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PE20110876A1 - Formulacion de deposito de octreotida con niveles de exposicion constantemente altos - Google Patents

Formulacion de deposito de octreotida con niveles de exposicion constantemente altos

Info

Publication number
PE20110876A1
PE20110876A1 PE2011001218A PE2011001218A PE20110876A1 PE 20110876 A1 PE20110876 A1 PE 20110876A1 PE 2011001218 A PE2011001218 A PE 2011001218A PE 2011001218 A PE2011001218 A PE 2011001218A PE 20110876 A1 PE20110876 A1 PE 20110876A1
Authority
PE
Peru
Prior art keywords
octreotida
formulation
exposure levels
high exposure
lactite
Prior art date
Application number
PE2011001218A
Other languages
English (en)
Inventor
Markus Ahlheim
Holger Petersen
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=PE20110876(A1) "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 PE20110876A1 publication Critical patent/PE20110876A1/es

Links

Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/31—Somatostatins
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/34—Macromolecular 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
    • 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
    • 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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61P1/12—Antidiarrhoeals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08—Drugs 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
    • 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

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)
  • Molecular Biology (AREA)
  • Biochemistry (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)

Abstract

SE REFIERE A UNA FORMULACION DE LIBERACION SOSTENIDA QUE CONTIENE: A) PAMOATO DE OCTREOTIDA COMO PRINCIPIO ACTIVO; Y B) DOS POLIMEROS LINEALES DE POLI-LACTIDO-CO-GLICOLIDO (PLGAs) QUE TIENEN UNA PROPORCION DE COMONOMERO DE LACTIDO:GLICOLIDO (L:G) DE 75:25 Y DIFERENTES VISCOSIDADES INHERENTES DE ENTRE 0.8 dl/gr Y 0.1 dl/gr EN CHCl3, EN DONDE UN POLIMERO TIENE UN GRUPO DE EXTREMO DE ESTER Y EL OTRO POLIMERO TIENE UN GRUPO DE EXTREMO DE ACIDO. DICHA FORMULACION SE PRESENTA EN LA FORMA DE MICROPARTICULAS LAS CUALES ESTAN CUBIERTAS CON UN AGENTE CONTRA LA AGLOMERACION, Y ES UTIL EN EL TRATAMIENTO DE DEPOSICION REPENTINA ASOCIADA CON TUMORES CARCINOIDES MALIGNOS Y TUMORES PEPTIDICOS INTESTINALES VASOACTIVOS
PE2011001218A 2008-12-15 2009-12-14 Formulacion de deposito de octreotida con niveles de exposicion constantemente altos PE20110876A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP08171712 2008-12-15

Publications (1)

Publication Number Publication Date
PE20110876A1 true PE20110876A1 (es) 2011-12-21

Family

ID=40520410

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2011001218A PE20110876A1 (es) 2008-12-15 2009-12-14 Formulacion de deposito de octreotida con niveles de exposicion constantemente altos

Country Status (25)

Country Link
US (10) US20100151033A1 (es)
EP (1) EP2376070B1 (es)
JP (1) JP5721635B2 (es)
KR (1) KR101708517B1 (es)
CN (3) CN105233251A (es)
AR (1) AR074603A1 (es)
AU (1) AU2009336718B9 (es)
BR (1) BRPI0922607B1 (es)
CA (1) CA2746968C (es)
CL (1) CL2011001438A1 (es)
CO (1) CO6382109A2 (es)
EC (1) ECSP11011199A (es)
ES (1) ES2602614T3 (es)
IL (1) IL213034A (es)
MA (1) MA32964B1 (es)
MX (1) MX2011006335A (es)
MY (1) MY159789A (es)
NZ (1) NZ592998A (es)
PE (1) PE20110876A1 (es)
PL (1) PL2376070T3 (es)
PT (1) PT2376070T (es)
RU (1) RU2526822C2 (es)
SG (1) SG171255A1 (es)
TN (1) TN2011000261A1 (es)
WO (1) WO2010079047A2 (es)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2009294320B2 (en) 2008-09-17 2015-04-16 Amryt Endo, Inc. Pharmaceutical compositions and related methods of delivery
TWI636799B (zh) * 2012-05-14 2018-10-01 日商帝人股份有限公司 滅菌組成物
SMT202000692T1 (it) * 2014-03-31 2021-01-05 Pharmathen Sa Preparazione di microsfere di plga caricate con peptidi con caratteristiche di rilascio controllato
AU2015360485B2 (en) 2014-12-10 2020-06-25 Amryt Endo, Inc. Oral octreotide administered in combination with other therapeutic agents
AU2016215350B2 (en) 2015-02-03 2021-11-25 Amryt Endo, Inc. Method of treating diseases
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
BR112020004978A2 (pt) 2017-09-15 2020-09-15 Oxular Limited composição farmacológica liofilizada estéril, formulação farmacêutica, forma farmacêutica unitária, kit, método para o tratamento de uma doença ou afecção, método para o tratamento de uma doença ou afecção ocular e composição farmacológica, composição farmacológica para uso
WO2021056020A1 (en) 2019-09-16 2021-03-25 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
PL377333A1 (pl) * 2002-11-06 2006-01-23 Alza Corporation Preparaty depot o kontrolowanym uwalnianiu
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
MY158342A (en) * 2003-11-14 2016-09-30 Novartis Ag Pharmaceutical composition
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
US7456254B2 (en) * 2004-04-15 2008-11-25 Alkermes, Inc. Polymer-based sustained release device
CA2590696A1 (en) * 2004-12-15 2006-06-22 Qlt Usa, Inc. Sustained delivery formulations of octreotide compounds
KR101245919B1 (ko) * 2005-12-22 2013-03-20 노파르티스 아게 옥트레오티드 및 ２종 이상의 폴리락티드-코-글리콜리드중합체를 포함하는 서방형 제제

Also Published As

Publication number Publication date
RU2526822C2 (ru) 2014-08-27
AU2009336718A1 (en) 2011-06-30
BRPI0922607A2 (pt) 2015-12-22
US20140363513A1 (en) 2014-12-11
WO2010079047A3 (en) 2010-09-16
WO2010079047A2 (en) 2010-07-15
CN102245210A (zh) 2011-11-16
US20100151033A1 (en) 2010-06-17
CL2011001438A1 (es) 2011-11-04
MX2011006335A (es) 2011-07-13
AU2009336718B2 (en) 2014-01-30
KR20110104042A (ko) 2011-09-21
US20170143791A1 (en) 2017-05-25
US20160089336A1 (en) 2016-03-31
AU2009336718B9 (en) 2014-04-03
PT2376070T (pt) 2016-11-16
NZ592998A (en) 2013-02-22
CA2746968C (en) 2016-10-04
MA32964B1 (fr) 2012-01-02
ES2602614T3 (es) 2017-02-21
EP2376070B1 (en) 2016-08-10
RU2011128538A (ru) 2013-01-20
MY159789A (en) 2017-01-31
EP2376070A2 (en) 2011-10-19
US20180036230A1 (en) 2018-02-08
TN2011000261A1 (en) 2012-12-17
CN105233251A (zh) 2016-01-13
CA2746968A1 (en) 2010-07-15
IL213034A0 (en) 2011-07-31
CN105031607A (zh) 2015-11-11
JP5721635B2 (ja) 2015-05-20
IL213034A (en) 2017-04-30
US20110262545A1 (en) 2011-10-27
US20210161806A1 (en) 2021-06-03
HK1159505A1 (zh) 2012-08-03
JP2012512147A (ja) 2012-05-31
BRPI0922607B1 (pt) 2019-11-05
US20240082148A1 (en) 2024-03-14
ECSP11011199A (es) 2011-08-31
SG171255A1 (en) 2011-07-28
KR101708517B1 (ko) 2017-02-20
PL2376070T3 (pl) 2017-04-28
CO6382109A2 (es) 2012-02-15
US20250205147A1 (en) 2025-06-26
AR074603A1 (es) 2011-01-26
US20190209462A1 (en) 2019-07-11

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