WO2012005500A3 - 다폭세틴을 포함하는 시간차 서방출 경구투여형 약학적 조성물 - Google Patents

다폭세틴을 포함하는 시간차 서방출 경구투여형 약학적 조성물 Download PDF

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Publication number
WO2012005500A3
WO2012005500A3 PCT/KR2011/004919 KR2011004919W WO2012005500A3 WO 2012005500 A3 WO2012005500 A3 WO 2012005500A3 KR 2011004919 W KR2011004919 W KR 2011004919W WO 2012005500 A3 WO2012005500 A3 WO 2012005500A3
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WIPO (PCT)
Prior art keywords
sustained release
release phase
pharmaceutical composition
dapoxetine
present
Prior art date
Application number
PCT/KR2011/004919
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English (en)
French (fr)
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WO2012005500A2 (ko
Inventor
이창규
박상근
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주식회사 네비팜
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Publication date
Application filed by 주식회사 네비팜 filed Critical 주식회사 네비팜
Priority to EP11803786.0A priority Critical patent/EP2591773A4/en
Priority to JP2013518273A priority patent/JP2013530220A/ja
Priority to MX2013000001A priority patent/MX2013000001A/es
Priority to RU2012157127/15A priority patent/RU2012157127A/ru
Priority to CN2011800325737A priority patent/CN102958513A/zh
Priority to KR1020127032723A priority patent/KR101465077B1/ko
Priority to US13/805,028 priority patent/US20130095180A1/en
Priority to CA2804341A priority patent/CA2804341A1/en
Publication of WO2012005500A2 publication Critical patent/WO2012005500A2/ko
Publication of WO2012005500A3 publication Critical patent/WO2012005500A3/ko

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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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

본 발명은 속방출상 및 지연 서방출상으로 이루어지며, 상기 속방출상 및 지연 서방출상 내에 각각 다폭세틴을 유효성분으로 포함하고 있는 시간차 서방출 경구투여형 약학적 조성물에 관한 것이다. 본 발명의 약학적 조성물은 속방출상과 지연 서방출상 내에 조루증 치료제인 다폭세틴을 동시에 포함시킴으로써, 신속한 약효 발현을 통한 복용 초기 환자들의 성적 만족도 충족과 함께, 지연 서방출상의 시간차 서방출을 통해 복용 초기 부작용 감소와 함께 지속적으로 다폭세틴을 체내에 흡수시킴으로써 약효 지속시간을 장기화할 수 있다. 또한, 속방출상 내에 실데나필이나 타달라필 등의 발기부전 치료제를 추가로 포함시킴으로써, 조루증과 발기부전 치료제 약물간에 반감기 차이가 있더라도 약효 지속시간을 일치시킬 수 있어 환자의 만족도를 극대화시킬 수 있다.
PCT/KR2011/004919 2010-07-06 2011-07-05 다폭세틴을 포함하는 시간차 서방출 경구투여형 약학적 조성물 WO2012005500A2 (ko)

Priority Applications (8)

Application Number Priority Date Filing Date Title
EP11803786.0A EP2591773A4 (en) 2010-07-06 2011-07-05 TEMPORARY RELEASED PHARMACEUTICAL COMPOSITION WITH DAPOXIN FOR ORAL ADMINISTRATION
JP2013518273A JP2013530220A (ja) 2010-07-06 2011-07-05 ダポキセチンを含む時間差徐放性経口投与型の薬学的組成物
MX2013000001A MX2013000001A (es) 2010-07-06 2011-07-05 Composición farmaceutica de liberacion prolongada y acción retardada que comprende dapoxetina para administaracion oral.
RU2012157127/15A RU2012157127A (ru) 2010-07-06 2011-07-05 Фармацевтическая композиция, содержащая дапоксетин, для перорального введения с замедленным высвобождением
CN2011800325737A CN102958513A (zh) 2010-07-06 2011-07-05 含达泊西汀的延时释放口服药用组合物
KR1020127032723A KR101465077B1 (ko) 2010-07-06 2011-07-05 다폭세틴을 포함하는 시간차 서방출 경구투여형 약학적 조성물
US13/805,028 US20130095180A1 (en) 2010-07-06 2011-07-05 Time-delayed sustained release pharmaceutical composition comprising dapoxetine for oral administration
CA2804341A CA2804341A1 (en) 2010-07-06 2011-07-05 Time-delayed sustained release pharmaceutical composition comprising dapoxetine for oral administration

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2010-0064988 2010-07-06
KR20100064988 2010-07-06

Publications (2)

Publication Number Publication Date
WO2012005500A2 WO2012005500A2 (ko) 2012-01-12
WO2012005500A3 true WO2012005500A3 (ko) 2012-05-03

Family

ID=45441646

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2011/004919 WO2012005500A2 (ko) 2010-07-06 2011-07-05 다폭세틴을 포함하는 시간차 서방출 경구투여형 약학적 조성물

Country Status (9)

Country Link
US (1) US20130095180A1 (ko)
EP (1) EP2591773A4 (ko)
JP (1) JP2013530220A (ko)
KR (1) KR101465077B1 (ko)
CN (1) CN102958513A (ko)
CA (1) CA2804341A1 (ko)
MX (1) MX2013000001A (ko)
RU (1) RU2012157127A (ko)
WO (1) WO2012005500A2 (ko)

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KR101230178B1 (ko) 2010-06-10 2013-02-06 주식회사 네비팜 골다공증 예방 또는 치료용 조성물 및 이의 제조방법
CN103100085A (zh) * 2011-11-09 2013-05-15 上海兰蒂斯生物医药科技有限公司 一种药物组合物
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CN103127023B (zh) * 2013-03-01 2014-08-27 河北天成药业股份有限公司 一种盐酸度洛西汀肠溶片及其制备方法
CN103340869B (zh) * 2013-06-28 2015-04-01 王立强 用于阳痿早泄的组合物
CN105987971B (zh) * 2015-02-12 2020-07-14 重庆华邦制药有限公司 盐酸达泊西汀中间体sm1及相关杂质的分离与测定方法
EP3280697A1 (en) 2015-04-08 2018-02-14 INVISTA Textiles (U.K.) Limited Materials and methods for the selective recovery of monovalent products from aqueous solutions using continuous ion exchange
US10343084B2 (en) 2015-04-10 2019-07-09 Invista North America S.A.R.L. Process for separation of diamines and/or omega-aminoacids from a feed mixture
WO2017017511A1 (en) * 2015-07-28 2017-02-02 Kameel Selim Modified release formulation for treating premature ejaculation
CN106389360A (zh) * 2015-07-31 2017-02-15 重庆华邦制药有限公司 盐酸达泊西汀直压片及其制备方法
CN106511312A (zh) * 2015-09-11 2017-03-22 扬子江药业集团江苏紫龙药业有限公司 一种复方西地那非达泊西汀缓释胶囊及其制备方法
CN107536821A (zh) * 2016-06-29 2018-01-05 康普药业股份有限公司 一种盐酸达泊西汀缓释制剂
CN107536817A (zh) * 2016-06-29 2018-01-05 康普药业股份有限公司 一种盐酸达泊西汀药物组合物
TR201715231A2 (tr) * 2017-10-09 2019-04-22 Montero Gida Sanayi Ve Ticaret Anonim Sirketi Dapokseti̇n ve fosfodi̇esteraz ti̇p-5 i̇nhi̇bi̇törü i̇çeren farmasöti̇k kombi̇nasyon
CN108033960A (zh) * 2018-01-23 2018-05-15 中国药科大学 一种他达拉非的共无定形物
CN210583153U (zh) * 2019-01-05 2020-05-22 厦门赛诺邦格生物科技股份有限公司 一种阳痿早泄治疗药物的固体制剂
US20230040902A1 (en) * 2019-12-19 2023-02-09 Celltrion Inc. Pharmaceutical Formulation Comprising Cibenzoline or Salt Thereof
CN113456606A (zh) * 2020-03-30 2021-10-01 北京新领先医药科技发展有限公司 一种盐酸达泊西汀片制备方法
CN113143879A (zh) * 2021-05-07 2021-07-23 苏州康恒研新药物技术有限公司 一种盐酸达泊西汀缓释片的制备方法
CN115887462A (zh) * 2021-09-30 2023-04-04 上海汇伦医药股份有限公司 一种口服药物组合物

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Also Published As

Publication number Publication date
KR20130032316A (ko) 2013-04-01
CA2804341A1 (en) 2012-01-12
KR101465077B1 (ko) 2014-11-26
CN102958513A (zh) 2013-03-06
EP2591773A2 (en) 2013-05-15
RU2012157127A (ru) 2014-08-20
MX2013000001A (es) 2013-05-01
WO2012005500A2 (ko) 2012-01-12
EP2591773A4 (en) 2014-11-26
JP2013530220A (ja) 2013-07-25
US20130095180A1 (en) 2013-04-18

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