CA3034552C - Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration - Google Patents

Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration Download PDF

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Publication number
CA3034552C
CA3034552C CA3034552A CA3034552A CA3034552C CA 3034552 C CA3034552 C CA 3034552C CA 3034552 A CA3034552 A CA 3034552A CA 3034552 A CA3034552 A CA 3034552A CA 3034552 C CA3034552 C CA 3034552C
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CA
Canada
Prior art keywords
testosterone
gel
tbs
dose
study
Prior art date
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Active
Application number
CA3034552A
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English (en)
French (fr)
Other versions
CA3034552A1 (en
Inventor
Wayne KREPPNER
Siobhan Fogarty
Werner Oberegger
Paul Jose Pierre Marie Maes
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.)
Acerus Biopharma Inc
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Acerus Biopharma Inc
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Publication of CA3034552A1 publication Critical patent/CA3034552A1/en
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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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds 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
    • A61K31/568—Compounds 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, 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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0043—Nose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M31/00—Devices 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (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)
  • Psychiatry (AREA)
  • Pain & Pain Management (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)
CA3034552A 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration Active CA3034552C (en)

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
CA2836405A CA2836405C (en) 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2836405A Division CA2836405C (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
CA3034552A1 CA3034552A1 (en) 2012-11-22
CA3034552C true CA3034552C (en) 2023-02-07

Family

ID=46579248

Family Applications (3)

Application Number Title Priority Date Filing Date
CA3034552A Active CA3034552C (en) 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration
CA2836405A Active CA2836405C (en) 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration
CA2836398A Active CA2836398C (en) 2011-05-15 2012-05-15 Intranasal testosterone bio-adhesive gel formulations and use thereof for treating male hypogonadism

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA2836405A Active CA2836405C (en) 2011-05-15 2012-05-15 Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration
CA2836398A Active CA2836398C (en) 2011-05-15 2012-05-15 Intranasal testosterone bio-adhesive gel formulations and use thereof for treating male hypogonadism

Country Status (16)

Country Link
EP (3) EP3977982A1 (enExample)
JP (9) JP6152092B2 (enExample)
KR (10) KR20230041081A (enExample)
CN (4) CN103813784A (enExample)
AR (2) AR086409A1 (enExample)
AU (11) AU2012257492A1 (enExample)
BR (2) BR112013029332A2 (enExample)
CA (3) CA3034552C (enExample)
DK (1) DK2714006T3 (enExample)
EA (1) EA201391701A1 (enExample)
ES (1) ES2859784T3 (enExample)
IL (2) IL229401A0 (enExample)
MX (4) MX2013013369A (enExample)
PL (1) PL2714006T3 (enExample)
WO (2) WO2012156822A1 (enExample)
ZA (2) ZA201309265B (enExample)

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Also Published As

Publication number Publication date
EP3977982A1 (en) 2022-04-06
AU2017204182A1 (en) 2017-07-20
KR20210135003A (ko) 2021-11-11
CN103813784A (zh) 2014-05-21
AU2020267162A1 (en) 2020-12-03
AU2012257490A1 (en) 2013-12-19
KR20190006194A (ko) 2019-01-17
EP2714006B1 (en) 2020-12-09
AR086409A1 (es) 2013-12-11
WO2012156820A1 (en) 2012-11-22
JP2022105175A (ja) 2022-07-12
AU2012257492A1 (en) 2013-12-19
JP2020079257A (ja) 2020-05-28
JP2021001206A (ja) 2021-01-07
KR20200028503A (ko) 2020-03-16
EP2709588B1 (en) 2021-08-25
CA2836398A1 (en) 2012-11-22
EA201391701A1 (ru) 2014-04-30
IL229400A0 (en) 2014-01-30
CN109481394B (zh) 2023-05-05
KR20140033408A (ko) 2014-03-18
KR102568894B1 (ko) 2023-08-21
ZA201309264B (en) 2015-09-30
AR089553A1 (es) 2014-09-03
JP7017254B2 (ja) 2022-02-08
AU2020267162B2 (en) 2022-06-09
KR20200118228A (ko) 2020-10-14
DK2714006T3 (da) 2021-03-15
AU2019203067A1 (en) 2019-05-23
MX2019003340A (es) 2019-07-04
CN109481394A (zh) 2019-03-19
ZA201309265B (en) 2016-01-27
KR20140045400A (ko) 2014-04-16
PL2714006T4 (pl) 2021-08-16
MX363561B (es) 2019-03-27
BR112013029332A2 (pt) 2021-06-01
KR20190117803A (ko) 2019-10-16
BR112013029336B1 (pt) 2021-11-30
CA2836398C (en) 2021-12-14
KR20230041081A (ko) 2023-03-23
CA3034552A1 (en) 2012-11-22
CA2836405A1 (en) 2012-11-22
JP6152092B2 (ja) 2017-06-28
AU2017203470A1 (en) 2017-06-22
AU2019201618A1 (en) 2019-04-18
CN103796636A (zh) 2014-05-14
JP2018199701A (ja) 2018-12-20
EP2709588A1 (en) 2014-03-26
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