ES2586412T3 - Formulaciones de rasagilina con uniformidad de contenido mejorada - Google Patents
Formulaciones de rasagilina con uniformidad de contenido mejorada Download PDFInfo
- Publication number
- ES2586412T3 ES2586412T3 ES06720975.9T ES06720975T ES2586412T3 ES 2586412 T3 ES2586412 T3 ES 2586412T3 ES 06720975 T ES06720975 T ES 06720975T ES 2586412 T3 ES2586412 T3 ES 2586412T3
- Authority
- ES
- Spain
- Prior art keywords
- aminoindane
- particles
- content uniformity
- improved content
- uniformity
- 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.)
- Active
Links
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Psychology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
Una composición sólida que comprende una cantidad terapéuticamente eficaz de una mezcla de partículas de una sal farmacéuticamente aceptable de R(+)-N-propargil-1-aminoindano que tiene una distribución de tamaños de partícula en la cual más de 90%, en volumen, de la cantidad total de partículas de sal de mesilato de R(+)-Npropargil- 1-aminoindano tienen un tamaño inferior a 200 micrómetros y al menos 90%, en volumen, de la cantidad total de las partículas de sal de R(+)-N-propargil-1-aminoindano tienen un tamaño superior a 6 micrómetros, siendo la distribución de tamaños de partícula resultado de la molienda de partículas de mayor tamaño, como lo determinan los valores de d(0,9) y d(0,1), en donde el tamaño de partícula se mide mediante difracción láser; y un vehículo farmacéuticamente aceptable .
Description
La uniformidad de mezcla promedio de cada lote de granulado se determinó tomando 10 muestras que representaban la capa superior, la capa media y la capa inferior de cada lote de mezcla final (antes de la compresión), realizando un análisis por HPLC para medir la cantidad de ingrediente activo en las muestras y comparando la cantidad de ingrediente activo en cada muestra con la cantidad declarada de ingrediente activo. Después se determinaron la desviación típica y la desviación típica relativa según las siguientes fórmulas:
En las fórmulas anteriores, s es la desviación típica; DTR es la desviación típica relativa; x1, x2, x3 ... xn son cantidades individuales de las muestras ensayadas, expresadas como porcentajes de la cantidad declarada de
10 sustancia medicamentosa en cada muestra; X(con barra) es la media de los valores obtenidos de las muestras analizadas, expresada como porcentaje de la cantidad declarada de sustancia medicamentosa en cada muestra; y n es el número de unidades analizadas.
La uniformidad de contenido de los comprimidos se determinó utilizando 10 comprimidos al azar, realizando un análisis HPLC para medir la cantidad de ingrediente activo en cada comprimido y comparando la cantidad de
15 ingrediente activo en cada comprimido con la cantidad declarada de ingrediente activo. La desviación típica y la desviación típica relativa se determinaron como antes.
Se determinaron d(0,1) y d(0,9) como en el Ejemplo 1. En la Tabla 2 se exponen los resultados.
Tabla 2
- Número de lote de sustancia medicamentosa
- 100 200 300 300
- Número de lote de producto medicamentoso
- 021 022 023 063
- d(0,1) (micrómetros)
- 12,5 12,9 12,1 12,1
- d(0,9) (micrómetros)
- 190,3 111,9 121,0 121,0
- Uniformidad de mezcla/DTR (tanto por ciento)
- 98,2/1,7 99,8/0,8 98,7/1,1 98,1/0,7
- Uniformidad de contenido/DTR (tanto por ciento)
- 99,3/1,6 99,0/1,4 98,6/1,3 100,6/1,2
20 Resultados:
La uniformidad del contenido de los lotes ensayados varió de 98,6% a 100,6%. La DTR (desviación típica relativa, expresada como porcentaje de la media) fue inferior a 2,0% para todos los lotes de comprimidos, lo que indica que la uniformidad de los comprimidos era elevada a pesar de la pequeña cantidad de ingrediente activo en cada comprimido. Así, estos resultados cumplirían los criterios de aceptación establecidos por la primera fase del ensayo
25 USP de uniformidad de contenido.
8
Claims (1)
-
imagen1 imagen2
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US65562205P | 2005-02-23 | 2005-02-23 | |
US655622P | 2005-02-23 | ||
US72090805P | 2005-09-27 | 2005-09-27 | |
US720908P | 2005-09-27 | ||
PCT/US2006/006252 WO2006091657A1 (en) | 2005-02-23 | 2006-02-22 | Rasagiline formulations of improved content uniformity |
Publications (2)
Publication Number | Publication Date |
---|---|
ES2586412T3 true ES2586412T3 (es) | 2016-10-14 |
ES2586412T5 ES2586412T5 (es) | 2019-05-16 |
Family
ID=36927751
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES06720975T Active ES2586412T5 (es) | 2005-02-23 | 2006-02-22 | Formulaciones de rasagilina con uniformidad de contenido mejorada |
Country Status (16)
Country | Link |
---|---|
US (1) | US7815942B2 (es) |
EP (1) | EP1848402B2 (es) |
JP (2) | JP5738509B2 (es) |
KR (5) | KR20170023211A (es) |
AU (1) | AU2006216696B2 (es) |
BR (1) | BRPI0608209A2 (es) |
CA (2) | CA2901244A1 (es) |
ES (1) | ES2586412T5 (es) |
HK (1) | HK1103366A1 (es) |
IL (2) | IL184033A0 (es) |
IS (1) | IS8669A (es) |
MX (1) | MX2007010233A (es) |
NO (1) | NO20074823L (es) |
NZ (1) | NZ560660A (es) |
RU (1) | RU2404746C2 (es) |
WO (1) | WO2006091657A1 (es) |
Families Citing this family (47)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5744500A (en) * | 1990-01-03 | 1998-04-28 | Teva Pharmaceutical Industries, Ltd. | Use of R-enantiomer of N-propargyl-1-aminoindan, salts, and compositions thereof |
AU2003290838A1 (en) | 2002-11-15 | 2004-06-15 | Teva Pharmaceutical Industries, Ltd. | Use of rasagiline with or without riluzole to treat amyotrophic lateral sclerosis |
US20060018957A1 (en) * | 2004-07-26 | 2006-01-26 | Lerner E I | Pharmaceutical dosage forms including rasagiline |
ZA200704917B (en) * | 2004-11-24 | 2008-11-26 | Teva Pharma | Rasagiline orally disintegrating compositions |
AU2006211510B8 (en) * | 2005-02-02 | 2011-04-21 | Teva Pharmaceutical Industries, Ltd. | Process for producing polypeptide mixtures using hydrogenolysis |
PL1848415T3 (pl) * | 2005-02-17 | 2013-10-31 | Teva Pharma | Terapia kombinowana obejmująca octan glatirameru oraz rasagilinę do leczenia stwardnienia rozsianego |
CA2901244A1 (en) | 2005-02-23 | 2006-08-31 | Teva Pharmaceutical Industries, Ltd. | Rasagiline formulations of improved content uniformity |
AU2006316585B2 (en) * | 2005-11-17 | 2012-09-20 | Teva Pharmaceutical Industries, Ltd. | Methods for isolating propargylated aminoindans |
US7572834B1 (en) | 2005-12-06 | 2009-08-11 | Teva Pharmaceutical Industries, Ltd. | Rasagiline formulations and processes for their preparation |
ES2551481T3 (es) | 2006-02-21 | 2015-11-19 | Teva Pharmaceutical Industries, Ltd. | Uso de rasagilina para el tratamiento de atrofia multisistémica |
NZ571591A (en) * | 2006-04-03 | 2011-09-30 | Teva Pharma | Use of rasagiline for the treatment of restless legs syndrome |
EP1892233A1 (de) | 2006-08-18 | 2008-02-27 | Ratiopharm GmbH | Neue Salze des Wirkstoffs Rasagilin |
BRPI0718339A2 (pt) * | 2006-12-14 | 2014-02-18 | Teva Pharma | Composto, composição, composição farmacêutica e processo de fabricação de tanato de rasagilina |
AU2007334428B2 (en) * | 2006-12-14 | 2014-05-29 | Teva Pharmaceutical Industries, Ltd. | Crystalline solid rasagiline base |
EP1987816A1 (de) * | 2007-04-30 | 2008-11-05 | Ratiopharm GmbH | Adsorbate eines Rasagilinsalzes mit einem wasserlöslichen Hilfsstoff |
US20090062400A1 (en) * | 2007-09-05 | 2009-03-05 | Laurence Oron | Method of treating glaucoma using rasagiline |
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CN101909438A (zh) * | 2008-01-11 | 2010-12-08 | 泰华制药工业有限公司 | 雷沙吉兰制剂、其制备及用途 |
EP2271612B1 (en) * | 2008-03-31 | 2016-08-10 | Actavis Group PTC EHF | Rasagiline mesylate particles and process for the preparation thereof |
ES2389353T3 (es) * | 2008-06-10 | 2012-10-25 | Teva Pharmaceutical Industries Ltd. | Cápsulas de gelatina blanda de rasagilina |
BRPI0909894A2 (pt) * | 2008-06-13 | 2015-07-28 | Teva Pharma | "método de redução da velocidade de progressão de mal de parkinson em um paciente com mal de parkinson em estágio inicial, método de redução da velocidade de progressão de mal de parkinson, método de atraso da necessidade de terapia antiparkinsoniana sintomática em um paciente de mal de parkinson em estágio inicial, método de redução do risco de um paciente com mal de parkinson que necessita de terapia antiparkinsoniana, método de redução do declínio funcional de um paciente com mal de parkinson em estágio inicial, método de redução do declínio funcional em um paciente com mal de parkinson, método de tratamento de um paciente que exibe sinais iniciais de mal de parkinson, método de redução da fadiga em um paciente com mal de parkinson em estágio inicial, método de redução da velocidade de progressão clínica e tratamento de sintomas de mal de parkinson em um paciente com mal de parkinson, rasagilina ou um sal farmaceuticamente aceitável de rasagilina, composição farmacêutica. |
NZ589547A (en) * | 2008-06-19 | 2013-03-28 | Teva Pharma | Dried rasagiline base having a water content less than 0.5 % by weight |
CA2727021A1 (en) | 2008-06-19 | 2009-12-23 | Teva Pharmaceutical Industries Ltd. | Process for purifying rasagiline base |
EP2657221A1 (en) | 2008-11-20 | 2013-10-30 | Dr. Reddy's Laboratories Ltd. | Preparation of rasagiline and salts thereof |
DE102008064061A1 (de) | 2008-12-19 | 2010-06-24 | Ratiopharm Gmbh | Feste Zusammensetzung mit dem Wirkstoff Rasagilin |
US20100189791A1 (en) * | 2009-01-23 | 2010-07-29 | Teva Pharmaceutical Industries, Ltd. | Delayed release rasagiline malate formulation |
US20120122993A1 (en) | 2009-03-05 | 2012-05-17 | Sandoz Ag | Pharmaceutical composition containing 1h-inden-1-amine, 2,3-dihydro-n-2-propynyl-(1r)-, methanesulfonate |
WO2010111264A2 (en) * | 2009-03-24 | 2010-09-30 | Dr. Reddy's Laboratories Ltd. | Rasagiline formulations |
PL2451771T3 (pl) | 2009-07-09 | 2014-12-31 | Ratiopharm Gmbh | Sole rasagiliny i ich preparaty farmaceutyczne |
US8741962B2 (en) | 2009-11-26 | 2014-06-03 | Usv Limited | Process for preparation of Rasagiline and salts thereof |
US20120321896A1 (en) * | 2010-02-01 | 2012-12-20 | Kuppuswamy Nagarajan | Rasagiline mesylate having large particle size and a process for preparation thereof |
RS55487B1 (sr) * | 2010-02-12 | 2017-04-28 | Pfizer | Soli i polimorfi 8-fluoro-2-{4-[(metilamino}metil]fenil}-1,3,4,5-tetrahidro-6h-azepino[5,4,3-cd]indol-6-ona |
EA023786B1 (ru) | 2010-04-30 | 2016-07-29 | ТЕЙКОКУ ФАРМА ЮЭсЭй, ИНК. | Трансдермальные композиции на основе пропиниламиноиндана |
EP2389927A1 (en) | 2010-05-30 | 2011-11-30 | Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi | Pharmaceutical formulations of rasagiline |
CA2806740A1 (en) | 2010-07-27 | 2012-02-02 | Teva Pharmaceutical Industries Ltd. | Use of rasagiline for the treatment of olfactory dysfunction |
AU2011282716A1 (en) | 2010-07-27 | 2013-03-14 | Teva Pharmaceutical Industries Ltd. | Dispersions of rasagiline citrate |
EP2688561B1 (en) | 2011-03-24 | 2018-08-22 | Teikoku Pharma USA, Inc. | Transdermal compositions comprising an active agent layer and an active agent conversion layer |
EP2705021A2 (en) | 2011-05-04 | 2014-03-12 | Cadila Healthcare Limited | Rasagiline and its pharmaceutically acceptable salts |
BR112014008552A2 (pt) | 2011-10-10 | 2017-04-18 | Teva Pharma | r(+)-n-metil-propargilaminoindano |
KR20140090996A (ko) | 2011-10-10 | 2014-07-18 | 테바 파마슈티컬 인더스트리즈 리미티드 | R(+)-n-폼일-프로파길-아미노인단 |
US9913812B2 (en) | 2011-11-09 | 2018-03-13 | Teikoku Pharma Usa, Inc. | Methods for the treatment of skin neoplasms |
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MX343986B (es) | 2012-03-21 | 2016-12-01 | Synthon Bv | Composiciones farmaceuticas estabilizadas que comprenden sales de rasagilina. |
BR112015003451A2 (pt) | 2012-08-17 | 2017-07-04 | Teva Pharma | formulação parentérica de rasagilina |
JP6050896B2 (ja) | 2012-11-02 | 2016-12-21 | テイコク ファーマ ユーエスエー インコーポレーテッド | プロピニルアミノインダン経皮組成物 |
US20160046582A1 (en) | 2013-03-14 | 2016-02-18 | Teva Pharmaceutical Industries Ltd. | Crystals of laquinimod sodium and improved process for the manufacture thereof |
BR112019009594A2 (pt) * | 2016-11-10 | 2019-10-22 | Medisca Pharmaceutique Inc | processos e sistemas de composição farmacêutica |
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NZ555470A (en) | 2004-11-24 | 2011-02-25 | Teva Pharma | Rasagiline orally disintegrating compositions |
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US7572834B1 (en) * | 2005-12-06 | 2009-08-11 | Teva Pharmaceutical Industries, Ltd. | Rasagiline formulations and processes for their preparation |
ES2551481T3 (es) | 2006-02-21 | 2015-11-19 | Teva Pharmaceutical Industries, Ltd. | Uso de rasagilina para el tratamiento de atrofia multisistémica |
NZ571591A (en) | 2006-04-03 | 2011-09-30 | Teva Pharma | Use of rasagiline for the treatment of restless legs syndrome |
EP1892233A1 (de) | 2006-08-18 | 2008-02-27 | Ratiopharm GmbH | Neue Salze des Wirkstoffs Rasagilin |
BRPI0718339A2 (pt) * | 2006-12-14 | 2014-02-18 | Teva Pharma | Composto, composição, composição farmacêutica e processo de fabricação de tanato de rasagilina |
AU2007334428B2 (en) | 2006-12-14 | 2014-05-29 | Teva Pharmaceutical Industries, Ltd. | Crystalline solid rasagiline base |
EP1987816A1 (de) | 2007-04-30 | 2008-11-05 | Ratiopharm GmbH | Adsorbate eines Rasagilinsalzes mit einem wasserlöslichen Hilfsstoff |
CN101909438A (zh) * | 2008-01-11 | 2010-12-08 | 泰华制药工业有限公司 | 雷沙吉兰制剂、其制备及用途 |
-
2006
- 2006-02-22 CA CA2901244A patent/CA2901244A1/en not_active Abandoned
- 2006-02-22 CA CA2600011A patent/CA2600011C/en active Active
- 2006-02-22 ES ES06720975T patent/ES2586412T5/es active Active
- 2006-02-22 RU RU2007135169/15A patent/RU2404746C2/ru active
- 2006-02-22 KR KR1020177004882A patent/KR20170023211A/ko active Application Filing
- 2006-02-22 NZ NZ560660A patent/NZ560660A/en unknown
- 2006-02-22 JP JP2007557120A patent/JP5738509B2/ja active Active
- 2006-02-22 KR KR1020137025486A patent/KR20130129300A/ko active Application Filing
- 2006-02-22 EP EP06720975.9A patent/EP1848402B2/en active Active
- 2006-02-22 KR KR1020077021509A patent/KR20070111534A/ko active Application Filing
- 2006-02-22 MX MX2007010233A patent/MX2007010233A/es active IP Right Grant
- 2006-02-22 AU AU2006216696A patent/AU2006216696B2/en active Active
- 2006-02-22 KR KR1020187006228A patent/KR20180026580A/ko not_active Application Discontinuation
- 2006-02-22 KR KR1020147021536A patent/KR20140103356A/ko active Search and Examination
- 2006-02-22 US US11/359,324 patent/US7815942B2/en active Active
- 2006-02-22 BR BRPI0608209-2A patent/BRPI0608209A2/pt not_active Application Discontinuation
- 2006-02-22 WO PCT/US2006/006252 patent/WO2006091657A1/en active Application Filing
-
2007
- 2007-06-19 IL IL184033A patent/IL184033A0/en unknown
- 2007-08-15 IS IS8669A patent/IS8669A/is unknown
- 2007-09-21 NO NO20074823A patent/NO20074823L/no not_active Application Discontinuation
- 2007-11-05 HK HK07112028.4A patent/HK1103366A1/zh not_active IP Right Cessation
-
2013
- 2013-02-12 JP JP2013024784A patent/JP2013139452A/ja active Pending
-
2016
- 2016-03-28 IL IL244802A patent/IL244802A/en active IP Right Grant
Also Published As
Publication number | Publication date |
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RU2007135169A (ru) | 2009-03-27 |
IS8669A (is) | 2007-08-15 |
IL184033A0 (en) | 2007-10-31 |
US7815942B2 (en) | 2010-10-19 |
AU2006216696B2 (en) | 2011-08-18 |
JP5738509B2 (ja) | 2015-06-24 |
KR20130129300A (ko) | 2013-11-27 |
JP2013139452A (ja) | 2013-07-18 |
KR20070111534A (ko) | 2007-11-21 |
AU2006216696A1 (en) | 2006-08-31 |
ES2586412T5 (es) | 2019-05-16 |
RU2404746C2 (ru) | 2010-11-27 |
MX2007010233A (es) | 2007-11-07 |
HK1103366A1 (zh) | 2007-12-21 |
EP1848402A4 (en) | 2012-01-18 |
KR20170023211A (ko) | 2017-03-02 |
BRPI0608209A2 (pt) | 2010-11-09 |
CA2901244A1 (en) | 2006-08-31 |
US20060188581A1 (en) | 2006-08-24 |
KR20140103356A (ko) | 2014-08-26 |
EP1848402B1 (en) | 2016-05-11 |
NO20074823L (no) | 2007-11-16 |
EP1848402A1 (en) | 2007-10-31 |
EP1848402B2 (en) | 2019-02-20 |
CA2600011A1 (en) | 2006-08-31 |
CA2600011C (en) | 2015-11-10 |
WO2006091657A1 (en) | 2006-08-31 |
IL244802A (en) | 2016-08-31 |
IL244802A0 (en) | 2016-04-21 |
JP2008531572A (ja) | 2008-08-14 |
NZ560660A (en) | 2010-11-26 |
KR20180026580A (ko) | 2018-03-12 |
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