AU2006275718B8 - Pharmaceutical formulations/composition of guanfacine suitable for single dose form adminstration daily - Google Patents

Pharmaceutical formulations/composition of guanfacine suitable for single dose form adminstration daily Download PDF

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Publication number
AU2006275718B8
AU2006275718B8 AU2006275718A AU2006275718A AU2006275718B8 AU 2006275718 B8 AU2006275718 B8 AU 2006275718B8 AU 2006275718 A AU2006275718 A AU 2006275718A AU 2006275718 A AU2006275718 A AU 2006275718A AU 2006275718 B8 AU2006275718 B8 AU 2006275718B8
Authority
AU
Australia
Prior art keywords
weight
dosage form
oral dosage
form according
guanfacine
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.)
Active
Application number
AU2006275718A
Other languages
English (en)
Other versions
AU2006275718B2 (en
AU2006275718A1 (en
AU2006275718A8 (en
Inventor
Michael Pennick
Amir H. Shojaei
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.)
Takeda Pharmaceutical Co Ltd
Original Assignee
Takeda Pharmaceutical Co 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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37668083&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2006275718(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Takeda Pharmaceutical Co Ltd filed Critical Takeda Pharmaceutical Co Ltd
Publication of AU2006275718A1 publication Critical patent/AU2006275718A1/en
Publication of AU2006275718B2 publication Critical patent/AU2006275718B2/en
Application granted granted Critical
Publication of AU2006275718A8 publication Critical patent/AU2006275718A8/en
Publication of AU2006275718B8 publication Critical patent/AU2006275718B8/en
Assigned to TAKEDA PHARMACEUTICAL COMPANY LIMITED reassignment TAKEDA PHARMACEUTICAL COMPANY LIMITED Request for Assignment Assignors: SHIRE LLC
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2027—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
    • A61K9/20—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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
    • 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
    • A61P15/06—Antiabortive agents; Labour repressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • 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
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2006275718A 2005-07-28 2006-07-27 Pharmaceutical formulations/composition of guanfacine suitable for single dose form adminstration daily Active AU2006275718B8 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US70298205P 2005-07-28 2005-07-28
US60/702,982 2005-07-28
PCT/US2006/029277 WO2007016284A2 (en) 2005-07-28 2006-07-27 Pharmaceutical formulations/composition of guanfacine suitable for single dose form adminstration daily

Publications (4)

Publication Number Publication Date
AU2006275718A1 AU2006275718A1 (en) 2007-02-08
AU2006275718B2 AU2006275718B2 (en) 2012-10-04
AU2006275718A8 AU2006275718A8 (en) 2012-11-01
AU2006275718B8 true AU2006275718B8 (en) 2012-11-01

Family

ID=37668083

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2006275718A Active AU2006275718B8 (en) 2005-07-28 2006-07-27 Pharmaceutical formulations/composition of guanfacine suitable for single dose form adminstration daily

Country Status (18)

Country Link
US (1) US20070048371A1 (https=)
EP (1) EP1909766B1 (https=)
JP (2) JP5726401B2 (https=)
KR (1) KR20080041669A (https=)
CN (1) CN101252917A (https=)
AR (1) AR054595A1 (https=)
AU (1) AU2006275718B8 (https=)
BR (1) BRPI0615989B8 (https=)
CA (1) CA2616181C (https=)
DK (1) DK1909766T3 (https=)
ES (1) ES2566395T3 (https=)
IL (1) IL188980A0 (https=)
NO (1) NO20081038L (https=)
NZ (1) NZ565649A (https=)
RU (1) RU2435573C2 (https=)
TW (1) TW200744672A (https=)
WO (1) WO2007016284A2 (https=)
ZA (1) ZA200801575B (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0916163D0 (en) * 2009-09-15 2009-10-28 Shire Llc Prodrugs of guanfacine
JP6045347B2 (ja) * 2010-02-03 2016-12-14 ファーマ ツー ビー リミテッド ラサギリンの持続放出性製剤およびその使用
MX2012014432A (es) * 2010-06-11 2013-05-20 Shire Llc Terapia de combinacion con lisdexanfetamina y guanfacina de liberacion prolongada.
US20120041068A1 (en) * 2010-08-11 2012-02-16 Aptapharma, Inc. Extended Release Pharmaceutical Preparations for Active Pharmaceutical Ingredients with pH Dependent Solubility
CN102525983A (zh) * 2010-12-31 2012-07-04 北京万全阳光医药科技有限公司 胍法新缓释片及其制备方法
CN102579381B (zh) * 2012-03-30 2013-07-10 河南中帅医药科技发展有限公司 盐酸胍法辛缓释制剂及其制备方法
US9180104B2 (en) 2013-03-13 2015-11-10 Tris Pharma, Inc. Benzonatate modified release solid tablets and capsules
CN105188677A (zh) * 2013-03-13 2015-12-23 特瑞斯制药股份有限公司 苯佐那酯调释固体片剂和胶囊剂
WO2016089997A1 (en) 2014-12-02 2016-06-09 Yale University Methods of preventing neurodegeneration of association cortex in a mammal
PE20181521A1 (es) * 2015-12-08 2018-09-24 Ardea Biosciences Inc Composicion farmaceutica que comprende un potente inhibidor de urat1
JP6656670B2 (ja) * 2016-03-11 2020-03-04 国立大学法人 鹿児島大学 抗ｈｃｖ活性を有する薬剤
US10251857B2 (en) * 2016-04-20 2019-04-09 New Frontier Labs, Llc Azelaic acid esters in the treatment of insulin resistance
WO2019136224A1 (en) * 2018-01-05 2019-07-11 Shire Human Genetic Therapies, Inc. Amphetamine-guanfacine combinations for treatment of neuropsychiatric disorders
JP7814869B2 (ja) * 2021-09-01 2026-02-17 東和薬品株式会社 グアンファシン製剤
JP7835098B2 (ja) * 2022-04-15 2026-03-25 ニプロ株式会社 グアンファシン含有徐放性製剤
EP4292587A1 (en) 2022-06-15 2023-12-20 Sawai Pharmaceutical Co., Ltd. Guanfacine hydrochloride containing pharmaceutical preparation

Citations (1)

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US6811794B2 (en) * 2001-12-20 2004-11-02 Shire Laboratories, Inc. Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles

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CH649918A5 (de) * 1981-07-09 1985-06-28 Sandoz Ag Verwendung von n-amidino-2-phenylacetamiden als wirkstoff zur herstellung von pharmazeutischen zubereitungen gegen schizophrenie.
IE56999B1 (en) * 1983-12-22 1992-03-11 Elan Corp Plc Pharmaceutical formulation
US5102668A (en) * 1990-10-05 1992-04-07 Kingaform Technology, Inc. Sustained release pharmaceutical preparation using diffusion barriers whose permeabilities change in response to changing pH
US5854290A (en) * 1995-09-21 1998-12-29 Amy F. T. Arnsten Use of guanfacine in the treatment of behavioral disorders
DE19834573A1 (de) * 1998-07-31 2000-02-03 Bayer Ag Doppelmetallcyanid-Katalysatoren für die Herstellung von Polyetherpolyolen
FR2781152B1 (fr) * 1998-07-20 2001-07-06 Permatec Tech Ag Utilisation d'un polymere de type acrylique en tant qu'agent de desagregation
PE20001396A1 (es) * 1999-01-18 2000-12-23 Gruenenthal Chemie Formulaciones medicamentosas retardadas que contienen una combinacion de un opioide o una sal fisiologicamente tolerables del mismo, un o-agonista
US6635277B2 (en) * 2000-04-12 2003-10-21 Wockhardt Limited Composition for pulsatile delivery of diltiazem and process of manufacture
US6287599B1 (en) * 2000-12-20 2001-09-11 Shire Laboratories, Inc. Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
EP1355633B1 (en) * 2001-12-19 2005-01-19 AstraZeneca AB NEW FILM COATING containing an ethyl acrylate/methyl methacrylate copolymer and polyvinyl acetate
DE60322371D1 (de) * 2002-03-29 2008-09-04 Alza Corp Volumensparende arzneiform zur kontrollierten freisetzung
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Also Published As

Publication number Publication date
BRPI0615989A2 (pt) 2011-05-31
ES2566395T3 (es) 2016-04-12
WO2007016284A2 (en) 2007-02-08
RU2435573C2 (ru) 2011-12-10
CA2616181C (en) 2015-02-17
DK1909766T3 (en) 2016-04-04
AR054595A1 (es) 2007-06-27
EP1909766A2 (en) 2008-04-16
BRPI0615989B8 (pt) 2021-05-25
AU2006275718B2 (en) 2012-10-04
JP5726401B2 (ja) 2015-06-03
AU2006275718A1 (en) 2007-02-08
AU2006275718A8 (en) 2012-11-01
RU2008102911A (ru) 2009-09-10
EP1909766B1 (en) 2016-03-16
NO20081038L (no) 2008-04-23
JP2009502951A (ja) 2009-01-29
ZA200801575B (en) 2008-12-31
CN101252917A (zh) 2008-08-27
CA2616181A1 (en) 2007-02-08
KR20080041669A (ko) 2008-05-13
BRPI0615989B1 (pt) 2020-05-26
IL188980A0 (en) 2008-08-07
WO2007016284A3 (en) 2007-03-29
US20070048371A1 (en) 2007-03-01
TW200744672A (en) 2007-12-16
JP2012229253A (ja) 2012-11-22
NZ565649A (en) 2011-03-31

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Legal Events

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TH Corrigenda

Free format text: IN VOL 22 , NO 7 , PAGE(S) 765 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME SHIRE LLC, APPLICATION NO. 2006275718, UNDER INID (72) CORRECT THE COINVENTOR TO SHOJAEI, AMIR H.

Free format text: IN VOL 26 , NO 38 , PAGE(S) 5070 UNDER THE HEADING APPLICATIONS ACCEPTED - NAME INDEX UNDER THE NAME SHIRE LLC, APPLICATION NO. 2006275718, UNDER INID (72) CORRECT THE CO-INVENTOR TO SHOJAEI, AMIR H.

FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Free format text: FORMER OWNER(S): SHIRE LLC