BRPI1016132A2 - composição, formulação farmacêutica, método para fabricar uma formulação farmacêutica estável. - Google Patents

composição, formulação farmacêutica, método para fabricar uma formulação farmacêutica estável.

Info

Publication number
BRPI1016132A2
BRPI1016132A2 BRPI1016132A BRPI1016132A BRPI1016132A2 BR PI1016132 A2 BRPI1016132 A2 BR PI1016132A2 BR PI1016132 A BRPI1016132 A BR PI1016132A BR PI1016132 A BRPI1016132 A BR PI1016132A BR PI1016132 A2 BRPI1016132 A2 BR PI1016132A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
manufacturing
composition
stable
stable pharmaceutical
Prior art date
Application number
BRPI1016132A
Other languages
English (en)
Inventor
Lígia Sofia De Castro Pereira
Pedro Miguel Da Costa Barrocas
Ricardo Jorge Dos Santos Lima
Rui Cerdeira De Campos Costa
Teófilo Cardoso De Vaconcelos
Original Assignee
Bial Portela & Ca Sa
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 Bial Portela & Ca Sa filed Critical Bial Portela & Ca Sa
Publication of BRPI1016132A2 publication Critical patent/BRPI1016132A2/pt
Publication of BRPI1016132B1 publication Critical patent/BRPI1016132B1/pt
Publication of BRPI1016132B8 publication Critical patent/BRPI1016132B8/pt

Links

Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4245—Oxadiazoles
    • 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
    • A61K31/4415—Pyridoxine, i.e. Vitamin B6
    • 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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/20—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive 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
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics
    • 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)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Psychology (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BRPI1016132A 2009-04-01 2010-03-31 composição, formulação farmacêutica, processo de obtenção de uma formulação farmacêutica estável BRPI1016132B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16579409P 2009-04-01 2009-04-01
US61/165794 2009-04-01
PCT/PT2010/000015 WO2010114405A2 (en) 2009-04-01 2010-03-31 Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making the same

Publications (3)

Publication Number Publication Date
BRPI1016132A2 true BRPI1016132A2 (pt) 2016-04-19
BRPI1016132B1 BRPI1016132B1 (pt) 2020-11-24
BRPI1016132B8 BRPI1016132B8 (pt) 2021-05-25

Family

ID=42229943

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI1016132A BRPI1016132B8 (pt) 2009-04-01 2010-03-31 composição, formulação farmacêutica, processo de obtenção de uma formulação farmacêutica estável

Country Status (15)

Country Link
US (3) US20100256194A1 (pt)
EP (1) EP2413913B1 (pt)
JP (2) JP5864410B2 (pt)
KR (1) KR101824257B1 (pt)
CN (2) CN102438595B (pt)
AU (1) AU2010231962B2 (pt)
BR (1) BRPI1016132B8 (pt)
CA (1) CA2757418C (pt)
DK (1) DK2413913T3 (pt)
ES (1) ES2915698T3 (pt)
MX (1) MX361618B (pt)
PL (1) PL2413913T3 (pt)
PT (1) PT2413913T (pt)
RU (1) RU2550133C2 (pt)
WO (1) WO2010114405A2 (pt)

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AU2006272978B2 (en) 2005-07-26 2012-06-07 Bial - Portela & Ca, S.A. Nitrocatechol derivatives as COMT inhibitors
EP1845097A1 (en) 2006-04-10 2007-10-17 Portela & Ca., S.A. Oxadiazole derivatives as COMT inhibitors
DK2481410T3 (en) 2007-01-31 2016-10-24 Bial - Portela & Ca S A Nitrocatecholderivater as COMT inhibitors administered in a specific dosage regimen
MX2010009610A (es) 2008-03-17 2010-09-30 Bial Portela & Ca Sa Formas de cristal de 5-[3-(2,5-dicloro-4,6-dimetil-1-oxi-piridin-3 -il)-[1,2,4]oxadiazol-5-il]-3-nitrobenceno-1,2-diol.
WO2010114404A1 (en) 2009-04-01 2010-10-07 Bial - Portela & Ca., S.A. Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof
US20140045900A1 (en) * 2011-02-11 2014-02-13 Bial-Portela & Ca, S.A. Administration regime for nitrocatechols
JP6456143B2 (ja) 2011-12-13 2019-01-23 ノヴィファーマ，エス．アー． カテコール−ｏ−メチル転移酵素阻害剤を調製するための中間体として有用な化学的化合物
NO2699580T3 (pt) 2014-01-24 2018-02-24
RU2017120184A (ru) 2014-11-28 2018-12-28 БИАЛ - ПОРТЕЛА ЭНД Ка, С.А. Лекарства для замедления течения болезни паркинсона
EP3728241A4 (en) * 2017-12-18 2021-02-24 Unichem Laboratories Ltd OPICAPONE PREPARATION PROCESS AND INTERMEDIARIES THEREOF
US20210369732A1 (en) * 2018-03-01 2021-12-02 Astrazeneca Ab PHARMACEUTICAL COMPOSITIONS COMPRISING (2S)-N-{(1S)-1-CYANO-2-[4-(3-METHYL-2-OXO-2,3-DIHYDRO-1,3-BENZOXAZOL-5-yl)PHENYL]ETHYL}-1,4-OXAZEPANE-2-CARBOXAMIDE
KR20210032431A (ko) 2018-07-17 2021-03-24 인스메드 인코포레이티드 루푸스 신염을 치료하기 위한 특정 (2s)-n-[(1s)-1-시아노-2-페닐에틸]-1,4-옥사제판-2-카복스아미드
CA3112994A1 (en) 2018-10-05 2020-04-09 Neurocrine Biosciences, Inc. Methods for the administration of comt inhibitors
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CN115335036A (zh) 2020-03-13 2022-11-11 巴尔-波特拉及康邦亚股份有限公司 微粉化的奥匹卡朋
GB202011709D0 (en) 2020-07-28 2020-09-09 Bial Portela & Ca Sa Solid dispersion of opicapone
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KR20230118933A (ko) 2020-12-17 2023-08-14 바이알 - 포르텔라 앤드 씨에이 에스에이 초기 특발성 파킨슨병에 대한 치료 요법
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GB202212082D0 (en) 2022-08-18 2022-10-05 Bial Portela & Ca Sa Treatment regimens for parkinson's disease

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Also Published As

Publication number Publication date
AU2010231962A1 (en) 2011-11-17
CN102438595A (zh) 2012-05-02
RU2011143619A (ru) 2013-05-10
BRPI1016132B8 (pt) 2021-05-25
KR20120008040A (ko) 2012-01-25
JP6336420B2 (ja) 2018-06-06
KR101824257B1 (ko) 2018-01-31
BRPI1016132B1 (pt) 2020-11-24
ES2915698T3 (es) 2022-06-24
EP2413913A2 (en) 2012-02-08
JP2012522764A (ja) 2012-09-27
JP2016020369A (ja) 2016-02-04
PT2413913T (pt) 2022-06-09
CA2757418C (en) 2021-06-15
CN102438595B (zh) 2016-04-27
CA2757418A1 (en) 2010-10-07
CN105816456A (zh) 2016-08-03
WO2010114405A2 (en) 2010-10-07
US20210315824A1 (en) 2021-10-14
MX2011010311A (es) 2012-03-07
RU2550133C2 (ru) 2015-05-10
AU2010231962B2 (en) 2015-05-21
MX361618B (es) 2018-12-13
JP5864410B2 (ja) 2016-02-17
EP2413913B1 (en) 2022-05-18
DK2413913T3 (da) 2022-06-13
WO2010114405A3 (en) 2011-01-06
PL2413913T3 (pl) 2022-09-26
US20100256194A1 (en) 2010-10-07
US20190008774A1 (en) 2019-01-10

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