BR112014014131A2 - formulações de pastilha e cápsula com taxas melhoradas de dissolução de fenofibrato - Google Patents

formulações de pastilha e cápsula com taxas melhoradas de dissolução de fenofibrato

Info

Publication number
BR112014014131A2
BR112014014131A2 BR112014014131A BR112014014131A BR112014014131A2 BR 112014014131 A2 BR112014014131 A2 BR 112014014131A2 BR 112014014131 A BR112014014131 A BR 112014014131A BR 112014014131 A BR112014014131 A BR 112014014131A BR 112014014131 A2 BR112014014131 A2 BR 112014014131A2
Authority
BR
Brazil
Prior art keywords
tablet
capsule formulations
dissolution rates
improved
fenofibrate dissolution
Prior art date
Application number
BR112014014131A
Other languages
English (en)
Other versions
BR112014014131B1 (pt
Inventor
Li Michael
Original Assignee
Lts Lohmann Therapie Systeme Ag
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 Lts Lohmann Therapie Systeme Ag filed Critical Lts Lohmann Therapie Systeme Ag
Publication of BR112014014131A2 publication Critical patent/BR112014014131A2/pt
Publication of BR112014014131B1 publication Critical patent/BR112014014131B1/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

resumo patente de invenção: "formulações de pastilha e cápsula com taxas melhoradas de dissolução de fenofibrato". a presente invenção refere-se ao desenvolver novas formulações de pastilha e de cápsula usando fenofibrato que é difícil de dissolver e controlar a sua taxa de liberação in vitro.
BR112014014131-2A 2011-12-14 2012-12-14 formulações de pastilha e cápsula com taxas melhoradas de dissolução de fenofibrato e processos para produzir as mesmas BR112014014131B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161570381P 2011-12-14 2011-12-14
US61/570,381 2011-12-14
PCT/IB2012/003123 WO2013114153A2 (en) 2011-12-14 2012-12-14 Wafer and capsule formulations with enhanced dissolution rates for fenofibrate

Publications (2)

Publication Number Publication Date
BR112014014131A2 true BR112014014131A2 (pt) 2017-06-13
BR112014014131B1 BR112014014131B1 (pt) 2021-02-23

Family

ID=48790490

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014014131-2A BR112014014131B1 (pt) 2011-12-14 2012-12-14 formulações de pastilha e cápsula com taxas melhoradas de dissolução de fenofibrato e processos para produzir as mesmas

Country Status (8)

Country Link
US (2) US9849184B2 (pt)
EP (1) EP2790680B1 (pt)
JP (3) JP6149865B2 (pt)
CN (2) CN110496108A (pt)
BR (1) BR112014014131B1 (pt)
CA (1) CA2857430C (pt)
ES (1) ES2717470T3 (pt)
WO (1) WO2013114153A2 (pt)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7365409B2 (ja) 2018-06-28 2023-10-19 エイアールエックス エルエルシー 溶解性単位用量膜構造物を製造するための分配方法

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5785976A (en) * 1993-03-05 1998-07-28 Pharmacia & Upjohn Ab Solid lipid particles, particles of bioactive agents and methods for the manufacture and use thereof
US5362496A (en) 1993-08-04 1994-11-08 Pharmetrix Corporation Method and therapeutic system for smoking cessation
US6096337A (en) 1996-06-10 2000-08-01 Spireas; Spiridon Liquisolid systems and methods of preparing same
DE19646392A1 (de) 1996-11-11 1998-05-14 Lohmann Therapie Syst Lts Zubereitung zur Anwendung in der Mundhöhle mit einer an der Schleimhaut haftklebenden, Pharmazeutika oder Kosmetika zur dosierten Abgabe enthaltenden Schicht
AU7984200A (en) * 1999-09-21 2001-04-24 Skyepharma Canada Inc. Surface modified particulate compositions of biologically active substances
AU8847101A (en) * 2000-08-31 2002-03-13 Rtp Pharma Inc Milled particles
WO2003013607A1 (en) * 2001-08-07 2003-02-20 Galephar M/F ORAL PHARMACEUTICAL COMPOSITION CONTAINING A COMBINATION OF FENOFIBRATE AND A HMG-CoA REDUCTASE INHIBITOR
DE10207394B4 (de) 2002-02-21 2007-03-29 Lts Lohmann Therapie-Systeme Ag Geschmacksmaskierte oblatenförmige Arzneizubereitung
KR20060085682A (ko) * 2003-10-10 2006-07-27 라이프사이클 파마 에이/에스 피브레이트 및 스타틴을 함유하는 고형 제제
KR20060085686A (ko) * 2003-10-10 2006-07-27 라이프사이클 파마 에이/에스 피브레이트를 포함하는 고형 제제
US20070014846A1 (en) 2003-10-10 2007-01-18 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin
US20050096390A1 (en) 2003-10-10 2005-05-05 Per Holm Compositions comprising fenofibrate and pravastatin
EP1861084A1 (en) * 2005-03-30 2007-12-05 Teva Pharmaceutical Industries Ltd. Improved formulations of fenofibrate containing menthol or peg/poloxamer
CN101495150B (zh) * 2006-08-01 2011-06-01 大塚制药株式会社 药理活性物质的吸收性被改善的药物组合物
US8623401B2 (en) * 2008-03-27 2014-01-07 Fenwafe Inc. Wafer formulation
GB2462022B (en) * 2008-06-16 2011-05-25 Biovascular Inc Controlled release compositions of agents that reduce circulating levels of platelets and methods thereof
US8524280B2 (en) 2008-12-15 2013-09-03 Banner Pharmacaps, Inc. Methods for enhancing the release and absorption of water insoluble active agents

Also Published As

Publication number Publication date
CA2857430A1 (en) 2013-08-08
JP2017122099A (ja) 2017-07-13
JP6391731B2 (ja) 2018-09-19
US20140377342A1 (en) 2014-12-25
CN103987383A (zh) 2014-08-13
EP2790680B1 (en) 2018-12-12
CA2857430C (en) 2019-12-03
BR112014014131B1 (pt) 2021-02-23
JP2015500330A (ja) 2015-01-05
EP2790680A2 (en) 2014-10-22
US9849184B2 (en) 2017-12-26
US11497811B2 (en) 2022-11-15
US20180092979A1 (en) 2018-04-05
WO2013114153A2 (en) 2013-08-08
CN110496108A (zh) 2019-11-26
JP2017114885A (ja) 2017-06-29
JP6149865B2 (ja) 2017-06-21
WO2013114153A3 (en) 2013-10-31
JP6391730B2 (ja) 2018-09-19
ES2717470T3 (es) 2019-06-21

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/12/2012, OBSERVADAS AS CONDICOES LEGAIS.