WO2019074464A3 - Combinaison pharmaceutique comprenant de la dapoxétine et de la phosphodiestérase de type 5 - Google Patents

Combinaison pharmaceutique comprenant de la dapoxétine et de la phosphodiestérase de type 5 Download PDF

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Publication number
WO2019074464A3
WO2019074464A3 PCT/TR2018/050568 TR2018050568W WO2019074464A3 WO 2019074464 A3 WO2019074464 A3 WO 2019074464A3 TR 2018050568 W TR2018050568 W TR 2018050568W WO 2019074464 A3 WO2019074464 A3 WO 2019074464A3
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WO
WIPO (PCT)
Prior art keywords
dapoxetine
pharmaceutical combination
phosphodiesterase type
polymorph
solvate
Prior art date
Application number
PCT/TR2018/050568
Other languages
English (en)
Other versions
WO2019074464A2 (fr
Inventor
Ali TÜRKYILMAZ
Arzu Palantöken
Dicle Güner
Original Assignee
Montero Gida Sanayi Ve Ticaret Anonim Sirketi
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 Montero Gida Sanayi Ve Ticaret Anonim Sirketi filed Critical Montero Gida Sanayi Ve Ticaret Anonim Sirketi
Priority to EP18865578.1A priority Critical patent/EP3694519A4/fr
Publication of WO2019074464A2 publication Critical patent/WO2019074464A2/fr
Publication of WO2019074464A3 publication Critical patent/WO2019074464A3/fr

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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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/501—Inorganic compounds

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La présente invention concerne une combinaison pharmaceutique comprenant de la dapoxétine ou un sel, un solvate ou un polymorphe pharmaceutiquement acceptable de celle-ci et un inhibiteur de PDE5 ou un sel, un solvate ou un polymorphe pharmaceutiquement acceptable de celui-ci ayant un profil de libération comprenant à la fois une libération immédiate et une libération modifiée.
PCT/TR2018/050568 2017-10-09 2018-10-08 Combinaison pharmaceutique comprenant de la dapoxétine et de la phosphodiestérase de type 5 WO2019074464A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP18865578.1A EP3694519A4 (fr) 2017-10-09 2018-10-08 Combinaison pharmaceutique comprenant de la dapoxétine et de la phosphodiestérase de type 5

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2017/15231 2017-10-09
TR2017/15231A TR201715231A2 (tr) 2017-10-09 2017-10-09 Dapokseti̇n ve fosfodi̇esteraz ti̇p-5 i̇nhi̇bi̇törü i̇çeren farmasöti̇k kombi̇nasyon

Publications (2)

Publication Number Publication Date
WO2019074464A2 WO2019074464A2 (fr) 2019-04-18
WO2019074464A3 true WO2019074464A3 (fr) 2019-05-31

Family

ID=66100099

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/TR2018/050568 WO2019074464A2 (fr) 2017-10-09 2018-10-08 Combinaison pharmaceutique comprenant de la dapoxétine et de la phosphodiestérase de type 5

Country Status (3)

Country Link
EP (1) EP3694519A4 (fr)
TR (1) TR201715231A2 (fr)
WO (1) WO2019074464A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112263581A (zh) * 2020-11-29 2021-01-26 长沙晶易医药科技有限公司 一种治疗pe和ed的双层片复方制剂及其制备方法
CN116687888A (zh) * 2023-06-02 2023-09-05 苏州易合医药有限公司 伐地那非和达泊西汀复方干粉吸入制剂及其制备方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006038217A1 (fr) * 2004-10-05 2006-04-13 Strides Acrolab Limited Systeme ameliore d’administration de medicaments a base de bromhydrate de citalopram et processus de production dudit systeme
AU2006233567A1 (en) * 2005-04-13 2006-10-19 Bayer Healthcare Ag Therapeutic combination in case of benign prostate hyperplasia
EP2316435A1 (fr) * 2009-10-22 2011-05-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi La composition pharmaceutique des inhibiteurs de la PDE-5 et dapoxetine
CN103550775A (zh) * 2013-10-18 2014-02-05 广州共禾医药科技有限公司 一种抗失眠组合物及其应用及利用该组合物制备的多相脉冲顿释制剂及其制备方法
EP2698147A1 (fr) * 2012-08-17 2014-02-19 Sanovel Ilac Sanayi ve Ticaret A.S. Formulation de film oral comprenant du diapoxetine et tadalafil
CN106727439A (zh) * 2016-12-21 2017-05-31 河南中帅医药科技股份有限公司 一种盐酸美金刚缓释‑多奈哌齐速释复方胶囊
TR201620151A2 (en) * 2016-12-30 2018-07-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING TADALAFIL AND DAPOXETIN

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130095180A1 (en) * 2010-07-06 2013-04-18 Navipharm. Co., Ltd. Time-delayed sustained release pharmaceutical composition comprising dapoxetine for oral administration
US20150216798A1 (en) * 2012-08-17 2015-08-06 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Novel orally administered pharmaceutical formulations

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006038217A1 (fr) * 2004-10-05 2006-04-13 Strides Acrolab Limited Systeme ameliore d’administration de medicaments a base de bromhydrate de citalopram et processus de production dudit systeme
AU2006233567A1 (en) * 2005-04-13 2006-10-19 Bayer Healthcare Ag Therapeutic combination in case of benign prostate hyperplasia
EP2316435A1 (fr) * 2009-10-22 2011-05-04 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi La composition pharmaceutique des inhibiteurs de la PDE-5 et dapoxetine
EP2698147A1 (fr) * 2012-08-17 2014-02-19 Sanovel Ilac Sanayi ve Ticaret A.S. Formulation de film oral comprenant du diapoxetine et tadalafil
CN103550775A (zh) * 2013-10-18 2014-02-05 广州共禾医药科技有限公司 一种抗失眠组合物及其应用及利用该组合物制备的多相脉冲顿释制剂及其制备方法
CN106727439A (zh) * 2016-12-21 2017-05-31 河南中帅医药科技股份有限公司 一种盐酸美金刚缓释‑多奈哌齐速释复方胶囊
TR201620151A2 (en) * 2016-12-30 2018-07-23 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi ORAL PHARMACEUTICAL COMPOSITIONS CONTAINING TADALAFIL AND DAPOXETIN

Also Published As

Publication number Publication date
TR201715231A2 (tr) 2019-04-22
WO2019074464A2 (fr) 2019-04-18
EP3694519A2 (fr) 2020-08-19
EP3694519A4 (fr) 2021-10-20

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