PL2376070T3 - Formulacja oktreoytdu o przedłużonym uwalnianiu ze stale wysoką szybkością uwalniania - Google Patents
Formulacja oktreoytdu o przedłużonym uwalnianiu ze stale wysoką szybkością uwalnianiaInfo
- Publication number
- PL2376070T3 PL2376070T3 PL09799316T PL09799316T PL2376070T3 PL 2376070 T3 PL2376070 T3 PL 2376070T3 PL 09799316 T PL09799316 T PL 09799316T PL 09799316 T PL09799316 T PL 09799316T PL 2376070 T3 PL2376070 T3 PL 2376070T3
- Authority
- PL
- Poland
- Prior art keywords
- release rates
- depot formulation
- high release
- constantly high
- octreotide depot
- Prior art date
Links
- DEQANNDTNATYII-OULOTJBUSA-N (4r,7s,10s,13r,16s,19r)-10-(4-aminobutyl)-19-[[(2r)-2-amino-3-phenylpropanoyl]amino]-16-benzyl-n-[(2r,3r)-1,3-dihydroxybutan-2-yl]-7-[(1r)-1-hydroxyethyl]-13-(1h-indol-3-ylmethyl)-6,9,12,15,18-pentaoxo-1,2-dithia-5,8,11,14,17-pentazacycloicosane-4-carboxa Chemical compound C([C@@H](N)C(=O)N[C@H]1CSSC[C@H](NC(=O)[C@H]([C@@H](C)O)NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC=2C3=CC=CC=C3NC=2)NC(=O)[C@H](CC=2C=CC=CC=2)NC1=O)C(=O)N[C@H](CO)[C@H](O)C)C1=CC=CC=C1 DEQANNDTNATYII-OULOTJBUSA-N 0.000 title 1
- 108010016076 Octreotide Proteins 0.000 title 1
- 238000009472 formulation Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 229960002700 octreotide Drugs 0.000 title 1
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)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (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)
- Anesthesiology (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Vascular Medicine (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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP08171712 | 2008-12-15 | ||
| EP09799316.6A EP2376070B1 (en) | 2008-12-15 | 2009-12-14 | Octreotide depot formulation with constantly high release rates |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL2376070T3 true PL2376070T3 (pl) | 2017-04-28 |
Family
ID=40520410
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL09799316T PL2376070T3 (pl) | 2008-12-15 | 2009-12-14 | Formulacja oktreoytdu o przedłużonym uwalnianiu ze stale wysoką szybkością uwalniania |
Country Status (25)
| Country | Link |
|---|---|
| US (10) | US20100151033A1 (pl) |
| EP (1) | EP2376070B1 (pl) |
| JP (1) | JP5721635B2 (pl) |
| KR (1) | KR101708517B1 (pl) |
| CN (3) | CN105031607A (pl) |
| AR (1) | AR074603A1 (pl) |
| AU (1) | AU2009336718B9 (pl) |
| BR (1) | BRPI0922607B1 (pl) |
| CA (1) | CA2746968C (pl) |
| CL (1) | CL2011001438A1 (pl) |
| CO (1) | CO6382109A2 (pl) |
| EC (1) | ECSP11011199A (pl) |
| ES (1) | ES2602614T3 (pl) |
| IL (1) | IL213034A (pl) |
| MA (1) | MA32964B1 (pl) |
| MX (1) | MX2011006335A (pl) |
| MY (1) | MY159789A (pl) |
| NZ (1) | NZ592998A (pl) |
| PE (1) | PE20110876A1 (pl) |
| PL (1) | PL2376070T3 (pl) |
| PT (1) | PT2376070T (pl) |
| RU (1) | RU2526822C2 (pl) |
| SG (1) | SG171255A1 (pl) |
| TN (1) | TN2011000261A1 (pl) |
| WO (1) | WO2010079047A2 (pl) |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ591810A (en) | 2008-09-17 | 2012-12-21 | Chiasma Inc | Pharmaceutical compositions and related methods of delivery the composition comprises a medium chain fatty acid |
| PT2851085T (pt) * | 2012-05-14 | 2019-10-11 | Teijin Pharma Ltd | Composição proteica esterilizada por radiação |
| RS61209B1 (sr) * | 2014-03-31 | 2021-01-29 | Pharmathen Sa | Dobijanje plga mikrosfera napunjenih peptidima sa karakteristikama kontrolisanog oslobađanja |
| HK1245115A1 (zh) | 2014-12-10 | 2018-08-24 | Amryt Endo, Inc. | 口腔奥曲肽与其他治疗剂联合应用 |
| PL3253401T3 (pl) | 2015-02-03 | 2025-08-04 | Amryt Endo, Inc. | Leczenie akromegalii oktreotydem doustnym |
| 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 |
| JP7344197B2 (ja) | 2017-09-15 | 2023-09-13 | オクラー リミテッド | 眼科用送達装置 |
| CA3150482A1 (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)
| 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 |
| DE60325511D1 (de) * | 2002-11-06 | 2009-02-05 | Alza Corp | Depot-formulierungen mit verzögerter freisetzung |
| 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 |
| US20090092650A1 (en) * | 2004-12-15 | 2009-04-09 | Warren Stephen L | Sustained Delivery Formulations of Octreotide Compounds |
| KR20130024987A (ko) * | 2005-12-22 | 2013-03-08 | 노파르티스 아게 | 옥트레오티드 및 ２종 이상의 폴리락티드-코-글리콜리드 중합체를 포함하는 서방형 제제 |
-
2009
- 2009-12-11 US US12/635,761 patent/US20100151033A1/en not_active Abandoned
- 2009-12-11 AR ARP090104820A patent/AR074603A1/es unknown
- 2009-12-14 KR KR1020117016340A patent/KR101708517B1/ko not_active Expired - Fee Related
- 2009-12-14 NZ NZ592998A patent/NZ592998A/xx not_active IP Right Cessation
- 2009-12-14 JP JP2011540134A patent/JP5721635B2/ja active Active
- 2009-12-14 ES ES09799316.6T patent/ES2602614T3/es active Active
- 2009-12-14 RU RU2011128538/15A patent/RU2526822C2/ru active
- 2009-12-14 US US13/133,968 patent/US20110262545A1/en not_active Abandoned
- 2009-12-14 CA CA2746968A patent/CA2746968C/en not_active Expired - Fee Related
- 2009-12-14 AU AU2009336718A patent/AU2009336718B9/en not_active Ceased
- 2009-12-14 PT PT97993166T patent/PT2376070T/pt unknown
- 2009-12-14 PL PL09799316T patent/PL2376070T3/pl unknown
- 2009-12-14 MA MA34011A patent/MA32964B1/fr unknown
- 2009-12-14 BR BRPI0922607-9A patent/BRPI0922607B1/pt not_active IP Right Cessation
- 2009-12-14 MY MYPI2011002392A patent/MY159789A/en unknown
- 2009-12-14 CN CN201510542237.7A patent/CN105031607A/zh active Pending
- 2009-12-14 CN CN201510542720.5A patent/CN105233251A/zh active Pending
- 2009-12-14 PE PE2011001218A patent/PE20110876A1/es active IP Right Grant
- 2009-12-14 WO PCT/EP2009/067049 patent/WO2010079047A2/en not_active Ceased
- 2009-12-14 EP EP09799316.6A patent/EP2376070B1/en active Active
- 2009-12-14 MX MX2011006335A patent/MX2011006335A/es active IP Right Grant
- 2009-12-14 SG SG2011034345A patent/SG171255A1/en unknown
- 2009-12-14 CN CN2009801503147A patent/CN102245210A/zh active Pending
-
2011
- 2011-05-19 IL IL213034A patent/IL213034A/en active IP Right Grant
- 2011-05-23 TN TN2011000261A patent/TN2011000261A1/fr unknown
- 2011-06-14 CL CL2011001438A patent/CL2011001438A1/es unknown
- 2011-06-15 CO CO11074834A patent/CO6382109A2/es not_active Application Discontinuation
- 2011-07-13 EC EC2011011199A patent/ECSP11011199A/es unknown
-
2014
- 2014-08-25 US US14/467,212 patent/US20140363513A1/en not_active Abandoned
-
2015
- 2015-12-09 US US14/964,079 patent/US20160089336A1/en not_active Abandoned
-
2017
- 2017-01-10 US US15/402,657 patent/US20170143791A1/en not_active Abandoned
- 2017-10-19 US US15/788,047 patent/US20180036230A1/en not_active Abandoned
-
2019
- 2019-03-14 US US16/352,986 patent/US20190209462A1/en not_active Abandoned
-
2021
- 2021-02-09 US US17/171,836 patent/US20210161806A1/en not_active Abandoned
-
2023
- 2023-04-27 US US18/308,597 patent/US20240082148A1/en not_active Abandoned
-
2024
- 2024-08-08 US US18/797,888 patent/US20250205147A1/en active Pending
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