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ES2531646T3 - Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágeno - Google Patents

Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágeno
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Publication number
ES2531646T3
ES2531646T3ES11717561.2TES11717561TES2531646T3ES 2531646 T3ES2531646 T3ES 2531646T3ES 11717561 TES11717561 TES 11717561TES 2531646 T3ES2531646 T3ES 2531646T3
Authority
ES
Spain
Prior art keywords
weight
vol
progestogen
low oil
emulsion compositions
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
Application number
ES11717561.2T
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English (en)
Inventor
Laura Pickersgill
Eva-Maria Di Hoiser
Georg Achleitner
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Besins Healthcare Luxembourg SARL
Original Assignee
Besins Healthcare Luxembourg SARL
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.)
Filing date
Publication date
Application filed by Besins Healthcare Luxembourg SARLfiledCriticalBesins Healthcare Luxembourg SARL
Application grantedgrantedCritical
Publication of ES2531646T3publicationCriticalpatent/ES2531646T3/es
Activelegal-statusCriticalCurrent
Anticipated expirationlegal-statusCritical

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Abstract

Una composición de emulsión aceite en agua farmacéutica, estéril, lista para su uso, para administración por vía parenteral que comprende: * 0.015 a 0.5% en peso/vol., preferiblemente de 0.05 a 0.4% en peso/vol. de progesterona; * 0.5 a 10% en peso/vo l. de aceite, en donde el aceite comprende al menos 85% en peso/peso de triglicéridos; * 0.0425 a 4.1% en peso/vol., preferiblemente de 0.064 a 3.4% en peso/vol. de fosfolípido; * 80 a 99.4% en peso/vol. de medio acuoso; en donde la composición tiene una osmolalidad en el intervalo de 200-1000 mOsm/kg, y en donde la emulsión contiene no más de 1.2% en peso/peso de polietilenglicol 15-hidroxiestearato.

Description

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EJEMPLO 4B
NO ESTÉRIL ESTERILIZADO 1x ESTERILIZADO 2x ESTERILIZADO 3x 3 SEMANAS, 60°C 4 SEMANAS, 60°C
MASTERSIZER UNIFORMIDAD
0.587 0.587 0.590 0.589 0.590 0.583
MASTERSIZER d(0,5) [M]
0.176 0.176 0.174 0.175 0.174 0.179
ACCUSIZER [%]
0.02 0.02 0.03 0.02 0.02 0.02
VALOR DE PH
8.3 7.9 7.6 7.4 6.4 6.5
EJEMPLO 4C
NO ESTÉRIL ESTERILIZADO 1x ESTERILIZADO 2x ESTERILIZADO 3x 3 SEMANAS, 60°C 4 SEMANAS, 60°C
Apariencia
BLANCO,HOMOGÉNEO BLANCO,HOMOGÉNEO BLANCO,HOMOGÉNEO BLANCO,HOMOGÉNEO BLANCO,HOMOGÉNEO BLANCO,HOMOGÉNEO
CONTROL VISUAL
SIN PARTÍCULAS SIN PARTÍCULAS SIN PARTÍCULAS SIN PARTÍCULAS SIN PARTÍCULAS SIN PARTÍCULAS
MASTERSIZER D[4,3] [M]
0.228 0.229 0.228 0.229 0.232 0.227
MASTERSIZER SPAN
2.065 2.059 2.069 2.066 2.041 2.069
MASTERSIZER UNIFORMIDAD
0.633 0.632 0.635 0.635 0.628 0.637
MASTERSIZER d(0.5) [M]
0.181 0.182 0.180 0.182 0.185 0.80
ACCUSIZER [%] (USP 729)
0.01 0.01 0.03 0.01 0.02 0.02
VALOR DE PH
8.2 8.0 7.8 7.6 7.2 6.8
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Claims (1)

ES11717561.2T2010-04-262011-04-26Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágenoActiveES2531646T3 (es)

Applications Claiming Priority (25)

Application NumberPriority DateFiling DateTitle
US32795910P2010-04-262010-04-26
US32796310P2010-04-262010-04-26
US32796810P2010-04-262010-04-26
EP101610342010-04-26
EP101610342010-04-26
EP101610322010-04-26
EP101610322010-04-26
US327968P2010-04-26
EP101610292010-04-26
EP101610292010-04-26
US327959P2010-04-26
US327963P2010-04-26
US201061424411P2010-12-172010-12-17
US201061424407P2010-12-172010-12-17
US201061424402P2010-12-172010-12-17
EP101957642010-12-17
EP101957602010-12-17
EP101957662010-12-17
EP101957662010-12-17
EP101957642010-12-17
EP101957602010-12-17
US424411P2010-12-17
US424402P2010-12-17
US424407P2010-12-17
PCT/EP2011/056548WO2011134944A2 (en)2010-04-262011-04-26Low-oil pharmaceutical emulsion compositions comprising progestogen

Publications (1)

Publication NumberPublication Date
ES2531646T3true ES2531646T3 (es)2015-03-18

Family

ID=44001967

Family Applications (4)

Application NumberTitlePriority DateFiling Date
ES14176970.3TActiveES2576190T3 (es)2010-04-262011-04-26Composiciones farmacéuticas de emulsión que comprenden progestógeno
ES14196653.1TActiveES2606585T3 (es)2010-04-262011-04-26Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágeno
ES11717561.2TActiveES2531646T3 (es)2010-04-262011-04-26Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágeno
ES11716893.0TActiveES2514690T3 (es)2010-04-262011-04-26Composiciones farmacéuticas de emulsión que comprenden progestógeno

Family Applications Before (2)

Application NumberTitlePriority DateFiling Date
ES14176970.3TActiveES2576190T3 (es)2010-04-262011-04-26Composiciones farmacéuticas de emulsión que comprenden progestógeno
ES14196653.1TActiveES2606585T3 (es)2010-04-262011-04-26Composiciones de emulsión farmacéuticas con bajo contenido de aceite que comprenden progestágeno

Family Applications After (1)

Application NumberTitlePriority DateFiling Date
ES11716893.0TActiveES2514690T3 (es)2010-04-262011-04-26Composiciones farmacéuticas de emulsión que comprenden progestógeno

Country Status (23)

CountryLink
US (4)US8476252B2 (es)
EP (4)EP2857042B1 (es)
JP (1)JP5886273B2 (es)
KR (1)KR101822680B1 (es)
CN (2)CN102946865B (es)
AR (1)AR081542A1 (es)
AU (1)AU2011246527B2 (es)
BR (1)BR112012027279B1 (es)
CA (2)CA2797253C (es)
EA (1)EA022460B1 (es)
ES (4)ES2576190T3 (es)
GE (1)GEP20166457B (es)
HK (1)HK1181998A1 (es)
IL (2)IL222710A (es)
MX (1)MX2012012491A (es)
MY (1)MY156858A (es)
NZ (1)NZ603176A (es)
PH (1)PH12012502120B1 (es)
PL (1)PL2563335T3 (es)
PT (1)PT2563335E (es)
SG (1)SG185025A1 (es)
TW (1)TW201138782A (es)
WO (2)WO2011134937A2 (es)

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US20180207097A1 (en)*2017-01-232018-07-26Government Of The United States As Represented By The Secretary Of The Air ForceNon-toxic vehicle to solubilize, deliver, and obtain biological activity of steroid hormones at cell, tissue, and organ targets, in vitro and in vivo
EP3574116A1 (en)2017-01-242019-12-04The Broad Institute, Inc.Compositions and methods for detecting a mutant variant of a polynucleotide
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Also Published As

Publication numberPublication date
CA2797253A1 (en)2011-11-03
CA2797141A1 (en)2011-11-03
CA2797141C (en)2018-05-15
WO2011134944A2 (en)2011-11-03
ES2606585T3 (es)2017-03-24
NZ603176A (en)2014-05-30
WO2011134937A2 (en)2011-11-03
EA201291108A1 (ru)2013-04-30
PT2563335E (pt)2015-03-31
WO2011134944A3 (en)2012-02-09
KR20130069638A (ko)2013-06-26
WO2011134937A3 (en)2012-02-02
KR101822680B1 (ko)2018-01-26
ES2576190T3 (es)2016-07-06
EP2801353B1 (en)2016-03-30
US20110262494A1 (en)2011-10-27
US20140335133A1 (en)2014-11-13
PL2563335T3 (pl)2015-05-29
TW201138782A (en)2011-11-16
AU2011246527B2 (en)2016-09-15
CA2797253C (en)2019-02-05
MX2012012491A (es)2013-02-15
IL222738A (en)2015-11-30
IL222710A0 (en)2012-12-31
PH12012502120B1 (en)2018-01-12
BR112012027279B1 (pt)2020-12-29
US8476252B2 (en)2013-07-02
BR112012027279A2 (pt)2018-05-15
MY156858A (en)2016-04-15
US8765149B2 (en)2014-07-01
GEP20166457B (en)2016-04-11
SG185025A1 (en)2012-11-29
JP2013525402A (ja)2013-06-20
AR081542A1 (es)2012-10-03
IL222738A0 (en)2012-12-31
JP5886273B2 (ja)2016-03-16
IL222710A (en)2015-11-30
PH12012502120A1 (en)2013-02-04
EP2563334B1 (en)2014-07-16
US20110262495A1 (en)2011-10-27
EP2801353A1 (en)2014-11-12
EP2857042A1 (en)2015-04-08
EA022460B1 (ru)2016-01-29
CN102946865B (zh)2016-06-22
CN102946864A (zh)2013-02-27
US20140147474A1 (en)2014-05-29
CN102946865A (zh)2013-02-27
EP2857042B1 (en)2016-08-31
US9572818B2 (en)2017-02-21
EP2563335B1 (en)2014-12-17
EP2563335A2 (en)2013-03-06
ES2514690T3 (es)2014-10-28
EP2563334A2 (en)2013-03-06
AU2011246527A1 (en)2012-11-15
HK1181998A1 (en)2013-11-22

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