HRP960598A2 - Rapid release tablet comprising tolfenamic acid or a pharmaceutically acceptable salt thereof as active ingredient and a method of preparing such tablet - Google Patents

Rapid release tablet comprising tolfenamic acid or a pharmaceutically acceptable salt thereof as active ingredient and a method of preparing such tablet Download PDF

Info

Publication number: HRP960598A2
Authority: HR; Croatia
Prior art keywords: tablet; pharmaceutically acceptable; acceptable salt; active ingredient; acid
Prior art date: 1995-12-20

Application number

HR1448/95A

Other languages

English (en)

Croatian (hr)

Inventor

Knud Erik Gebhard-Hansen

Karen Bjornsdottir

Lars Hedevang Christensen

Soren Bols Pedersen

Original Assignee

Bristol Myers Squibb Co

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.)

1995-12-20

Filing date

1996-12-19

Publication date

1998-02-28

1996-12-19 Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co

1998-02-28 Publication of HRP960598A2 publication Critical patent/HRP960598A2/hr

Links

YEZNLOUZAIOMLT-UHFFFAOYSA-N tolfenamic acid Chemical compound CC1=C(Cl)C=CC=C1NC1=CC=CC=C1C(O)=O YEZNLOUZAIOMLT-UHFFFAOYSA-N 0.000 title claims description 53
229960002905 tolfenamic acid Drugs 0.000 title claims description 52
150000003839 salts Chemical class 0.000 title claims description 30
239000004480 active ingredient Substances 0.000 title claims description 27
238000000034 method Methods 0.000 title claims description 15
239000007884 disintegrant Substances 0.000 claims description 22
230000036470 plasma concentration Effects 0.000 claims description 19
238000002360 preparation method Methods 0.000 claims description 19
239000002245 particle Substances 0.000 claims description 18
239000000783 alginic acid Substances 0.000 claims description 17
235000010443 alginic acid Nutrition 0.000 claims description 17
229920000615 alginic acid Polymers 0.000 claims description 17
229960001126 alginic acid Drugs 0.000 claims description 17
150000004781 alginic acids Chemical class 0.000 claims description 17
239000008187 granular material Substances 0.000 claims description 16
239000003795 chemical substances by application Substances 0.000 claims description 14
238000002156 mixing Methods 0.000 claims description 9
229920003109 sodium starch glycolate Polymers 0.000 claims description 9
239000008109 sodium starch glycolate Substances 0.000 claims description 9
229940079832 sodium starch glycolate Drugs 0.000 claims description 9
229920002785 Croscarmellose sodium Polymers 0.000 claims description 7
235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 claims description 7
239000007916 tablet composition Substances 0.000 claims description 7
208000019695 Migraine disease Diseases 0.000 claims description 6
DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 6
229960001681 croscarmellose sodium Drugs 0.000 claims description 6
206010027599 migraine Diseases 0.000 claims description 6
239000000203 mixture Substances 0.000 claims description 6
239000002253 acid Substances 0.000 claims description 5
238000001035 drying Methods 0.000 claims description 5
239000000945 filler Substances 0.000 claims description 5
229920002472 Starch Polymers 0.000 claims description 4
239000012752 auxiliary agent Substances 0.000 claims description 4
238000000227 grinding Methods 0.000 claims description 4
229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 4
239000000546 pharmaceutical excipient Substances 0.000 claims description 4
235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 4
208000005171 Dysmenorrhea Diseases 0.000 claims description 3
206010013935 Dysmenorrhoea Diseases 0.000 claims description 3
230000001154 acute effect Effects 0.000 claims description 3
238000005469 granulation Methods 0.000 claims description 3
230000003179 granulation Effects 0.000 claims description 3
229940032147 starch Drugs 0.000 claims description 3
239000008107 starch Substances 0.000 claims description 3
235000019698 starch Nutrition 0.000 claims description 3
206010061218 Inflammation Diseases 0.000 claims description 2
229920000881 Modified starch Polymers 0.000 claims description 2
208000002193 Pain Diseases 0.000 claims description 2
206010037660 Pyrexia Diseases 0.000 claims description 2
239000011230 binding agent Substances 0.000 claims description 2
239000006185 dispersion Substances 0.000 claims description 2
239000008240 homogeneous mixture Substances 0.000 claims description 2
230000004054 inflammatory process Effects 0.000 claims description 2
238000004898 kneading Methods 0.000 claims description 2
239000000314 lubricant Substances 0.000 claims description 2
235000019426 modified starch Nutrition 0.000 claims description 2
229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 2
235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 2
239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
238000003825 pressing Methods 0.000 claims description 2
WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 1
229960000913 crospovidone Drugs 0.000 claims 1
239000002775 capsule Substances 0.000 description 18
HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
230000000052 comparative effect Effects 0.000 description 6
239000004615 ingredient Substances 0.000 description 6
239000007963 capsule composition Substances 0.000 description 5
238000003801 milling Methods 0.000 description 5
238000004090 dissolution Methods 0.000 description 4
239000003979 granulating agent Substances 0.000 description 3
229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
239000000843 powder Substances 0.000 description 3
LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
108010010803 Gelatin Proteins 0.000 description 2
208000025747 Rheumatic disease Diseases 0.000 description 2
VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
230000008901 benefit Effects 0.000 description 2
150000001875 compounds Chemical class 0.000 description 2
238000007922 dissolution test Methods 0.000 description 2
238000009472 formulation Methods 0.000 description 2
229920000159 gelatin Polymers 0.000 description 2
239000008273 gelatin Substances 0.000 description 2
239000007903 gelatin capsule Substances 0.000 description 2
235000019322 gelatine Nutrition 0.000 description 2
235000011852 gelatine desserts Nutrition 0.000 description 2
239000011159 matrix material Substances 0.000 description 2
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
238000005303 weighing Methods 0.000 description 2
-1 Alkali metal salts Chemical class 0.000 description 1
235000019890 Amylum Nutrition 0.000 description 1
PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 description 1
229920002261 Corn starch Polymers 0.000 description 1
DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
239000007836 KH2PO4 Substances 0.000 description 1
239000002202 Polyethylene glycol Substances 0.000 description 1
229920003110 Primojel Polymers 0.000 description 1
229910052783 alkali metal Inorganic materials 0.000 description 1
239000000730 antalgic agent Substances 0.000 description 1
230000001760 anti-analgesic effect Effects 0.000 description 1
230000003110 anti-inflammatory effect Effects 0.000 description 1
239000008280 blood Substances 0.000 description 1
210000004369 blood Anatomy 0.000 description 1
229920002678 cellulose Polymers 0.000 description 1
235000010980 cellulose Nutrition 0.000 description 1
239000008120 corn starch Substances 0.000 description 1
239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 description 1
238000011161 development Methods 0.000 description 1
238000007865 diluting Methods 0.000 description 1
230000000694 effects Effects 0.000 description 1
MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 description 1
238000011049 filling Methods 0.000 description 1
210000001035 gastrointestinal tract Anatomy 0.000 description 1
230000002209 hydrophobic effect Effects 0.000 description 1
239000012729 immediate-release (IR) formulation Substances 0.000 description 1
230000002757 inflammatory effect Effects 0.000 description 1
238000012986 modification Methods 0.000 description 1
230000004048 modification Effects 0.000 description 1
229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
235000019796 monopotassium phosphate Nutrition 0.000 description 1
229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 description 1
229920001223 polyethylene glycol Polymers 0.000 description 1
GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 1
159000000001 potassium salts Chemical class 0.000 description 1
230000008569 process Effects 0.000 description 1
230000000069 prophylactic effect Effects 0.000 description 1
230000009467 reduction Effects 0.000 description 1
238000011160 research Methods 0.000 description 1
239000000377 silicon dioxide Substances 0.000 description 1
235000012239 silicon dioxide Nutrition 0.000 description 1
229910052708 sodium Inorganic materials 0.000 description 1
239000011734 sodium Substances 0.000 description 1
229940045902 sodium stearyl fumarate Drugs 0.000 description 1
239000008279 sol Substances 0.000 description 1
238000012360 testing method Methods 0.000 description 1
238000011287 therapeutic dose Methods 0.000 description 1
230000001225 therapeutic effect Effects 0.000 description 1
238000000870 ultraviolet spectroscopy Methods 0.000 description 1

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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
- 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
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
- 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
- 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
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
- 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
- A61P25/06—Antimigraine agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

Health & Medical Sciences (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
Public Health (AREA)
Life Sciences & Earth Sciences (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Bioinformatics & Cheminformatics (AREA)
Engineering & Computer Science (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Pain & Pain Management (AREA)
Biomedical Technology (AREA)
Neurology (AREA)
Neurosurgery (AREA)
Rheumatology (AREA)
Medicinal Preparation (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

HR1448/95A 1995-12-20 1996-12-19 Rapid release tablet comprising tolfenamic acid or a pharmaceutically acceptable salt thereof as active ingredient and a method of preparing such tablet HRP960598A2 (en)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
DK144895		1995-12-20

Publications (1)

Publication Number	Publication Date
HRP960598A2 true HRP960598A2 (en)	1998-02-28

Family

ID=8104933

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
HR1448/95A HRP960598A2 (en)	1995-12-20	1996-12-19	Rapid release tablet comprising tolfenamic acid or a pharmaceutically acceptable salt thereof as active ingredient and a method of preparing such tablet

Country Status (27)

Country	Link
US (1)	US6036975A (pt)
EP (1)	EP0869783B1 (pt)
JP (1)	JP2000515489A (pt)
CN (1)	CN1147295C (pt)
AR (1)	AR004395A1 (pt)
AT (1)	ATE234085T1 (pt)
AU (1)	AU1190097A (pt)
BR (1)	BR9612057A (pt)
CA (1)	CA2244396A1 (pt)
CZ (1)	CZ293422B6 (pt)
DE (1)	DE69626676T2 (pt)
DK (1)	DK0869783T3 (pt)
EE (1)	EE9800186A (pt)
ES (1)	ES2191781T3 (pt)
HR (1)	HRP960598A2 (pt)
HU (1)	HU224030B1 (pt)
IL (1)	IL124356A (pt)
MX (1)	MX9803918A (pt)
NO (1)	NO316869B1 (pt)
NZ (1)	NZ324674A (pt)
PL (1)	PL186915B1 (pt)
RO (1)	RO117589B1 (pt)
RU (1)	RU2166939C2 (pt)
TR (1)	TR199801126T2 (pt)
TW (1)	TW430561B (pt)
WO (1)	WO1997022340A1 (pt)
ZA (1)	ZA9610714B (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
SE9802973D0 (sv)	1998-09-03	1998-09-03	Astra Ab	Immediate release tablet
US6599530B2 (en) *	1998-09-14	2003-07-29	Orion Corporation	Oral compacted composition comprising catechol derivatives
IL150053A0 (en) *	1999-12-06	2002-12-01	Mendell Co Inc Edward	Pharmaceutical superdisintegrant
CA2311734C (en) *	2000-04-12	2011-03-08	Bristol-Myers Squibb Company	Flash-melt oral dosage formulation
WO2005028621A2 (en) *	2003-09-15	2005-03-31	Vitra Bioscience, Inc.	Assays with primary cells
US20070259829A1 (en) *	2006-03-24	2007-11-08	Maen Abdelrahim	Uses of diphenyl/diphenylamine carboxylic acids
TWI405574B (zh) *	2007-06-21	2013-08-21	Otsuka Pharma Co Ltd	藥學固體製劑及其製造方法
US8367427B2 (en) *	2008-08-20	2013-02-05	Baxter International Inc.	Methods of processing compositions containing microparticles
MX392941B (es) *	2016-09-07	2025-03-24	Celgene Corp	Composiciones para comprimidos.
CN111184707B (zh) *	2020-02-20	2021-04-27	中山大学	托芬那酸或其药学上可接受的盐在制备预防和/或治疗新型冠状病毒炎症药物中的应用

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE116061C (pt) *
FI89004C (fi) *	1988-02-16	1993-08-10	Pertti J Neuvonen	Anvaendning av tillsatsmedel foer oekning av absorptionshastigheten av laekemedel i orala laekemedelspreparat
JPH03501490A (ja) *	1988-09-16	1991-04-04	エス・アール・アイ・インターナシヨナル	８，１０‐ジデアザテトラヒドロ葉酸誘導体
IT1276689B1 (it) *	1995-06-09	1997-11-03	Applied Pharma Res	Forma farmaceutica solida ad uso orale

1996
- 1996-12-10 TW TW085115247A patent/TW430561B/zh active
- 1996-12-18 AR ARP960105763A patent/AR004395A1/es active IP Right Grant
- 1996-12-19 AU AU11900/97A patent/AU1190097A/en not_active Abandoned
- 1996-12-19 CN CNB961998652A patent/CN1147295C/zh not_active Expired - Fee Related
- 1996-12-19 RO RO98-01088A patent/RO117589B1/ro unknown
- 1996-12-19 DE DE69626676T patent/DE69626676T2/de not_active Expired - Fee Related
- 1996-12-19 DK DK96943021T patent/DK0869783T3/da active
- 1996-12-19 NZ NZ324674A patent/NZ324674A/xx unknown
- 1996-12-19 PL PL96327584A patent/PL186915B1/pl not_active IP Right Cessation
- 1996-12-19 WO PCT/DK1996/000548 patent/WO1997022340A1/en not_active Ceased
- 1996-12-19 ES ES96943021T patent/ES2191781T3/es not_active Expired - Lifetime
- 1996-12-19 HR HR1448/95A patent/HRP960598A2/hr not_active Application Discontinuation
- 1996-12-19 EE EE9800186A patent/EE9800186A/xx unknown
- 1996-12-19 CA CA002244396A patent/CA2244396A1/en not_active Abandoned
- 1996-12-19 BR BR9612057A patent/BR9612057A/pt not_active Application Discontinuation
- 1996-12-19 IL IL12435696A patent/IL124356A/en active IP Right Grant
- 1996-12-19 EP EP96943021A patent/EP0869783B1/en not_active Expired - Lifetime
- 1996-12-19 HU HU9903410A patent/HU224030B1/hu not_active IP Right Cessation
- 1996-12-19 JP JP09522437A patent/JP2000515489A/ja active Pending
- 1996-12-19 RU RU98113714/14A patent/RU2166939C2/ru active
- 1996-12-19 US US09/091,526 patent/US6036975A/en not_active Expired - Fee Related
- 1996-12-19 CZ CZ19981943A patent/CZ293422B6/cs not_active IP Right Cessation
- 1996-12-19 ZA ZA9610714A patent/ZA9610714B/xx unknown
- 1996-12-19 AT AT96943021T patent/ATE234085T1/de not_active IP Right Cessation
- 1996-12-19 TR TR1998/01126T patent/TR199801126T2/xx unknown
1998
- 1998-05-18 MX MX9803918A patent/MX9803918A/es unknown
- 1998-06-19 NO NO19982875A patent/NO316869B1/no not_active IP Right Cessation

Also Published As

Publication number	Publication date
PL327584A1 (en)	1998-12-21
TR199801126T2 (xx)	1998-08-21
IL124356A0 (en)	1998-12-06
CZ194398A3 (cs)	1998-11-11
NO982875D0 (no)	1998-06-19
CN1208345A (zh)	1999-02-17
RU2166939C2 (ru)	2001-05-20
DE69626676T2 (de)	2003-12-18
WO1997022340A1 (en)	1997-06-26
DE69626676D1 (de)	2003-04-17
EE9800186A (et)	1998-12-15
HUP9903410A3 (en)	2000-05-29
HU224030B1 (hu)	2005-05-30
ZA9610714B (en)	1997-06-30
TW430561B (en)	2001-04-21
HUP9903410A2 (hu)	2000-04-28
MX9803918A (es)	1998-09-30
CN1147295C (zh)	2004-04-28
PL186915B1 (pl)	2004-03-31
NO316869B1 (no)	2004-06-07
RO117589B1 (ro)	2002-05-30
US6036975A (en)	2000-03-14
AU1190097A (en)	1997-07-14
DK0869783T3 (da)	2003-06-02
EP0869783B1 (en)	2003-03-12
IL124356A (en)	2001-05-20
JP2000515489A (ja)	2000-11-21
EP0869783A1 (en)	1998-10-14
NO982875L (no)	1998-08-19
NZ324674A (en)	2000-01-28
AR004395A1 (es)	1998-11-04
CA2244396A1 (en)	1997-06-26
BR9612057A (pt)	1999-02-23
ATE234085T1 (de)	2003-03-15
CZ293422B6 (cs)	2004-04-14
ES2191781T3 (es)	2003-09-16

Legal Events

Date	Code	Title	Description
1998-02-28	A1OB	Publication of a patent application
1999-05-07	ODBC	Application rejected

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HRP960598A2 (en)	1998-02-28	Rapid release tablet comprising tolfenamic acid or a pharmaceutically acceptable salt thereof as active ingredient and a method of preparing such tablet
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