜脈投予等,而熱烈地開發—種貼附劑, 其黏著劑層位於支持體上,該點著劑層在翁著劑中調配了 有效成刀。貼附劑在下述觀點上為有帛:能夠在貼附皮膚 後直到剝下為止之期間’長時間使大約一定量的有效成分 經皮吸收。 另方面,在貼附劑的黏著劑層中,除了有效成分以 外:亦包含以黏著劑為首之各種成分,因此,貼附劑中之 有效成分谷易經時劣化,而提高其安定性相當重要。 貼附劑中有下述兩種型式:包含水之含水系貼附劑(貼 片知丨)及非水系貼附劑(膠布劑、硬膏劑等)。其中,關於 非水系貼附劑,已教示有下述事實:使用2_巯基苯并咪唑 等抗氧化劑夠提高有效成/分之安定性(專利文獻 [先前技術文獻] (專利文獻) 專利文獻1 :曰本特開平11_79980號公報 201236701 【發明内容】 [發明所欲解決之問;|| ] 然而,在含水系貼附劑方面,因 水,因此從與非水系貼附劑不同的觀 高有效成分之安定性。此外,由於有 有效成分而異,故揾高容宗批π & 由’因黏著劑層中進而包含 同的觀點來看,應該需要提 由於有效成分之分解會因該 有效成分來個别進行研究。 故提高安定性所需的對策,亦必須對各種 需的對策’亦必須對各種
含水系貼附劑,其有效成分(藥物)的安定性優異,該有效 成分是具有特定的環狀酮結構之成分,例如洛索洛芬 (loxoprofen)等。 [解決問題之技術手段] 本發明人發現,具有特定的環狀酮結構之有效成分在 水系中之反應性(分解性),會被非離子性界面活性劑抑 制,遂完成本發明。具體而言,本發明係提供下述。 (1) 一種含水系貼附劑’其係具備:支持體、及位於此支 持體上之黏著劑層,其中, 前述黏著劑層係包含:有效成分、非離子性界面活性 劑及水,該有效成分是由通式1所示之化合物、其藥理學 上〇所容許之鹽或溶劑合物所構成 ,
•通式1 4 201236701 (式中,η為0、1或2’ R為有機基)。 (2)如⑴所述之含水系貼附劑,其中,前述化合物為洛索 洛芬。 、 (3) 如⑴或(2)所述之含水系貼附劑,其中,前述非離子性 界面活性劑係具有6.0以上且9.5以下之HLB (hydr〇philic_ lipophilic balance’親水親油平衡)值。 (4) 如⑴至(3)中任-項所述之含水系貼附劑,其中,前述 非離子性界面活性劑為環氧乙烧加成型,且其環氧乙烧加 成莫耳數為5 mol以下。 (5) 如(4)所述之含水系貼附劑,其中,前述非離子性界面 :舌I·生劑疋從由4氧乙烯硬化蓖麻油(環氧乙烷加成莫耳數 為5则1)、及聚氧乙稀月桂基喊(P〇iy〇Xyethylene lauryl ether)(%氧乙烧加成莫耳數為2则⑽構成之群組中選出 之1種以上。 (6)種方法’其係針對含水㈣附劑m "貼㈣ 係具備:支持體、及位於此支持體上之黏編,將有效 :分'水及非離子性界面活性劑一起調配在前述黏著劑層 ,該有效成分是由通式丨所示之化合物、其藥理學上所 :許之鹽或溶劑合物所構成’藉此來抑制前述化合物變化 為f式2或通式3所示之化合物的情況,
......通式1 !ί 5 201236701
•通式2 (通式1〜3中’n為0、1或21為有機基)。 (:對含種^劑’其係由非離子性界面活性劑所構成,並且 此支持體Γ附劑,該含水系貼附劑具備支持體、及位於 著劑層’將有效成分、水及該製劑-起調 -在刖返黏者劑層中’該有效成分是由通式]所示之化合 物、其藥理學上所容許H㈣合物所構成,藉此來: 忒製劑用於抑制前述化合物變化為通式2或通式3所示之 化合物的情況。 ' [功效] 根據本發明,由於具有特定的環狀鲷結構之有效成分 在水系中之反應性,會被非離子性界面活性劑抑制,故能 夠提高含水系貼附劑中之洛索洛芬等具有特定的環狀酮結 構之有效成分的安定性。 201236701 【實施方式】 [實施發明的較佳形態] 以下說明本發明之實施形態,但並非限定本發明。 本發明之貼附劑係具備:支持體、及位於此支持體上 之黏著劑層,纟中,此黏著劑層係至少包含有效成分、非 離子性界面活性劑及水,該有效成分是由通式丨所示之化 合物、其藥理學上所容許之鹽或溶劑合物所構成。 [黏著劑層] 至今,一直使用非離子性界面活性劑來作為水系貼附 劑中之界面活性劑,但未曾設想到非離子性界面活性劑是 有用於作為藥物安定劑。本發明人發現,令人驚訝地,非 離子性界©活性劑在水系貼附劑中會抑制具有特定的環狀 酮結構之有效成分在水系中之反應性(分解性)。具體而 言,非離子性界面活性劑在水系貼附劑中會抑制通式丨所 示之化合物變化為通式2或3所示之化合物,該非離子性 界面活性劑之HLB值為6.〇以上且9.5以下,並且/或為環 氧乙烷加成型,且其環氧乙烷加成莫耳數為5 m〇i以下。 再者,該反應,與有效成分之酯化(特別是與薄荷醇等生成 醋體)完全不同(詳細内容請參照J〇urnal 〇f Chronograph A,2008 年,1208, p.164-174)。 從通式1變化至通式2,係由酮之碳與其以立之碳之 201236701 間之鍵結斷裂所產生,從通式丨變化至通式3,係由α位 之碳經羥基化所產生。由於環式結構之碳數及R應該無助 於任一反應’故n可為〇、【或2之任一者,R可為任意有 機基。再者,在本發明中,有效成分之安定性係指由通式 1之化合物所生成之通式2及3之化合物之總和減少,較 佳係指通式2 & 3之化合物兩者的生成量均減少,但只要 其中至少一者的生成量減少即可。 因此,通式1所示之化合物無特別限定,可為洛索洛 芬等。此外,藥理學上所容許之鹽,為上述化合物及/或其 溶劑合物之鹽’無特別限定,可為下述鹽t i種或2種以 上.鈉鹽、鉀鹽等鹼金屬鹽;鈣鹽、鎂鹽等鹼土金屬鹽等。 此外,备劑合物為上述化合物及/或其藥理學上所容許之鹽 之溶劑合物’無特別限定,一般而言為水合物。再者,有 效成分(藥物)可以鹽、游離體、溶劑合物(例如水合物)、非 溶劑合物(例如非水合物)等任意形態來調配。 具體而5,洛索洛芬,一般以下述化學式1所示之鈉 瓜一水σ物之形態來調配,但無特別限定’也可以其他鹽、 ^離體、非水合物之任一形態來調配。
• · · •化學式1 而且,非離子性界面活性劑,在水系中會抑制下述化 201236701
• · · ·化學式2
.....十丨、J HLB值為6.0以上且9.5以下之非離子性界面活性劑, 並無特別限定’可為下述化合物t 1種或2種以上:甘油 硬知醚Sg (含有2〇%的單甘油酯,HLB值為7 〇)、聚甘油單 值為9.0)、聚甘油三硬脂酸酯(HLB值為 9.5)、十甘油三硬脂酸酯(hlb值為7 5)、聚甘油三油酸酯 (HLB值為7.0)、聚氧乙烯甘油單硬脂酸酯(環氧乙烷加成 莫耳數為5 ’ HLB值為9.5)、山梨糖醇酐椰子油脂肪酸醋 (HLB值為8.6)、山梨糖醇酐單棕櫚酸S旨(HLB值為6.7)、 聚氧乙烯山梨糖醇酐單硬脂酸酯(環氧乙烷加成莫耳數為 6 HLB值為9.5)、聚氧乙烯山梨糖醇四油酸酯(環氧乙烷 加成莫耳數為6’ HLB值為8.5)、聚氧乙烯硬化萬麻油(環 氧乙烧加成莫耳數^ 5,则值為6())、聚氧乙烯硬化乾 麻油(環氧乙炫加成莫耳數為1〇,则值為65)、聚氧乙稀 植物固醇(環氧乙燒加成莫耳數為5,则值為Μ)、聚氧 乙烯月桂基醚(環氧乙烧加成莫耳數為2,細值為Μ)、 201236701 聚氧乙稀硬脂基趟(環齑7斤上上* 8 〇, ^ . 氧乙烷加成莫耳數為2, HLB值為 8.〇)、聚氣乙烯月桂基
(辰氧乙烷加成莫耳數為4,HLB 值為9.0)、聚氧乙烯油基 值為7.5)、聚戟乙婦一十^虎加成莫耳數為2,動 …值為7·。)= (環氧乙貌加成莫耳數為 、 氧乙烯聚氧丙烯鯨蠟基醚(環氧乙产 為h環氧丙貌加成莫耳數為4_值為9.5)、 :氧乙烯聚氧丙稀錄蟻基轉(環氧乙烧加成莫耳數為 氧丙烧加成莫耳數為8,HLB值為95)、聚乙二 醋(環氧乙貌加成莫耳數為6,HLB值為8.5)等。此外,非 離子性界面活性劑為環氧乙院加成型,且較佳是其環氧乙 烷加成莫耳數為5 m〇1以下, 卜具體而5 ,較佳是聚氧乙嫌 硬化Μ麻油(環氧乙烷加成莫 神 加成冥耳數為5 mo1)、及聚氧乙烯月 ㈣(環氧乙烧加成莫耳數為2福)之1種或2種。 非離子性界面活性劑的調配量並無特別限定,較佳θ 相對於有效成分的調配量為1〇〜5〇〇質量%。一般而+, 非離子性界面活性劑的調配量,從相對於點㈣Μ以 質量%以下之範圍選擇即可。 . 由於有效成分之安定性會因非離子性界面活性劑 幅提升’故為了安定性之目的而調配之其他成分的調配量 為少量即可’亦可不調配。具體而言,黏著劑層中 配從由亞硫酸鹽、亞硫酸氫鹽、及焦亞硫酸鹽所構成 組中選出之1種以上,相對於有效成分的調配量, 量為1質量%以下即可。 d 亞硫酸鹽可為亞硫酸氫之下述鹽:鈉鹽、鉀鹽等鹼金 10 201236701 屬鹽;鈣鹽、鋇鹽等鹼土金屬鹽等。凸技綠好成 鹽:納鹽、卸鹽等驗金屬鹽;錄鹽等:酸 為下述 哥焦亞硫酸鹽可為下 2鹽:納鹽、卸鹽等驗金屬鹽等。具體而言可為:亞硫酸 鈉、亞硫酸氫鈉、焦亞硫酸鈉。 本發明之含水系貼附劑中,黏著劑層係包含水。水的 調配量並無特別限定,相對於黏著劑層為3〇〜7〇質量 右即可。 里〇左 除了上述成分以外’黏著劑層還可因應需要而包含下 述任意成分1丙婦酸及/或其料賦形劑、界面活性劑、 交聯劑、交聯麵、黏著增強劑、保濕劑、藥物之容解 助劑、PH調整劑、清涼化劑、水溶性高分子化合物、無機 粉體、抗氧化劑、防腐劑、色素等。 聚丙稀酸及/或其鹽可舉例如:聚丙稀酸、聚丙稀酸 鈉、聚丙稀酸部分中和物「Νρ·_(商品名)」及「隊彻(商 品名)」(昭和電工公司製)等,此等可單獨包含4、或,且 合包含2種以上。 ' .除了非離子性界面活性劑以外,亦可調配一般的界面 活性劑。這樣的界面活性劑可添加例如:二辛基磺基琥拍 酸鈉、烷基硫酸鹽、烷基硫酸2-乙基己酯鈉鹽、正十二烷 基苯靖酸納等陰離子界面活性劑;氣化十六烧基三^ 銨、氯化十八烷基二曱基苯甲基銨、氯化聚氧乙烯十二烷 基單甲基銨等陽離子界面活性劑。 交聯劑可舉例如多價金屬鹽,其中,以鋁化合物為佳。 銘化口物可舉例如:像胺基乙酸二經基紹、氫氧化紹般的 201236701 氯氧化物;或像氣化紹、硫酸銘、乙酸紹、硬脂酸銘般的 無機酸或有機酸之鹽,·像紹明礬般的複合鹽;像鋁酸鈉般 的銘酸鹽,·無機性鋁錯合物及有機性铭鉗合化合物等。此 等鋁化合物可為水溶性或難溶性。 此外,可使用氫氧化鋁凝膠來作為交聯劑,但此時阳 以4.5以上且6.0以下為佳。若pH超過6〇,則氫氧化紹 凝膠之I呂不容易溶出,而黏著劑之交聯反應會不充分且保 型性容易惡化。相對地’當使用胺基乙酸二經基紹時,黏 著劑層之pH可超過6.0。 再者,PH能夠使用pH調整劑設定’這樣的pH調整 劑可舉例如:酒石酸、磷酸、蘋果酸、檸檬酸、鹽酸、氫 氧化鈉、彡乙醇胺、二乙醇胺、二異丙醇胺等,此等可單 獨包含1種、或組合包含2種以上,較佳是酒石酸。 黏著增強劑可舉例如:甲基丙烯酸-丙浠酸正丁酿共聚 物、丙烯酸曱酿-丙烯酸2_乙基己酷共聚物、聚丁烯、醋膠 (ester gum)、萜烯(terpene)樹脂、脂環族飽和烴樹脂等。相 對於黏著劑層,黏著增強劑的調配量可為〗質量%以上且 30質量%以下,較佳是2質量%以上且10質量%以下。 交聯控制劑可舉例如:依地酸鈉(乙二胺四乙酸二 鈉)、檸檬酸等’此等可單獨包含1種、或組合包含2種以 上,以依地酸鈉為佳。 保濕劑可舉例如:濃甘油、山梨糖醇、乙二醇、丙二 醇、聚乙二醇、聚丙二醇、流動石蠟、1,3-丙二醇、^弘丁 二醇、麥芽糖醇、木糖醇等多元醇等,此等可單獨包含艾
.S 12 201236701 種、或組合包含2種以上,其中,以濃甘油為佳。再者, 甘油的調配量可考慮製造成本和滲出容易度等來適當設 定。 藥物之溶解助劑可舉例如:克羅米 曱基吡咯啶酮等吡咯啶酮衍生物、薄荷油、1,3-丁二醇 等,此等可單獨包含1種、或組合包含2種以上。 凊凉化劑,除了樟腦、百里酚(thym〇l)以外,還可舉例 如:1-薄荷醇(l、menth〇l)、dl_薄荷醇、2_曱基_3(丨薄荷氧 基)丙 _1,2-二醇(2_methyl_3_(1_menthyl〇xy)pr〇pa加 dl01)、3·(1-薄荷氧基)丙-1,2-二醇、2-羥基丙酸5 -甲基_2_(卜 甲基乙基)環己酯等薄荷醇衍生物等,此等可單獨包含丄 種、或組合包含2種以上。 水溶性高分子化合物可舉例如:明膠、寒天、聚乙烯 醇、聚乙烯吡咯啶酮、碳酸伸丙酯、羧基甲基纖維素、羧 基甲基纖維素納、經基丙基纖維素、經基丙基甲基纖維素、 羥基乙基纖維素、甲基纖維素、褐藻酸鈉、馬來酸酐共聚 物、鹿角菜膠等’此等可單獨包含、或組合 以上。 無機粉體可舉例如:高嶺土、氧化鋅、氧化欽、石夕酸 肝等此等可單獨包含1種、或組合包含2種以上。 ~抗氧化劑可舉例如:生育酴乙酸s|、抗壞血酸及/或其 何生物、亞硫酸鈉、二丁基經基甲苯等, 1種、或組合包含2種以上。 “3 防腐劑可舉例如:對經基苯甲酸甲醋、對經基苯甲酸 13 201236701 此等可單獨包含j 丁西曰、對經基苯甲酸丙酯、百里齡等 種、或組合包含2種以上。 冊中所 2種以 ............. 芈例如法定色素_ 記載之色素,此等能夠單獨使用】種、或組合使, 上0 [支持體] 支持體可由至今已知之貼附劑所使用之下述材料 成:織布、不織布、編布等布帛;樹脂薄膜;紙;以及此 等之積層體。支持體之材質可為從由聚丙烯、$乙烯、令 丁烯、聚對笨二甲酸乙二8旨、„、棉、聚㈣—Μ⑽叫 所構成之群組中選出之i種或2種以上,無特別限定,以 聚對苯二曱酸乙二酯為佳。從成本面來看,較佳係使 不織布所構成之支持體,該残布係、由聚料二甲酸乙二 酉旨所構成。此外,當使用樹脂薄膜時,可使用經印刷或= :白色、膚色等的塗料而施予著色之支持體 '《寫入有文 字等之支持體’ A 了提高黏著劑之定錨性,亦能夠使用經 施予聚胺酯處理或消光處理等之支持體。 [剝離襯墊] 本發明之貼附劑,可進而具備:用以被覆黏著劑層之 剝離襯墊。這樣的剝離襯墊,較佳是聚對苯二甲酸乙二酯、 聚丙烯等之樹脂薄膜,亦可使用經矽等的剝離處理後之襯 墊、經施予壓花加工後之襯墊。此外,亦能夠使用印刷或 14 201236701 摻入有白色等的塗料後之襯墊,來作為剝離襯墊。 (調製方法) 本發明之貼附劑能夠以習知方法來調製,且能夠以下 述方式調製:適當調配上述必須成分及因應需要之上述任 意成分,並以習知方法來揉合直到成為均勻為止,並且以 使每單位面積之貼附劑中之黏著劑質量成為〇 〇3〜〇15 g/cm2之方式在剝離襯墊上延展開後,於該黏著劑層之表面 進一步積層支持體,然後裁切成100 mmX14〇 mm之矩形 狀。此外,亦能夠藉由下述方式調製:先將黏著劑在支持 體上延展開後,於其上積層剝離襯墊。 以下,列舉實施例及比較例來具體說明本發明,但本 發明並不受實施例所限定。 [實施例] [試驗例1] 將表1所示之各成分攪拌一定時間來混合後,以使每 1片貼附劑(140 mm X 1〇〇 mm)的黏著劑質量成為約1〇 g之 方式’在剝離襯墊上均勻延展開。然後,在黏著劑層的表 面貼合聚對苯二曱酸乙二酯製不織布,而調製貼附劑。 15 201236701 [表l] 成分 調配量(質量%) ................................ 绛索洛芬鈉二水合物 1 聚丙烯酸部分中和物 6 聚丙烯酸鈉 2 幾·基甲基纖維素納 3 丙烯酸曱酯-丙烯酸2-乙基己酯共聚物 3 . .. 乾燥氫氧化鋁膠 0.1 ..... 無機粉體 適量 pH調整劑 適量 1-薄荷醇 0.2 N-曱基·2_σιΐι略咬酮 5 濃甘油 1 30 界面活性劑 如其他表所述 精製水 45 合計 100 將表1中之界面活性劑設為表 而調製貼附劑。將各貼附劑在4(rc或60°c放置後,切取表 面積10cm2之切片,並精密秤量其質量。然後,將剝離襯 墊薄膜剝下後,置入5 0 mL之離心管中,並在其中添加 醇後,震盪30分鐘萃取出藥物。將萃取液進行高速離心2 進行過濾處理而獲得溶液後,以該溶液作為樣品溶液, 由HPLC來測定化學式卜3、洛索洛芬之下述醋之質曰9 甘油酯(稱為「GE」)、薄荷醇酯(稱為「μ 姓$ 表3所示。 」” 201236701 [表2] 界面活性齊|J HLB 值 1 聚氧乙稀山梨糖醇酐三油酸酯 (環氧乙烷加成莫耳:¾•為30) ---- 11 2 聚山梨糖醇酯80 3 聚氧乙稀山梨糖醇針單油酸酯 _(_環氧乙烷加成莫耳數為6) 10 4 聚氧乙稀山梨糖醇酐椰子油脂肪酸酯 ——(環氧乙烷加成莫耳數為2〇) 16.9 實施例 5 聚氧乙烯硬化蓖麻油 (環氧乙烷加成莫耳數為6〇) ~·-- 14 6 聚氧乙烯月桂基醚 —(環氧乙烷加成莫耳數盍Q) ----- 14.5 7 --…梨糖醇酐倍半油酴酤 —---. 8 9 10 11 12 13 聚氧乙烯硬化蓖麻油 (環氧乙烷加成莫耳數為5) ------ ’ 6 聚氧乙烯月桂基醚 (環氧乙烷加成莫耳數為2) 9.5 ' [表3] -~~-~~-- --一 3
Ji3| 97. 7) ΊΓγ---- [π妾 9 Β ,〜_ 之生 如表2乃q - '— 及3所不,在所有實施例 成均受到抑制,其中,在眚 ’特別是 Ψ在貫施例8〜13 ψ 化學化學 式 式 17 201236701 及3兩者之生成更加受到抑制。由此可知,非離子性界面 活性劑會抑制化學式3在水系中生成,並且下述非離子性 界面活性劑會進一步抑制化學式2及3兩者生成:具有6 〇 以上且9.5以下之HLB值,並且該非離子性界面活性劑是 環氧乙烷加成型,且其環氧乙烷加成莫耳數為5m〇1以下。 另一方面,無法確認洛索洛芬之酯體的生成量在各貼附劑 之間有顯著差異。由此可知,非離子性界面活性劑,會具 有特異性地抑制化學式1在水系中變化成化學式2及3。 在4(TC及60t:將實施例8及市售物α〇χ〇ΝΐΝ(註冊商 標)貼>1 100mg :調配有$山梨糖醇酉旨8〇來作為界面活性 劑)之貼附劑,放置i〜6個月後,以色差(ΔΕ)來評估下述: 從剛製作成貼附劑後開始,黏著劑層(藥劑面)著色至何種 程度。結果係如表4所示。色差(ΛΕ)係藉由下述方式獲得: 藉由色彩色差計(X-Rite公司创,λ/Γ」, ]製 Model SP64)來測定黏著 劑層表面之色度後,以下诚★冰曾b丄 式來舁出在剛製作成貼附劑後 與在40°C及60°C放置1〜6個日你— 個月後之間之色度的差值。換 言之,當以L-刻度來表示白—里 …、之知度’以a-刻度來表示紅 _綠之程度,以b -刻唐决矣-* 、 來表不藍-黃之程度時,色差係以各 刻度的差值之平方和之平方讲七士 十万根來表示(Δ£=((Δ^2 + (△ b)2+ (△ l)2)"2) 〇 [表4]
18 201236701 如表4所示,隨著時間經過所造成之黏著劑層著色, 在實施例8中較市售物更受到抑制。 【圖式簡單說明】 無 【主要元件符號說明】 無 19
Claims (1)
- 201236701 七、申請專利範圍: 1. 一種含水系貼附劑,甘及„ ^ ^ 係具備:支持體、及位於此支 持體上之黏者劑層,其中, 前述黏著劑層係包含 > « ^ _. 有政成/刀、非離子性界面活性劑 及水,該有效成分是由通式 # — 4 ^ 巧1所不之化合物、其藥理學上 所ί5+之鹽或溶劑合物所構成,、 .....通式 1 (式中,η為0、1或2,R為有機基)。 2·如申請專利範圍第丨項所.十.#人u ^ 項所述之含水系貼附劑’其中, 刖边化合物為洛索洛芬。 3 ·如申請專利範圍第1 ϊΐ如·、#人, 項所述之含水系貼附劑,其中, 别述非離子性界 值。 劑係具有6.。以上且9.5以下之HLB 4.如申請專利範圍第2項所、+、+人u . 項所述之含水系貼附劑,其中, 刖述非離子性界面活 則係具有6.0以上且9_5以下之HLB 值。 5·如申請專利範圍第i項至第4項中任一項所述之含水 二附劑其中’刖述非離子性界面活性劑為環氧乙烧加 I,且其環氧乙烷加成莫耳數為5叫以下。 V申請專利範圍第5項所述之含水系貼附劑,其中, 月h非離子性界面活性劑是從由聚氧乙烯硬Μ麻油(環 20 201236701 氧乙烷加成莫耳數為5 m〇1)、及聚氧乙烯月桂 院加成莫耳數為2m〇1)所構成之群組中選出之!種以:。 1備針對含水系貼附劑,該含水二劑 具備支持體及位於此支持體上之黏著劑層,將有 、 水及非離子性界面活性劑一起調配在前述黏著: 有效成分是由通式1所示之化合物、其藥理學上:料: 鹽或溶劑合物所構成’藉此來抑制前述化合物變化為通式 2或◦通式3所示之化合物的情況, ’’’、".....通式2(通式1〜3中 8. 一種製劑 ’ ^ 〇、1或2, R為有機基)。 ,其係由非離子性界面活性劑齊 並且 21 201236701 針對含水系貼附劑,該含水系貼附劑具備支持體及位於此 支持體上之黏著劑層,將有效成分、水及該製劑一起調配 在前述黏著劑層中,該有效成分是由通式1所示之化合 物、其藥理學上所容許之鹽或溶劑合物所構成,藉此來將 該製劑用於抑制前述化合物變化為通式2或通式3所示之 化合物的情況, 0籲 (通式1〜3中, ......通式3 η為0、1或2,R為有機基)。 201236701 四、指定代表圖: (一) 本案指定代表圖為:無 (二) 本代表圖之元件符號簡單說明:無 五、本案若有化學式時,請揭示最能顯示發明特徵的化學式:
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TWI625131B (zh) * | 2013-08-23 | 2018-06-01 | Hisamitsu Pharmaceutical Co., Inc. | 膏劑及其製造方法 |
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KR102094586B1 (ko) * | 2014-12-22 | 2020-03-27 | 히사미쓰 세이야꾸 가부시키가이샤 | 파프제 |
WO2016136556A1 (ja) * | 2015-02-24 | 2016-09-01 | 久光製薬株式会社 | パップ剤 |
JP6613878B2 (ja) * | 2015-12-25 | 2019-12-04 | ライオン株式会社 | 口腔用ポリマーゲル製剤 |
JP6594937B2 (ja) * | 2016-09-05 | 2019-10-23 | 久光製薬株式会社 | シート状パック剤及びその製造方法 |
KR102000435B1 (ko) * | 2018-01-18 | 2019-07-16 | 대화제약 주식회사 | 하이드로겔 패치 형태의 경피투여용 약학 조성물 |
JP2019206497A (ja) | 2018-05-30 | 2019-12-05 | 小林製薬株式会社 | 外用医薬組成物 |
WO2020066188A1 (ja) * | 2018-09-26 | 2020-04-02 | ニチバン株式会社 | 含水系貼付剤 |
BR112021015884A2 (pt) | 2019-02-14 | 2021-10-05 | Hisamitsu Pharmaceutical Co., Inc. | Cataplasma |
JP7515277B2 (ja) * | 2019-03-25 | 2024-07-12 | 第一三共ヘルスケア株式会社 | ロキソプロフェン配合皮膚外用剤 |
JP2020164471A (ja) * | 2019-03-29 | 2020-10-08 | ニチバン株式会社 | 貼付材 |
EP3988172A4 (en) * | 2019-06-24 | 2023-04-19 | Teikoku Seiyaku Co., Ltd. | WATER-BASED ADHESIVE PLASTER |
JP2021109838A (ja) * | 2020-01-08 | 2021-08-02 | 株式会社タフリーインターナショナル | 冷感剤組成物 |
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JP3184534B2 (ja) * | 1994-10-05 | 2001-07-09 | 久光製薬株式会社 | N−置換−o−トルイジン誘導体からなる薬用配合剤および経皮吸収型製剤 |
JP3466305B2 (ja) * | 1994-12-12 | 2003-11-10 | 久光製薬株式会社 | 溶解剤および該溶解剤を含有する外用製剤 |
JPH0987171A (ja) * | 1995-09-25 | 1997-03-31 | Lion Corp | 水性粘着剤組成物の製造法 |
JPH0987170A (ja) * | 1995-09-25 | 1997-03-31 | Lion Corp | 水性粘着剤組成物の製造法 |
JPH10120560A (ja) * | 1996-08-26 | 1998-05-12 | Sankyo Co Ltd | ロキソプロフェン含有外用製剤 |
JP2002193793A (ja) * | 2000-12-26 | 2002-07-10 | Teikoku Seiyaku Co Ltd | 非ステロイド系消炎鎮痛貼付剤 |
US20100022614A1 (en) * | 2006-12-06 | 2010-01-28 | Naohisa Kawamura | Pharmaceutical composition for external application and adhesive skin patch |
WO2009031318A1 (ja) * | 2007-09-05 | 2009-03-12 | Kowa Co., Ltd. | 鎮痛・抗炎症剤含有外用剤 |
ES2378597T3 (es) * | 2007-12-12 | 2012-04-16 | Teikoku Seiyaku Co., Ltd. | Emplastos acuosos con contenido de loxoprofeno |
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TWI625131B (zh) * | 2013-08-23 | 2018-06-01 | Hisamitsu Pharmaceutical Co., Inc. | 膏劑及其製造方法 |
US10369115B2 (en) | 2013-08-23 | 2019-08-06 | Hisamitsu Pharmaceutical Co., Ltd. | Cataplasm and method for producing the same |
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WO2012102242A1 (ja) | 2012-08-02 |
KR20140035879A (ko) | 2014-03-24 |
CN103501779B (zh) | 2016-08-10 |
JP5981488B2 (ja) | 2016-08-31 |
JP5702489B2 (ja) | 2015-04-15 |
JPWO2012102242A1 (ja) | 2014-06-30 |
JP2014156499A (ja) | 2014-08-28 |
JP2014156497A (ja) | 2014-08-28 |
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CN103501779A (zh) | 2014-01-08 |
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