EA201401348A1 - Технология приготовления имплантируемой формы палиперидона - Google Patents
Технология приготовления имплантируемой формы палиперидонаInfo
- Publication number
- EA201401348A1 EA201401348A1 EA201401348A EA201401348A EA201401348A1 EA 201401348 A1 EA201401348 A1 EA 201401348A1 EA 201401348 A EA201401348 A EA 201401348A EA 201401348 A EA201401348 A EA 201401348A EA 201401348 A1 EA201401348 A1 EA 201401348A1
- Authority
- EA
- Eurasian Patent Office
- Prior art keywords
- lactic
- glycolic acid
- drug
- paliperidon
- preparation
- Prior art date
Links
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
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychiatry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Materials For Medical Uses (AREA)
Abstract
Внутримышечная инъецируемая депокомпозиция замедленного высвобождения, подходящая для формирования in situ твердого имплантата в организме с содержанием лекарственного средства палиперидона и/или любых его фармацевтически приемлемых солей в любой комбинации, биосовместимого сополимера на основе молочной и гликолевой кислоты с соотношением мономеров молочной к гликолевой кислоте в пределах от 50:50 и растворителя диметилсульфоксида (ДМСО), в котором композиция высвобождает лекарственный препарат, начинающий действовать сразу же и действующий на протяжении минимум 8 недель При этом композиция имеет фармакокинетический профиль in vivo, делающий ее пригодной для введения каждые 8 недель или с более длительными интервалами.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12170366.4A EP2529757B1 (en) | 2011-05-31 | 2012-05-31 | Paliperidone implant formulation |
| PCT/EP2013/061319 WO2013178811A1 (en) | 2012-05-31 | 2013-05-31 | Paliperidone implant formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EA201401348A1 true EA201401348A1 (ru) | 2015-04-30 |
| EA029921B1 EA029921B1 (ru) | 2018-05-31 |
Family
ID=47074463
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EA201401348A EA029921B1 (ru) | 2012-05-31 | 2013-05-31 | Депо-композиция палиперидона с замедленным высвобождением, способ ее получения и способ психиатрического лечения с использованием этой композиции |
Country Status (29)
| Country | Link |
|---|---|
| EP (1) | EP2529757B1 (ru) |
| JP (1) | JP6430933B2 (ru) |
| KR (1) | KR101892496B1 (ru) |
| CN (2) | CN104349792A (ru) |
| AU (1) | AU2013269546B2 (ru) |
| BR (1) | BR112014029208B1 (ru) |
| CA (1) | CA2874702C (ru) |
| CL (1) | CL2014003215A1 (ru) |
| CO (1) | CO7160109A2 (ru) |
| CY (1) | CY1114975T1 (ru) |
| DK (1) | DK2529757T3 (ru) |
| EA (1) | EA029921B1 (ru) |
| ES (1) | ES2456917T3 (ru) |
| HR (1) | HRP20140158T1 (ru) |
| IL (1) | IL235850A0 (ru) |
| IN (1) | IN2014DN10673A (ru) |
| MA (1) | MA37661B1 (ru) |
| MX (1) | MX365097B (ru) |
| MY (1) | MY181549A (ru) |
| NZ (1) | NZ703319A (ru) |
| PH (1) | PH12014502668A1 (ru) |
| PL (1) | PL2529757T3 (ru) |
| PT (1) | PT2529757E (ru) |
| SG (1) | SG11201407971QA (ru) |
| SI (1) | SI2529757T1 (ru) |
| SM (1) | SMT201400044B (ru) |
| UA (1) | UA115987C2 (ru) |
| WO (1) | WO2013178811A1 (ru) |
| ZA (1) | ZA201409297B (ru) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
| US10335366B2 (en) | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
| US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| HUE029895T2 (en) | 2010-05-31 | 2017-04-28 | Farm Rovi Lab Sa | Antipsychotic injectable depot preparation |
| LT2394663T (lt) | 2010-05-31 | 2022-02-10 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozicijos, skirtos įšvirkščiamiems in situ biologiškai skaidiems implantams |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| PL2529757T3 (pl) * | 2011-05-31 | 2014-04-30 | Farm Rovi Lab Sa | Formulacja implantu zawierającego paliperydon |
| SI2529756T1 (sl) * | 2011-05-31 | 2021-09-30 | Laboratorios Farmaceuticos Rovi, S.A. | Formulacija vsadka z risperidonom in/ali paliperidonom |
| BR112017021383A2 (pt) | 2015-04-07 | 2018-07-03 | Janssen Pharmaceuticals, Inc. | regime de dosagem para doses omitidas de ésteres de paliperidona injetáveis de longa ação |
| CN106038569A (zh) * | 2016-05-26 | 2016-10-26 | 湖南赛沃药业有限公司 | 一种帕利哌酮植入剂及其制备方法 |
| MX2019002284A (es) * | 2016-08-31 | 2019-09-04 | Mapi Pharma Ltd | Sistemas de deposito que comprenden acetato de glatiramer. |
| JP7337080B2 (ja) * | 2017-10-27 | 2023-09-01 | 嘉奥制薬（石家庄）有限公司 | パリペリドンパルミチン酸エステル徐放性懸濁注射液の投薬レジメン |
| JP2021524841A (ja) | 2018-05-24 | 2021-09-16 | セラニーズ・イーブイエイ・パフォーマンス・ポリマーズ・エルエルシー | 高分子薬剤化合物の持続放出用の埋め込み型デバイス |
| CN111989068A (zh) | 2018-05-24 | 2020-11-24 | 塞拉尼斯伊娃高性能聚合物公司 | 用于持续释放大分子药物化合物的可植入器件 |
| FI4025188T3 (fi) | 2020-11-30 | 2024-02-21 | Janssen Pharmaceutica Nv | Pitkävaikutteisiin injektoitaviin paliperidoniformulaatioihin liittyviä annosteluohjelmia |
| PT4025187T (pt) | 2020-11-30 | 2024-02-28 | Janssen Pharmaceutica Nv | Regimes de administração associados a formulações injetáveis de paliperidona de libertação prolongada |
| IL303252A (en) | 2020-11-30 | 2023-07-01 | Janssen Pharmaceutica Nv | Dosing regimens associated with delayed-release injectable formulations of paliperidone |
| TW202313047A (zh) | 2021-09-21 | 2023-04-01 | 西班牙商禾霏藥品實驗室有限公司 | 抗精神病可注射儲積型組合物 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| JP2008509144A (ja) | 2004-08-04 | 2008-03-27 | アルザ・コーポレーシヨン | 上昇するゼロ次放出パターンを示す持続薬剤放出組成物、そのような組成物を製造する方法 |
| US8852638B2 (en) * | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| KR101244185B1 (ko) | 2007-04-19 | 2013-03-25 | 유씬 리 | 정신 장애 치료용 신규 화합물, 그의 제조 방법 및 용도 |
| BRPI0811319A2 (pt) * | 2007-05-25 | 2015-02-10 | Tolmar Therapeutics Inc | Composição fluida, método de formação de uma composição fluida, implante biodegrádavel formado in situ, método de formação de um implante biodegradável in situ, kit, implante e método de trataento |
| WO2009015828A1 (en) | 2007-07-27 | 2009-02-05 | Synthon B.V. | Paliperidone derivatives |
| EP3909585A1 (en) | 2007-12-19 | 2021-11-17 | Janssen Pharmaceutica NV | Dosing regimen associated with long acting injectable paliperidone esters |
| EP2485712A1 (en) | 2009-10-06 | 2012-08-15 | Ascendis Pharma A/S | Subcutaneous paliperidone composition |
| HUE029895T2 (en) * | 2010-05-31 | 2017-04-28 | Farm Rovi Lab Sa | Antipsychotic injectable depot preparation |
| LT2394663T (lt) * | 2010-05-31 | 2022-02-10 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozicijos, skirtos įšvirkščiamiems in situ biologiškai skaidiems implantams |
| PL2529757T3 (pl) * | 2011-05-31 | 2014-04-30 | Farm Rovi Lab Sa | Formulacja implantu zawierającego paliperydon |
| SI2529756T1 (sl) * | 2011-05-31 | 2021-09-30 | Laboratorios Farmaceuticos Rovi, S.A. | Formulacija vsadka z risperidonom in/ali paliperidonom |
-
2012
- 2012-05-31 PL PL12170366T patent/PL2529757T3/pl unknown
- 2012-05-31 ES ES12170366.4T patent/ES2456917T3/es active Active
- 2012-05-31 DK DK12170366.4T patent/DK2529757T3/en active
- 2012-05-31 SI SI201230022T patent/SI2529757T1/sl unknown
- 2012-05-31 PT PT121703664T patent/PT2529757E/pt unknown
- 2012-05-31 EP EP12170366.4A patent/EP2529757B1/en active Active
-
2013
- 2013-05-31 SG SG11201407971QA patent/SG11201407971QA/en unknown
- 2013-05-31 BR BR112014029208A patent/BR112014029208B1/pt active IP Right Grant
- 2013-05-31 JP JP2015514532A patent/JP6430933B2/ja active Active
- 2013-05-31 MX MX2014014484A patent/MX365097B/es active IP Right Grant
- 2013-05-31 CA CA2874702A patent/CA2874702C/en active Active
- 2013-05-31 CN CN201380028041.5A patent/CN104349792A/zh active Pending
- 2013-05-31 AU AU2013269546A patent/AU2013269546B2/en active Active
- 2013-05-31 UA UAA201414185A patent/UA115987C2/uk unknown
- 2013-05-31 NZ NZ703319A patent/NZ703319A/en unknown
- 2013-05-31 IN IN10673DEN2014 patent/IN2014DN10673A/en unknown
- 2013-05-31 EA EA201401348A patent/EA029921B1/ru unknown
- 2013-05-31 KR KR1020147036778A patent/KR101892496B1/ko active IP Right Grant
- 2013-05-31 WO PCT/EP2013/061319 patent/WO2013178811A1/en active Application Filing
- 2013-05-31 CN CN201910004281.0A patent/CN109966239A/zh active Pending
- 2013-05-31 MY MYPI2014703550A patent/MY181549A/en unknown
-
2014
- 2014-02-19 HR HRP20140158AT patent/HRP20140158T1/hr unknown
- 2014-02-26 CY CY20141100156T patent/CY1114975T1/el unknown
- 2014-04-03 SM SM201400044T patent/SMT201400044B/xx unknown
- 2014-11-23 IL IL235850A patent/IL235850A0/en active IP Right Grant
- 2014-11-26 CL CL2014003215A patent/CL2014003215A1/es unknown
- 2014-11-28 PH PH12014502668A patent/PH12014502668A1/en unknown
- 2014-12-16 MA MA37661A patent/MA37661B1/fr unknown
- 2014-12-17 ZA ZA2014/09297A patent/ZA201409297B/en unknown
- 2014-12-30 CO CO14285846A patent/CO7160109A2/es unknown
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