MX2016008729A - Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma. - Google Patents

Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma.

Info

Publication number
MX2016008729A
MX2016008729A MX2016008729A MX2016008729A MX2016008729A MX 2016008729 A MX2016008729 A MX 2016008729A MX 2016008729 A MX2016008729 A MX 2016008729A MX 2016008729 A MX2016008729 A MX 2016008729A MX 2016008729 A MX2016008729 A MX 2016008729A
Authority
MX
Mexico
Prior art keywords
preparation
clomipramine
method therefor
pharmaceutical composition
composition containing
Prior art date
Application number
MX2016008729A
Other languages
English (en)
Inventor
Hyun-Jung Park
Seong-Shin Kwak
Ryeol Jeon Hong
Sang Lee Bong-
Jin LEE Dong-
Hwa KIM Jung-
Original Assignee
Ctc Bio Inc
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 Ctc Bio Inc filed Critical Ctc Bio Inc
Publication of MX2016008729A publication Critical patent/MX2016008729A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5084Mixtures 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invención proporciona una formulación farmacéutica que comprende clomipramina o su sal farmacéuticamente aceptable (preferiblemente, hidrocloruro de clomipramina) como el primer ingrediente activo, y sildenafil o su sal farmacéuticamente aceptable (preferiblemente, citrato de sildenafil) como el segundo ingrediente activo, en donde la estabilidad de la clomipramina es mejorada, y un método para fabricar esta formulación farmacéutica. En particular, la presente invención proporciona una formulación farmacéutica que comprende los dos ingredientes activos anteriores y es fabricada mediante el uso de un método de granulación en húmedo, en donde la estabilidad de la clomipramina es mejorada, y un método para la fabricación de esta formulación farmacéutica.
MX2016008729A 2013-12-31 2014-12-29 Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma. MX2016008729A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20130168702 2013-12-31
PCT/KR2014/012969 WO2015102337A1 (ko) 2013-12-31 2014-12-29 클로미프라민 함유 약학 조성물 및 이의 제조 방법

Publications (1)

Publication Number Publication Date
MX2016008729A true MX2016008729A (es) 2017-02-28

Family

ID=53493626

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2016008729A MX2016008729A (es) 2013-12-31 2014-12-29 Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma.
MX2021000769A MX2021000769A (es) 2013-12-31 2014-12-29 Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2021000769A MX2021000769A (es) 2013-12-31 2014-12-29 Composicion farmaceutica que contiene clomipramina y metodo de preparacion de la misma.

Country Status (7)

Country Link
US (2) US10045944B2 (es)
EP (1) EP3090732A4 (es)
KR (3) KR20150079449A (es)
CN (1) CN105899193A (es)
BR (1) BR112016015175A2 (es)
MX (2) MX2016008729A (es)
WO (1) WO2015102337A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20150079449A (ko) * 2013-12-31 2015-07-08 주식회사 씨티씨바이오 클로미프라민 함유 약학 조성물 및 이의 제조 방법
CN108126203A (zh) * 2018-01-05 2018-06-08 黄平 一种药物组合物及其药物递送系统与用途
US11957692B2 (en) 2022-05-23 2024-04-16 National Institute Of Immunology Clomipramine for the treatment of Alzheimer's Disease

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6403597B1 (en) 1997-10-28 2002-06-11 Vivus, Inc. Administration of phosphodiesterase inhibitors for the treatment of premature ejaculation
US20020091129A1 (en) * 2000-11-20 2002-07-11 Mitradev Boolell Treatment of premature ejaculation
US6495154B1 (en) * 2000-11-21 2002-12-17 Vivus Inc. On demand administration of clomipramine and salts thereof to treat premature ejaculation
US6863901B2 (en) * 2001-11-30 2005-03-08 Collegium Pharmaceutical, Inc. Pharmaceutical composition for compressed annular tablet with molded triturate tablet for both intraoral and oral administration
US20090118211A1 (en) * 2005-06-27 2009-05-07 Daniel Drai Compositions and Methods for Enhancement of Sexual Function
CA2629904C (en) * 2005-11-28 2018-07-10 Imaginot Pty Ltd. Oral therapeutic compound delivery system
WO2009142428A2 (en) * 2008-05-19 2009-11-26 Yuhan Corporation Pharmaceutical composition for the treatment of premature ejaculation
BR112013033475A2 (pt) * 2011-06-28 2017-12-19 Ctc Bio Inc composição farmacêutica para tratamento, prevenção ou melhora da ejaculação precoce e método para tratamento, prevenção ou melhora da ejaculação precoce
KR20150079449A (ko) * 2013-12-31 2015-07-08 주식회사 씨티씨바이오 클로미프라민 함유 약학 조성물 및 이의 제조 방법

Also Published As

Publication number Publication date
KR20210104618A (ko) 2021-08-25
KR20220017458A (ko) 2022-02-11
BR112016015175A2 (pt) 2017-08-08
US10512610B2 (en) 2019-12-24
CN105899193A (zh) 2016-08-24
US10045944B2 (en) 2018-08-14
KR102527999B1 (ko) 2023-05-02
US20160324789A1 (en) 2016-11-10
EP3090732A4 (en) 2017-06-28
EP3090732A1 (en) 2016-11-09
KR20150079449A (ko) 2015-07-08
US20180311170A1 (en) 2018-11-01
KR102357423B1 (ko) 2022-02-08
MX2021000769A (es) 2022-07-29
WO2015102337A1 (ko) 2015-07-09

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