RU2526822C2 - Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия - Google Patents

Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия Download PDF

Info

Publication number
RU2526822C2
RU2526822C2 RU2011128538/15A RU2011128538A RU2526822C2 RU 2526822 C2 RU2526822 C2 RU 2526822C2 RU 2011128538/15 A RU2011128538/15 A RU 2011128538/15A RU 2011128538 A RU2011128538 A RU 2011128538A RU 2526822 C2 RU2526822 C2 RU 2526822C2
Authority
RU
Russia
Prior art keywords
pharmaceutical composition
sustained release
microparticles
octreotide
present
Prior art date
Application number
RU2011128538/15A
Other languages
English (en)
Russian (ru)
Other versions
RU2011128538A (ru
Inventor
АЛЬХАЙМ Маркус
ПЕТЕРЗЕН Хольгер
Original Assignee
Новартис Аг
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=RU2526822(C2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Новартис Аг filed Critical Новартис Аг
Publication of RU2011128538A publication Critical patent/RU2011128538A/ru
Application granted granted Critical
Publication of RU2526822C2 publication Critical patent/RU2526822C2/ru

Links

Images

Classifications

    • 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
    • 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
    • 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
    • A61K9/0012Galenical 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
    • A61K9/14Particulate 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)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (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)
RU2011128538/15A 2008-12-15 2009-12-14 Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия RU2526822C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP08171712.6 2008-12-15
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
RU2011128538A RU2011128538A (ru) 2013-01-20
RU2526822C2 true RU2526822C2 (ru) 2014-08-27

Family

ID=40520410

Family Applications (1)

Application Number Title Priority Date Filing Date
RU2011128538/15A RU2526822C2 (ru) 2008-12-15 2009-12-14 Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия

Country Status (25)

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

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20170929T1 (hr) 2008-09-17 2017-09-22 Chiasma Inc. Farmaceutski pripravci i odgovarajući postupci za isporuku
BR112014028443B1 (pt) * 2012-05-14 2021-01-19 Teijin Limited composição estéril esterilizada com radiação
EP3125871B1 (en) * 2014-03-31 2020-10-21 Pharmathen S.A. Preparation of peptide loaded plga microspheres with controlled release characteristics
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
EP3681471B1 (en) 2017-09-15 2025-03-05 Oxular Limited Ophthalmic delivery device
JP7704740B2 (ja) 2019-09-16 2025-07-08 アムジエン・インコーポレーテツド 薬物送達デバイスの外部滅菌の方法
US11141457B1 (en) 2020-12-28 2021-10-12 Amryt Endo, Inc. Oral octreotide therapy and contraceptive methods

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2160741C2 (ru) * 1995-06-29 2000-12-20 Новартис Аг Соматостатиновые пептиды
US20040151753A1 (en) * 2002-11-06 2004-08-05 Guohua Chen Controlled release depot formulations
WO2005046645A1 (en) * 2003-11-14 2005-05-26 Novartis Ag Microparticles comprising somatostatin analogues
EA200601905A1 (ru) * 2004-04-15 2007-08-31 Амилин Фармасьютикалз, Инк. Микрокапсулы с замедленным высвобождением, основанные на сополимере лактида и гликолида, включающие полипептид и сахар

Family Cites Families (5)

* 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.
US20040097419A1 (en) * 2002-11-19 2004-05-20 Holger Petersen Organic compounds
GB0326602D0 (en) * 2003-11-14 2003-12-17 Novartis Ag Organic compounds
US20090092650A1 (en) * 2004-12-15 2009-04-09 Warren Stephen L Sustained Delivery Formulations of Octreotide Compounds
EP1968549B1 (en) * 2005-12-22 2014-05-14 Novartis AG Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2160741C2 (ru) * 1995-06-29 2000-12-20 Новартис Аг Соматостатиновые пептиды
US20040151753A1 (en) * 2002-11-06 2004-08-05 Guohua Chen Controlled release depot formulations
WO2005046645A1 (en) * 2003-11-14 2005-05-26 Novartis Ag Microparticles comprising somatostatin analogues
EA200601905A1 (ru) * 2004-04-15 2007-08-31 Амилин Фармасьютикалз, Инк. Микрокапсулы с замедленным высвобождением, основанные на сополимере лактида и гликолида, включающие полипептид и сахар

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
0. *

Also Published As

Publication number Publication date
AU2009336718B2 (en) 2014-01-30
PE20110876A1 (es) 2011-12-21
AU2009336718B9 (en) 2014-04-03
WO2010079047A2 (en) 2010-07-15
US20140363513A1 (en) 2014-12-11
US20170143791A1 (en) 2017-05-25
US20160089336A1 (en) 2016-03-31
RU2011128538A (ru) 2013-01-20
CA2746968C (en) 2016-10-04
BRPI0922607A2 (pt) 2015-12-22
US20250205147A1 (en) 2025-06-26
US20180036230A1 (en) 2018-02-08
US20100151033A1 (en) 2010-06-17
AR074603A1 (es) 2011-01-26
IL213034A0 (en) 2011-07-31
PL2376070T3 (pl) 2017-04-28
TN2011000261A1 (en) 2012-12-17
ES2602614T3 (es) 2017-02-21
US20240082148A1 (en) 2024-03-14
ECSP11011199A (es) 2011-08-31
MY159789A (en) 2017-01-31
BRPI0922607B1 (pt) 2019-11-05
US20110262545A1 (en) 2011-10-27
SG171255A1 (en) 2011-07-28
CO6382109A2 (es) 2012-02-15
PT2376070T (pt) 2016-11-16
AU2009336718A1 (en) 2011-06-30
CN105233251A (zh) 2016-01-13
CA2746968A1 (en) 2010-07-15
CL2011001438A1 (es) 2011-11-04
JP2012512147A (ja) 2012-05-31
MA32964B1 (fr) 2012-01-02
US20210161806A1 (en) 2021-06-03
EP2376070B1 (en) 2016-08-10
KR20110104042A (ko) 2011-09-21
JP5721635B2 (ja) 2015-05-20
CN105031607A (zh) 2015-11-11
HK1159505A1 (zh) 2012-08-03
US20190209462A1 (en) 2019-07-11
CN102245210A (zh) 2011-11-16
EP2376070A2 (en) 2011-10-19
NZ592998A (en) 2013-02-22
MX2011006335A (es) 2011-07-13
KR101708517B1 (ko) 2017-02-20
IL213034A (en) 2017-04-30
WO2010079047A3 (en) 2010-09-16

Similar Documents

Publication Publication Date Title
RU2526822C2 (ru) Содежащий октреотид состав с замедленным высвобождением со стабильно высоким уровнем воздействия
RU2464972C2 (ru) Композиции с замедленным высвобождением, включающие октреотид и два или более сополимера полилактида и гликолида
RU2541104C2 (ru) Препаративная форма с замедленным высвобождением, содержащая октреотид и три линейных полимера поли(лактид-со-гликолида)
US20100266704A1 (en) Octreotide depot formulation with constantly high exposure levels
HK1159505B (en) Octreotide depot formulation with constantly high release rates