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

Info

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
Authority
CN
China
Prior art keywords
milligrams
silaenafil
preparation
mouthspray
auc
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
CN201280068898.5A
Other languages
English (en)
Chinese (zh)
Other versions
CN104822368A (zh
Inventor
大卫·伯格斯道姆
弗耶·奥派沃
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Su Da Co
Original Assignee
Su Da Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Su Da Co filed Critical Su Da Co
Publication of CN104822368A publication Critical patent/CN104822368A/zh
Application granted granted Critical
Publication of CN104822368B publication Critical patent/CN104822368B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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 (enExample)
EP (1) EP2787967B1 (enExample)
JP (1) JP6047174B2 (enExample)
KR (1) KR20140117360A (enExample)
CN (1) CN104822368B (enExample)
AU (1) AU2012347997B2 (enExample)
BR (1) BR112014013650A2 (enExample)
CA (1) CA2858364C (enExample)
IL (1) IL232970A0 (enExample)
RU (1) RU2611403C1 (enExample)
SG (1) SG11201402938RA (enExample)
WO (1) WO2013085904A1 (enExample)
ZA (1) ZA201404091B (enExample)

Families Citing this family (9)

* 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 (enExample) 2014-03-19 2018-03-10
US10111833B2 (en) 2015-04-03 2018-10-30 Insys Development Company, Inc. Sildenafil sublingual spray formulations
US9662334B2 (en) 2015-04-03 2017-05-30 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
JP2019536769A (ja) * 2016-10-31 2019-12-19 スダ リミテッド 粘膜活性剤送達
CN114641276A (zh) * 2019-11-07 2022-06-17 诺和诺德股份有限公司 包含glp-1激动剂、sglt2抑制剂和n-(8-(2-羟基苯甲酰基)氨基)辛酸的盐的固体组合物
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

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
IL143846A0 (en) * 1998-12-23 2002-04-21 Alza Corp Dosage forms comprising porous particles
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
US20060035905A1 (en) 2004-02-06 2006-02-16 Becton, Dickinson And Company Formulations of phosphodiesterase 5 inhibitors and methods of use
WO2007080382A1 (en) * 2006-01-11 2007-07-19 Astrazeneca Ab Morpholino pyrimidine derivatives and their use in therapy
EP2046274A1 (en) * 2006-08-02 2009-04-15 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)

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

Similar Documents

Publication Publication Date Title
CN104822368B (zh) 西地那非口腔喷雾制剂及其给药方法
EP2575765B1 (en) Oral spray formulations and methods for administration of sildenafil citrate
US12109196B2 (en) Non-sedating dexmedetomidine treatment regimens
US12364683B2 (en) Non-sedating dexmedetomidine treatment regimens
TW202228682A (zh) 使用右美托咪啶(dexmedetomidine)鹽酸鹽治療躁鬱症及精神病
US20250302741A1 (en) Intranasal olanzapine formulations and methods of their use
HK1199843B (en) Oral spray formulations and methods for administration of sildenafil
NZ625922B2 (en) Oral spray formulations and methods for administration of sildenafil
HK1183818A (en) Oral spray formulations and methods for administration of sildenafil citrate
HK1183818B (en) Oral spray formulations and methods for administration of sildenafil citrate

Legal Events

Date Code Title Description
PB01 Publication
EXSB Decision made by sipo to initiate substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20190111

Termination date: 20201204