CN104822368B - 西地那非口腔喷雾制剂及其给药方法 - Google Patents

西地那非口腔喷雾制剂及其给药方法 Download PDF

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Publication number
CN104822368B
CN104822368B CN201280068898.5A CN201280068898A CN104822368B CN 104822368 B CN104822368 B CN 104822368B CN 201280068898 A CN201280068898 A CN 201280068898A CN 104822368 B CN104822368 B CN 104822368B
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China
Prior art keywords
milligrams
silaenafil
preparation
mouthspray
auc
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Expired - Fee Related
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CN201280068898.5A
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English (en)
Chinese (zh)
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CN104822368A (zh
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大卫·伯格斯道姆
弗耶·奥派沃
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Su Da Co
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Su Da Co
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    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN201280068898.5A 2011-12-05 2012-12-04 西地那非口腔喷雾制剂及其给药方法 Expired - Fee Related CN104822368B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161566879P 2011-12-05 2011-12-05
US61/566,879 2011-12-05
PCT/US2012/067763 WO2013085904A1 (en) 2011-12-05 2012-12-04 Oral spray formulations and methods for administration of sildenafil

Publications (2)

Publication Number Publication Date
CN104822368A CN104822368A (zh) 2015-08-05
CN104822368B true CN104822368B (zh) 2019-01-11

Family

ID=47430090

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201280068898.5A Expired - Fee Related CN104822368B (zh) 2011-12-05 2012-12-04 西地那非口腔喷雾制剂及其给药方法

Country Status (13)

Country Link
US (1) US9186321B2 (https=)
EP (1) EP2787967B1 (https=)
JP (1) JP6047174B2 (https=)
KR (1) KR20140117360A (https=)
CN (1) CN104822368B (https=)
AU (1) AU2012347997B2 (https=)
BR (1) BR112014013650A2 (https=)
CA (1) CA2858364C (https=)
IL (1) IL232970A0 (https=)
RU (1) RU2611403C1 (https=)
SG (1) SG11201402938RA (https=)
WO (1) WO2013085904A1 (https=)
ZA (1) ZA201404091B (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015070049A1 (en) * 2013-11-08 2015-05-14 Insys Pharma, Inc. Sildenafil sublingual spray formulation
NO2723977T3 (https=) * 2014-03-19 2018-03-10
CN108367010A (zh) * 2015-04-03 2018-08-03 因塞斯发展股份有限公司 西地那非舌下喷雾制剂
US10111833B2 (en) 2015-04-03 2018-10-30 Insys Development Company, Inc. Sildenafil sublingual spray formulations
BR102015020720A2 (pt) * 2015-08-27 2017-03-01 Henrique Leonardo Pereira Luis composição hidrofíilica atóxica, bioidêntica e biodegradável à base de partículas micronizadas de acido hialurônico, com propriedades mucoadesivas e carreadoras via transmucosa aglutinadas por bioengenharia a um ipde5, para tratamento de disfunção erétil, com aplicação em sistema de spray de aerossol sublingual
WO2018070971A1 (ru) * 2016-10-10 2018-04-19 Товарыство З Обмэжэною Видповидальнистю Науково-Выробныча Фирма "Микрохим" Фармацевтическая композиция в форме оромукозного спрея для лечения эректильной дисфункции и легочной артериальной гипертензии
WO2018076074A1 (en) * 2016-10-31 2018-05-03 Suda Ltd Mucosal active agent delivery
WO2021089752A1 (en) * 2019-11-07 2021-05-14 Novo Nordisk A/S Solid compositions comprising a glp-1 agonist, an sglt2 inhibitor and a salt of n-(8-(2-hydroxybenzoyl)amino)caprylic acid
CN111110633B (zh) * 2020-01-21 2022-12-02 合肥医工医药股份有限公司 一种他达拉非喷雾剂及其制备方法
JP2023552389A (ja) * 2020-12-04 2023-12-15 ティグラス，リミテッド ライアビリティ カンパニー 呼吸器疾病を有する患者に対処するための、少なくとも１種の病原体に対して活性な低ｐＨおよび低毒性を有する治療用材料

Citations (4)

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CN1277021A (zh) * 2000-06-20 2000-12-20 王建华 一种治疗阳痿病的喷雾剂药物及其制备方法
CA2391968A1 (en) * 1999-11-18 2001-05-25 Natco Pharma Limited An improved pharmaceutical composition for treating male erectile dysfunction
CA2612917A1 (en) * 2005-06-23 2007-01-04 Schering Corporation Rapidly absorbing oral formulations of pde5 inhibitors
CN101014321A (zh) * 2004-08-23 2007-08-08 曼金德公司 5型磷酸二酯酶抑制剂的肺部给予

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US20030082107A1 (en) * 1997-10-01 2003-05-01 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing drugs for treating an infectious disease or cancer
US20030077229A1 (en) * 1997-10-01 2003-04-24 Dugger Harry A. Buccal, polar and non-polar spray or capsule containing cardiovascular or renal drugs
DE19834506A1 (de) 1998-07-31 2000-02-03 Hexal Ag Transmucosales therapeutisches System zur Anwendung von Sildenafil
KR100618234B1 (ko) * 1998-12-23 2006-09-01 알자 코포레이션 다공성 입자를 포함하는 제형
IL139457A0 (en) * 1999-11-08 2001-11-25 Pfizer Compounds for the treatment of female sexual dysfunction
DE10248601B4 (de) * 2002-10-17 2006-05-24 Goldstein, Naum, Dr.habil.nat. Pharmazeutisches Mittel zur endonasalen Applikation bei der Behandlung von Krankheiten und Störungen des zentralen Nervensystems
US7554270B2 (en) * 2003-05-28 2009-06-30 Tokyo Ohka Kogyo Co., Ltd. Composition for dielectric of plasma display panel, laminate for dielectric, and method for forming the dielectric
WO2005077374A1 (en) * 2004-02-06 2005-08-25 Becton, Dickinson And Company Formulations of phosphodiesterase 5 inhibitors and methods of use
EP1979325A1 (en) * 2006-01-11 2008-10-15 AstraZeneca AB Morpholino pyrimidine derivatives and their use in therapy
US20090317461A1 (en) * 2006-08-02 2009-12-24 Wm. Wrigley Jr. Company Oral compositions effective for the treatment of oral cavity malodor associated with the consumption of odor-causing compounds
JP5686978B2 (ja) * 2009-03-18 2015-03-18 第一三共ヘルスケア株式会社 シルデナフィルクエン酸塩含有内服液剤及びその液剤含有容器

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2391968A1 (en) * 1999-11-18 2001-05-25 Natco Pharma Limited An improved pharmaceutical composition for treating male erectile dysfunction
CN1277021A (zh) * 2000-06-20 2000-12-20 王建华 一种治疗阳痿病的喷雾剂药物及其制备方法
CN101014321A (zh) * 2004-08-23 2007-08-08 曼金德公司 5型磷酸二酯酶抑制剂的肺部给予
CA2612917A1 (en) * 2005-06-23 2007-01-04 Schering Corporation Rapidly absorbing oral formulations of pde5 inhibitors

Non-Patent Citations (3)

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Title
mechanistic analysis of pH-dependent and trans-memberane permeability of amphoteric compounds: application to sildenafil;Yanfeng Wang等;《Int J Pharm》;20080320;第352卷(第1-2期);第220页表1和第221页图2；第223页左栏第29行和第30行 *
Yanfeng Wang等.mechanistic analysis of pH-dependent and trans-memberane permeability of amphoteric compounds: application to sildenafil.《Int J Pharm》.2008,第352卷(第1-2期), *
西地那非治疗选择性SSRI抑制药相关的性功能障碍无效或部分有效患者的疗效;卫生部中日友好医院男科;《中华男科学杂志》;中华人民共和国国家人口和计划生育委员会;20070831;第13卷(第8期);第766页第6段 *

Also Published As

Publication number Publication date
RU2611403C1 (ru) 2017-02-21
US9186321B2 (en) 2015-11-17
ZA201404091B (en) 2017-11-29
NZ625922A (en) 2015-05-29
JP6047174B2 (ja) 2016-12-21
EP2787967A1 (en) 2014-10-15
EP2787967B1 (en) 2018-10-31
CA2858364C (en) 2018-07-24
SG11201402938RA (en) 2014-07-30
CN104822368A (zh) 2015-08-05
KR20140117360A (ko) 2014-10-07
US20150051216A1 (en) 2015-02-19
CA2858364A1 (en) 2013-06-13
AU2012347997A1 (en) 2014-07-03
WO2013085904A1 (en) 2013-06-13
JP2015500285A (ja) 2015-01-05
IL232970A0 (en) 2014-08-31
BR112014013650A2 (pt) 2017-07-04
AU2012347997B2 (en) 2017-07-20
HK1199843A1 (en) 2015-07-24

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Granted publication date: 20190111

Termination date: 20201204