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BR122019027412B8 - composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração - Google Patents

composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração

Info

Publication number
BR122019027412B8
BR122019027412B8 BR122019027412A BR122019027412A BR122019027412B8 BR 122019027412 B8 BR122019027412 B8 BR 122019027412B8 BR 122019027412 A BR122019027412 A BR 122019027412A BR 122019027412 A BR122019027412 A BR 122019027412A BR 122019027412 B8 BR122019027412 B8 BR 122019027412B8
Authority
BR
Brazil
Prior art keywords
microparticles
preparing
pharmaceutical composition
sustained release
release pharmaceutical
Prior art date
Application number
BR122019027412A
Other languages
English (en)
Other versions
BR122019027412B1 (pt
Inventor
Petersen Holger
Ahlheim Markus
Original Assignee
Novartis 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=37772904&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR122019027412(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from GB0526247A external-priority patent/GB0526247D0/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of BR122019027412B1 publication Critical patent/BR122019027412B1/pt
Publication of BR122019027412B8 publication Critical patent/BR122019027412B8/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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/31Somatostatins
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • 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
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5015Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Peptides Or Proteins (AREA)
  • Polyesters Or Polycarbonates (AREA)

Abstract

a presente invenção se refere às formulações de liberação controlada compreendendo como ingrediente ativo octreotídeo ou um sal farmaceuticamente aceitável do mesmo e dois ou mais polímeros de polilactídeo-co-glicolídeo (plgas) diferentes.
BR122019027412A 2005-12-22 2006-12-20 composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração BR122019027412B8 (pt)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
GB0526247.2 2005-12-22
GB0526247A GB0526247D0 (en) 2005-12-22 2005-12-22 Organic compounds
EP06119086 2006-08-17
EP06119086.4 2006-08-17
BRPI0620063A BRPI0620063B8 (pt) 2005-12-22 2006-12-20 composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração
PCT/EP2006/012313 WO2007071395A1 (en) 2005-12-22 2006-12-20 Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers

Publications (2)

Publication Number Publication Date
BR122019027412B1 BR122019027412B1 (pt) 2020-12-01
BR122019027412B8 true BR122019027412B8 (pt) 2021-07-27

Family

ID=37772904

Family Applications (2)

Application Number Title Priority Date Filing Date
BRPI0620063A BRPI0620063B8 (pt) 2005-12-22 2006-12-20 composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração
BR122019027412A BR122019027412B8 (pt) 2005-12-22 2006-12-20 composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração

Family Applications Before (1)

Application Number Title Priority Date Filing Date
BRPI0620063A BRPI0620063B8 (pt) 2005-12-22 2006-12-20 composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração

Country Status (22)

Country Link
US (7) US20090004283A1 (pt)
EP (3) EP3603623A1 (pt)
JP (4) JP2009520727A (pt)
KR (5) KR20140133968A (pt)
CN (1) CN103251929A (pt)
AR (1) AR058591A1 (pt)
AU (1) AU2006328950B2 (pt)
BR (2) BRPI0620063B8 (pt)
CA (1) CA2631811C (pt)
CL (1) CL2018003398A1 (pt)
EC (1) ECSP088560A (pt)
ES (2) ES2492641T3 (pt)
IL (1) IL191842A0 (pt)
IN (1) IN2015DN03936A (pt)
MA (1) MA30064B1 (pt)
NO (1) NO20082988L (pt)
PE (1) PE20071139A1 (pt)
PL (2) PL2359809T3 (pt)
PT (2) PT1968549E (pt)
RU (1) RU2464972C2 (pt)
TW (2) TWI468172B (pt)
WO (1) WO2007071395A1 (pt)

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Also Published As

Publication number Publication date
CN103251929A (zh) 2013-08-21
PT1968549E (pt) 2014-08-29
BRPI0620063A2 (pt) 2011-11-01
KR20130024988A (ko) 2013-03-08
NO20082988L (no) 2008-08-29
JP6178772B2 (ja) 2017-08-09
KR20080078000A (ko) 2008-08-26
CA2631811A1 (en) 2007-06-28
EP2359809A1 (en) 2011-08-24
TWI468172B (zh) 2015-01-11
US20200206306A1 (en) 2020-07-02
EP1968549A1 (en) 2008-09-17
PT2359809T (pt) 2019-11-04
US20180140662A1 (en) 2018-05-24
IN2015DN03936A (pt) 2015-10-02
ECSP088560A (es) 2008-07-30
AR058591A1 (es) 2008-02-13
JP2015044823A (ja) 2015-03-12
ES2755032T3 (es) 2020-04-21
IL191842A0 (en) 2008-12-29
EP3603623A1 (en) 2020-02-05
MA30064B1 (fr) 2008-12-01
RU2464972C2 (ru) 2012-10-27
US20250082718A1 (en) 2025-03-13
TWI469788B (zh) 2015-01-21
CA2631811C (en) 2017-06-20
KR101245919B1 (ko) 2013-03-20
CL2018003398A1 (es) 2019-04-26
RU2008129626A (ru) 2010-01-27
PE20071139A1 (es) 2007-11-16
WO2007071395A1 (en) 2007-06-28
KR20140133968A (ko) 2014-11-20
PL1968549T3 (pl) 2014-10-31
JP6239851B2 (ja) 2017-11-29
PL2359809T3 (pl) 2020-01-31
US20220296675A1 (en) 2022-09-22
TW201424747A (zh) 2014-07-01
JP2013177406A (ja) 2013-09-09
US20090004283A1 (en) 2009-01-01
BRPI0620063B1 (pt) 2020-09-08
AU2006328950A1 (en) 2007-06-28
EP1968549B1 (en) 2014-05-14
BRPI0620063A8 (pt) 2018-05-02
US20150037420A1 (en) 2015-02-05
AU2006328950B2 (en) 2010-07-29
KR101458728B1 (ko) 2014-11-05
EP2359809B1 (en) 2019-08-14
KR20130024987A (ko) 2013-03-08
BRPI0620063B8 (pt) 2021-05-25
TW200803921A (en) 2008-01-16
ES2492641T3 (es) 2014-09-10
JP2009520727A (ja) 2009-05-28
JP2016216467A (ja) 2016-12-22
US20160120935A1 (en) 2016-05-05
KR20130024986A (ko) 2013-03-08
BR122019027412B1 (pt) 2020-12-01

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