MX2019003340A - Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion prenasal. - Google Patents
Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion prenasal.Info
- Publication number
- MX2019003340A MX2019003340A MX2019003340A MX2019003340A MX2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A MX 2019003340 A MX2019003340 A MX 2019003340A
- Authority
- MX
- Mexico
- Prior art keywords
- testosterone
- low
- sexual
- present
- 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
-
- 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
-
- 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)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (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)
- Neurology (AREA)
- Neurosurgery (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pregnancy & Childbirth (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Anesthesiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (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.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161486324P | 2011-05-15 | 2011-05-15 | |
| US201161486634P | 2011-05-16 | 2011-05-16 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2019003340A true MX2019003340A (es) | 2019-07-04 |
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. |
| MX2020008599A MX2020008599A (es) | 2011-05-15 | 2012-05-15 | Geles nasales de liberación controlada de testosterona, métodos y sistemas aplicadores multidosis pre cargados para administración pernasal. |
| MX2019003340A MX2019003340A (es) | 2011-05-15 | 2013-11-15 | Geles nasales de liberacion controlada de testosterona, metodos y sistemas aplicadores multidosis pre cargados para administracion prenasal. |
Family Applications Before (3)
| 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. |
| MX2020008599A MX2020008599A (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) | EP2714006B1 (es) |
| JP (9) | JP2014513716A (es) |
| KR (9) | KR20210135003A (es) |
| CN (4) | CN103813784A (es) |
| AR (2) | AR089553A1 (es) |
| AU (10) | AU2012257490A1 (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) | WO2012156820A1 (es) |
| ZA (2) | ZA201309264B (es) |
Families Citing this family (43)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| DK2714006T3 (da) * | 2011-05-15 | 2021-03-15 | Acerus Biopharma Inc | Intranasale bioadhæsive testosterongelformuleringer og anvendelse deraf til behandling af mandlig hypogonadisme |
| US8971800B2 (en) * | 2011-05-31 | 2015-03-03 | Qualcomm Incorporated | Methods and apparatus for improving NFC activation and data exchange reporting mechanisms |
| US9301920B2 (en) | 2012-06-18 | 2016-04-05 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| BR112014012444B1 (pt) | 2011-11-23 | 2021-12-14 | Therapeuticsmd, Inc | Composição farmacêutica compreendendo estradiol solubilizado, progesterona e um agente de solubilização, bem como usos desta para tratar um sintoma relacionado à menopausa em uma mulher |
| US20130338122A1 (en) | 2012-06-18 | 2013-12-19 | Therapeuticsmd, Inc. | Transdermal hormone replacement therapies |
| US10806697B2 (en) | 2012-12-21 | 2020-10-20 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
| US20150196640A1 (en) | 2012-06-18 | 2015-07-16 | Therapeuticsmd, Inc. | Progesterone formulations having a desirable pk profile |
| 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 |
| US10471072B2 (en) | 2012-12-21 | 2019-11-12 | 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 |
| US9180091B2 (en) | 2012-12-21 | 2015-11-10 | Therapeuticsmd, Inc. | Soluble estradiol capsule for vaginal insertion |
| US10537581B2 (en) | 2012-12-21 | 2020-01-21 | 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 |
| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | 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 |
| CA2926439C (en) * | 2013-10-07 | 2019-04-16 | Antares Pharma, Inc. | Hematocrit modulation through needle assisted jet injection of testosterone |
| CA2939791C (en) * | 2014-02-19 | 2021-06-15 | Hermanus L. Jooste | Needle assisted jet injection administration of testosterone compositions |
| JP2017516768A (ja) | 2014-05-22 | 2017-06-22 | セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． | 天然の併用ホルモン補充療法剤及び療法 |
| MX2016013693A (es) | 2014-07-29 | 2017-10-31 | Therapeuticsmd Inc | Crema transdermica. |
| 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. |
| EP4091601A1 (en) * | 2016-01-07 | 2022-11-23 | Viramal Limited | Gel compositions for transdermal delivery to maximize drug concentrations in the stratum corneum and serum and methods of use thereof |
| EP3435977A4 (en) | 2016-04-01 | 2019-10-16 | Therapeuticsmd, Inc. | PHARMACEUTICAL COMPOSITION OF STEROID HORMONE |
| US10286077B2 (en) | 2016-04-01 | 2019-05-14 | 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 |
| SG11201810628XA (en) * | 2016-06-03 | 2018-12-28 | M et P Pharma AG | Nasal pharmaceutical compositions with a porous excipient |
| CA3050361A1 (en) | 2017-01-20 | 2018-07-26 | M et P Pharma AG | Nasal pharmaceutical compositions for reducing the risks of exposure to air pollutants |
| WO2018231028A1 (ko) * | 2017-06-17 | 2018-12-20 | 엘지전자(주) | 무선 통신 시스템에서 단말의 등록 방법 및 이를 위한 장치 |
| US11234928B2 (en) * | 2017-11-27 | 2022-02-01 | Aska Pharmaceutical Co., Ltd. | Powder preparation for nasal administration |
| JP2021512868A (ja) | 2018-02-02 | 2021-05-20 | エイセルス バイオファーマ インコーポレイテッド | テストステロン療法の方法 |
| 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 |
| EP3659583B1 (en) | 2018-11-30 | 2023-06-07 | Viramal Limited | A method of preparing a gelling agent, the gelling agent obtained thereby, and the use of said gelling agent |
| EP3893885A4 (en) * | 2018-12-14 | 2022-09-07 | Acerus Biopharma Inc. | ACTIVE ESTER DERIVATIVES OF TESTOSTERONE, COMPOSITIONS AND USES THEREOF |
| 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 |
| CA3198930A1 (en) * | 2020-11-19 | 2022-05-27 | Acousia Therapeutics Gmbh | Non-aqueous gel composition |
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| US4082881A (en) * | 1976-12-23 | 1978-04-04 | E. R. Squibb & Sons, Inc. | Topical and other type pharmaceutical formulations containing isosorbide carrier |
| DE4214953C2 (de) | 1992-05-06 | 1995-05-18 | Arrowdean Ltd | Arzneimittel zur Erhöhung des Testosteronspiegels |
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| JP4825305B2 (ja) * | 2007-09-20 | 2011-11-30 | 株式会社 資生堂 | 経皮吸収製剤 |
| EP2949361B1 (en) * | 2007-11-13 | 2017-03-22 | Athenion AG | C-19 steroids for treating cellulite |
| GB0807605D0 (en) * | 2008-04-28 | 2008-06-04 | Diurnal Ltd | Lipid composition |
| DK2714006T3 (da) * | 2011-05-15 | 2021-03-15 | Acerus Biopharma Inc | Intranasale bioadhæsive testosterongelformuleringer og anvendelse deraf til behandling af mandlig hypogonadisme |
-
2012
- 2012-05-15 DK DK12748245.3T patent/DK2714006T3/da active
- 2012-05-15 JP JP2014510900A patent/JP2014513716A/ja active Pending
- 2012-05-15 MX MX2013013369A patent/MX2013013369A/es unknown
- 2012-05-15 CA CA3034552A patent/CA3034552C/en active Active
- 2012-05-15 WO PCT/IB2012/001112 patent/WO2012156820A1/en active Application Filing
- 2012-05-15 BR BR112013029332-2A patent/BR112013029332A2/pt not_active Application Discontinuation
- 2012-05-15 KR KR1020217036024A patent/KR20210135003A/ko not_active Application Discontinuation
- 2012-05-15 WO PCT/IB2012/001127 patent/WO2012156822A1/en active Application Filing
- 2012-05-15 EP EP12748245.3A patent/EP2714006B1/en active Active
- 2012-05-15 KR KR1020237008221A patent/KR20230041081A/ko not_active Application Discontinuation
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