BR112013029336B1 - Gel de testosterona intranasal de liberação controlada, sistema aplicador e uso - Google Patents
Gel de testosterona intranasal de liberação controlada, sistema aplicador e uso Download PDFInfo
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- BR112013029336B1 BR112013029336B1 BR112013029336-5A BR112013029336A BR112013029336B1 BR 112013029336 B1 BR112013029336 B1 BR 112013029336B1 BR 112013029336 A BR112013029336 A BR 112013029336A BR 112013029336 B1 BR112013029336 B1 BR 112013029336B1
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- Prior art keywords
- testosterone
- gel
- tbs
- intranasal
- dose
- Prior art date
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| KR20140045400A (ko) * | 2011-05-15 | 2014-04-16 | 트리멜 바이오파마 에스알엘 | 비내용 테스토스테론 바이오-접착제 겔 제형 및 남성의 성선기능저하증을 치료하기 위한 그의 용도 |
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| 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 |
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| US10806740B2 (en) | 2012-06-18 | 2020-10-20 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
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| US11246875B2 (en) | 2012-12-21 | 2022-02-15 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
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| US10568891B2 (en) | 2012-12-21 | 2020-02-25 | Therapeuticsmd, Inc. | Vaginal inserted estradiol pharmaceutical compositions and methods |
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| US11266661B2 (en) | 2012-12-21 | 2022-03-08 | 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 |
| ES2749588T3 (es) * | 2013-10-07 | 2020-03-23 | Antares Pharma Inc | Modulación de hematocrito mediante inyección de testosterona a chorro asistida por aguja |
| US10238662B2 (en) * | 2014-02-19 | 2019-03-26 | Antares Pharma, Inc. | Needle assisted jet injection administration of testosterone compositions |
| CA2947767A1 (en) | 2014-05-22 | 2015-11-26 | Therapeuticsmd, Inc. | Natural combination hormone replacement formulations and therapies |
| US10098894B2 (en) | 2014-07-29 | 2018-10-16 | 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 |
| CN108135688B (zh) * | 2015-06-29 | 2021-06-04 | 莱拉医药公司 | 用于治疗鼻窦炎的可植入支架 |
| 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. |
| CN108712901A (zh) * | 2016-01-07 | 2018-10-26 | 维拉玛尔有限公司 | 用于经皮递送以使角质层和血清中的药物浓度最大化的凝胶组合物及其使用方法 |
| WO2017173044A1 (en) | 2016-04-01 | 2017-10-05 | Therapeuticsmd Inc. | Steroid hormone compositions in medium chain oils |
| WO2017173071A1 (en) | 2016-04-01 | 2017-10-05 | Therapeuticsmd, Inc. | Steroid hormone pharmaceutical composition |
| EP3448466A1 (en) | 2016-04-25 | 2019-03-06 | Koska Family Ltd. | Medical delivery system |
| CA3026274A1 (en) * | 2016-06-02 | 2017-12-07 | Acerus Pharmaceutical Corporation | Nasal cannabidiol compositions |
| SG11201810628XA (en) | 2016-06-03 | 2018-12-28 | M et P Pharma AG | Nasal pharmaceutical compositions with a porous excipient |
| SG11201906616VA (en) * | 2017-01-20 | 2019-08-27 | M et P Pharma AG | Nasal pharmaceutical compositions for reducing the risks of exposure to air pollutants |
| 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 |
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| JP7321096B2 (ja) * | 2017-11-27 | 2023-08-04 | あすか製薬株式会社 | 粉末経鼻投与製剤 |
| BR112020015650A2 (pt) | 2018-02-02 | 2020-12-08 | Aytu Bioscience, Inc. | Métodos de terapia de testosterona |
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| 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 |
| CA3117842A1 (en) | 2018-10-26 | 2020-04-30 | Viramal Limited | Mucoadhesive gel composition |
| 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 |
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| WO2020118437A1 (en) * | 2018-12-14 | 2020-06-18 | Acerus Biopharma Inc. | Active ester derivatives of testosterone, compositions and uses thereof |
| USD1052082S1 (en) | 2020-06-01 | 2024-11-19 | Koska Family Limited | Sealed fluid container |
| 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 |
| EP4247332A1 (en) * | 2020-11-19 | 2023-09-27 | Acousia Therapeutics GmbH | Non-aqueous gel composition |
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Family Cites Families (25)
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| DE4214953C2 (de) | 1992-05-06 | 1995-05-18 | Arrowdean Ltd | Arzneimittel zur Erhöhung des Testosteronspiegels |
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| JP2000514065A (ja) * | 1997-07-03 | 2000-10-24 | アルザ コーポレイション | ドラッグデリバリーディバイスとその製造法 |
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| US6503894B1 (en) * | 2000-08-30 | 2003-01-07 | Unimed Pharmaceuticals, Inc. | Pharmaceutical composition and method for treating hypogonadism |
| DE10064950A1 (de) * | 2000-12-23 | 2002-07-11 | Impetus Ag Basel | Thixotropes Nasenspray |
| JP2005505587A (ja) * | 2001-10-12 | 2005-02-24 | シーエヌエス・インコーポレーテッド | 含水性の点鼻ゲル及びその塗布装置 |
| MY139721A (en) * | 2002-04-19 | 2009-10-30 | Cpex Pharmaceuticals Inc | Pharmaceutical composition |
| IL152575A (en) * | 2002-10-31 | 2008-12-29 | Transpharma Medical Ltd | A skin-to-skin transmission system of water-insoluble drugs |
| PT1670433E (pt) * | 2003-10-10 | 2012-02-08 | Ferring Bv | Fórmula farmacológica transdérmica para a minimização de resíduos na pele |
| EP1530965B1 (en) | 2003-11-11 | 2006-03-08 | Mattern, Udo | Controlled release delivery system of sexual hormones for nasal application |
| JP5002462B2 (ja) * | 2004-12-09 | 2012-08-15 | バイエル・アニマル・ヘルス・ゲゼルシヤフト・ミツト・ベシユレンクテル・ハフツング | 酸によるグルココルチコイドエステルの安定化 |
| MX2007015255A (es) * | 2005-06-03 | 2008-02-22 | Acrux Dds Pty Ltd | Metodo y composicion para administracion transdermica de un farmaco. |
| EP1790343A1 (en) * | 2005-11-11 | 2007-05-30 | Emotional Brain B.V. | Pharmaceuticals formulations and uses thereof in the treatment of female sexual dysfunction |
| CN101099742A (zh) * | 2006-07-06 | 2008-01-09 | 上海富海科申药业有限公司 | 能够减少皮肤刺激的睾酮凝胶制剂 |
| ZA200902902B (en) | 2006-10-04 | 2010-07-28 | M & P Patent Aktinegesellschaf | Controlled release delivery system for nasal application of neurotransmitters |
| CN101754764A (zh) * | 2007-03-23 | 2010-06-23 | 优尼麦德药物股份有限公司 | 治疗小儿性腺机能减退的组合物和方法 |
| JP4825305B2 (ja) * | 2007-09-20 | 2011-11-30 | 株式会社 資生堂 | 経皮吸収製剤 |
| ES2628507T3 (es) * | 2007-11-13 | 2017-08-03 | Athenion Ag | Esteroides C-19 para el tratamiento de la celulitis |
| GB0807605D0 (en) * | 2008-04-28 | 2008-06-04 | Diurnal Ltd | Lipid composition |
| KR20140045400A (ko) * | 2011-05-15 | 2014-04-16 | 트리멜 바이오파마 에스알엘 | 비내용 테스토스테론 바이오-접착제 겔 제형 및 남성의 성선기능저하증을 치료하기 위한 그의 용도 |
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