JP5800826B2 - ペプチドの投与のための経皮治療システム - Google Patents
ペプチドの投与のための経皮治療システム Download PDFInfo
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- JP5800826B2 JP5800826B2 JP2012541360A JP2012541360A JP5800826B2 JP 5800826 B2 JP5800826 B2 JP 5800826B2 JP 2012541360 A JP2012541360 A JP 2012541360A JP 2012541360 A JP2012541360 A JP 2012541360A JP 5800826 B2 JP5800826 B2 JP 5800826B2
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Images
Classifications
-
- 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
- A61K9/70—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
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/27—Growth hormone [GH], i.e. somatotropin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Reproductive Health (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Diabetes (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Description
−感圧接着層を備えた裏打ち層、
−FSH、テキスタイルのシート状構造の形をした担体物質を含んでなる層、及び
−不妊治療の一部としての保護シート、
を含む経皮治療システムの使用を想定する。
・ トレイトール、エリトリトール、ペンタエリトリトール、アラビトール、アドニトール、キシリトール、ソルビトール、マンニトール、ズルシトールなどの多価アルコール類、
・ アラビノース、リボース、キシロース、グルコース、マンノース、ガラクトース(galatose)、フルクトース、ソルボースなどの単糖類、
・ 蔗糖、乳糖、マルトース、トレハロース、セロビオースなどの二糖類、
・ ラフィノースのようなオリゴ糖、
・ シクロデキストリン、
が挙げられる。
FSHの水溶液を、水性リン酸緩衝液(pH7.0)と混合した。この溶液にタンパク質安定剤のシクロデキストリン、メチオニン、ポロキサマ188、及びメタクレゾールを添加した。次にこの溶液を、オーバーパッチ上に置かれているシート状のテキスタイル構造(不織布)上に面積精度的に計量した。
実施例1により、FSHの負荷が300I.U./5cm2、600I.U./5cm2、及び1200I.U./5cm2に相当する違いを持つ試料を作成した。
活性成分としてFSHを用いて、実施例2で作成した経皮治療システムの試料は、切除的にレーザー前処置した牛の乳房皮膚を通るそれらの透過挙動をFranzセルで調べた。これらの調査結果を図4に示した。
Claims (12)
- 少なくとも1つの水不溶性ポリマーを含んでなる感圧接着層を備えた裏打ち層;少なくとも1つのペプチド及びシート状のテキスタイル構造の形態の担体物質を含む活性成分層;及び保護シート;を含んでなる、患者の切除処置された皮膚にペプチドを適用する経皮治療システム(TTS)であって、ペプチドが、卵胞刺激ホルモン又は成長ホルモンであり、そして活性成分層が、1cm2から100cm 2 の間の面積、及び10μmと200μmの間の厚さを有し、活性成分層の水分含量(残留含水率)が該層の全質量の20%未満であることを特徴とする、上記TTS。
- 担体物質が水溶性でないことを特徴とする、請求項1に記載のTTS。
- ペプチドが、卵胞刺激ホルモンであることを特徴とする、請求項1又は2に記載のTTS。
- ペプチドが、薬学的に許容される塩の形態で使われることを特徴とする、請求項1〜3のいずれか1項に記載のTTS。
- ペプチドが、0.01質量%から99質量%(乾燥)の濃度で活性成分層に存在することを特徴とする、請求項1〜4のいずれか1項に記載のTTS。
- 活性成分層の水分含量(残留含水率)が、該層の全質量の10%未満であることを特徴とする、請求項1〜5のいずれか1項に記載のTTS。
- 活性成分層が非ポリマー性の助剤、緩衝剤、安定剤、及び保存剤のグループの1つからの少なくとも1つの物質を含むことを特徴とする、請求項1〜6のいずれか1項に記載のTTS。
- 請求項1に記載のTTSの製造法であって:
a.シート状のテキスタイル構造の形態で存在する担体物質を、水不溶性で感圧接着性のポリマーでコーティングされた裏打ち層のその側上に載置する工程;
b.ペプチドを水及び場合により少なくとも1つの助剤と混合して活性成分溶液を調製する工程;
c.活性成分溶液をシート状のテキスタイ構造に塗布する工程;
d.20%未満、好ましくは10%未満の所定の水分含量に乾燥して、活性成分層を形成させる工程;及び
e.裏打ち層及び活性成分層で構成されるアセンブリを保護シートでライニングし、それを包装する工程;
による、上記TTSの製造法。 - 乾燥が、40℃より低い温度で行われることを特徴とする、請求項8に記載の方法。
- ペプチドを切除処置された皮膚を通して患者に投与するための、請求項1に記載のTTS。
- ペプチドが、卵胞刺激ホルモンであり、患者が、補助的不妊治療を必要とするヒトである、請求項10に記載のTTS。
- まず初めに、最初のステップで、女性患者の皮膚がレーザー皮膚切除技術で切除処置され、第2のステップで、GnRHアゴニストを備えたTTSがこのように処置された皮膚位置に適用され、そして長時間この皮膚位置に適用したままにされ、そしてこの操作で放出されたGnRHアゴニストが、経皮的に患者に送達され;第3のステップでは、患者のさらなる皮膚位置がレーザー皮膚切除技術で切除処置され、そして第4ステップでは、この位置に、卵胞刺激ホルモンを上のように経皮的に投与して患者に卵胞の形成をもたらすために、活性成分卵胞刺激ホルモンを備えたTTSが適用される、請求項3に記載のTTS。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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DE102009056745A DE102009056745A1 (de) | 2009-12-04 | 2009-12-04 | Transdermales therapeutisches System für die Verabreichung von Peptiden |
DE102009056745.3 | 2009-12-04 | ||
PCT/EP2010/007323 WO2011066971A2 (de) | 2009-12-04 | 2010-12-02 | Transdermales therapeutisches system für die verabreichung von peptiden |
Publications (3)
Publication Number | Publication Date |
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JP2013512865A JP2013512865A (ja) | 2013-04-18 |
JP2013512865A5 JP2013512865A5 (ja) | 2014-01-16 |
JP5800826B2 true JP5800826B2 (ja) | 2015-10-28 |
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JP2012541360A Active JP5800826B2 (ja) | 2009-12-04 | 2010-12-02 | ペプチドの投与のための経皮治療システム |
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EP (1) | EP2533771B1 (ja) |
JP (1) | JP5800826B2 (ja) |
CN (1) | CN103118671A (ja) |
BR (1) | BR112012014102B1 (ja) |
CA (1) | CA2782751C (ja) |
DE (1) | DE102009056745A1 (ja) |
ES (1) | ES2753455T3 (ja) |
WO (1) | WO2011066971A2 (ja) |
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ES2518765B2 (es) * | 2014-07-16 | 2015-03-05 | Nabari Textil S L | Tejidos textiles funcionales |
GB201604124D0 (en) | 2016-03-10 | 2016-04-27 | Ucb Biopharma Sprl | Pharmaceutical formulation |
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JP2013512865A (ja) | 2013-04-18 |
EP2533771B1 (de) | 2019-09-18 |
US9895319B2 (en) | 2018-02-20 |
US20180133165A1 (en) | 2018-05-17 |
CA2782751C (en) | 2018-10-16 |
BR112012014102A2 (pt) | 2016-07-05 |
CA2782751A1 (en) | 2011-06-09 |
BR112012014102B1 (pt) | 2021-07-20 |
DE102009056745A1 (de) | 2011-06-09 |
WO2011066971A2 (de) | 2011-06-09 |
US20120238942A1 (en) | 2012-09-20 |
EP2533771A2 (de) | 2012-12-19 |
CN103118671A (zh) | 2013-05-22 |
WO2011066971A3 (de) | 2012-11-15 |
US10471021B2 (en) | 2019-11-12 |
ES2753455T3 (es) | 2020-04-08 |
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