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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Canada
Prior art keywords
testosterone
gel
tbs
dose
study
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Application number
CA3034552A
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English (en)
French (fr)
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CA3034552A1 (en
Inventor
Wayne KREPPNER
Siobhan Fogarty
Werner Oberegger
Paul Jose Pierre Marie Maes
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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

    • 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
    • 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
    • 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
    • A61K47/44Oils, 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)
  • 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
CA2836398A Active CA2836398C (en) 2011-05-15 2012-05-15 Intranasal testosterone bio-adhesive gel formulations and use thereof for treating male hypogonadism
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

Family Applications After (2)

Application Number Title Priority Date Filing Date
CA2836398A Active CA2836398C (en) 2011-05-15 2012-05-15 Intranasal testosterone bio-adhesive gel formulations and use thereof for treating male hypogonadism
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

Country Status (16)

Country Link
EP (3) EP3977982A1 (cg-RX-API-DMAC7.html)
JP (9) JP6152092B2 (cg-RX-API-DMAC7.html)
KR (10) KR102568894B1 (cg-RX-API-DMAC7.html)
CN (4) CN103796636B (cg-RX-API-DMAC7.html)
AR (2) AR089553A1 (cg-RX-API-DMAC7.html)
AU (11) AU2012257492A1 (cg-RX-API-DMAC7.html)
BR (2) BR112013029332A2 (cg-RX-API-DMAC7.html)
CA (3) CA3034552C (cg-RX-API-DMAC7.html)
DK (1) DK2714006T3 (cg-RX-API-DMAC7.html)
EA (1) EA201391701A1 (cg-RX-API-DMAC7.html)
ES (1) ES2859784T3 (cg-RX-API-DMAC7.html)
IL (2) IL229400A0 (cg-RX-API-DMAC7.html)
MX (4) MX395212B (cg-RX-API-DMAC7.html)
PL (1) PL2714006T3 (cg-RX-API-DMAC7.html)
WO (2) WO2012156822A1 (cg-RX-API-DMAC7.html)
ZA (2) ZA201309265B (cg-RX-API-DMAC7.html)

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EA201391701A1 (ru) * 2011-05-15 2014-04-30 Тримел Биофарма Дрл ŠŠ°Š·Š°Š»ŃŒŠ½Ń‹Šµ тестостероновые гели с ŠŗŠ¾Š½Ń‚Ń€Š¾Š»ŠøŃ€ŃƒŠµŠ¼Ń‹Š¼ высвобожГением, способы ŠæŠµŃ€Š½Š°Š·Š°Š»ŃŒŠ½Š¾Š³Š¾ Š²Š²ŠµŠ“ŠµŠ½ŠøŃ Šø ŠæŃ€ŠµŠ“Š²Š°Ń€ŠøŃ‚ŠµŠ»ŃŒŠ½Š¾ заполненные многоГозные аппликаторные системы Š“Š»Ń ŠæŠµŃ€Š½Š°Š·Š°Š»ŃŒŠ½Š¾Š³Š¾ Š²Š²ŠµŠ“ŠµŠ½ŠøŃ

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