EA201391701A1 - Назальные тестостероновые гели с контролируемым высвобождением, способы перназального введения и предварительно заполненные многодозные аппликаторные системы для перназального введения - Google Patents
Назальные тестостероновые гели с контролируемым высвобождением, способы перназального введения и предварительно заполненные многодозные аппликаторные системы для перназального введенияInfo
- Publication number
- EA201391701A1 EA201391701A1 EA201391701A EA201391701A EA201391701A1 EA 201391701 A1 EA201391701 A1 EA 201391701A1 EA 201391701 A EA201391701 A EA 201391701A EA 201391701 A EA201391701 A EA 201391701A EA 201391701 A1 EA201391701 A1 EA 201391701A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- testosterone
- low
- introduction
- levels
- gels
- Prior art date
Links
Classifications
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- 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
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- 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
- 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
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- 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)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (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)
- Neurosurgery (AREA)
- Pregnancy & Childbirth (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)
Abstract
Настоящее изобретение относится к интраназальным тестостероновым гелям для контролируемого высвобождения тестостерона в системный кровоток субъектов мужского и женского пола с обеспечением постоянных эффективных уровней тестостерона в крови, не вызывающих нежелательные всплески тестостерона в крови после перназального введения. Интраназальные тестостероновые гели согласно настоящему изобретению безопасны, удобны в использовании, хорошо переносятся, стабильны и их можно легко и воспроизводимо получать в увеличенном масштабе. Кроме того, так как считается, что уровни тестостерона выше нормальных и ниже нормальных предположительно сведены, по существу, к минимуму или избегаются, а уровни тестостерона в сыворотке предположительно остаются, по существу, постоянными в течение периода выведения дозы, т.е. интраназальные тестостероновые гели согласно настоящему изобретению имитируют или восстанавливают уровни тестостерона в крови до нормальных физиологических уровней тестостерона с ежесуточным ритмом, указанные новые интраназальные тестостероновые гели очень хорошо подходят для заместительной или дополнительной терапии тестостероном и эффективны для лечения субъектов мужского пола, у которых диагностирован, например, дефицит тестостерона, в частности низкое либидо, низкое половое влечение, низкая сексуальная активность, низкая фертильность, низкий сперматогенез, асперматогенез, депрессия и/или гипогонадизм, и субъектов женского пола, у которых диагностирована, например, женская сексуальная дисфункция, в частности низкое либидо, низкое половое влечение, низкая сексуальная активность, низкая
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 (1)
| Publication Number | Publication Date |
|---|---|
| EA201391701A1 true EA201391701A1 (ru) | 2014-04-30 |
Family
ID=46579248
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201391701A EA201391701A1 (ru) | 2011-05-15 | 2012-05-15 | Назальные тестостероновые гели с контролируемым высвобождением, способы перназального введения и предварительно заполненные многодозные аппликаторные системы для перназального введения |
Country Status (16)
| Country | Link |
|---|---|
| EP (3) | EP2714006B1 (ru) |
| JP (9) | JP6152092B2 (ru) |
| KR (9) | KR102088038B1 (ru) |
| CN (4) | CN103796636B (ru) |
| AR (2) | AR089553A1 (ru) |
| AU (10) | AU2012257492A1 (ru) |
| BR (2) | BR112013029332A2 (ru) |
| CA (3) | CA3034552C (ru) |
| DK (1) | DK2714006T3 (ru) |
| EA (1) | EA201391701A1 (ru) |
| ES (1) | ES2859784T3 (ru) |
| IL (2) | IL229401A0 (ru) |
| MX (4) | MX363561B (ru) |
| PL (1) | PL2714006T4 (ru) |
| WO (2) | WO2012156822A1 (ru) |
| ZA (2) | ZA201309265B (ru) |
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| US9757388B2 (en) | 2011-05-13 | 2017-09-12 | Acerus Pharmaceuticals Srl | Intranasal methods of treating women for anorgasmia with 0.6% and 0.72% testosterone gels |
| US20130045958A1 (en) | 2011-05-13 | 2013-02-21 | Trimel Pharmaceuticals Corporation | Intranasal 0.15% and 0.24% testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
| US20130040923A1 (en) | 2011-05-13 | 2013-02-14 | Trimel Pharmaceuticals Corporation | Intranasal lower dosage strength testosterone gel formulations and use thereof for treating anorgasmia or hypoactive sexual desire disorder |
| WO2012156822A1 (en) * | 2011-05-15 | 2012-11-22 | Trimel Pharmaceuticals Corp. | Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration |
| US8971800B2 (en) * | 2011-05-31 | 2015-03-03 | Qualcomm Incorporated | Methods and apparatus for improving NFC activation and data exchange reporting mechanisms |
| MX365818B (es) | 2011-11-23 | 2019-05-30 | Therapeuticsmd Inc | Formulaciones y terapias de reemplazo hormonal de combinacion naturales. |
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| US20130338122A1 (en) | 2012-06-18 | 2013-12-19 | Therapeuticsmd, Inc. | Transdermal hormone replacement therapies |
| US20150196640A1 (en) | 2012-06-18 | 2015-07-16 | Therapeuticsmd, Inc. | Progesterone formulations having a desirable pk profile |
| US10806697B2 (en) | 2012-12-21 | 2020-10-20 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10806740B2 (en) | 2012-06-18 | 2020-10-20 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| WO2014076569A2 (en) * | 2012-11-14 | 2014-05-22 | Trimel Biopharma Srl | Controlled release topical testosterone formulations and methods |
| WO2014093818A2 (en) * | 2012-12-14 | 2014-06-19 | Bioject, Inc. | Use of a novel subcutaneous needle-free technique to deliver testosterone in hypogonadal men |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US9180091B2 (en) | 2012-12-21 | 2015-11-10 | Therapeuticsmd, Inc. | Soluble estradiol capsule for vaginal insertion |
| US10471072B2 (en) | 2012-12-21 | 2019-11-12 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US11744838B2 (en) | 2013-03-15 | 2023-09-05 | Acerus Biopharma Inc. | Methods of treating hypogonadism with transnasal testosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event |
| JP6338658B2 (ja) * | 2013-10-07 | 2018-06-06 | アンタレス・ファーマ・インコーポレーテッド | テストステロンの針補助ジェット注射を通じたヘマトクリット調節 |
| JP2017513809A (ja) | 2014-02-19 | 2017-06-01 | アンタレス・ファーマ・インコーポレーテッド | テストステロン組成物の針に補助されるジェット注射投与 |
| US10206932B2 (en) | 2014-05-22 | 2019-02-19 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| CA2951284A1 (en) | 2014-07-29 | 2016-02-04 | Therapeuticsmd, Inc. | Transdermal cream |
| TW201636045A (zh) * | 2015-01-28 | 2016-10-16 | 波美西恩製藥有限責任公司 | 組成物、促進或增強受試者之局部毛髮飽滿度及厚度或毛髮生長之方法、包括該組成物之套組及裝置 |
| US10328087B2 (en) | 2015-07-23 | 2019-06-25 | Therapeuticsmd, Inc. | Formulations for solubilizing hormones |
| BR102015020878B1 (pt) * | 2015-08-28 | 2019-08-27 | F B M Ind Farmaceutica Ltda | formulação farmacêutica nasal de testosterona e “kit” em forma de cartela de dispositivos nasais unitários para aplicação de monodose de testosterona. |
| IL300437A (en) * | 2016-01-07 | 2023-04-01 | Viramal Ltd | Gel preparations for administering a drug through the skin to maximize drug concentrations in the rough layer and serum and methods of using them |
| AU2017239645A1 (en) | 2016-04-01 | 2018-10-18 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical composition |
| WO2017173044A1 (en) | 2016-04-01 | 2017-10-05 | Therapeuticsmd Inc. | Steroid hormone compositions in medium chain oils |
| TWI790204B (zh) * | 2016-06-02 | 2023-01-21 | 加拿大商阿爾宙斯製藥有限公司 | 鼻用大麻素組成物 |
| JP2019517590A (ja) * | 2016-06-03 | 2019-06-24 | エム エ ペ ファルマ アクチェンゲゼルシャフト | 多孔性賦形剤を含む経鼻用医薬組成物 |
| HUE063346T2 (hu) * | 2017-01-20 | 2024-01-28 | M et P Pharma AG | Nazális gyógyszerészeti készítmények légszennyezõ anyagoknak való kitettség kockázatainak csökkentésére |
| CN110999431B (zh) * | 2017-06-17 | 2022-04-05 | Lg电子株式会社 | 用于在无线通信系统中注册终端的方法及其设备 |
| WO2019103108A1 (ja) * | 2017-11-27 | 2019-05-31 | あすか製薬株式会社 | 粉末経鼻投与製剤 |
| CA3090262A1 (en) * | 2018-02-02 | 2019-08-08 | Aytu Bioscience, Inc. | Methods of testosterone therapy |
| WO2019175290A1 (en) | 2018-03-13 | 2019-09-19 | Beckley Canopy Therapeutics Limited | Cannabis or cannabis derived compositions for promoting cessation of chemical dependence |
| CN108771622B (zh) * | 2018-07-11 | 2022-01-07 | 尹振图 | 一种自闭式针形滴嘴及眼药水瓶 |
| CN113164384A (zh) | 2018-10-26 | 2021-07-23 | 维拉莫有限公司 | 黏膜粘附性凝胶组合物 |
| MX2021007032A (es) * | 2018-12-14 | 2021-10-22 | Acerus Biopharma Inc | Derivados activos de éster de testosterona, composiciones y usos de los mismos. |
| CN112121049B (zh) * | 2020-08-28 | 2022-02-01 | 嘉兴市第一医院 | 顺式阿曲库铵在制备治疗男性性腺功能减退症的药物中的应用 |
| JP2023550422A (ja) * | 2020-11-19 | 2023-12-01 | アコージア セラピューティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング | 非水性ゲル組成物 |
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| DE4214953C2 (de) | 1992-05-06 | 1995-05-18 | Arrowdean Ltd | Arzneimittel zur Erhöhung des Testosteronspiegels |
| US5756071A (en) | 1992-06-03 | 1998-05-26 | Arrowdean Limited | Method for nasally administering aerosols of therapeutic agents to enhance penetration of the blood brain barrier |
| DE4405898A1 (de) * | 1994-02-18 | 1995-08-24 | Schering Ag | Transdermale therapeutische Systeme enthaltend Sexualsteroide |
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| CA2623477C (en) * | 2007-03-23 | 2011-05-31 | Robert E. Dudley | Compositions and method for treating pediatric hypogonadism |
| WO2009037813A1 (ja) * | 2007-09-20 | 2009-03-26 | Shiseido Company, Ltd. | 経皮吸収製剤 |
| EP2500062B1 (en) * | 2007-11-13 | 2015-08-12 | Curadis GmbH | C-19 steroids for specific therapeutic uses |
| GB0807605D0 (en) * | 2008-04-28 | 2008-06-04 | Diurnal Ltd | Lipid composition |
| WO2012156822A1 (en) * | 2011-05-15 | 2012-11-22 | Trimel Pharmaceuticals Corp. | Controlled release nasal testosterone gels, methods and pre-filled multi-dose applicator systems for pernasal administration |
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2012
- 2012-05-15 WO PCT/IB2012/001127 patent/WO2012156822A1/en active Application Filing
- 2012-05-15 KR KR1020187038088A patent/KR102088038B1/ko active IP Right Grant
- 2012-05-15 MX MX2013013388A patent/MX363561B/es unknown
- 2012-05-15 BR BR112013029332-2A patent/BR112013029332A2/pt not_active Application Discontinuation
- 2012-05-15 KR KR1020137033180A patent/KR20140033408A/ko not_active Application Discontinuation
- 2012-05-15 CA CA3034552A patent/CA3034552C/en active Active
- 2012-05-15 AU AU2012257492A patent/AU2012257492A1/en not_active Abandoned
- 2012-05-15 KR KR1020197029484A patent/KR20190117803A/ko not_active Application Discontinuation
- 2012-05-15 MX MX2020008599A patent/MX2020008599A/es unknown
- 2012-05-15 CN CN201280035150.5A patent/CN103796636B/zh not_active Expired - Fee Related
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