AR058591A1 - Formulacion de liberacion sostenida que comprende octreotida y dos o mas polimeros de polilactido-coglicolido - Google Patents

Formulacion de liberacion sostenida que comprende octreotida y dos o mas polimeros de polilactido-coglicolido

Info

Publication number
AR058591A1
AR058591A1 ARP060105668A ARP060105668A AR058591A1 AR 058591 A1 AR058591 A1 AR 058591A1 AR P060105668 A ARP060105668 A AR P060105668A AR P060105668 A ARP060105668 A AR P060105668A AR 058591 A1 AR058591 A1 AR 058591A1
Authority
AR
Argentina
Prior art keywords
microparticles
tumors
octreotide
polymers
pharmaceutically acceptable
Prior art date
Application number
ARP060105668A
Other languages
English (en)
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=AR058591(A1) "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 AR058591A1 publication Critical patent/AR058591A1/es

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

Abstract

La presente se refiere a composiciones de liberacion sostenida que comprenden, como ingrediente activo, octreotida o una sal farmacéuticamente aceptable de la misma y dos o más diferentes polímeros de poliláctido-co-glicolido (PLGAs). Reivindicacion 20: El uso de una composicion farmacéutica de acuerdo con cualquiera de las reivindicaciones 1 a 19 para una terapia de mantenimiento a largo plazo en pacientes acromegálicos, y tratamiento de diarrea severa y brote asociado con tumores carcinoides malignos y tumores de péptido intestinales vasoactivos (tumores vipoma). Reivindicacion 21: Un método para administrar octreotida o una sal farmacéuticamente aceptable de la misma para una terapia de mantenimiento a largo plazo en pacientes acromegálicos, y tratamiento de diarrea severa y brote asociado con tumores carcinoides malignos y tumores de péptido intestinales vasoactivos /tumores vipoma), dicho método comprende administrar, a un paciente con la necesidad de octreotida o una sal farmacéuticamente aceptable de la misma, una composicion farmacéutica de acuerdo con cualquiera de las reivindicaciones 1 a 19. Reivindicacion 22: Un procedimiente para la fabricacion de micropartículas de acuerdo con la reivindicacion 14, que comrpende: (i) la preparacion de una fase orgánica interna que comprende: (ia) disolver el polímero o polímeros en un solvente orgánico adecuado o mezcla de solventes; (ib) disolver/suspender/emulsificar la substancia de fármaco en la solucion de polímero obtenida en el paso (ia); (ii) la preparacion de una fase acuosa externa conteniendo estabilizadores; (iii) mezclar la fase orgánica interna con una fase acuosa externa para formar una emulsion; y (iv) endurecer las micropartículas a través de evaporacion del solvente o extraccion del solvente, lavar las micropartículas, secar las micropartículas y tamizar las micropartículas a través de 140 micrometros. reivindicacion 23: Un equipo de administracion que comprende la composicion farmacéutica de acuerdo con cualquiera de las reivindicaciones 1 a 19 en un frasco, junto con un vehículo a base de agua en una ampolla, frasco o jeringa pre-llenada o como micropartículas y vehículo separado en una jeringa de cámara doble.
ARP060105668A 2005-12-22 2006-12-20 Formulacion de liberacion sostenida que comprende octreotida y dos o mas polimeros de polilactido-coglicolido AR058591A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0526247A GB0526247D0 (en) 2005-12-22 2005-12-22 Organic compounds
EP06119086 2006-08-17

Publications (1)

Publication Number Publication Date
AR058591A1 true AR058591A1 (es) 2008-02-13

Family

ID=37772904

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP060105668A AR058591A1 (es) 2005-12-22 2006-12-20 Formulacion de liberacion sostenida que comprende octreotida y dos o mas polimeros de polilactido-coglicolido

Country Status (22)

Country Link
US (6) US20090004283A1 (es)
EP (3) EP2359809B1 (es)
JP (4) JP2009520727A (es)
KR (5) KR101245919B1 (es)
CN (1) CN103251929A (es)
AR (1) AR058591A1 (es)
AU (1) AU2006328950B2 (es)
BR (2) BR122019027412B8 (es)
CA (1) CA2631811C (es)
CL (1) CL2018003398A1 (es)
EC (1) ECSP088560A (es)
ES (2) ES2755032T3 (es)
IL (1) IL191842A0 (es)
IN (1) IN2015DN03936A (es)
MA (1) MA30064B1 (es)
NO (1) NO20082988L (es)
PE (1) PE20071139A1 (es)
PL (2) PL1968549T3 (es)
PT (2) PT1968549E (es)
RU (1) RU2464972C2 (es)
TW (2) TWI469788B (es)
WO (1) WO2007071395A1 (es)

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KR101245919B1 (ko) 2013-03-20
CA2631811C (en) 2017-06-20
BRPI0620063A2 (pt) 2011-11-01
JP2015044823A (ja) 2015-03-12
KR20130024988A (ko) 2013-03-08
TWI468172B (zh) 2015-01-11
JP2013177406A (ja) 2013-09-09
US20150037420A1 (en) 2015-02-05
KR20130024987A (ko) 2013-03-08
EP2359809B1 (en) 2019-08-14
US20160120935A1 (en) 2016-05-05
CA2631811A1 (en) 2007-06-28
NO20082988L (no) 2008-08-29
PT2359809T (pt) 2019-11-04
PT1968549E (pt) 2014-08-29
EP1968549A1 (en) 2008-09-17
IN2015DN03936A (es) 2015-10-02
JP6239851B2 (ja) 2017-11-29
JP2009520727A (ja) 2009-05-28
ES2755032T3 (es) 2020-04-21
TWI469788B (zh) 2015-01-21
RU2464972C2 (ru) 2012-10-27
RU2008129626A (ru) 2010-01-27
ES2492641T3 (es) 2014-09-10
WO2007071395A1 (en) 2007-06-28
MA30064B1 (fr) 2008-12-01
KR101458728B1 (ko) 2014-11-05
US20200206306A1 (en) 2020-07-02
US20220296675A1 (en) 2022-09-22
ECSP088560A (es) 2008-07-30
TW200803921A (en) 2008-01-16
KR20130024986A (ko) 2013-03-08
PE20071139A1 (es) 2007-11-16
US20090004283A1 (en) 2009-01-01
AU2006328950B2 (en) 2010-07-29
EP3603623A1 (en) 2020-02-05
BRPI0620063B1 (pt) 2020-09-08
AU2006328950A1 (en) 2007-06-28
US20180140662A1 (en) 2018-05-24
KR20140133968A (ko) 2014-11-20
BRPI0620063B8 (pt) 2021-05-25
KR20080078000A (ko) 2008-08-26
TW201424747A (zh) 2014-07-01
CL2018003398A1 (es) 2019-04-26
JP2016216467A (ja) 2016-12-22
EP1968549B1 (en) 2014-05-14
EP2359809A1 (en) 2011-08-24
IL191842A0 (en) 2008-12-29
BR122019027412B8 (pt) 2021-07-27
PL2359809T3 (pl) 2020-01-31
JP6178772B2 (ja) 2017-08-09
CN103251929A (zh) 2013-08-21
PL1968549T3 (pl) 2014-10-31
BR122019027412B1 (pt) 2020-12-01
BRPI0620063A8 (pt) 2018-05-02

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