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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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=42229943&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI1016132(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Psychology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (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)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
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ES2545178T3 (es) 2005-07-26 2015-09-09 Bial-Portela & Ca, S.A. Derivados de nitrocatecol como inhibidores de la COMT
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
CL2009000628A1 (es) 2008-03-17 2010-04-09 Bial Portela & Companhia S A Forma cristalina 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, composicion farmaceutica que la comprende, proceso para obtenerla y su uso para tratar trastornos del animo, enfermedad de parkinson y trastornos parkinsonianos, alteraciones gastrointestinales, entre otros.
KR20210009441A (ko) 2009-04-01 2021-01-26 바이알 - 포르텔라 앤드 씨에이 에스에이 니트로카테콜 유도체를 포함하는 제약 제제 및 그의 제조 방법
US20140045900A1 (en) * 2011-02-11 2014-02-13 Bial-Portela & Ca, S.A. Administration regime for nitrocatechols
EP2791134B1 (en) 2011-12-13 2019-09-25 BIAL - Portela & Cª S.A. Chemical compound useful as intermediate for preparing a catechol-o-methyltransferase inhibitor
NO2699580T3 (pt) 2014-01-24 2018-02-24
WO2016083863A1 (en) 2014-11-28 2016-06-02 Bial - Portela & Ca, S.A. Medicaments for slowing parkinson's disease
EP3728241A4 (en) * 2017-12-18 2021-02-24 Unichem Laboratories Ltd OPICAPONE PREPARATION PROCESS AND INTERMEDIARIES THEREOF
CN112055593B (zh) 2018-03-01 2024-04-09 阿斯利康(瑞典)有限公司 药物组合物
EP3823627A4 (en) 2018-07-17 2022-04-20 Insmed Incorporated CERTAIN (2S)-N-[(1S)-1-CYANO-2-PHENYLETHYL]-1,4-OXAZEPANE-2-CARBOXAMIDES FOR THE TREATMENT OF LUPUS ENEHROPATHY
CA3112994A1 (en) 2018-10-05 2020-04-09 Neurocrine Biosciences, Inc. Methods for the administration of comt inhibitors
EP3860603A1 (en) 2018-10-05 2021-08-11 Neurocrine Biosciences, Inc. Methods for the administration of comt inhibitors
JP2023517690A (ja) 2020-03-13 2023-04-26 ビアル－ポルテラ エ コンパニア，ソシエダッド アノニマ 微粉化オピカポン
GB202011709D0 (en) 2020-07-28 2020-09-09 Bial Portela & Ca Sa Solid dispersion of opicapone
GB202016425D0 (en) 2020-10-16 2020-12-02 Bial Portela & Ca Sa Treatment regimens for parkinson's disease
KR20230118933A (ko) 2020-12-17 2023-08-14 바이알 - 포르텔라 앤드 씨에이 에스에이 초기 특발성 파킨슨병에 대한 치료 요법
WO2022180649A1 (en) * 2021-02-26 2022-09-01 Msn Laboratories Private Limited, R&D Center Novel process for the preparation of 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
GB202212082D0 (en) 2022-08-18 2022-10-05 Bial Portela & Ca Sa Treatment regimens for parkinson's disease
AU2024206233A1 (en) 2023-01-06 2025-08-21 Insmed Incorporated Novel, reversible dpp1 inhibitors and uses thereof
WO2024242579A1 (en) 2023-05-25 2024-11-28 Bial-Portela & Ca., S.A. Treatment regimens for early idiopathic parkinson's disease

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CL2009000628A1 (es) * 2008-03-17 2010-04-09 Bial Portela & Companhia S A Forma cristalina 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, composicion farmaceutica que la comprende, proceso para obtenerla y su uso para tratar trastornos del animo, enfermedad de parkinson y trastornos parkinsonianos, alteraciones gastrointestinales, entre otros.

Also Published As

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

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