JPWO2010041684A1 - タクロリムス外用剤 - Google Patents
タクロリムス外用剤 Download PDFInfo
- Publication number
- JPWO2010041684A1 JPWO2010041684A1 JP2010532940A JP2010532940A JPWO2010041684A1 JP WO2010041684 A1 JPWO2010041684 A1 JP WO2010041684A1 JP 2010532940 A JP2010532940 A JP 2010532940A JP 2010532940 A JP2010532940 A JP 2010532940A JP WO2010041684 A1 JPWO2010041684 A1 JP WO2010041684A1
- Authority
- JP
- Japan
- Prior art keywords
- tacrolimus
- ointment
- external preparation
- triacetin
- present
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
Classifications
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/04—Antipruritics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
- A61P17/06—Antipsoriatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Abstract
Description
好適な安定剤または安定化剤は、例えばエデト酸(EDTA)、クエン酸、クエン酸ナトリウム、L−アルギニン、トコフェノール、シリコーン、ポリオキシエチレンソルビタン脂肪酸エステル等を含むが、これらに限定されない。
好適な清涼剤は、カンフル、メントール、植物抽出フレーバー等を含むが、これらに限定されない。
好適な増粘剤は、例えばアラビアゴム、グアガム、カラギーナン、カルボキシビニルポリマー、セルロース、ポリアクリル酸塩等を含むが、これらに限定されない。
(1)トリアセチンにタクロリムスを可溶化し、
(2)タクロリムスのトリアセチン溶液を基剤と混合する
工程を含む。添加剤は各々独立して、または添加剤の混合物の形態で、工程(1)の前もしくは途中、または工程(2)の前、途中もしくは後で、基剤、トリアセチン、タクロリムスのトリアセチン溶液または該溶液と基剤の混合物に加えることができる。
トリアセチン4.0gにタクロリムス0.1gを60℃から80℃で加温溶解させた(I液)。ミツロウ1.0gおよびワセリン94.9gを融解混合したものに前記I液を加え、マグネティックスターラー(矢沢科学:KF−800)およびホモジナイザー(IKAジャパン:T−25)を用いて攪拌し、水冷下で内容物が40℃になるまで同条件で攪拌を続けて、タクロリムス0.1%軟膏剤を調製した(実施例)。
また、トリアセチンに代えて炭酸プロピレンを用いた軟膏剤を調製した(比較例)。
上記実施例および比較例の軟膏剤を、3℃または30℃で1週間保存した。保存後の各軟膏剤10g(タクロリムスとして10mg)を、アセトニトリル5mLおよびヘキサン20mLに加え、攪拌混合した。溶媒を分離し、アセトニトリル層にさらにヘキサン20mLを加え、攪拌混合した。アセトニトリル層を分取し、これを試料溶液として下記条件で高速液体クロマトグラフィーに付し、タクロリムス分解産物であるTautomerおよびその他の類縁物質の量を測定した。
ウサギ皮膚一次刺激性試験
適用前日にウサギ(日本白色種、雄、体重2.0kg以上)の背部を電気バリカンで除毛し、製剤例に記載の実施例1及び実施例1から活性成分を除いた基剤のみの製剤のそれぞれ0.5gを、パラフィルムにて裏打ちして動物用パッチテスト用絆創膏(鳥居薬品(株))に貼付したリント布(2.5×2.5cm)に塗布して貼付した。絆創膏の剥離防止のため、ネックレスを24時間装着させた。なお、1群は5匹とした。
適用後24時間経過時にネックレス及び絆創膏をはずし、適用局所を脱脂綿で清拭した。適用後24、48及び72時間経過時に、Draize法の皮膚反応の評価基準に従って、紅斑及び痂皮形成又は浮腫形成の程度を評点化した:
タクロリムス水和物1.02gをトリアセチン5gに加熱溶解させ、そこにマクロゴール400:83.98g及びマクロゴール4000:10gを加えてさらに加熱混合し、冷却して、非水性ゲル製剤を製造する。
タクロリムス水和物1.02gをトリアセチン5gに加熱溶解させ、トリ2−エチルヘキサン酸グリセリル5gを加える。この液を流動パラフィン83.98gに加え、スターラーを用いて分散させる。さらに、撹拌しながらパルミチン酸デキストリン5gをくわえてゲル化させて、乳剤性リオゲル製剤を製造する。
メチルパラベン0.15g、プロピルパラベン0.1gを精製水に加熱溶解させ、40℃以下に冷却後、濃グリセリン10g、クエン酸0.5g及びカーボポール980:0.5gを溶解させる。この液に、タクロリムス水和物1.02gをトリアセチン20gに加熱溶解させ冷却した液を加え、スターラーを用いて分散させる。さらに、撹拌しながら、水酸化ナトリウム水溶液を滴下し、pH4〜7に調節してゲル化させ、最後に全量を100gに精製水で補正して、水性ゲル剤を製造する。なお、カーボポール980を0.1g〜0.2gとすると、ローション剤を得ることができる。
Claims (8)
- タクロリムス、トリアセチンおよび基剤を含む外用剤。
- トリアセチンに対してタクロリムスが0.03〜30重量%である、請求項1の外用剤。
- 軟膏剤の形態である、請求項1または2に記載の外用剤。
- 軟膏基剤としてミツロウとワセリンの混合物を含む、請求項3の外用剤。
- ミツロウがカラム精製ミツロウである、請求項4の外用剤。
- ワセリンがカラム精製ワセリンである、請求項4の外用剤。
- タクロリムスを可溶化したトリアセチンの液滴が基剤中に分散した形態である、請求項3〜6の何れかに記載の軟膏剤。
- タクロリムスを含む外用剤の製造方法であって、トリアセチンにタクロリムスを可溶化する工程を含むことを特徴とする、製造方法。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2010532940A JP5135441B2 (ja) | 2008-10-08 | 2009-10-07 | タクロリムス外用剤 |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2008261987 | 2008-10-08 | ||
JP2008261987 | 2008-10-08 | ||
PCT/JP2009/067488 WO2010041684A1 (ja) | 2008-10-08 | 2009-10-07 | タクロリムス外用剤 |
JP2010532940A JP5135441B2 (ja) | 2008-10-08 | 2009-10-07 | タクロリムス外用剤 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012106155A Division JP2012149097A (ja) | 2008-10-08 | 2012-05-07 | タクロリムス外用剤 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPWO2010041684A1 true JPWO2010041684A1 (ja) | 2012-03-08 |
JP5135441B2 JP5135441B2 (ja) | 2013-02-06 |
Family
ID=42100633
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2010532940A Active JP5135441B2 (ja) | 2008-10-08 | 2009-10-07 | タクロリムス外用剤 |
JP2012106155A Pending JP2012149097A (ja) | 2008-10-08 | 2012-05-07 | タクロリムス外用剤 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2012106155A Pending JP2012149097A (ja) | 2008-10-08 | 2012-05-07 | タクロリムス外用剤 |
Country Status (7)
Country | Link |
---|---|
US (1) | US8575189B2 (ja) |
EP (1) | EP2345414B1 (ja) |
JP (2) | JP5135441B2 (ja) |
CN (1) | CN102176913B (ja) |
CA (1) | CA2738831C (ja) |
ES (1) | ES2478845T3 (ja) |
WO (1) | WO2010041684A1 (ja) |
Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2738831C (en) * | 2008-10-08 | 2016-05-24 | Takata Seiyaku Co., Ltd. | Tacrolimus preparation for external applications |
JP2010132607A (ja) * | 2008-12-05 | 2010-06-17 | Taisho Pharm Ind Ltd | アトピー性皮膚炎治療用軟膏剤 |
JP2010202546A (ja) * | 2009-03-02 | 2010-09-16 | Taisho Pharm Ind Ltd | アトピー性皮膚炎の治療用軟膏製剤 |
DE102012207989A1 (de) * | 2012-05-14 | 2013-11-14 | Beiersdorf Ag | Aromatisierte Lippenbutter |
CN102885761B (zh) * | 2012-09-24 | 2015-08-05 | 浙江万晟药业有限公司 | 一种制备他克莫司软膏的方法 |
CN103271826B (zh) * | 2013-05-15 | 2014-08-06 | 广东恒健制药有限公司 | 一种他克莫司软膏的工业化生产方法 |
CN103239391B (zh) * | 2013-05-16 | 2015-03-18 | 江苏知原药业有限公司 | 一种他克莫司软膏 |
CN104127369A (zh) * | 2014-07-02 | 2014-11-05 | 人福医药集团股份公司 | 他克莫司软膏及其制备方法 |
CN104612504B (zh) * | 2015-01-23 | 2017-04-26 | 王宗超 | 一种推拉式门窗扇定位器 |
WO2017068673A1 (ja) * | 2015-10-21 | 2017-04-27 | マルホ株式会社 | 皮膚用の医薬組成物 |
TWI726027B (zh) * | 2015-12-28 | 2021-05-01 | 日商大塚製藥股份有限公司 | 軟膏 |
CN107753419B (zh) * | 2017-10-18 | 2020-11-03 | 江苏知原药业有限公司 | 他克莫司外用制剂 |
JOP20210029A1 (ar) * | 2018-08-16 | 2021-02-14 | Dr Reddys Laboratories Ltd | تركيبات زيتية موضعية |
EP3930713A4 (en) | 2018-12-04 | 2022-11-16 | Ilko Ilaç Sanayi Ve Ticaret Anonim Sirketi | STABLE TACROLIMUS OINTMENT FORMULATION FOR TOPICAL TREATMENT OF SKIN DISEASES |
CN110403902A (zh) * | 2019-09-05 | 2019-11-05 | 四川明欣药业有限责任公司 | 一种他克莫司软膏的制备方法 |
CN113712900A (zh) * | 2020-05-25 | 2021-11-30 | 南京帝昌医药科技有限公司 | 一种枸橼酸托法替布软膏组合物及其制备方法 |
CN112022798B (zh) * | 2020-08-11 | 2022-04-29 | 四川大学华西医院 | 一种速效他克莫司软膏、制备方法及应用 |
CN114159380A (zh) * | 2021-12-27 | 2022-03-11 | 卓和药业集团股份有限公司 | 一种他克莫司乳膏及其制备方法 |
CN114428133B (zh) * | 2021-12-28 | 2023-06-09 | 江苏知原药业股份有限公司 | 一种用反相色谱法检测他克莫司软膏中杂质xv含量的方法 |
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CA2738831C (en) * | 2008-10-08 | 2016-05-24 | Takata Seiyaku Co., Ltd. | Tacrolimus preparation for external applications |
JP2010132607A (ja) * | 2008-12-05 | 2010-06-17 | Taisho Pharm Ind Ltd | アトピー性皮膚炎治療用軟膏剤 |
JP2010202546A (ja) * | 2009-03-02 | 2010-09-16 | Taisho Pharm Ind Ltd | アトピー性皮膚炎の治療用軟膏製剤 |
-
2009
- 2009-10-07 CA CA2738831A patent/CA2738831C/en active Active
- 2009-10-07 US US13/122,820 patent/US8575189B2/en not_active Expired - Fee Related
- 2009-10-07 CN CN200980140109.2A patent/CN102176913B/zh active Active
- 2009-10-07 JP JP2010532940A patent/JP5135441B2/ja active Active
- 2009-10-07 EP EP09819218.0A patent/EP2345414B1/en not_active Not-in-force
- 2009-10-07 WO PCT/JP2009/067488 patent/WO2010041684A1/ja active Application Filing
- 2009-10-07 ES ES09819218.0T patent/ES2478845T3/es active Active
-
2012
- 2012-05-07 JP JP2012106155A patent/JP2012149097A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
WO2010041684A1 (ja) | 2010-04-15 |
US20110212988A1 (en) | 2011-09-01 |
CA2738831C (en) | 2016-05-24 |
US8575189B2 (en) | 2013-11-05 |
EP2345414A4 (en) | 2012-02-22 |
JP2012149097A (ja) | 2012-08-09 |
ES2478845T3 (es) | 2014-07-23 |
CN102176913B (zh) | 2014-08-13 |
EP2345414B1 (en) | 2014-06-25 |
CN102176913A (zh) | 2011-09-07 |
CA2738831A1 (en) | 2010-04-15 |
EP2345414A1 (en) | 2011-07-20 |
JP5135441B2 (ja) | 2013-02-06 |
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