TW200819360A - Packages for ophthalmic lenses containing pharmaceutical agents - Google Patents

Packages for ophthalmic lenses containing pharmaceutical agents Download PDF

Info

Publication number
TW200819360A
TW200819360A TW096124847A TW96124847A TW200819360A TW 200819360 A TW200819360 A TW 200819360A TW 096124847 A TW096124847 A TW 096124847A TW 96124847 A TW96124847 A TW 96124847A TW 200819360 A TW200819360 A TW 200819360A
Authority
TW
Taiwan
Prior art keywords
blister bowl
bowl
blister
glass transition
transition temperature
Prior art date
Application number
TW096124847A
Other languages
English (en)
Inventor
Michael Tokarski
Shivkumar Mahadevan
Scott Ansell
Vincent Barre
Original Assignee
Johnson & Johnson Vision Care
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38924016&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=TW200819360(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Johnson & Johnson Vision Care filed Critical Johnson & Johnson Vision Care
Publication of TW200819360A publication Critical patent/TW200819360A/zh

Links

Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/18Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient
    • B65D81/22Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents providing specific environment for contents, e.g. temperature above or below ambient in moist conditions or immersed in liquids
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • AHUMAN NECESSITIES
    • A45HAND OR TRAVELLING ARTICLES
    • A45CPURSES; LUGGAGE; HAND CARRIED BAGS
    • A45C11/00Receptacles for purposes not provided for in groups A45C1/00-A45C9/00
    • A45C11/005Contact lens cases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4535Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/38Packaging materials of special type or form
    • B65D65/40Applications of laminates for particular packaging purposes
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D73/00Packages comprising articles attached to cards, sheets or webs
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/326Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/366Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming one compartment
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D85/00Containers, packaging elements or packages, specially adapted for particular articles or materials
    • B65D85/54Containers, packaging elements or packages, specially adapted for particular articles or materials for articles of special shape not otherwise provided for
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65BMACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B25/00Packaging other articles presenting special problems
    • B65B25/008Packaging other articles presenting special problems packaging of contact lenses
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2585/00Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/54Containers, packaging elements or packages specially adapted for particular articles or materials for articles of special shape not otherwise provided for
    • B65D2585/545Contact lenses

Landscapes

  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Packages (AREA)
  • Medicinal Preparation (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Eyeglasses (AREA)
  • Wrappers (AREA)
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200819360 九、發明說明: 【發明所屬之技術領域】 本發明有關用於儲存含有藥劑(諸如酮替务 (ketotifen))之眼部裝置的包裝。 5 本發明係為2006年7月10曰申請之美國專利申讀 案編號60/819,759的非臨時檔案且整體以引用方式讲 入本文。 【先前技術】 ίο 隱形眼鏡自1950年代起已上市用來改善視力。起 初,隱形眼鏡係由硬質材料製得,包裝於玻瑜管瓶中’ 但許多患者配戴不舒適。後來發展出由疏水性水凝膠製 得之較柔軟較舒適的鏡片,通稱為軟式隱形眼鏡。因為 此等鏡片之製造簡易,故有建議指出軟式隱形眼鏡可用 15 以將藥劑輸送至患者眼睛。目前隱形眼鏡係大規模製造 且包裝成具有碗狀部分及頂部箔層之個別泡罩包裝。此 等包裝容納軟式隱形眼鏡及其包裝水溶液。該碗狀部分 係由疏水性材料(諸如聚丙烯)製得。聚丙烯係為一般用 於隱形眼鏡包裝之材料。聚丙烯具有足以受隱形眼鏡製 20 造之滅菌步驟的彈性,且可注射模塑成許多適當之形狀 及尺寸。該種包裝之非限制實例參見美國專利編號 4,691,820; 5,054,610; 5,337,888; 5,375,698; 5,409,104 ; 5,467,868; 5,515,964; 6,609,246; 5,695,049; 5,697,495 ; 5,704,468; 5,711,416; 5,722,536; 5,573,108; 5,823,327 ; 5 200819360 5,704,468 ; 5,983,608 ; 6,029,808 ; 6,044,966 及 6,401,915,所有專利皆以引用方式完全併入本文。然 而,軟式隱形眼鏡包裝之碗狀部分使用聚丙烯在該軟式 隱形眼鏡或其包裝溶液含有藥劑(尤其是抗組織胺,諸 5 如酮替芬)時會產生問題。 已知_替分作為眼滴劑以治療諸如過敏性結膜炎 之症狀的用途。中請人已添加g同替芬反丁烯二酸鹽(酉同 替酝之,藥活性鹽)於軟式隱形眼鏡且將此等鏡片包括 於聚丙烯碗中。然而,此等鏡片包裝於聚丙烯碗中會產 1〇生問題。在所需之藥物濃度下,超過五十百分比之.物 隨著時間被聚丙烯包裝材料所吸收,而自軟式隱形眼鏡 :、匕衣洛液中之一或兩者移除。此非期望中之狀況, 因為若包裝材料吸收藥物,則難以決定有多少藥物可被 =利用。因此㈣尋得對於軟式隱形眼鏡及其包裝溶 Ϊ ^之或兩者中所含藥物的吸收性最低而適用於泡 之碗的材料。以下發明滿足此項需求。 【發明内容】 20 钤冶tv月包括用於包裝含藥劑之眼鏡的泡罩碗,其中 甘碗係包含對該藥劑之吸收性低於約16%之材 ,:限制條件為該材料基本上不為全氟聚合物。 2明所❹之「眼鏡」係表示存在於眼睛内或眼 二此等裝置可提供光學校正或可具有化粧效 又H (但不限於)軟式隱形眼鏡 、眼内鏡片、覆 6 200819360 層鏡片、眼部嵌入物及光學嵌入物。較佳之本發明鏡片 係為由水凝膠及矽酮彈料製得之軟式隱形眼鏡,包括 (例不限於)矽酮水凝膠及含氟水凝膠。軟式隱形眼鏡調 配物係揭示於美國專利編號5,710,302、WO 9421698、 5 EP 40616卜 JP 2000016905、美國專利編號 5,998,498、 美國專利編號6,087,415、美國專利編號5,760,100、美 國專利編號5,776,999、美國專利編號5,789,461、美國 專利編號5,849,811及美國專利編號5,965,631中。前 述參考資料以引用方式整體併入本文。特佳之本發明眼 ίο 鏡之美國批准名稱為 etafilcon A,genfilccm A, lenefilcon A,lotrafilcon A,lotrafilcon B,balafilcon A, polymacon, bafilcon, acofilcon A acquafilcon A, alofilcon A alphafilcon A,amifilcon A,astifilcon A, atalafilcon A,bisfilcon A bufilcon A,crofilcon A, 15 cyclofilcon A, darfilcon A deltafilcon A,deltafilcon B, dimefilcon A,drooxifilcon A, epsifilcon A,esterifilcon A, focofilcon A,galyfilcon A,govafilcon A,hefilcon A hefilcon B,hefilcon D, hilafilcon A,hilafilcon B, hixoifilcon A,hioxifilcon B,hioxifilcon C,hydrofilcon 20 A,lenefilcon A,licryfilcon A, licryfilcon B,lidofilcon B, lidofilcon A,mafilcon A,mesifilcon A,methafilcon B, mipafilcon A,nelfilcon A,netrafilcon A,ocufilcon A, ocufilcon B,ocufilcon C,ocufilcon D,ocufilcon E, ofilcon A,omafilcon A,oxyfilcon A,pentafilcon A, 200819360 perfilcon A,pevafilcon A,phemfilcon A,senofilcon A, silafilcon A,siloxyfilcon A,tefilcon A,tetrafilcon A, trifilcon A, vifilcon A,或 xylofilcon A。更佳之本發明 眼鏡係為 genfilcon A、lenefilcon A、lotrafilcon A、 5 lotrafilcon B或balacilcon A。最佳鏡片包括(但不限於) galyfilcon、senofilcon、etafilcon A、nelfilcon A、 hilafilcon 及 polymacon o 藥劑係為可用於治療或預防眼睛疾病。藥劑係包括 (但不限於)抗組織胺、抗生素、抗細菌劑、抗病毒劑、 10 抗真菌劑、止痛劑、麻醉劑、抗過敏劑、肥大細胞安定 劑、類固醇及非類固醇消炎劑、血管生成抑制劑;抗代 謝劑、纖維蛋白質分解劑、神經保護性藥物、血管生成 抑制性類固醇、散瞳劑、睫狀肌麻醉劑;縮瞳劑;血管 收縮劑;血管舒張劑、抗凝血劑;抗癌劑、抗致敏劑、 15 免疫調節劑、碳酸酐酶抑制劑、整合素拮抗劑 (antabonistsl);環氧合酶抑制劑、VEGF拮抗劑;免疫 抑制劑、維生素、補充劑及諸如此類者。「抗組織胺」 係為用以處理過敏性病況之藥劑類型。抗組織胺之實例 係包括(但不限於)新敏靈(acrivastine)、安他琳 20 (antazoline)、阿斯喃峻(astemizole)、阿扎他咬 (azatadine)、氮箪斯彡丁(azelastine)、漠苯那敏 (brompheniramine)、氯苯丁醇(buclizine)、17米丁 硫脲 (burimamide)、卡比沙明(carbinoxamine)、卡瑞斯 ί丁 (carebastine)、西替利 11 井(cetirizine)、氯環利 口井 200819360 (chlorcyclizine)、西口米替咬(cimetidine)、西普賽凡 (ciproxifam)、氣馬斯、;丁(clemastine)、克本普比 (clobenpropit)、氯氮平(clozapine)、赛克利口井 (cyclizine)、賽庚咬(cyproheptadine)、地伯尼胺 5 (desbrompherniramine)、地洛他 口定(desloratadine)、右漠 苯那敏(dexbrompheniramine)、 右氯苯那敏 (dexchlorpherniramine)、二苯胺明(diphenhydramine)、 多西拉敏(doxylamine)、暈海寧(dimenhydrinate)、二甲 茚定(dimethindene)、二苯胺明(diphenhydramine)、二 L0 苯拉林(diphenylpyraMnd)、多西拉敏(doxylamine)、依 巴斯、;丁(ebastine)、乙氟利。井(efletirizine)、依美斯 ί丁 (emedastine)、依匹斯、;丁(epinastine)、法莫替咬 (famotidine)、非索那口定(fexofenadine)、經口井 (hydroxyzine)、因潘他明(impentamine)、碘胺伯提咬 15 (iodoaminopotentidine)、填吩普比(iodophenpropit)、酮 替芬(ketotifen)、左卡巴斯、;丁(levocabastine)、左西替利 σ井(levoceterizine)、氯雷他咬(loratadine)、氯苯甲口井 (meclizine)、美口比拉敏(mepyramine)、美。奎他 口井 (mequitazine)、曱地啡(methdilazine)、喧吩甲吼胺 2〇 (methapyrilene)、米安色林(mianserin)、米非提咬 (mifetidine)、咪嗤斯汀(mizolastine)、諾司米唾 (norastemizole)、諾瑞巴斯、;丁(norebastine)、奥洛他咬 (olopatadine)、非尼拉敏(pheniramine)、苯基托沙敏 (phenyltoxamine)、π辰香豆斯特(picumast)、異丙口井 9 200819360 (promethazine)、口比拉明(pyrilamine)、口比口各他敏 (pyrrobutamin)、雷尼替淀(rantidine)、R-索普口米口定 (R-sopromidine)、S-索普口米咬(S_sopromidine)、替卡米 唾(tecastemizole)、替美司、汀(temelastine)、特非那唆 5 (terfenadine)、硫乙拉口井(thiethylperazine)、硫替唆 (tiotidine)、異丁 口井(trimeprazine)、午 σ比二胺 (tripelennamine)、胺石風拉口井(thioperamide)、曲普利咬 (triprolidine)及其醫藥上可接受之鹽。較佳抗組織胺係 為酮替芬及非尼拉敏。最佳抗組織胺係為酮替芬及其醫 10 (藥上可接受之鹽。該藥劑可·數種方法添加於眼鏡。一 種方法係將水合水凝膠眼鏡浸泡於含有藥劑之溶液 中。另一種方法係在含有抗組織胺之溶液將水合水凝膠 眼鏡滅菌。再另一種方法係在固化鏡片之前將藥劑摻入 眼鏡調配物中。 15 術語「泡罩碗(blister bowl)」係表示眼鏡包裝之容 器部分。適當形狀之泡罩碗的實例係揭示於以下文件, 其係以引用方式完全併入本文··美國專利編號D 458,023; 4,691,820; 5,054,610; 5,337,888; 5,375,698; 5,409,104; 5,467,868; 5,515,964; 5,609,246; 5,695,049; 20 5,697,495; 5,704,468; 5,711,416; 5,722,536; 5,573,108;
5,823,327; 5,704,468; 5,983,608; 6,029,808; 6,044,966; 及6,401,915中。有些眼鏡包裝之容器部分並非碗形。 就本發明之目的而言,該等包裝之容器係包括於術語泡 罩碗中。該等包裝之實例係包括(但不限於)WO 200819360 2005/082721、美國專利編號 7,086,526、WO 03/016175 及US 2004/0238380 (以引用方式完全併入本文)所揭示 之眼鏡包裝中。本發明所使用之吸收低於約16%該藥 劑的「材料」係為聚合物。此等材料可藉注射模塑、熱 5 成形、轉移模塑、貼體包裝、吹塑、共注射模塑、薄膜 擠塑或薄膜共擠塑及諸如此類方法成形為適當之形 狀。讓泡罩碗較佳係具有所需程度之穿透性,以容許目 測檢視、以蒸汽處理、紫外線滅菌及諸如此類者。 任何泡罩碗所吸收之藥劑量皆係藉由以含已知量 10 藥劑或其醫藥上可接受之鹽(的溶液處理泡罩碗(或已知 量之可形成泡罩碗的材料)而測量。該泡罩碗(或未成形 之材料)的處理可使該藥劑之溶液與泡罩碗於室溫或高 溫下接觸一段時間。吸收於泡罩碗(或未成形材料)之藥 劑的量係藉著於處理前後以HPLC分析藥劑含量而測 15 量。較佳材料吸收介於約16%及約〇%之間之藥劑,更 佳係介於約8%及約3%之間,最佳係介於約5%及1% 之間。 該泡罩碗可自可成形以容納鏡片或鏡片等及其包 裝溶液之材料形成,其限制條件為該材料符合前述吸收 20 標準。形成該泡罩碗之較佳材料係為聚砜、聚醚醯亞胺 或聚碳酸醋共聚物。由Solvay Advanced Polymers所售 商標 UDEL®> 1700 (CAS 編號 25135-51-7)及 RADEL® R-5000 (CAS編號25839-81-0)之聚砜聚合物較佳。 UDEL係為一種玻璃轉化溫度約190°C之聚颯聚合物。 11 200819360 RADEL® R-5000係為一種Solvay戶斤售玻璃轉化溫度約 220 C的聚石風。另一種聚石風’ BASF所售之Ultrason,亦 可使用於本發明。Ultrason具有藉差示掃描熱量法(DSC) 在每分鐘20°C測量約188°C的玻璃轉化溫度。其他具有 5 約180°C至約230°C玻璃轉化溫度之類型的聚砜聚合物 適用於本發明。其他較佳材料包括(但不限於)General Electric所售商標Ultem之聚醚醯亞胺(CAS編號 61128-24-3) cUltem具有約229°C之玻璃轉化溫度(藉 ASTM 1525 自 219°C 之 VICAT 溫度計算)。General :i〇 Electric所售商標LEXAN HPB3144玻璃轉化溫度約 147°C之聚碳酸酯共聚物特佳。就本發明目的而言,若 特定聚合物之玻璃轉化溫度未知,但可得到VICAT數 據,則玻璃轉化溫度可藉由在VICAT溫度加10度而計 算(ASTM D1525,ISO 306,A2LA Accredited)。 15 該泡罩可藉著將聚合物片粒導入注模機内而製 得。往復式螺桿將熱及剪切輸入該片粒並將其熔融。熔 體隨之使用冷或熱流遒(備擇方法中使用活塞,而另一 方法可充填部分開收之模具且藉由關閉模具將其鑄造 成其最終形狀)注射於模具中。該塑料會填滿具有適於 20 得到本發明所揭示零件之設計及形狀的模槽。聚合物隨 之於壓力下固化,以補償部分收縮。零件固化後,進一 步冷卻至達到可操作之溫度。隨之經由機械或氣動裝置 自模具取出且移至下游之機器。 可使用之注射模塑器的實例係包括(但不限於) 12 200819360
Arburg、Battenfeld、Engel、Husky、Netstal、Sumitomo 〇 術語「溶液」係表示内部儲存醫藥裝置之任何液體 介質。較佳溶液係包括而不限於鹽水溶液、其他緩衝溶 液及去離子水。較佳水溶液係為含有包括而不限於氯化 5 鈉、硼酸鈉、磷酸鈉、磷酸氫鈉、磷酸二氳鈉或其對應 之鉀鹽的鹽類之鹽水溶液。此等成份通常組合以形成缓 衝溶液,此溶液包括酸及其共軛鹼,故添加酸及鹼時僅 有極小之pH變化。緩衝溶液可另外包括2-雙(羥基甲 基)-2,2’,2’’-氮基三乙醇、11-三(羥基曱基)曱基-2-胺基乙 10 \磺酸、檸檬酸、檸檬酸鈉、碳酸鈉、碳酸氳鈉〃乙酸、 乙酸鈉、乙二胺四乙酸及諸如此類者及其組合物。該溶 液較佳係經硼酸鹽緩衝或經磷酸鹽缓衝之鹽水溶液。 此外,本發明包括儲存包括藥劑之眼鏡的方法,其 中該方法包含將該眼鏡放置於泡罩碗中且以蓋子覆蓋 15 該泡罩碗,其中該泡罩碗係包含吸收低於約16%該藥 劑之材料,其限制條件為該泡罩碗之材料基本上非全氟 聚合物。本發明所使用之術語藥劑、眼鏡及泡罩,皆具 有前述意義及較佳範圍。術語「蓋子」係表示將眼鏡封 閉於該泡罩碗中之任何器具。該蓋子較佳係由鋁箔及經 20 擠塑或共擠塑之聚合物薄膜(可密封於該泡罩碗頂面, 以形成眼鏡之密閉封著物)之黏著劑層合物所製得之可 撓性薄片。 該等材料之實例係揭示於以下刊物中:美國專利編 號 2002/0197478;美國專利編號 6,090,471 ; 5,908,527 ; 13 200819360 5,656,362 ; 5,653,844 及 5,620,087,其係以引用方式完 全併入本文。使用於本發明時,該層合物之内層係表示 藉熱封著或其他方式黏著於該碗之層。若該泡罩碗係由 聚飆材料製得,則該碗可覆以數層之層積物(其具有熱 5 封於該碗之聚砜内層)。一種該層狀層合物蓋子之實例 自封著於該碗至最外層之材料係依序含有下列材料:聚 砜(即UDEL,RADEL)黏著劑(即Henkel所售Liofol商 標)鋁箔黏著劑及聚乙烯萘酚酯或聚苯基颯。層狀層合 物之另一實例係自封著於該碗之材料至最外層依序含 10 有以下材料:聚碳酸酯共聚物(即LEXAN)黏著劑(即"
Henkel所售Lifol商標)鋁箔黏著劑及聚乙烯萘酚酯或 聚苯基砜。 包含藥劑之眼鏡經常包裝於水溶液中,諸如鹽水或 其他缓衝溶液。此等溶液通稱為包裝溶液。某些吸收低 15 於16%藥劑且可用於形成本發明泡罩碗之材料係為可 使水蒸汽隨時間擴散出該泡罩碗及蓋子的材料。已知此 種水蒸汽之喪失縮短該等眼鏡之適用期。為改善該等藥 劑之適用期,可在該泡罩碗之部分表面環繞抑制水蒸汽 之擴散的材料。本發明滿足此項要求。 20 本發明包括用以包裝包含藥劑之眼鏡的泡罩碗,其 中該泡罩碗係包含鏡片接觸表面及外表面,其中該鏡片 接觸表面係包含吸收少於約16%該藥劑之材料,且外 表面包含蒸汽障壁材料,其限制條件為該鏡片接觸表面 之材料基本上並非全氟聚合物。本發明所使用之眼鏡、 200819360 樂劑、泡罩碗及吸收少於約16%該藥劑之材料皆具有 前述意義及較佳範圍。 術5吾「鏡片接觸表面」係表示泡罩碗與眼鏡或與眼 鏡及其包裝溶液接觸之部分。術語「外表面」係表示該 5 碗除了鏡片接觸表面以外之部分。術語「蒸汽障壁材料」 係表示抑制包裝溶液擴散通經該泡罩碗之材料。較佳蒸 汽障壁材料係包括(但不限於)聚丙烯及含有兩種不同 之脂環族單體的脂環族共聚物,Zeon Chemicals L.P.所 售商標ZEONOR。有數種不同等級之ZEONOR,具有 10 7〇至163°C之玻璃轉化溫度。特佳之ZEONOR係為 ZEONOR 1600 或 1420R,根據製造商 ΖΕΟΝ Chemicals L.P·,1420R具有20克/10分鐘之熔流速率(’,MFR,,)範 圍,1600為7克/10分鐘(於280°C藉JISK 6719測試), 藉ASTMD792測量時,兩者之比重(H20=1)皆為1.01, 15 且1420R之玻璃轉化溫度為136°C,而1600為163°C。 以下圖式進一步詳細說明本發明。 圖1說明本發明泡罩碗1〇之透視圖。鏡片接觸表 面12係成形以容納含或不含包裝溶液之眼鏡。鏡片接 觸表面12係由吸收少於約16%該藥劑之材料製得。環 20 狀密封環16係突出表面,以層合箔封著以在封閉泡罩 碗10時封包鏡片。較佳鏡片接觸表面材料係前述聚砜 及前述聚碳酸酯共聚物。外表面14係為蒸汽障壁材 料。較佳蒸汽障壁材料係為熱塑料,其可熱封著且具有 足以增加適用期之蒸汽障壁。特佳蒸汽障壁係為聚丙烯 15 200819360 不同之脂環族單體的脂環族共聚物。圖2 說明夕 表面12及其周圍凸緣18之剖面圖。圖3 10 15 20 之透視圖。圖4說明具有内部通道2〇 山2面14的剖面圖。圖5說明在鏡片接觸表面12 部通道2G時之外表面14。圖中所示之具體實施 ^ ^ ,周圍凸緣18係由如同鏡片接觸表面12之材料 ‘得,周圍凸緣18係由内部通道2〇覆蓋且連結。本發 體貝%態樣係以圖6說明。此具體實施態樣 中袠狀環26 (用以封著泡罩碗内之鏡片)係位於周圍 凸緣28上。圖7說明鏡片接觸表面22、其厨圍凸緣28 及環狀環26。圖8說明具有内部通道3〇之外表面24 的剖面圖。鏡片接觸表面22之周圍凸緣28係嵌入外表 面24内,如圖9所示。圖1〇說明另一具體實施態樣。 鏡片接觸表面32夾合於實質平面凸緣34,此凸緣覆蓋 鏡片接觸表面32之相對表面(未示)。此具體實施態樣 中,鏡片接觸表面32較佳係自異於平面凸緣34之材料 製得。 前述泡罩包裝可藉各種2塑料處理注射模塑機(包 覆模塑、夾層模塑或嵌入模塑)製得,包括(但不限於)
Arburg Gmbh,Ferromatik,Elektra,Engel 所製造者及其 他。此外有數種組件注射模塑機可用於製造多層蒸汽障 壁材料。 為了說明本發明,包括以下實施例。此實施例不限 制本發明。其僅用以建議施行本發明之方法。暸解隱形 16 200819360 鏡者及其他專家可發現其他施行本發明之 ,該等方法確實包括於本發明範圍内 5 【實施方式】 實施例 以下使用下列縮寫 包裝溶液A以重量計含有 NaCl (0.83%),领酸(〇 91%),四 及0.2%聚丙稀酸納鹽 以下成份之去離子水·· 领酸納十水合物(0.1%) 10 實施例1 使用不同枯料豐 15 20 在匕衣办液A中之不同酮替芬反丁二 ,注意溶液製劑中使用晴芬之反 :χ^但數據記錄存在於溶液中之酮替芬量)。表”克表示)裁成小片,置入含二毫升 有趨:畔丁~—酸鹽溶液之玻璃管瓶中。該管瓶以塗覆 之丁基塞子密封,於加熱18分鐘。溶 G卒包t藉HPLC測試’以決定_芬之濃度(與不 〇/' ' 料而以試驗試樣滅菌之對照管瓶比較之 /〇)。 17 200819360 表1 材料商標 化學類型 材料克數 酮替芬對照濃 度(微克/亳升) 處理後被吸收之 酮替芬百分比 UDEL®1700 聚砜 0.505 49.31 3.4% RADEL®R-5000 聚謎石風 0.499 49.31 4.4% UDEL®1700 聚石風 0.363 49.42 3.6% RADEL®R-5000 聚醚石風 0.363 49.42 2.4% LEXAN HPB3144 聚碳酸酯共 聚物 0.397 48.85 10.3% LEXAN HPB3144 聚碳酸酯共 聚物 0.400 47.60 0.9% Achieve Exxon 1605 聚丙烯 0.400 49.62 30% Ultem 聚醚醯亞胺 0.400 46.60 4.6% GE Ultem 聚醚醯亞胺 0.3634 49.42 2.1% GE Ultem 1000 聚醚醯亞胺 0.3634 48.82 5.3% GE Ultem 1285 聚醚醯亞胺 0.3634 48.82 4.5% GE Ultem CR55001 聚醚醯亞胺 0.3634 48.82 3.9% GE HPX8R 聚碳酸酯共 聚物 0.3634 49.25 25.6% GE Ultem 1000B 聚醚醯亞胺 0.3634 49.25 1.8% GE Valox 315 聚對苯二曱 酸丁二酯 0.3634 49.25 31.5% GE Valox 195 聚對苯二曱 酸丁二酯 0.3634 49.25 29.4% GE EX180 聚碳酸酯共 聚物 0.4000 48.85 10.3% GE EX198 聚碳酸酯共 聚物 0.4000 48.85 8.5% GE Valox 聚對苯二甲 酸丁二酯 0.4000 48.85 94.2% BASF PSF 聚砜 0.3634 48.82 1.5% 18 200819360
Ultrason PET-Mylar (經定向) 聚對苯二甲 酸丁二酯 0.4000 47.60 0.2% PFA 全氟烧氧基 共聚物 0.4000 47.60 0.0% FEP IL化乙烯丙 烯 0.4000 47.60 0.0% POM (Delrin) 聚環氧甲烷 0.4000 47.60 26.8% PVDF (Kynar) 聚偏二氟乙 烯 0.4000 47.60 8.9% PMMA PMMA 0.4000 47.60 2.6% PEEK 聚醚醚酮 0.4000 47.60 0.0% Noryl 經修飾聚苯 醚 0.4000 47.60 6.8% Halar 乙烯氯三氟 乙烯 0.4000 47.60 14.4% Nylon-6 經定向聚醯 胺 0.4000 47.60 31.9% POM(Celcon) 聚環氧甲烷 0.4000 47.60 35.4% PVC(HTP800) 聚氣乙細 0.4000 47.60 17.2% PMP(TPX) 聚甲基戊烯 0.4000 47.60 9.6% PBT(Hydex) 聚對苯二甲 酸丁二酯 0.4000 47.60 27.1% PPS(Techtron) 聚苯硫醚 0.4000 47.60 3.8% PET(Ertalyte) 聚對苯二曱 酸乙二酯 0.4000 47.60 18.3% PBT(Valox 195) 聚對苯二甲 酸丁二酯 0.4000 47.60 15.9% UHMWPE 超高分子量 聚乙烯 0.4000 47.60 32.2% 19 200819360 GE FRI 1001 聚對苯二甲 酸丁二酯 0.4000 47.60 9.5% PEI(Ultem) 聚醚醯亞胺 0.4000 47.60 0.0% PSF(Ultrason) 聚石風 0.4000 47.60 0.0% GE V2205 聚對苯二甲 酸丁二酯 0.4000 47.60 89.6% PSF (Udel) 聚颯 0.4000 47.60 2.3% GE Xylex 聚碳酸酯+ 聚酯 0.4000 47.60 7.1% GE EXRL0180 聚碳酸酯共 聚物 0.4000 47.60 0.9% PPS (Techtron) 聚苯硫醚 0.4000 47.60 16.6% 【圖式簡單說明】 圖1說明泡罩包裝之透視圖。 圖2說明泡罩包裝之一部分的剖面圖。 圖3說明泡罩包裝之一部分之透視圖。 圖4說明泡罩包裝之一部分剖面的透視圖。 圖5說明泡罩包裝之一部分的透視剖面圖。 圖6說明泡罩包裝之透視圖。 圖7說明泡罩包裝之一部分的透視圖。 10 圖8說明泡罩包裝之一部分剖面的透視圖。 圖9說明泡罩包裝之剖面的透視圖。 圖10說明泡罩包裝之一部分剖面的透視圖。 【主要元件符號說明】 20 200819360 10-泡罩碗 12 -鏡片接觸表面 14-外表面 16-環狀密封環 5 18-周圍凸緣 20-内部通道 22-鏡片接觸表面 24-外表面 26-環狀環 ίο 28-周爵凸緣 30-内部通道 32-鏡片接觸表面 34-實質平面凸緣 21

Claims (1)

  1. 200819360 十、申請專利範圍: 1. 一種用於包裝含藥劑之眼鏡的泡罩碗,其中該泡罩碗係 包含吸收少於約16%該藥劑之材料,其條件為該材料基 本上不為全氟聚合物。 5 2.如申請專利範圍第1項之泡罩碗,其中該材料係吸收介 於約8%及約3%之間的該藥劑。 3. 如申請專利範圍第1項之泡罩碗,其中該材料係吸收介 於約5%及約1%之間的該藥劑。 4. 如申請專利範圍第1項之泡罩碗,其中該材料係選自由 ίο 聚砜、聚醚醯亞胺及聚碳酸酯共聚物所組成之群。 5. 如申請專利範圍第1項之泡罩碗,其中該材料係選自由 具有高於約180°C之玻璃轉化溫度的聚砜聚合物所組成 之群。 6. 如申請專利範圍第1項之泡罩碗,其中該材料係選自由 15 具有高於約140°C之玻璃轉化溫度的聚碳酸酯共聚物所 組成之群。 7. 如申請專利範圍第1項之泡罩碗,其中該材料係選自由 具有高於約220°C之玻璃轉化溫度的聚醚醯亞胺所組成 之群。 20 8.如申請專利範圍第1項之泡罩碗,其中該藥劑係選自由 新敏靈(acrivastine)、安他琳(antazoline)、阿斯咪口坐 (astemizole)、阿扎他咬(azatadine)、氮箪斯江 (azelastine)、漠苯那敏(brompheniramine)、氯苯丁醇 (buclizine)、味 丁硫脲(burimamide)、卡比沙明 22 200819360 (carbinoxamine)、卡瑞斯 $丁(carebastine)、西替利口井 (cetirizine)、氯環利畊(chlorcyclizine)、西口米替咬 (cimetidine)、西普賽凡(ciproxifam)、氯馬斯汀 (clemastine)、克本普比(clobenpropit)、氯氮平 5 (clozapine)、赛克利口井(cyclizine)、赛庚咬 (cyproheptadine)、地伯尼胺(desbrompherniramine)、地 洛他咬 (desloratadine)、 右溴 苯那敏 (dexbrompheniramine) 、 右氯 苯那敏 (dexchlorpherniramine)、二苯胺明(diphenhydramine)、 10 多西拉敏(doxylamine)、暈海寧(dimenhydrinate)、二甲 茚定(dimethindene)、二苯胺明(diphenhydramine)、二苯 拉林(diphenylpyraline)、多西拉敏(doxylamine)、依巴斯 ί丁(ebastine)、乙氟利口井(efletirizine)、依美斯汀 (emedastine)、依匹斯、汀(epinastine)、法莫替唆 15 (famotidine)、非索那唆(fexofenadine)、經 口井 (hydroxyzine)、因潘他明(impentamine)、蛾胺伯提唆 (iodoaminopotentidine)、姨吩普比(iodophenpropit)、酉同 替芬(ketotifen)、左卡巴斯灯(levocabastine)、左西替利 口井(levoceterizine)、氯雷他咬(loratadine)、氯苯甲口井 20 (meclizine)、美吼拉敏(mepyramine)、美 ϋ奎他 口井 (mequitazine)、甲地口井(methdilazine)、口塞吩曱吼胺 (methapyrilene)、米安色林(mianserin)、米非提喷 (mifetidine)、味嗅斯汀(mizolastine)、諾司米 π坐 (norastemizole)、諾瑞巴斯汀(norebastine)、奥洛他唆 23 200819360 (olopatadine)、非尼拉敏(pheniramine)、苯基托沙敏 (phenyltoxamine)、旅香豆斯特(picumast)、異丙口井 (promethazine)、口比拉明(pyrilamine) 、口比 口各他敏 (pyrrobutamin)、雷尼替咬(rantidine)、R-索普咪口定 5 (R-sopromidine)、S-索普咪咬(S-sopromidine)、替卡米 口坐(tecastemizole)、替美司 丁(temelastine)、特非那口定 (terfenadine)、硫乙拉。井(thiethylperazine)、硫替咬 (tiotidine)、異丁 °井(trimeprazine)、+ σ比二胺 (tripelennamine)、胺石風拉口井(thioperamide)、曲普利咬 ίο (triprolidine)及其醫藥上可接受之鹽所組成之群。 9·如申請專利範圍第1項之泡罩碗,其中該藥劑係為酮替 芬。 10·如申請專利範圍第1項之泡罩碗,其中該眼鏡係為 etafilcon A 鏡片。 is 11·—種儲存包含藥劑之眼鏡的方法,其中該方法係包含將 該眼鏡置於泡罩碗中,以蓋子覆蓋該泡罩碗,其中該泡 罩碗係包含吸收低於約16%該藥劑之材料,其條件為該 泡罩碗之材料基本上不為全氟聚合物。 12·如申請專利範圍第11項之方法,其中該蓋子係包含黏 20 著劑層合物,其係包含内層。 13 ·如申請專利範圍第12項之方法,其中該内層係包含具 有高於約18 0 C之玻璃轉化溫度的聚石風。 14·如申請專利範圍第12項之方法,其中該内層係包含具 有高於約140°C之玻璃轉化溫度的聚碳酸酯共聚物。 24 200819360 &如申請專鄉圍第η項之方法,其巾該泡罩碗係包含 吸收低於約10%該藥劑之材料。 16. 如申請專利範圍第η項之方法,其中該㈣係選自由 聚砜及聚碳酸酯共聚物所組成之群。 17. 如申請專利範圍第U項之方法,其中該聚㈣具有高 於約180°C之玻璃轉化溫度。 18. 如申請專利範圍第Π項之方法,其中該聚碳酸酯共聚 物係具有高於約140°C之玻璃轉化溫度。 19. 如申請專利範圍第U項之方法,其中該泡罩碗係包含 吸收介於低於約8%及妁3%之間的該藥劑之材料。 20. 如申請專利範圍第η項之方法,其中該泡罩碗係包含 係吸收介於約3%及約1%之該藥劑的材料。 21· —種用以包裝包含藥劑之眼鏡的泡罩碗,其中該泡罩碗 係包含鏡片接觸表面及外表面,其中該鏡片接觸表面係 包含吸收少於約16%該藥劑之材料,且外表面包含蒸汽 J1平壁材料,其條件為該鏡片接觸表面之材料基本上並非 全氟聚合物。 22·如申請專利範圍第21項之泡罩碗,其中該鏡片接觸表 面係包含吸收介於低於約8%及約3%之間的該藥劑之 材料。 23·如申請專利範圍第21項之泡罩碗,其中該鏡片接觸表 面係包含吸收介於約5%及約1 %之間的藥劑的材料。 24·如申請專利範圍第21項之泡罩碗,其中該鏡片接觸表 面係包含選自由聚砜及聚碳酸酯共聚物所組成之群的 25 200819360 材料。 25. 如申請專利範圍第21項之泡罩碗,其中該鏡片接觸表 面係包3延自由玻璃轉化溫度高於約18〇。。之聚砜聚 物所組成之群的材料。 口 26. 如f料^圍f 21項之泡罩碗,其巾賴片接觸表 面係包含廷自由玻璃轉化溫度高於 共聚物所組成之群㈣^ H4GC:之錢酸醋 2=申請專㈣圍第21狀泡罩碗,其巾該蒸汽障壁材 料係包含聚丙烯。 10 15 2^申請專利範圍第21項之泡罩碗,其中該蒸汽障壁材 料係包含含有兩種$同脂環料體的 2=申請專㈣㈣21項之料碗,其中該^面物係包 含至少兩層蒸汽障壁材料。 3〇·=申請專利㈣第29項之泡罩碗,其巾該障 料係為聚丙烯。 ^ 26
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