MX374398B - Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal. - Google Patents

Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal.

Info

Publication number
MX374398B
MX374398B MX2019003340A MX2019003340A MX374398B MX 374398 B MX374398 B MX 374398B MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 374398 B MX374398 B MX 374398B
Authority
MX
Mexico
Prior art keywords
testosterone
low
sexual
present
gels
Prior art date
Application number
MX2019003340A
Other languages
English (en)
Other versions
MX2019003340A (es
Inventor
Paul José Pierre Marie MAES
Siobhan Fogarty
Wayne Kreppner
Werner Oberegger
Original Assignee
Acerus Biopharma Inc
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 Acerus Biopharma Inc filed Critical Acerus Biopharma Inc
Publication of MX2019003340A publication Critical patent/MX2019003340A/es
Publication of MX374398B publication Critical patent/MX374398B/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/568Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10Drugs for genital or sexual disorders; Contraceptives for impotence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26Androgens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Otolaryngology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a geles de testosterona intranasal para la liberación controlada de testosterona en la circulación sistémica de hombres y mujeres para proveer niveles sanguíneos efectivos constantes de testosterona, sin inducir picos repentinos indeseados de testosterona en los niveles sanguíneos, después de la administración pernasal. Los geles de testosterona intranasal de la presente invención son seguros, convenientes para usar, bien tolerados, estables y de elaboración fácil y reproducible a gran escala. Además, como se cree que el nivel sanguíneo supra-normal y sub-normal de testosterona se mantiene esencialmente en un mínimo o se evitan y los niveles séricos de testosterona se mantienen esencialmente constantes durante la vida útil de la dosis, es decir, los geles de testosterona intranasal de la presente invención reproducen o restauran los niveles sanguíneos de testosterona a los niveles de testosterona rítmicos diarios fisiológicos normales, los nuevos geles de testosterona intranasal de la presente invención son especialmente adecuados para la terapia suplementaria o de reemplazo de testosterona y efectivos para el tratamiento de hombres en los que se diagnosticó, por ejemplo, deficiencia de testosterona en el hombre, tal como, baja libido sexual, bajo impulso sexual, baja actividad sexual, baja fertilidad, baja espermatogénesis, aspermatogénesis, depresión y/o hipogonadismo, y mujeres en las que se diagnosticó, por ejemplo, disfunción sexual femenina, tal como, baja libido sexual, bajo impulso sexual, baja actividad sexual, baja reactividad de las amígdalas, baja estimulación sexual, enfermedad del deseo sexual hipoactivo (''HSDD"), trastorno del impulso sexual femenino y/o anorgasmia. La presente invención también se refiere a métodos y a sistemas de aplicadores sin aire, de múltiples dosis, prellenados para la administración pernasal del gel de testosterona nasal de la presente invención.
MX2019003340A 2011-05-15 2012-05-15 Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal. MX374398B (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161486324P 2011-05-15 2011-05-15
US201161486634P 2011-05-16 2011-05-16
PCT/IB2012/001127 WO2012156822A1 (en) 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration

Publications (2)

Publication Number Publication Date
MX2019003340A MX2019003340A (es) 2019-07-04
MX374398B true MX374398B (es) 2025-03-06

Family

ID=46579248

Family Applications (4)

Application Number Title Priority Date Filing Date
MX2013013369A MX2013013369A (es) 2011-05-15 2012-05-15 Formulaciones de gel bioadhesivo de testosterona intranasal y uso del mismo para tratar hipogonadismo masculino.
MX2013013388A MX363561B (es) 2011-05-15 2012-05-15 Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal.
MX2019003340A MX374398B (es) 2011-05-15 2012-05-15 Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal.
MX2020008599A MX395212B (es) 2011-05-15 2012-05-15 Geles nasales de liberación controlada de testosterona, métodos y sistemas aplicadores multidosis pre cargados para administración pernasal.

Family Applications Before (2)

Application Number Title Priority Date Filing Date
MX2013013369A MX2013013369A (es) 2011-05-15 2012-05-15 Formulaciones de gel bioadhesivo de testosterona intranasal y uso del mismo para tratar hipogonadismo masculino.
MX2013013388A MX363561B (es) 2011-05-15 2012-05-15 Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion pernasal.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2020008599A MX395212B (es) 2011-05-15 2012-05-15 Geles nasales de liberación controlada de testosterona, métodos y sistemas aplicadores multidosis pre cargados para administración pernasal.

Country Status (16)

Country Link
EP (3) EP3977982A1 (es)
JP (9) JP6152092B2 (es)
KR (10) KR20140045400A (es)
CN (4) CN109481394B (es)
AR (2) AR089553A1 (es)
AU (11) AU2012257492A1 (es)
BR (2) BR112013029332A2 (es)
CA (3) CA3034552C (es)
DK (1) DK2714006T3 (es)
EA (1) EA201391701A1 (es)
ES (1) ES2859784T3 (es)
IL (2) IL229400A0 (es)
MX (4) MX2013013369A (es)
PL (1) PL2714006T4 (es)
WO (2) WO2012156822A1 (es)
ZA (2) ZA201309265B (es)

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Also Published As

Publication number Publication date
AU2024216312A1 (en) 2024-10-24
CN109481394A (zh) 2019-03-19
MX2013013369A (es) 2014-10-17
JP2020079257A (ja) 2020-05-28
JP2021001206A (ja) 2021-01-07
AR089553A1 (es) 2014-09-03
KR20200118228A (ko) 2020-10-14
MX2013013388A (es) 2014-09-15
DK2714006T3 (da) 2021-03-15
JP7017254B2 (ja) 2022-02-08
EP3977982A1 (en) 2022-04-06
PL2714006T3 (pl) 2021-08-16
WO2012156822A1 (en) 2012-11-22
EP2714006A1 (en) 2014-04-09
KR20200028503A (ko) 2020-03-16
JP2014513716A (ja) 2014-06-05
EP2714006B1 (en) 2020-12-09
EA201391701A1 (ru) 2014-04-30
EP2709588B1 (en) 2021-08-25
AU2022202402A1 (en) 2022-05-12
BR112013029336B1 (pt) 2021-11-30
AU2017203470A1 (en) 2017-06-22
AU2020267162B2 (en) 2022-06-09
AU2012257490A1 (en) 2013-12-19
MX395212B (es) 2025-03-21
CN109481394B (zh) 2023-05-05
JP2020073469A (ja) 2020-05-14
JP2014515038A (ja) 2014-06-26
CN103796636B (zh) 2019-04-05
ZA201309265B (en) 2016-01-27
KR102568894B1 (ko) 2023-08-21
JP2017160204A (ja) 2017-09-14
AU2019203400A1 (en) 2019-08-01
IL229400A0 (en) 2014-01-30
KR20140045400A (ko) 2014-04-16
CA2836398C (en) 2021-12-14
PL2714006T4 (pl) 2021-08-16
AU2012257492A1 (en) 2013-12-19
AR086409A1 (es) 2013-12-11
CN110613679A (zh) 2019-12-27
JP2022105175A (ja) 2022-07-12
MX2020008599A (es) 2022-08-31
BR112013029332A2 (pt) 2021-06-01
CA3034552C (en) 2023-02-07
JP6152092B2 (ja) 2017-06-28
CN103813784A (zh) 2014-05-21
KR20230041081A (ko) 2023-03-23
JP6594924B2 (ja) 2019-10-23
JP2018199701A (ja) 2018-12-20
IL229401A0 (en) 2014-01-30
CA2836405A1 (en) 2012-11-22
MX363561B (es) 2019-03-27
CA3034552A1 (en) 2012-11-22
KR102088038B1 (ko) 2020-03-13
EP2709588A1 (en) 2014-03-26
BR112013029336A2 (pt) 2020-08-11
KR20190117803A (ko) 2019-10-16
AU2020267162A1 (en) 2020-12-03
KR20140033408A (ko) 2014-03-18
MX2019003340A (es) 2019-07-04
CA2836405C (en) 2021-09-07
KR20240162608A (ko) 2024-11-15
WO2012156820A1 (en) 2012-11-22
CN103796636A (zh) 2014-05-14
KR20210029849A (ko) 2021-03-16
AU2019203067A1 (en) 2019-05-23
AU2017204182A1 (en) 2017-07-20
WO2012156820A9 (en) 2014-02-20
ZA201309264B (en) 2015-09-30
KR20210135003A (ko) 2021-11-11
ES2859784T3 (es) 2021-10-04
AU2019201618A1 (en) 2019-04-18
JP2022078222A (ja) 2022-05-24
KR20190006194A (ko) 2019-01-17
AU2020210227A1 (en) 2020-08-20
CA2836398A1 (en) 2012-11-22

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