HRP20210058T1 - Priprema plga mikrokuglica punjenih peptidima s karakteristikama kontroliranog otpuštanja - Google Patents
Priprema plga mikrokuglica punjenih peptidima s karakteristikama kontroliranog otpuštanja Download PDFInfo
- Publication number
- HRP20210058T1 HRP20210058T1 HRP20210058TT HRP20210058T HRP20210058T1 HR P20210058 T1 HRP20210058 T1 HR P20210058T1 HR P20210058T T HRP20210058T T HR P20210058TT HR P20210058 T HRP20210058 T HR P20210058T HR P20210058 T1 HRP20210058 T1 HR P20210058T1
- Authority
- HR
- Croatia
- Prior art keywords
- temperature
- water
- glycolide
- lactide
- poly
- Prior art date
Links
- 239000004005 microsphere Substances 0.000 title claims 4
- 238000002360 preparation method Methods 0.000 title claims 2
- 238000013270 controlled release Methods 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 title 1
- 238000001704 evaporation Methods 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 230000008020 evaporation Effects 0.000 claims 5
- 229920000642 polymer Polymers 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 3
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 claims 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical group OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims 3
- 239000003960 organic solvent Substances 0.000 claims 3
- 239000008346 aqueous phase Substances 0.000 claims 2
- 239000000839 emulsion Substances 0.000 claims 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 2
- 238000001035 drying Methods 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 239000007764 o/w emulsion Substances 0.000 claims 1
- 239000012071 phase Substances 0.000 claims 1
- 239000007762 w/o emulsion Substances 0.000 claims 1
Classifications
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- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
-
- 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
- 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
- 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
- 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
-
- 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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Diabetes (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Claims (6)
1. Postupak pripreme poli (D, L laktid-ko-glikolid) polimer mikrokuglica okreotid acetata, obuhvaćajući:
a. Otapanje okreotid acetata u barem jednom organskom otapalu koje se može miješati s vodom, i koje opcionalno i sadrži vodu, kako bi se oblikovala vodena faza;
b. Oblikovanje ulje-u-vodi ili voda-u-ulju emulzije u odgovarajućoj uljnoj fazi koja obuhvaća organsku otopinu poli (D, L laktid-ko-glikolid) polimera, otopina koja se ne može miješati s vodenom fazom, pri čemu se navedena organska otopina poli (D, L laktid-ko-glikolid) polimera hladi na 5°C ili manje;
c. Evaporaciju barem jednog organskog otapala korištenog u koraku (a) iz emulzije kako bi se oblikovale mikrokuglice putem upravljanja temperaturom za vrijeme koraka evaporacije i povećanja temperature za vrijeme koraka evaporacije brzinom od 0,1°C/min do 1°C/min;
naznačen time što su in-vivo i in-vitro karakteristike otpuštanja okreotid acetata iz mikrokuglica kontrolirane odabirom brzine povećanja temperature za vrijeme koraka evaporacije.
2. Postupak u skladu sa zahtjevom 1, naznačen time što je organsko otapalo metanol i dodaje se voda.
3. Postupak u skladu sa zahtjevom 1, naznačen time što je poli (D, L laktid-ko-glikolid) polimer otopljen u diklorometanu.
4. Postupak u skladu sa zahtjevom 1, naznačen time što je evaporacija u koraku (c) započeta iznad 15°C i za vrijeme koraka evaporacije se temperatura emulzije podiže na veću od 35°C.
5. Postupak u skladu sa zahtjevom 1, naznačen time što se temperatura diže kroz vremenski period od 20 minuta do 3 sata.
6. Postupak u skladu sa zahtjevom 5, naznačen time što se daljnje sušenje nastavlja kroz produženi period nakon perioda podizanja temperature.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2014/000858 WO2015149820A1 (en) | 2014-03-31 | 2014-03-31 | Preparation of peptide loaded plga microspheres with controlled release characteristics |
| EP14717411.4A EP3125871B1 (en) | 2014-03-31 | 2014-03-31 | Preparation of peptide loaded plga microspheres with controlled release characteristics |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210058T1 true HRP20210058T1 (hr) | 2021-03-05 |
Family
ID=50486884
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210058TT HRP20210058T1 (hr) | 2014-03-31 | 2021-01-13 | Priprema plga mikrokuglica punjenih peptidima s karakteristikama kontroliranog otpuštanja |
Country Status (22)
| Country | Link |
|---|---|
| US (1) | US9943483B2 (hr) |
| EP (1) | EP3125871B1 (hr) |
| JP (1) | JP6494657B2 (hr) |
| KR (1) | KR102218655B1 (hr) |
| CN (2) | CN106170284A (hr) |
| AU (1) | AU2014389015B2 (hr) |
| BR (1) | BR112016022550B1 (hr) |
| CA (1) | CA2944561C (hr) |
| CY (1) | CY1124037T1 (hr) |
| DK (1) | DK3125871T3 (hr) |
| EA (1) | EA032580B1 (hr) |
| ES (1) | ES2837044T3 (hr) |
| HR (1) | HRP20210058T1 (hr) |
| HU (1) | HUE052289T2 (hr) |
| LT (1) | LT3125871T (hr) |
| MX (1) | MX371139B (hr) |
| PL (1) | PL3125871T3 (hr) |
| PT (1) | PT3125871T (hr) |
| RS (1) | RS61209B1 (hr) |
| SI (1) | SI3125871T1 (hr) |
| WO (1) | WO2015149820A1 (hr) |
| ZA (1) | ZA201607413B (hr) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2014089160A1 (en) | 2012-12-04 | 2014-06-12 | Phosphorex, Inc. | Microparticles and nanoparticles having negative surface charges |
| EP3212170A4 (en) * | 2014-11-02 | 2018-05-02 | Nano Precision Medical, Inc. | Implantable medical devices for extended release of therapeutic agents |
| KR102068578B1 (ko) * | 2016-08-16 | 2020-01-21 | 중앙대학교 산학협력단 | 세포전달을 위한 다공성 마이크로스피어 및 이의 제조방법 |
| WO2018111851A1 (en) * | 2016-12-12 | 2018-06-21 | Phosphorex, Inc. | Microparticles and nanoparticles having negative surface charges |
| CN108113975B (zh) * | 2018-02-02 | 2020-10-09 | 中国人民解放军军事科学院军事医学研究院 | 一种基于涡漩振荡器的plga微球制备方法及其应用 |
| KR101936040B1 (ko) * | 2018-04-23 | 2019-01-08 | 주식회사 씨트리 | 안정화된 단상 혼합액을 이용하는 생분해성 미립구의 제조방법 |
| CN109106688B (zh) * | 2018-08-22 | 2021-08-17 | 丽珠医药集团股份有限公司 | 一种醋酸奥曲肽微球的制备方法 |
| KR102181231B1 (ko) * | 2018-11-22 | 2020-11-20 | 주식회사 메디포럼제약 | 로티고틴 함유 고분자 미립자의 제조방법 |
| JP2021147329A (ja) * | 2020-03-16 | 2021-09-27 | 株式会社リコー | 粒子の製造方法 |
| KR20220163418A (ko) * | 2020-05-08 | 2022-12-09 | 엠. 테크닉 가부시키가이샤 | 생리 활성 물질이 균일하게 분산된 마이크로스피어 및 그것을 함유하는 서방성 제제 |
| KR20220163416A (ko) * | 2020-05-08 | 2022-12-09 | 엠. 테크닉 가부시키가이샤 | 생리 활성 물질이 균일하게 분산된 마이크로스피어 및 그것을 함유하는 서방성 제제 |
| US11617720B2 (en) | 2020-05-08 | 2023-04-04 | M. Technique Co., Ltd. | Main agent uniformly dispersed microsphere and a sustained release formulation comprising the same |
| US11865213B2 (en) * | 2021-07-05 | 2024-01-09 | Mapi Pharma Ltd. | Semaglutide depot systems and use thereof |
| CN116139256A (zh) * | 2023-03-14 | 2023-05-23 | 复旦大学附属肿瘤医院 | 生长抑素/生长抑素类似物缓释膜及其制备方法和应用 |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60100516A (ja) * | 1983-11-04 | 1985-06-04 | Takeda Chem Ind Ltd | 徐放型マイクロカプセルの製造法 |
| US5538739A (en) | 1989-07-07 | 1996-07-23 | Sandoz Ltd. | Sustained release formulations of water soluble peptides |
| US6913767B1 (en) * | 1993-10-25 | 2005-07-05 | Genentech, Inc. | Compositions for microencapsulation of antigens for use as vaccines |
| US6902743B1 (en) * | 1995-05-22 | 2005-06-07 | The United States Of America As Represented By The Secretary Of The Army | Therapeutic treatment and prevention of infections with a bioactive material(s) encapuslated within a biodegradable-bio-compatable polymeric matrix |
| WO2001010414A1 (en) * | 1999-08-04 | 2001-02-15 | Oakwood Laboratories L.L.C. | Slow release microspheres |
| DK1742616T3 (en) * | 2004-04-30 | 2015-01-12 | Abraxis Bioscience Llc | The microsphere-discharge-system for the prolonged delivery and methods of making and using the same |
| US20100086596A1 (en) * | 2008-10-06 | 2010-04-08 | Oakwood Laboratories LLC | Microspheres for releasing an octreotide compound without an initial time lag |
| US20100086597A1 (en) | 2008-10-06 | 2010-04-08 | Oakwood Laboratories LLC | Microspheres for the sustained release of octreotide with a low initial burst |
| AR074603A1 (es) * | 2008-12-15 | 2011-01-26 | Novartis Ag | Formulacion de deposito de octreotida con niveles de exposicion constantemente altos.uso. metodo. kit |
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2014
- 2014-03-31 CN CN201480077756.4A patent/CN106170284A/zh active Pending
- 2014-03-31 MX MX2016012846A patent/MX371139B/es active IP Right Grant
- 2014-03-31 JP JP2016559649A patent/JP6494657B2/ja active Active
- 2014-03-31 KR KR1020167029649A patent/KR102218655B1/ko active IP Right Grant
- 2014-03-31 EP EP14717411.4A patent/EP3125871B1/en active Active
- 2014-03-31 PT PT147174114T patent/PT3125871T/pt unknown
- 2014-03-31 HU HUE14717411A patent/HUE052289T2/hu unknown
- 2014-03-31 CA CA2944561A patent/CA2944561C/en active Active
- 2014-03-31 SI SI201431746T patent/SI3125871T1/sl unknown
- 2014-03-31 RS RS20201537A patent/RS61209B1/sr unknown
- 2014-03-31 EA EA201691884A patent/EA032580B1/ru unknown
- 2014-03-31 WO PCT/EP2014/000858 patent/WO2015149820A1/en active Application Filing
- 2014-03-31 LT LTEP14717411.4T patent/LT3125871T/lt unknown
- 2014-03-31 ES ES14717411T patent/ES2837044T3/es active Active
- 2014-03-31 PL PL14717411T patent/PL3125871T3/pl unknown
- 2014-03-31 AU AU2014389015A patent/AU2014389015B2/en active Active
- 2014-03-31 CN CN202111524730.8A patent/CN114191538A/zh active Pending
- 2014-03-31 US US15/124,587 patent/US9943483B2/en active Active
- 2014-03-31 BR BR112016022550-3A patent/BR112016022550B1/pt active IP Right Grant
- 2014-03-31 DK DK14717411.4T patent/DK3125871T3/da active
-
2016
- 2016-10-27 ZA ZA2016/07413A patent/ZA201607413B/en unknown
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2020
- 2020-11-09 CY CY20201101050T patent/CY1124037T1/el unknown
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2021
- 2021-01-13 HR HRP20210058TT patent/HRP20210058T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3125871A1 (en) | 2017-02-08 |
| PL3125871T3 (pl) | 2021-04-19 |
| CN106170284A (zh) | 2016-11-30 |
| PT3125871T (pt) | 2021-01-06 |
| SI3125871T1 (sl) | 2021-03-31 |
| EA201691884A1 (ru) | 2017-02-28 |
| EP3125871B1 (en) | 2020-10-21 |
| JP2017509661A (ja) | 2017-04-06 |
| CY1124037T1 (el) | 2022-03-24 |
| BR112016022550A2 (hr) | 2017-08-15 |
| CA2944561C (en) | 2019-06-18 |
| MX2016012846A (es) | 2017-05-09 |
| AU2014389015A1 (en) | 2016-09-29 |
| ZA201607413B (en) | 2018-11-28 |
| US9943483B2 (en) | 2018-04-17 |
| KR102218655B1 (ko) | 2021-02-22 |
| KR20160137608A (ko) | 2016-11-30 |
| DK3125871T3 (da) | 2020-12-21 |
| AU2014389015B2 (en) | 2019-05-09 |
| HUE052289T2 (hu) | 2021-04-28 |
| ES2837044T3 (es) | 2021-06-29 |
| CA2944561A1 (en) | 2015-10-08 |
| CN114191538A (zh) | 2022-03-18 |
| MX371139B (es) | 2020-01-20 |
| LT3125871T (lt) | 2020-12-28 |
| EA032580B1 (ru) | 2019-06-28 |
| JP6494657B2 (ja) | 2019-04-03 |
| US20170281547A1 (en) | 2017-10-05 |
| RS61209B1 (sr) | 2021-01-29 |
| BR112016022550B1 (pt) | 2023-03-28 |
| WO2015149820A1 (en) | 2015-10-08 |
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