WO2015019237A1 - Composition pharmaceutique de vilazodone - Google Patents

Composition pharmaceutique de vilazodone Download PDF

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Publication number
WO2015019237A1
WO2015019237A1 PCT/IB2014/063484 IB2014063484W WO2015019237A1 WO 2015019237 A1 WO2015019237 A1 WO 2015019237A1 IB 2014063484 W IB2014063484 W IB 2014063484W WO 2015019237 A1 WO2015019237 A1 WO 2015019237A1
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
vilazodone
pharmaceutically acceptable
acceptable excipients
particles
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.)
Ceased
Application number
PCT/IB2014/063484
Other languages
English (en)
Inventor
Abhishek Srivastava
Surajit Das
Mukesh Kumar Garg
Ajay Kumar Singla
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.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
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 Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Publication of WO2015019237A1 publication Critical patent/WO2015019237A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • a first aspect of the present invention provides a pharmaceutical composition comprising micronized particles of vilazodone and one or more pharmaceutically acceptable excipients.
  • Bioequivalence is defined to mean the term used by the drug approval agencies, such as the US Food and Drug Administration: "the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.” This is typically understood to mean that the reference drug is within +25% and -20% of the reference drug product for AUC and Cmax, for example as explained in the US FDA's various bioequivalence guidance documents for oral tablets and capsules, which are incorporated herein by reference.
  • step (d) compressing the blend of step (c) to form tablets
  • Suitable plasticizers are selected from the group consisting of triethyl citrate, dibutyl sebacate, acetylated triacetin, tributyl citrate, glycerol tributyrate, monoglyceride, rapeseed oil, olive oil, sesame oil, acetyl tributyl citrate, acetyl triethyl citrate, glycerin sorbitol, diethyl oxalate, diethyl phthalate, diethyl malate, diethyl fumarate, dibutyl succinate, diethyl malonate, dioctyl phthalate, or mixtures thereof.
  • Microcrystalline cellulose and colloidal silicon dioxide were sifted and mixed together.

Landscapes

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

Abstract

La présente invention concerne des compositions pharmaceutiques comprenant des particules micronisées de vilazodone et des procédés pour leur préparation. L'invention porte en outre sur une méthode de traitement et/ou de prévention de troubles du système nerveux central par administration desdites compositions pharmaceutiques.
PCT/IB2014/063484 2013-08-06 2014-07-28 Composition pharmaceutique de vilazodone Ceased WO2015019237A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2349/DEL/2013 2013-08-06
IN2349DE2013 2013-08-06

Publications (1)

Publication Number Publication Date
WO2015019237A1 true WO2015019237A1 (fr) 2015-02-12

Family

ID=51359416

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2014/063484 Ceased WO2015019237A1 (fr) 2013-08-06 2014-07-28 Composition pharmaceutique de vilazodone

Country Status (1)

Country Link
WO (1) WO2015019237A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106580914A (zh) * 2017-02-27 2017-04-26 佛山市弘泰药物研发有限公司 一种盐酸维拉佐酮软胶囊及其制备方法
EP3360543A1 (fr) 2017-02-13 2018-08-15 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions pharmaceutiques de chlorhydrate de vilazodone
EP3360542A1 (fr) * 2017-02-13 2018-08-15 Sanovel Ilac Sanayi ve Ticaret A.S. Formes de comprimés de chlorhydrate de vilazodone
US10688090B2 (en) 2016-11-02 2020-06-23 Sunshine Lake Pharma Co., Ltd. Vilazodone inclusion complexes, compositions and preparation thereof
EP4268802A4 (fr) * 2020-12-23 2024-11-06 Shanghai Yonsun Biotechnology Co., Ltd. Composition pharmaceutique de vilazodone, procédé de préparation associé et utilisation de celle-ci
US12171761B2 (en) 2016-11-02 2024-12-24 Sunshine Lake Pharma Co., Ltd. Vilazodone inclusion complexes, compositions and preparation thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5532241A (en) 1993-09-30 1996-07-02 Merck Patent Gesellschaft Mit Beschrankter Haftung Piperidines and piperazines
US7834020B2 (en) 2001-06-19 2010-11-16 Merck Patent Gesellschaft Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
WO2012131706A1 (fr) 2011-03-20 2012-10-04 Cadila Healthcare Limited Forme amorphe du chlorhydrate de vilazodone et son procédé de préparation
WO2013078361A1 (fr) 2011-11-23 2013-05-30 Assia Chemical Industries Ltd. Formes à l'état solide de vilazodone et de chlorhydrate de vilazodone

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5532241A (en) 1993-09-30 1996-07-02 Merck Patent Gesellschaft Mit Beschrankter Haftung Piperidines and piperazines
US7834020B2 (en) 2001-06-19 2010-11-16 Merck Patent Gesellschaft Polymorphic forms of 1-′4-(5-cyanoindol-3-yl)butyl-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
WO2012131706A1 (fr) 2011-03-20 2012-10-04 Cadila Healthcare Limited Forme amorphe du chlorhydrate de vilazodone et son procédé de préparation
WO2013078361A1 (fr) 2011-11-23 2013-05-30 Assia Chemical Industries Ltd. Formes à l'état solide de vilazodone et de chlorhydrate de vilazodone

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10688090B2 (en) 2016-11-02 2020-06-23 Sunshine Lake Pharma Co., Ltd. Vilazodone inclusion complexes, compositions and preparation thereof
US11517569B2 (en) 2016-11-02 2022-12-06 Sunshine Lake Pharma Co., Ltd. Vilazodone inclusion complexes, compositions and preparation thereof
US12171761B2 (en) 2016-11-02 2024-12-24 Sunshine Lake Pharma Co., Ltd. Vilazodone inclusion complexes, compositions and preparation thereof
EP3360543A1 (fr) 2017-02-13 2018-08-15 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions pharmaceutiques de chlorhydrate de vilazodone
EP3360542A1 (fr) * 2017-02-13 2018-08-15 Sanovel Ilac Sanayi ve Ticaret A.S. Formes de comprimés de chlorhydrate de vilazodone
CN106580914A (zh) * 2017-02-27 2017-04-26 佛山市弘泰药物研发有限公司 一种盐酸维拉佐酮软胶囊及其制备方法
EP4268802A4 (fr) * 2020-12-23 2024-11-06 Shanghai Yonsun Biotechnology Co., Ltd. Composition pharmaceutique de vilazodone, procédé de préparation associé et utilisation de celle-ci

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