TN2011000261A1 - Octreotide depot formulation with constantly high exposure levels - Google Patents

Octreotide depot formulation with constantly high exposure levels

Info

Publication number
TN2011000261A1
TN2011000261A1 TN2011000261A TN2011000261A TN2011000261A1 TN 2011000261 A1 TN2011000261 A1 TN 2011000261A1 TN 2011000261 A TN2011000261 A TN 2011000261A TN 2011000261 A TN2011000261 A TN 2011000261A TN 2011000261 A1 TN2011000261 A1 TN 2011000261A1
Authority
TN
Tunisia
Prior art keywords
exposure levels
high exposure
depot formulation
constantly high
octreotide depot
Prior art date
Application number
TN2011000261A
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=TN2011000261(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 TN2011000261A1 publication Critical patent/TN2011000261A1/fr

Links

Classifications

    • 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
    • A61K9/0012—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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (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)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (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)
TN2011000261A 2008-12-15 2011-05-23 Octreotide depot formulation with constantly high exposure levels TN2011000261A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP08171712 2008-12-15
PCT/EP2009/067049 WO2010079047A2 (fr) 2008-12-15 2009-12-14 Formulation à effet retard d'octréotide avec niveaux d'exposition constamment élevés

Publications (1)

Publication Number Publication Date
TN2011000261A1 true TN2011000261A1 (en) 2012-12-17

Family

ID=40520410

Family Applications (1)

Application Number Title Priority Date Filing Date
TN2011000261A TN2011000261A1 (en) 2008-12-15 2011-05-23 Octreotide depot formulation with constantly high exposure levels

Country Status (26)

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

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0918652B1 (pt) 2008-09-17 2021-10-19 Chiasma, Inc. Composição farmacêutica compreendendo um meio hidrofóbico e uma forma sólida que compreende polipeptídeo e sal de ácido graxo de cadeia média, processo de produção da mesma e forma de dosagem oral
RU2695522C2 (ru) * 2012-05-14 2019-07-23 Тейдзин Лимитед Стерильная композиция
CN106170284A (zh) * 2014-03-31 2016-11-30 法尔玛赞公司 具有控释特征的装载肽的plga微球体的制备
WO2016094662A1 (fr) 2014-12-10 2016-06-16 Chiasma Inc. Octréotide destiné à être administré par voie orale en association avec d'autres agents thérapeutiques
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
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
RU2355385C2 (ru) * 2002-11-06 2009-05-20 Алза Корпорейшн Композиции пролонгированного действия с контролируемым высвобождением
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
WO2006065951A2 (fr) * 2004-12-15 2006-06-22 Qlt Usa, Inc. Preparation a liberation continue de composes d'octreotide
BRPI0620063B8 (pt) * 2005-12-22 2021-05-25 Novartis Ag composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração

Also Published As

Publication number Publication date
CL2011001438A1 (es) 2011-11-04
PE20110876A1 (es) 2011-12-21
JP2012512147A (ja) 2012-05-31
WO2010079047A2 (fr) 2010-07-15
PT2376070T (pt) 2016-11-16
JP5721635B2 (ja) 2015-05-20
EP2376070B1 (fr) 2016-08-10
MX2011006335A (es) 2011-07-13
US20190209462A1 (en) 2019-07-11
US20210161806A1 (en) 2021-06-03
SG171255A1 (en) 2011-07-28
MY159789A (en) 2017-01-31
US20110262545A1 (en) 2011-10-27
KR20110104042A (ko) 2011-09-21
HK1159505A1 (zh) 2012-08-03
ECSP11011199A (es) 2011-08-31
IL213034A0 (en) 2011-07-31
AR074603A1 (es) 2011-01-26
CN105031607A (zh) 2015-11-11
KR101708517B1 (ko) 2017-02-20
CA2746968C (fr) 2016-10-04
AU2009336718B2 (en) 2014-01-30
RU2526822C2 (ru) 2014-08-27
EP2376070A2 (fr) 2011-10-19
US20160089336A1 (en) 2016-03-31
NZ592998A (en) 2013-02-22
US20140363513A1 (en) 2014-12-11
CA2746968A1 (fr) 2010-07-15
US20100151033A1 (en) 2010-06-17
PL2376070T3 (pl) 2017-04-28
RU2011128538A (ru) 2013-01-20
US20180036230A1 (en) 2018-02-08
CN102245210A (zh) 2011-11-16
CN105233251A (zh) 2016-01-13
MA32964B1 (fr) 2012-01-02
ES2602614T3 (es) 2017-02-21
AU2009336718B9 (en) 2014-04-03
BRPI0922607B1 (pt) 2019-11-05
CO6382109A2 (es) 2012-02-15
US20240082148A1 (en) 2024-03-14
US20170143791A1 (en) 2017-05-25
IL213034A (en) 2017-04-30
WO2010079047A3 (fr) 2010-09-16
AU2009336718A1 (en) 2011-06-30
BRPI0922607A2 (pt) 2015-12-22

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