HRP20201880T1 - Transdermalni terapijski sustav namijenjen primjeni aktivne tvari - Google Patents
Transdermalni terapijski sustav namijenjen primjeni aktivne tvari Download PDFInfo
- Publication number
- HRP20201880T1 HRP20201880T1 HRP20201880TT HRP20201880T HRP20201880T1 HR P20201880 T1 HRP20201880 T1 HR P20201880T1 HR P20201880T T HRP20201880T T HR P20201880TT HR P20201880 T HRP20201880 T HR P20201880T HR P20201880 T1 HRP20201880 T1 HR P20201880T1
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- Prior art keywords
- active ingredient
- layer
- therapeutic system
- transdermal therapeutic
- polymer
- Prior art date
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- 230000001225 therapeutic effect Effects 0.000 title claims 14
- 239000013543 active substance Substances 0.000 title 1
- 239000010410 layer Substances 0.000 claims 23
- 239000004480 active ingredient Substances 0.000 claims 20
- 229920000642 polymer Polymers 0.000 claims 19
- XSVMFMHYUFZWBK-NSHDSACASA-N Rivastigmine Chemical group CCN(C)C(=O)OC1=CC=CC([C@H](C)N(C)C)=C1 XSVMFMHYUFZWBK-NSHDSACASA-N 0.000 claims 9
- 229960004136 rivastigmine Drugs 0.000 claims 9
- 229920002367 Polyisobutene Polymers 0.000 claims 8
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 8
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 8
- 239000011159 matrix material Substances 0.000 claims 7
- 229920001083 polybutene Polymers 0.000 claims 7
- 239000012790 adhesive layer Substances 0.000 claims 6
- 229920001577 copolymer Polymers 0.000 claims 5
- 239000012528 membrane Substances 0.000 claims 4
- 239000000203 mixture Substances 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- 239000012453 solvate Substances 0.000 claims 4
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 2
- 239000003963 antioxidant agent Substances 0.000 claims 2
- 230000003078 antioxidant effect Effects 0.000 claims 2
- 235000006708 antioxidants Nutrition 0.000 claims 2
- 230000015556 catabolic process Effects 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 230000035515 penetration Effects 0.000 claims 2
- 229920000058 polyacrylate Polymers 0.000 claims 2
- 229930003799 tocopherol Natural products 0.000 claims 2
- 239000011732 tocopherol Substances 0.000 claims 2
- 235000019149 tocopherols Nutrition 0.000 claims 2
- QUEDXNHFTDJVIY-UHFFFAOYSA-N γ-tocopherol Chemical class OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1 QUEDXNHFTDJVIY-UHFFFAOYSA-N 0.000 claims 2
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 claims 1
- 206010012289 Dementia Diseases 0.000 claims 1
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 235000012239 silicon dioxide Nutrition 0.000 claims 1
- 239000000377 silicon dioxide Substances 0.000 claims 1
- 230000000087 stabilizing effect Effects 0.000 claims 1
- 229920003048 styrene butadiene rubber Polymers 0.000 claims 1
- 229940100640 transdermal system Drugs 0.000 claims 1
Classifications
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- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Dermatology (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hospice & Palliative Care (AREA)
- Psychology (AREA)
- Psychiatry (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (14)
1. Transdermalni terapijski sustav namijenjen primjeni aktivnog sastojka kroz kožu, koji sadrži slojeve naslagane jedan na drugog sljedećim redoslijedom:
a) pokrovni sloj;
b) sloj s aktivnim sastojkom koji sadrži polimerni matriks koji sadrži aktivni sastojak;
c) membrana koja kontrolira otpuštanje aktivnog sastojka;
d) sloj ljepila koji sadrži ljepilo osjetljivo na pritisak; i
e) ljušteći sloj;
gdje je aktivni sastojak rivastigmin, ili njegova fiziološki prihvatljiva sol, hidrat ili solvat, naznačen time što (i) jedan ili više polimera polimernog matriksa ne sadrže slobodne hidroksilne skupine i slobodne karboksilne skupine, te (ii) sloj s aktivnim sastojkom ne sadrži slobodne hidroksilne skupine i slobodne karboksilne skupine.
2. Transdermalni terapijski sustav u skladu s patentnim zahtjevom 1, naznačen time što (i) ne sadrži tokoferole, (ii) ne sadrži antioksidans kojeg se bira iz skupine koju čine tokoferoli, butilhidroksianisol, te butilhidroksitoluen i/ili (iii) ne sadrži antioksidans.
3. Transdermalni terapijski sustav u skladu s patentnim zahtjevom 1 ili 2, naznačen time što ljepilo osjetljivo na pritisak sadrži poliizobutilen ili smjesu više poliizobutilena, a sloj ljepila može dodatno sadržavati polibuten ili smjesu više polibutena.
4. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što se ljepilo osjetljivo na pritisak sastoji od najmanje dva poliizobutilena različitih prosječnih molekulskih težina i najmanje dva polibutena različitih prosječnih molekulskih težina, gdje prvi poliizobutilenski polimer po mogućnosti ima prosječnu molekulsku težinu Mv od 40.000 g/mol, a drugi poliizobutilenski polimer po mogućnosti ima prosječnu molekulsku težinu Mv od 400.000 g/mol; i/ili gdje prvi polibutenski polimer po mogućnosti ima prosječnu molekulsku težinu Mn u rasponu od 700-2.800 g/mol, a drugi polibutenski polimer po mogućnosti ima prosječnu molekulsku težinu Mn u rasponu od 2.200-6.500 g/mol.
5. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što sloj s aktivnim sastojkom sadrži 30-50%, težinski, aktivnog sastojka i 50-70%, težinski, polimernog matriksa na osnovi ukupne težine sloja s aktivnim sastojkom.
6. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što polimerni matriks sloja s aktivnim sastojkom sadrži najmanje jedan polimer i/ili kopolimer bez ikakvih slobodnih hidroksilnih skupina i bez ikakvih slobodnih karboksilnih skupina kojeg se bira iz skupine koju čine poliakrilati, akrilatno-vinil-acetatni kopolimeri, poliizobutilen, stirensko-butadienski kopolimeri i njihove smjese.
7. Transdermalni terapijski sustav u skladu s patentnim zahtjevom 1, naznačen time što sadrži:
a) pokrovni sloj;
b) sloj s aktivnim sastojkom na pokrovnom sloju koji sadrži 30-50%, težinski, aktivnog sastojka i 50-70% polimernog matriksa na osnovi ukupne težine sloja s aktivnim sastojkom, gdje se polimerni matriks uglavnom sastoji od akrilatnog polimera bez ikakvih slobodnih hidroksilnih skupina i bez ikakvih slobodnih karboksilnih skupina ili uglavnom od akrilatnog kopolimera bez ikakvih slobodnih hidroksilnih skupina i bez ikakvih slobodnih karboksilnih skupina, te gdje je aktivni sastojak rivastigmin, ili njegova fiziološki prihvatljiva sol, hidrat ili solvat;
c) membranu na sloju s aktivnim sastojkom koja kontrolira otpuštanje rivastigmina;
d) sloj ljepila na membrani koji se sastoji od 0-1%, težinski, silicijevog dioksida i 99-100%, težinski, smjese poliizobutilenskog polimera prosječne molekulske težine Mv od 40.000 g/mol, poliizobutilenskog polimera prosječne molekulske težine Mv od 400.000 g/mol, polibutenskoga polimer prosječne molekulske težine Mn od 2.500 g/mol i polibutenskog polimera prosječne molekulske težine Mn od 6.000 g/mol; i
e) ljušteći sloj na sloju ljepila.
8. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je pogodan za upotrebu u trajanju od najmanje 7 dana.
9. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što pokazuje uglavnom linearno prodiranje kroz kožu aktivnog sastojka u periodu od najmanje 72 sata, što je izmjereno u testu prodiranja kroz kožu in vitro.
10. Postupak priprave transdermalnog sustava u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što se sastoji u
i) pripravi komponente koja sadrži sloj s aktivnim sastojkom koji sadrži pokrovni sloj i sloj s aktivnim sastojkom koji se nalazi na strani pokrovnog sloja koja treba biti strana okrenuta prema koži;
ii) pripravi komponente koja sadrži sloj ljepila koji sadrži ljušteći sloj i sloj ljepila koji se nalazi na ljuštećem sloju i može sadržavati membranu koja kontrolira otpuštanje aktivnog sastojka;
iii) slaganje jedne na drugu komponenata i) i ii), tako da pokrovni i ljušteći sloj predstavljaju nasuprotne vanjske slojeve u poprečnom presjeku gotovog TTS-a.
11. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je namijenjen upotrebi u liječenju Alzheimerove bolesti i parkinsonske demencije, gdje se transdermalni terapijski sustav po mogućnosti primijenjuje u periodu od najmanje 72 sata.
12. Upotreba polimera ili kopolimera koji ne sadrži slobodne hidroksilne skupine i slobodne karboksilne skupine, naznačena time što su polimer ili kopolimer namijenjeni stabiliziranju rivastigmina u TTS-u, ili smanjivanju razgradnje rivastigmina u TTS-u.
13. Postupak stabiliziranja rivastigmina u TTS-u ili smanjivanja razgradnje rivastigmina u TTS-u, naznačen time što je rivastigmin, ili njegova sol ili solvat, uklopljen u polimerni matriks koji ne sadrži slobodne hidroksilne skupine i slobodne karboksilne skupine, te što je rivastigmin, ili njegova sol ili solvat, uklopljen u sloj s aktivnim sastojkom koji ne sadrži slobodne hidroksilne skupine i slobodne karboksilne skupine.
14. Transdermalni terapijski sustav u skladu s bilo kojim od patentnih zahtjeva 1 do 9, ili transdermalni terapijski sustav namijenjen upotrebi u skladu s patentnim zahtjevom 11, naznačen time što ima prosječnu brzinu otpuštanja in vivo između 0,1 mg/d/cm2 i 2 mg/d/cm2 i/ili od najmanje 0,3 mg/d/cm2.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10194968.3A EP2468274B1 (de) | 2010-12-14 | 2010-12-14 | Transdermales therapeutisches System zur Verabreichung eines Wirkstoffs |
| PCT/EP2011/072812 WO2012080365A1 (de) | 2010-12-14 | 2011-12-14 | Transdermales therapeutisches system zur verabreichung eines wirkstoffs |
| EP11799413.7A EP2651410B1 (de) | 2010-12-14 | 2011-12-14 | Transdermales therapeutisches system zur verabreichung eines wirkstoffs |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20201880T1 true HRP20201880T1 (hr) | 2021-02-05 |
Family
ID=43836835
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150881TT HRP20150881T1 (hr) | 2010-12-14 | 2015-08-19 | Transdermalni terapijski sustav za primjenu sredstva |
| HRP20201880TT HRP20201880T1 (hr) | 2010-12-14 | 2020-11-26 | Transdermalni terapijski sustav namijenjen primjeni aktivne tvari |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20150881TT HRP20150881T1 (hr) | 2010-12-14 | 2015-08-19 | Transdermalni terapijski sustav za primjenu sredstva |
Country Status (25)
| Country | Link |
|---|---|
| US (2) | US10660863B2 (hr) |
| EP (2) | EP2468274B1 (hr) |
| JP (1) | JP6043296B2 (hr) |
| KR (1) | KR101842309B1 (hr) |
| CN (3) | CN103269698B (hr) |
| AU (2) | AU2011343363B2 (hr) |
| BR (1) | BR112013014616B1 (hr) |
| CA (2) | CA2817461C (hr) |
| CY (2) | CY1116638T1 (hr) |
| DK (2) | DK2468274T3 (hr) |
| EA (1) | EA026520B1 (hr) |
| ES (2) | ES2545094T3 (hr) |
| HK (1) | HK1243336A1 (hr) |
| HR (2) | HRP20150881T1 (hr) |
| HU (2) | HUE027916T2 (hr) |
| LT (1) | LT2651410T (hr) |
| MX (1) | MX345344B (hr) |
| MY (1) | MY183873A (hr) |
| PL (2) | PL2468274T3 (hr) |
| PT (2) | PT2468274E (hr) |
| RS (2) | RS54173B1 (hr) |
| SI (2) | SI2468274T1 (hr) |
| SM (1) | SMT201500184B (hr) |
| WO (1) | WO2012080365A1 (hr) |
| ZA (1) | ZA201303965B (hr) |
Families Citing this family (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102012000369A1 (de) * | 2012-01-11 | 2013-07-11 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Transdermales therapeutisches System mit Cholinesterase-Hemmer |
| DE102012016317A1 (de) | 2012-08-14 | 2014-02-20 | Jenabatteries GmbH | Redox-Flow-Zelle zur Speicherung elektrischer Energie |
| JP2015530375A (ja) * | 2012-08-15 | 2015-10-15 | ダウ コーニング コーポレーションＤｏｗ Ｃｏｒｎｉｎｇ Ｃｏｒｐｏｒａｔｉｏｎ | 多層薬物送達システム |
| WO2014111790A2 (en) * | 2013-01-15 | 2014-07-24 | Zydus Technologies Limited | Stable transdermal pharmaceutical drug delivery system comprising rivastigmine |
| WO2018038022A1 (ja) | 2016-08-22 | 2018-03-01 | 救急薬品工業株式会社 | 貼付剤 |
| EP3656383A4 (en) * | 2017-07-19 | 2021-05-19 | Teikoku Seiyaku Co., Ltd. | RIVASTIGMIN-CONTAINING PERCUTICAL ABSORPTION PREPARATION |
| DE102018120505A1 (de) * | 2017-10-20 | 2019-04-25 | Amw Gmbh | Verhinderung der Kristallisation von Wirkstoffen in transdermalen Darreichungssystemen |
| DE102017127433A1 (de) * | 2017-11-21 | 2019-05-23 | Lts Lohmann Therapie-Systeme Ag | TTS auf Basis von klebenden Weichmacher-Polymer-Matrices |
| WO2019175109A1 (en) * | 2018-03-13 | 2019-09-19 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system comprising a silicone acrylic hybrid polymer |
| CN111885992B (zh) * | 2018-05-17 | 2023-12-08 | 松下知识产权经营株式会社 | 生物体贴附用选择性透过膜、透皮吸收套件和美容方法 |
| EP3871877A1 (en) * | 2018-08-08 | 2021-09-01 | Danapak Flexibles A/S | Improved films and laminates for use in packaging reactive compounds |
| KR20200025883A (ko) | 2018-08-31 | 2020-03-10 | 에스케이케미칼 주식회사 | 장기 투여용 리바스티그민 패취 |
| KR20200025888A (ko) | 2018-08-31 | 2020-03-10 | 에스케이케미칼 주식회사 | 장기 투여용 리바스티그민 패취 |
| JP2022540145A (ja) * | 2019-07-09 | 2022-09-14 | エルテーエス ローマン テラピー－ジステーメ アーゲー | アクリルポリマーを含む活性剤含有層及びシリコーンゲル接着剤を含む皮膚接触層を含む経皮治療システム |
| CN113616625B (zh) * | 2021-08-26 | 2023-05-30 | 大连科翔科技开发有限公司 | 一种卡巴拉汀的长效透皮贴剂 |
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| NL195004C (nl) | 1987-03-04 | 2003-11-04 | Novartis Ag | Fenylcarbamaat bevattend farmaceutisch preparaat. |
| AU3247193A (en) * | 1992-08-25 | 1994-03-15 | Cygnus Therapeutic Systems | Printed transdermal drug delivery device |
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| US6348210B1 (en) * | 1998-11-13 | 2002-02-19 | Alza Corporation | Methods for transdermal drug administration |
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| DE10033853A1 (de) | 2000-07-12 | 2002-01-31 | Hexal Ag | Transdermales therapeutisches System mit hochdispersem Siliziumdioxid |
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| US9248104B2 (en) * | 2006-08-17 | 2016-02-02 | Core Tech Solutions, Inc. | Transdermal methods and systems for treating Alzheimer's disease |
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| JP2010126450A (ja) * | 2008-11-25 | 2010-06-10 | Lintec Corp | 経皮吸収貼付剤 |
| BR112012017168B1 (pt) * | 2009-12-22 | 2022-03-15 | Luye Pharma Ag | Sistemas terapêuticos transdérmicos, seu processo de preparação, e usos de um polímero ou copolímero |
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