BR122019027412B8 - composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração - Google Patents
composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administraçãoInfo
- Publication number
- BR122019027412B8 BR122019027412B8 BR122019027412A BR122019027412A BR122019027412B8 BR 122019027412 B8 BR122019027412 B8 BR 122019027412B8 BR 122019027412 A BR122019027412 A BR 122019027412A BR 122019027412 A BR122019027412 A BR 122019027412A BR 122019027412 B8 BR122019027412 B8 BR 122019027412B8
- Authority
- BR
- Brazil
- Prior art keywords
- microparticles
- preparing
- pharmaceutical composition
- sustained release
- release pharmaceutical
- Prior art date
Links
- 239000011859 microparticle Substances 0.000 title 2
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 238000013268 sustained release Methods 0.000 title 1
- 239000012730 sustained-release form Substances 0.000 title 1
- 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 abstract 1
- 108010016076 Octreotide Proteins 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 238000013270 controlled release Methods 0.000 abstract 1
- 238000009472 formulation Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 abstract 1
- 229960002700 octreotide Drugs 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
Classifications
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
-
- 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
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5089—Processes
-
- 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
-
- 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
- A61P17/00—Drugs for dermatological disorders
-
- 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
- A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Endocrinology (AREA)
- Dermatology (AREA)
- Zoology (AREA)
- Diabetes (AREA)
- Inorganic Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Peptides Or Proteins (AREA)
- Polyesters Or Polycarbonates (AREA)
Abstract
a presente invenção se refere às formulações de liberação controlada compreendendo como ingrediente ativo octreotídeo ou um sal farmaceuticamente aceitável do mesmo e dois ou mais polímeros de polilactídeo-co-glicolídeo (plgas) diferentes.
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0526247.2 | 2005-12-22 | ||
GB0526247A GB0526247D0 (en) | 2005-12-22 | 2005-12-22 | Organic compounds |
EP06119086 | 2006-08-17 | ||
EP06119086.4 | 2006-08-17 | ||
BRPI0620063A BRPI0620063B8 (pt) | 2005-12-22 | 2006-12-20 | composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração |
PCT/EP2006/012313 WO2007071395A1 (en) | 2005-12-22 | 2006-12-20 | Sustained release formulation comprising octreotide and two or more polylactide-co-glycolide polymers |
Publications (2)
Publication Number | Publication Date |
---|---|
BR122019027412B1 BR122019027412B1 (pt) | 2020-12-01 |
BR122019027412B8 true BR122019027412B8 (pt) | 2021-07-27 |
Family
ID=37772904
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0620063A BRPI0620063B8 (pt) | 2005-12-22 | 2006-12-20 | composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração |
BR122019027412A BR122019027412B8 (pt) | 2005-12-22 | 2006-12-20 | composição farmacêutica de liberação sustentada na forma de micropartículas, processo para preparação das ditas micropartículas, e kit de administração |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BRPI0620063A BRPI0620063B8 (pt) | 2005-12-22 | 2006-12-20 | composição farmacêutica de liberação sustentada na forma de micropartículas, uso, e kit de administração |
Country Status (22)
Country | Link |
---|---|
US (7) | US20090004283A1 (pt) |
EP (3) | EP3603623A1 (pt) |
JP (4) | JP2009520727A (pt) |
KR (5) | KR20140133968A (pt) |
CN (1) | CN103251929A (pt) |
AR (1) | AR058591A1 (pt) |
AU (1) | AU2006328950B2 (pt) |
BR (2) | BRPI0620063B8 (pt) |
CA (1) | CA2631811C (pt) |
CL (1) | CL2018003398A1 (pt) |
EC (1) | ECSP088560A (pt) |
ES (2) | ES2492641T3 (pt) |
IL (1) | IL191842A0 (pt) |
IN (1) | IN2015DN03936A (pt) |
MA (1) | MA30064B1 (pt) |
NO (1) | NO20082988L (pt) |
PE (1) | PE20071139A1 (pt) |
PL (2) | PL2359809T3 (pt) |
PT (2) | PT1968549E (pt) |
RU (1) | RU2464972C2 (pt) |
TW (2) | TWI468172B (pt) |
WO (1) | WO2007071395A1 (pt) |
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DK2500014T4 (da) | 2007-06-06 | 2025-04-14 | Debiopharm Int Sa | Farmaceutisk sammensætning med langsom frigivelse lavet af mikropartikler |
US8470360B2 (en) * | 2008-04-18 | 2013-06-25 | Warsaw Orthopedic, Inc. | Drug depots having different release profiles for reducing, preventing or treating pain and inflammation |
ES2324009B1 (es) * | 2007-11-23 | 2010-05-21 | Gp Pharm S.A. | Composicion farmaceutica de liberacion sostenida de somatostatina o un analogo suyo. |
MX2010008365A (es) * | 2008-01-30 | 2010-08-23 | Novartis Ag | Formulacion de liberacion sostenida que comprende octreotido y tres polimeros lineales de polilactido-co-glicolido. |
AU2013201877B2 (en) * | 2008-01-30 | 2015-01-29 | Novartis Ag | Sustained release formulation comprising octreotide and three linear polylactide-co-glycolide polymers |
AU2015201581B2 (en) * | 2008-09-17 | 2017-03-09 | Amryt Endo, Inc. | Pharmaceutical Compositions and Related Methods of Delivery |
GB2482810A (en) | 2008-09-17 | 2012-02-15 | Chiasma Inc | Enhanced delivery of exenatide using a medium chain fatty acid and salt thereof |
AR074603A1 (es) * | 2008-12-15 | 2011-01-26 | Novartis Ag | Formulacion de deposito de octreotida con niveles de exposicion constantemente altos.uso. metodo. kit |
US20100189763A1 (en) * | 2009-01-23 | 2010-07-29 | Heather Nettles | Controlled release systems from polymer blends |
US20120022137A1 (en) * | 2010-07-21 | 2012-01-26 | Rivers Hongwen M | METHOD OF CONTROLLING INITIAL DRUG RELEASE OF siRNA FROM SUSTAINED-RELEASE IMPLANTS |
GB201016436D0 (en) | 2010-09-30 | 2010-11-17 | Q Chip Ltd | Method of making solid beads |
GB201016433D0 (en) | 2010-09-30 | 2010-11-17 | Q Chip Ltd | Apparatus and method for making solid beads |
US20120156304A1 (en) * | 2010-12-15 | 2012-06-21 | Thomas Tice | Branched polyol polyesters, blends, and pharmaceutical formulations comprising same |
ES2749864T3 (es) | 2011-04-25 | 2020-03-24 | Shan Dong Luye Pharm Co Ltd | Composición de risperidona de microesferas de liberación controlada |
CN102488619B (zh) * | 2011-12-05 | 2014-08-06 | 上海交通大学 | 连续生产艾塞那肽微球的装置及控制微球释放速度的方法 |
EP4527456A3 (en) | 2015-02-03 | 2025-05-21 | Amryt Endo, Inc. | Treating acromegaly with oral octreotide |
WO2016208685A1 (ja) * | 2015-06-26 | 2016-12-29 | オリンパス株式会社 | 内視鏡電源供給システム |
US20220000782A1 (en) * | 2016-12-27 | 2022-01-06 | Upexmed Co. Ltd. | Prevention of local tumor recurrence following surgery using sustainedand/or delayed release of medicaments contained in micro-particles |
KR102142026B1 (ko) * | 2017-05-31 | 2020-08-06 | 주식회사 대웅제약 | 방출제어가 용이한 서방성 약물 미립자의 제조방법 |
WO2021056020A1 (en) | 2019-09-16 | 2021-03-25 | Amgen Inc. | Method for external sterilization of drug delivery device |
CN111214643A (zh) * | 2020-03-11 | 2020-06-02 | 苏州善湾生物医药科技有限公司 | 一种基于皮下凝胶缓释的奥曲肽组合物、制备方法及应用 |
CN115551485B (zh) | 2020-05-08 | 2024-09-24 | M技术株式会社 | 均匀分散有生理活性物质的微球及含有其的缓释制剂 |
KR20220163418A (ko) * | 2020-05-08 | 2022-12-09 | 엠. 테크닉 가부시키가이샤 | 생리 활성 물질이 균일하게 분산된 마이크로스피어 및 그것을 함유하는 서방성 제제 |
CN114174385B (zh) | 2020-05-08 | 2023-03-14 | M技术株式会社 | 主剂均匀分散的微球和含有其的缓释制剂 |
US11141457B1 (en) | 2020-12-28 | 2021-10-12 | Amryt Endo, Inc. | Oral octreotide therapy and contraceptive methods |
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KR100466637B1 (ko) * | 2003-06-26 | 2005-01-13 | 주식회사 펩트론 | 서방성 미립구의 혼합 제형을 연속한 단일 공정으로제조하는 방법 |
DK1660039T3 (en) * | 2003-07-18 | 2017-01-16 | Oakwood Laboratories L L C | PREVENTION OF REDUCTION OF THE POLYMER MOLECULE WEIGHT, THE PREPARATION OF PURPOSES AND GELING IN POLYMER COMPOSITIONS |
JP5165240B2 (ja) * | 2003-07-23 | 2013-03-21 | ピーアール ファーマシューティカルズ, インコーポレイテッド | 徐放組成物 |
MY158342A (en) * | 2003-11-14 | 2016-09-30 | Novartis Ag | Pharmaceutical composition |
ATE424848T1 (de) * | 2004-08-12 | 2009-03-15 | Quest Pharmaceutical Services | Pharmazeutische zusammensetzungen für die kontrollierte freigabe von biologischen wirkstoffen |
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