BRPI0417043A - composição farmacêutica, forma de dosagem sólida, método de manufatura de forma de dosagem sólida, e, uso da composição - Google Patents

composição farmacêutica, forma de dosagem sólida, método de manufatura de forma de dosagem sólida, e, uso da composição

Info

Publication number
BRPI0417043A
BRPI0417043A BRPI0417043-1A BRPI0417043A BRPI0417043A BR PI0417043 A BRPI0417043 A BR PI0417043A BR PI0417043 A BRPI0417043 A BR PI0417043A BR PI0417043 A BRPI0417043 A BR PI0417043A
Authority
BR
Brazil
Prior art keywords
solid dosage
dosage form
composition
pharmaceutical composition
lercanidipine
Prior art date
Application number
BRPI0417043-1A
Other languages
English (en)
Inventor
Per Holm
Tomas Norling
Original Assignee
Lifecycle Pharma As
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 Lifecycle Pharma As filed Critical Lifecycle Pharma As
Publication of BRPI0417043A publication Critical patent/BRPI0417043A/pt

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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
    • 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
    • A61K9/1611—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
    • A61K9/14—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
    • A61K9/1617—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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • 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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)

Abstract

"COMPOSIçãO FARMACêUTICA, FORMA DE DOSAGEM SóLIDA, MéTODO DE MANUFATURA DE FORMA DE DOSAGEM SóLIDA, E, USO DA COMPOSIçãO". Uma composição farmacêutica de liberação controlada compreendendo lercanidipina dissolvida ou dispersada em um veículo sólido na temperatura ambiente, formando assim uma dispersão sólida, alcança a liberação retardada de lercanidipina durante um período de tempo prolongado, efeito de alimentação reduzida e biodisponibilidade aumentada comparada com os produtos contendo lercanidipina comercialmente disponíveis.
BRPI0417043-1A 2003-12-01 2004-12-01 composição farmacêutica, forma de dosagem sólida, método de manufatura de forma de dosagem sólida, e, uso da composição BRPI0417043A (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DKPA200301778 2003-12-01
DKPA200400249 2004-02-18
US55378704P 2004-03-16 2004-03-16
PCT/DK2004/000836 WO2005053689A2 (en) 2003-12-01 2004-12-01 Pharmaceutical compositions comprising lercanidipine

Publications (1)

Publication Number Publication Date
BRPI0417043A true BRPI0417043A (pt) 2007-02-06

Family

ID=34657505

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0417043-1A BRPI0417043A (pt) 2003-12-01 2004-12-01 composição farmacêutica, forma de dosagem sólida, método de manufatura de forma de dosagem sólida, e, uso da composição

Country Status (14)

Country Link
US (1) US20070105912A1 (pt)
EP (1) EP1694305B1 (pt)
JP (1) JP2007512265A (pt)
KR (1) KR20060125824A (pt)
AU (1) AU2004294674B2 (pt)
BR (1) BRPI0417043A (pt)
CA (1) CA2547657A1 (pt)
DE (1) DE04801160T1 (pt)
EA (1) EA013426B1 (pt)
ES (1) ES2281313T3 (pt)
IL (1) IL175973A (pt)
MX (1) MXPA06006118A (pt)
NO (1) NO340114B1 (pt)
WO (1) WO2005053689A2 (pt)

Families Citing this family (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101111245A (zh) * 2005-01-27 2008-01-23 阿雷姆贝克有限公司 左乙拉西坦延长释放制剂
AR053023A1 (es) * 2005-02-25 2007-04-18 Recordati Ireland Ltd Base libre de lercanidipina, metodos para su preparacion y composiciones farmaceuticas que las contienen
WO2006119779A2 (en) * 2005-05-10 2006-11-16 Lifecycle Pharma A/S A pharmaceutical composition comprising an aldosterone antagonist in form of solid solution
MX2009002166A (es) * 2006-08-31 2009-03-12 Eurand Inc Sistema de distribucion de farmacos, que comprenden soluciones solidas de farmacos debilmente basicos.
US20080175872A1 (en) * 2006-09-28 2008-07-24 Osmotica Corp. Controlled Release Dosage Form Containing Lercanidipine and a Performance-enhancing Acid
GB0709541D0 (en) * 2007-05-17 2007-06-27 Jagotec Ag Pharmaceutical excipient
AU2007356942B2 (en) * 2007-07-23 2011-12-15 Pharmathen S.A. Pharmaceutical composition containing dihydropyridine calcium channel antagonist and method for the preparation thereof
DE102008022520A1 (de) * 2008-05-07 2009-11-12 Bayer Animal Health Gmbh Feste Arzneimittelformulierung mit verzögerter Freisetzung
AR072477A1 (es) * 2008-07-11 2010-09-01 Solvay Pharm Bv Formulacion farmaceutica de eprosartan. uso.
US20100209348A1 (en) * 2009-02-18 2010-08-19 Arondo Pharma, Inc. Methods for determining liposome bioequivalence
EP2598136A4 (en) * 2010-07-27 2015-03-25 Teva Pharma DISPERSIONS OF RASAGILINE CITRATE
US9504664B2 (en) 2010-10-29 2016-11-29 Infirst Healthcare Limited Compositions and methods for treating severe pain
US11730709B2 (en) 2010-10-29 2023-08-22 Infirst Healthcare Limited Compositions and methods for treating severe pain
US9308213B2 (en) 2010-10-29 2016-04-12 Infirst Healthcare Limited Solid solution compositions and use in chronic inflammation
US9271950B2 (en) 2010-10-29 2016-03-01 Infirst Healthcare Limited Compositions for treating chronic inflammation and inflammatory diseases
US9744132B2 (en) 2010-10-29 2017-08-29 Infirst Healthcare Limited Solid solution compositions and use in chronic inflammation
US11202831B2 (en) 2010-10-29 2021-12-21 Infirst Healthcare Limited Solid solution compositions and use in cardiovascular disease
US8895536B2 (en) 2010-10-29 2014-11-25 Infirst Healthcare Ltd. Compositions and methods for treating chronic inflammation and inflammatory diseases
US10695432B2 (en) 2010-10-29 2020-06-30 Infirst Healthcare Limited Solid solution compositions and use in severe pain
US9737500B2 (en) 2010-10-29 2017-08-22 Infirst Healthcare Limited Compositions and methods for treating severe pain
US10695431B2 (en) 2010-10-29 2020-06-30 Infirst Healthcare Limited Solid solution compositions and use in cardiovascular disease
US11224659B2 (en) 2010-10-29 2022-01-18 Infirst Healthcare Limited Solid solution compositions and use in severe pain
UY33772A (es) * 2010-12-09 2012-07-31 Lg Life Sciences Ltd Composición farmacéutica que comprende clorhidrato de lercanidipina y valsartán como componentes activos y a un método para la preparacion de la misma.
EP2654729B1 (en) * 2010-12-24 2016-05-04 KRKA, d.d., Novo mesto Homogenous pharmaceutical oral dosage forms comprising lercanidipine and enalapril or their pharmaceutically acceptable salts together with an organic acid
BR112015015858B1 (pt) * 2013-01-14 2023-02-28 Infirst Healthcare Limited Uso de uma composição farmacêutica de solução sólida no tratamento de uma inflamação crônica
EP3218006A4 (en) * 2014-11-11 2018-08-15 Verdure Sciences Stable solid lipid particle composition for improved bioavailability of lipophilic compounds for age-related diseases
JP7378393B2 (ja) * 2017-11-10 2023-11-13 オースティンピーエックス リミテッド ライアビリティ カンパニー 改善された薬物製剤
JP6983139B2 (ja) * 2017-11-27 2021-12-17 信越化学工業株式会社 固形製剤用組成物並びに固形製剤及びその製造方法
US20210145036A1 (en) * 2018-04-17 2021-05-20 Poviva Tea, Llc Lipophilic active agent infused compositions with reduced food effect
CN115837012A (zh) * 2021-01-18 2023-03-24 广州一品红制药有限公司 一种氨氯地平干混悬剂及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20011726A1 (it) * 2001-08-06 2003-02-06 Recordati Ind Chimica E Farma Forme polimorfe della lercanidipina cloridrato
US20030180355A1 (en) * 2001-10-16 2003-09-25 Amedeo Leonardi Combination therapy for hypertension

Also Published As

Publication number Publication date
ES2281313T3 (es) 2020-07-24
CA2547657A1 (en) 2005-06-16
MXPA06006118A (es) 2006-08-11
JP2007512265A (ja) 2007-05-17
KR20060125824A (ko) 2006-12-06
AU2004294674B2 (en) 2009-02-26
EA200601075A1 (ru) 2006-12-29
EP1694305A2 (en) 2006-08-30
EA013426B1 (ru) 2010-04-30
AU2004294674A1 (en) 2005-06-16
ES2281313T1 (es) 2007-10-01
IL175973A0 (en) 2006-10-05
US20070105912A1 (en) 2007-05-10
WO2005053689A3 (en) 2006-04-27
NO340114B1 (no) 2017-03-13
EP1694305B1 (en) 2019-10-16
DE04801160T1 (de) 2007-08-09
IL175973A (en) 2016-03-31
NO20063036L (no) 2006-09-01
WO2005053689A2 (en) 2005-06-16

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Legal Events

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B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 5A,6A E 7A ANUIDADE(S)

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2129 DE 25/10/2011.