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BRPI0922607A2 - formulação de depósitos de octreotida com níveis de exposição constantemente altos - Google Patents

formulação de depósitos de octreotida com níveis de exposição constantemente altos

Info

Publication number
BRPI0922607A2
BRPI0922607A2 BRPI0922607A BRPI0922607A BRPI0922607A2 BR PI0922607 A2 BRPI0922607 A2 BR PI0922607A2 BR PI0922607 A BRPI0922607 A BR PI0922607A BR PI0922607 A BRPI0922607 A BR PI0922607A BR PI0922607 A2 BRPI0922607 A2 BR PI0922607A2
Authority
BR
Brazil
Prior art keywords
octreotide
deposits
formulation
exposure levels
high exposure
Prior art date
Application number
BRPI0922607A
Other languages
English (en)
Inventor
Holger Petersen
Markus Ahlheim
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=40520410&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0922607(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of BRPI0922607A2 publication Critical patent/BRPI0922607A2/pt
Publication of BRPI0922607B1 publication Critical patent/BRPI0922607B1/pt

Links

Classifications

    • 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
    • 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
    • A61K38/16Peptides 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/14Particulate 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
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/19Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • 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
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Diabetes (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
BRPI0922607-9A 2008-12-15 2009-12-14 formulação farmacêutica de depósitos de octreotida com níveis de exposição constantemente altos, seu uso, e kit de administração BRPI0922607B1 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08171712 2008-12-15
PCT/EP2009/067049 WO2010079047A2 (en) 2008-12-15 2009-12-14 Octreotide depot formulation with constantly high exposure levels

Publications (2)

Publication Number Publication Date
BRPI0922607A2 true BRPI0922607A2 (pt) 2015-12-22
BRPI0922607B1 BRPI0922607B1 (pt) 2019-11-05

Family

ID=40520410

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0922607-9A BRPI0922607B1 (pt) 2008-12-15 2009-12-14 formulação farmacêutica de depósitos de octreotida com níveis de exposição constantemente altos, seu uso, e kit de administração

Country Status (26)

Country Link
US (9) US20100151033A1 (pt)
EP (1) EP2376070B1 (pt)
JP (1) JP5721635B2 (pt)
KR (1) KR101708517B1 (pt)
CN (3) CN105031607A (pt)
AR (1) AR074603A1 (pt)
AU (1) AU2009336718B9 (pt)
BR (1) BRPI0922607B1 (pt)
CA (1) CA2746968C (pt)
CL (1) CL2011001438A1 (pt)
CO (1) CO6382109A2 (pt)
EC (1) ECSP11011199A (pt)
ES (1) ES2602614T3 (pt)
HK (1) HK1159505A1 (pt)
IL (1) IL213034A (pt)
MA (1) MA32964B1 (pt)
MX (1) MX2011006335A (pt)
MY (1) MY159789A (pt)
NZ (1) NZ592998A (pt)
PE (1) PE20110876A1 (pt)
PL (1) PL2376070T3 (pt)
PT (1) PT2376070T (pt)
RU (1) RU2526822C2 (pt)
SG (1) SG171255A1 (pt)
TN (1) TN2011000261A1 (pt)
WO (1) WO2010079047A2 (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102176900B (zh) 2008-09-17 2017-09-26 克艾思马有限公司 药物组合物和相关的给药方法
PT2851085T (pt) * 2012-05-14 2019-10-11 Teijin Pharma Ltd Composição proteica esterilizada por radiação
SI3125871T1 (sl) * 2014-03-31 2021-03-31 Pharmathen S.A. Priprava s peptidom napolnjenih PLGA mikrokroglic z značilnostmi nadzorovanega sproščanja
US20160193285A1 (en) 2014-12-10 2016-07-07 Chiasma Inc. Oral octreotide administered in combination with other therapeutic agents
MA41462A (fr) 2015-02-03 2021-05-12 Chiasma Inc Méthode de traitement de maladies
CN105963258B (zh) 2016-04-26 2021-01-22 广州帝奇医药技术有限公司 一种缓释微粒的制备方法
KR102142026B1 (ko) * 2017-05-31 2020-08-06 주식회사 대웅제약 방출제어가 용이한 서방성 약물 미립자의 제조방법
GB2568370B (en) * 2017-09-15 2020-09-30 Oxular Ltd Ophthalmic delivery device
AU2020348947A1 (en) 2019-09-16 2022-03-10 Amgen Inc. Method for external sterilization of drug delivery device
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PH30995A (en) * 1989-07-07 1997-12-23 Novartis Inc Sustained release formulations of water soluble peptides.
GB9513224D0 (en) * 1995-06-29 1995-09-06 Sandoz Ltd Organic compounds
EP1581181B1 (en) * 2002-11-06 2008-12-24 ALZA Corporation Controlled release depot formulations
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
MY158342A (en) * 2003-11-14 2016-09-30 Novartis Ag Pharmaceutical composition
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
WO2006065951A2 (en) * 2004-12-15 2006-06-22 Qlt Usa, Inc. Sustained delivery formulations of octreotide compounds
EP2359809B1 (en) * 2005-12-22 2019-08-14 Novartis AG Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers

Also Published As

Publication number Publication date
CN105233251A (zh) 2016-01-13
RU2526822C2 (ru) 2014-08-27
US20100151033A1 (en) 2010-06-17
PT2376070T (pt) 2016-11-16
US20180036230A1 (en) 2018-02-08
JP5721635B2 (ja) 2015-05-20
US20240082148A1 (en) 2024-03-14
TN2011000261A1 (en) 2012-12-17
SG171255A1 (en) 2011-07-28
IL213034A0 (en) 2011-07-31
US20210161806A1 (en) 2021-06-03
AU2009336718A1 (en) 2011-06-30
CL2011001438A1 (es) 2011-11-04
WO2010079047A3 (en) 2010-09-16
PE20110876A1 (es) 2011-12-21
AU2009336718B2 (en) 2014-01-30
MY159789A (en) 2017-01-31
ES2602614T3 (es) 2017-02-21
US20140363513A1 (en) 2014-12-11
US20160089336A1 (en) 2016-03-31
BRPI0922607B1 (pt) 2019-11-05
US20190209462A1 (en) 2019-07-11
JP2012512147A (ja) 2012-05-31
AR074603A1 (es) 2011-01-26
CA2746968A1 (en) 2010-07-15
AU2009336718B9 (en) 2014-04-03
KR101708517B1 (ko) 2017-02-20
MA32964B1 (fr) 2012-01-02
HK1159505A1 (zh) 2012-08-03
IL213034A (en) 2017-04-30
CN102245210A (zh) 2011-11-16
CA2746968C (en) 2016-10-04
KR20110104042A (ko) 2011-09-21
US20110262545A1 (en) 2011-10-27
ECSP11011199A (es) 2011-08-31
WO2010079047A2 (en) 2010-07-15
RU2011128538A (ru) 2013-01-20
CO6382109A2 (es) 2012-02-15
EP2376070B1 (en) 2016-08-10
US20170143791A1 (en) 2017-05-25
PL2376070T3 (pl) 2017-04-28
CN105031607A (zh) 2015-11-11
NZ592998A (en) 2013-02-22
EP2376070A2 (en) 2011-10-19
MX2011006335A (es) 2011-07-13

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B06T Formal requirements before examination [chapter 6.20 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/12/2009, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 13A ANUIDADE.

B24J Lapse because of non-payment of annual fees (definitively: art 78 iv lpi, resolution 113/2013 art. 12)

Free format text: EM VIRTUDE DA EXTINCAO PUBLICADA NA RPI 2701 DE 11-10-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDA A EXTINCAO DA PATENTE E SEUS CERTIFICADOS, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.