BR112013029332A2 - formulações de gel bioadesivas de testosterona intranasais e uso das mesmas para tratar hipogonadismo de indivíduo do sexo masculino - Google Patents

formulações de gel bioadesivas de testosterona intranasais e uso das mesmas para tratar hipogonadismo de indivíduo do sexo masculino Download PDF

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Publication number
BR112013029332A2
BR112013029332A2 BR112013029332-2A BR112013029332A BR112013029332A2 BR 112013029332 A2 BR112013029332 A2 BR 112013029332A2 BR 112013029332 A BR112013029332 A BR 112013029332A BR 112013029332 A2 BR112013029332 A2 BR 112013029332A2
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BR
Brazil
Prior art keywords
testosterone
gel formulation
gel
treatment
viscosity
Prior art date
Application number
BR112013029332-2A
Other languages
English (en)
Portuguese (pt)
Inventor
Wayne Kreppner
Siobhan Fogarty
Werner Oberegger
Paul José Pierre Marie Maes
Original Assignee
Trimel Biopharma Srl
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 Trimel Biopharma Srl filed Critical Trimel Biopharma Srl
Publication of BR112013029332A2 publication Critical patent/BR112013029332A2/pt

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    • 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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
  • Pain & Pain Management (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pregnancy & Childbirth (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)
BR112013029332-2A 2011-05-15 2012-05-15 formulações de gel bioadesivas de testosterona intranasais e uso das mesmas para tratar hipogonadismo de indivíduo do sexo masculino BR112013029332A2 (pt)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161486324P 2011-05-15 2011-05-15
US61/486,324 2011-05-15
US201161486634P 2011-05-16 2011-05-16
US61/486,634 2011-05-16
PCT/IB2012/001112 WO2012156820A1 (en) 2011-05-15 2012-05-15 Intranasal testosterone bio-adhesive gel formulations and use thereof for treating male hypogonadism

Publications (1)

Publication Number Publication Date
BR112013029332A2 true BR112013029332A2 (pt) 2021-06-01

Family

ID=46579248

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112013029336-5A BR112013029336B1 (pt) 2011-05-15 2012-05-15 Gel de testosterona intranasal de liberação controlada, sistema aplicador e uso
BR112013029332-2A BR112013029332A2 (pt) 2011-05-15 2012-05-15 formulações de gel bioadesivas de testosterona intranasais e uso das mesmas para tratar hipogonadismo de indivíduo do sexo masculino

Family Applications Before (1)

Application Number Title Priority Date Filing Date
BR112013029336-5A BR112013029336B1 (pt) 2011-05-15 2012-05-15 Gel de testosterona intranasal de liberação controlada, sistema aplicador e uso

Country Status (16)

Country Link
EP (3) EP2714006B1 (enExample)
JP (9) JP2014513716A (enExample)
KR (10) KR20200118228A (enExample)
CN (4) CN109481394B (enExample)
AR (2) AR089553A1 (enExample)
AU (11) AU2012257490A1 (enExample)
BR (2) BR112013029336B1 (enExample)
CA (3) CA3034552C (enExample)
DK (1) DK2714006T3 (enExample)
EA (1) EA201391701A1 (enExample)
ES (1) ES2859784T3 (enExample)
IL (2) IL229401A0 (enExample)
MX (4) MX363561B (enExample)
PL (1) PL2714006T3 (enExample)
WO (2) WO2012156822A1 (enExample)
ZA (2) ZA201309264B (enExample)

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AU2017204182A1 (en) 2017-07-20
WO2012156820A9 (en) 2014-02-20
JP2018199701A (ja) 2018-12-20
JP2022078222A (ja) 2022-05-24
KR20190117803A (ko) 2019-10-16
AU2022202402A1 (en) 2022-05-12
MX363561B (es) 2019-03-27
KR102568894B1 (ko) 2023-08-21
CA2836405C (en) 2021-09-07
AU2012257492A1 (en) 2013-12-19
KR20210029849A (ko) 2021-03-16
BR112013029336B1 (pt) 2021-11-30
MX2020008599A (es) 2022-08-31
KR102088038B1 (ko) 2020-03-13
IL229400A0 (en) 2014-01-30
AR089553A1 (es) 2014-09-03
PL2714006T4 (pl) 2021-08-16
CN109481394A (zh) 2019-03-19
KR20200028503A (ko) 2020-03-16
AU2020267162B2 (en) 2022-06-09
AU2024216312A1 (en) 2024-10-24
CA3034552A1 (en) 2012-11-22
JP2014513716A (ja) 2014-06-05
ZA201309265B (en) 2016-01-27
KR20240162608A (ko) 2024-11-15
AU2019201618A1 (en) 2019-04-18
CA3034552C (en) 2023-02-07
KR20210135003A (ko) 2021-11-11
JP6594924B2 (ja) 2019-10-23
MX2013013369A (es) 2014-10-17
KR20190006194A (ko) 2019-01-17
KR20230041081A (ko) 2023-03-23
AU2019203067A1 (en) 2019-05-23
AU2020210227A1 (en) 2020-08-20
PL2714006T3 (pl) 2021-08-16
IL229401A0 (en) 2014-01-30
CN109481394B (zh) 2023-05-05
BR112013029336A2 (pt) 2020-08-11
CN103813784A (zh) 2014-05-21
JP2017160204A (ja) 2017-09-14
WO2012156820A1 (en) 2012-11-22
MX374398B (es) 2025-03-06
AU2019203400A1 (en) 2019-08-01
ES2859784T3 (es) 2021-10-04
MX2019003340A (es) 2019-07-04
AU2017203470A1 (en) 2017-06-22
JP2020079257A (ja) 2020-05-28
CN103796636B (zh) 2019-04-05
DK2714006T3 (da) 2021-03-15
AU2020267162A1 (en) 2020-12-03
EP2709588B1 (en) 2021-08-25
CA2836398C (en) 2021-12-14
EA201391701A1 (ru) 2014-04-30
CN103796636A (zh) 2014-05-14
JP2021001206A (ja) 2021-01-07
EP2714006A1 (en) 2014-04-09
AR086409A1 (es) 2013-12-11
KR20140045400A (ko) 2014-04-16
MX2013013388A (es) 2014-09-15
CA2836405A1 (en) 2012-11-22
JP2020073469A (ja) 2020-05-14
EP2714006B1 (en) 2020-12-09
KR20200118228A (ko) 2020-10-14
JP6152092B2 (ja) 2017-06-28
JP7017254B2 (ja) 2022-02-08
EP3977982A1 (en) 2022-04-06
JP2022105175A (ja) 2022-07-12
WO2012156822A1 (en) 2012-11-22
EP2709588A1 (en) 2014-03-26
AU2012257490A1 (en) 2013-12-19
ZA201309264B (en) 2015-09-30
CN110613679A (zh) 2019-12-27
MX395212B (es) 2025-03-21
CA2836398A1 (en) 2012-11-22
KR20140033408A (ko) 2014-03-18
JP2014515038A (ja) 2014-06-26

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