BR112014029208A2 - formulação para implante de paliperidona - Google Patents
formulação para implante de paliperidonaInfo
- Publication number
- BR112014029208A2 BR112014029208A2 BR112014029208A BR112014029208A BR112014029208A2 BR 112014029208 A2 BR112014029208 A2 BR 112014029208A2 BR 112014029208 A BR112014029208 A BR 112014029208A BR 112014029208 A BR112014029208 A BR 112014029208A BR 112014029208 A2 BR112014029208 A2 BR 112014029208A2
- Authority
- BR
- Brazil
- Prior art keywords
- kda
- paliperidone
- composition
- drug
- range
- 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)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Materials For Medical Uses (AREA)
Abstract
resumo patente de invenção: "formulação para implante de paliperidona". uma composição de depósito intramuscular injetável adequada para a formação de um implante sólido in situ em um corpo, compreendendo um fármaco que é a paliperidona ou qualquer sal farmaceuticamente aceitável em qualquer combinação do mesmo, um copolímero biocompatível baseado em ácido láctico e glicólico com uma proporção de monômero de ácido láctico para ácido glicólico na faixa de 50:45 a 50:45 e preferivelmente 50:50 e um solvente dmso, em que a composição libera o fármaco com um início de ação imediato e de forma contínua durante pelo menos 8 semanas e, em que a composição possui um perfil farmacocinético in vivo adequado para ser administrado entre o 56° e o 65° dia aproximadamente após a injeção anterior, caracterizado pelo fato do copolímero biocompatível possuir um peso molecular entre 27 e 47 kda, e de preferência entre 31 e 43 kda e melhor ainda, entre 31 a 43 kda e possuir uma viscosidade inerente na faixa entre 0,27 e 0,31, dl/g ± 10%.
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 |
|---|---|
| BR112014029208A2 true BR112014029208A2 (pt) | 2017-06-27 |
| BR112014029208B1 BR112014029208B1 (pt) | 2020-04-07 |
Family
ID=47074463
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112014029208A BR112014029208B1 (pt) | 2012-05-31 | 2013-05-31 | composição para implante de paliperidona, método para fabricação da mesma e kit farmacêutico |
Country Status (29)
| Country | Link |
|---|---|
| EP (1) | EP2529757B1 (pt) |
| JP (1) | JP6430933B2 (pt) |
| KR (1) | KR101892496B1 (pt) |
| CN (2) | CN109966239A (pt) |
| AU (1) | AU2013269546B2 (pt) |
| BR (1) | BR112014029208B1 (pt) |
| CA (1) | CA2874702C (pt) |
| CL (1) | CL2014003215A1 (pt) |
| CO (1) | CO7160109A2 (pt) |
| CY (1) | CY1114975T1 (pt) |
| DK (1) | DK2529757T3 (pt) |
| EA (1) | EA029921B1 (pt) |
| ES (1) | ES2456917T3 (pt) |
| HR (1) | HRP20140158T1 (pt) |
| IL (1) | IL235850A0 (pt) |
| IN (1) | IN2014DN10673A (pt) |
| MA (1) | MA37661B1 (pt) |
| MX (1) | MX365097B (pt) |
| MY (1) | MY181549A (pt) |
| NZ (1) | NZ703319A (pt) |
| PH (1) | PH12014502668A1 (pt) |
| PL (1) | PL2529757T3 (pt) |
| PT (1) | PT2529757E (pt) |
| SG (1) | SG11201407971QA (pt) |
| SI (1) | SI2529757T1 (pt) |
| SM (1) | SMT201400044B (pt) |
| UA (1) | UA115987C2 (pt) |
| WO (1) | WO2013178811A1 (pt) |
| ZA (1) | ZA201409297B (pt) |
Families Citing this family (21)
| 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 |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| HRP20211853T1 (hr) | 2010-05-31 | 2022-03-04 | Laboratorios Farmaceuticos Rovi, S.A. | Sastavi in situ injekcijskih biorazgradivih implantata |
| PL2394664T3 (pl) | 2010-05-31 | 2016-12-30 | Preparat przeciwpsychotyczny do wstrzykiwań o przedłużonym uwalnianiu | |
| ES2456917T3 (es) * | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
| ES2878112T3 (es) * | 2011-05-31 | 2021-11-18 | Farm Rovi Lab Sa | Formulación de implante de risperidona y/o paliperidona |
| JP6728221B2 (ja) * | 2015-04-07 | 2020-07-22 | ヤンセン ファーマシューティカルズ，インコーポレーテッド | 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン |
| 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 |
| US12097292B2 (en) | 2016-08-28 | 2024-09-24 | Mapi Pharma Ltd. | Process for preparing microparticles containing glatiramer acetate |
| ES2952044T3 (es) * | 2016-08-31 | 2023-10-26 | Mapi Pharma Ltd | Sistemas de depósito que comprenden acetato de glatiramer |
| CA3077224A1 (en) * | 2017-10-27 | 2019-05-02 | Shandong Luye Pharmaceutical Co., Ltd. | Dosage regimen of paliperidone palmitate extended-release injectable suspension |
| AU2019275406A1 (en) | 2018-05-24 | 2020-07-16 | Celanese Eva Performance Polymers Llc | Implantable device for sustained release of a macromolecular drug compound |
| WO2019222856A1 (en) | 2018-05-24 | 2019-11-28 | Nureva Inc. | Method, apparatus and computer-readable media to manage semi-constant (persistent) sound sources in microphone pickup/focus zones |
| MX2020012459A (es) | 2018-05-24 | 2021-04-28 | Celanese Eva Performance Polymers Llc | Dispositivo implantable para liberacion sostenida de un compuesto de farmaco macromolecular. |
| JP2023552329A (ja) | 2020-11-30 | 2023-12-15 | ヤンセン ファーマシューティカ エヌ．ベー． | 持続放出パリペリドン注射可能製剤に関連する投与レジメン |
| CA3203015A1 (en) | 2020-11-30 | 2022-06-02 | Janssen Pharmaceutica Nv | Dosing regimens associated with extended release paliperidone injectable formulations |
| LT4025187T (lt) | 2020-11-30 | 2024-02-12 | Janssen Pharmaceutica Nv | Dozavimo režimai, susiję su prailginto atpalaidavimo injekcinėmis paliperidono vaisto formomis |
| 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 |
|---|---|---|---|---|
| ES2600554T3 (es) * | 2003-07-18 | 2017-02-09 | Oakwood Laboratories L.L.C. | Prevención de la reducción del peso molecular del polímero, de la formación de impurezas y de la gelificación en composiciones poliméricas |
| MX2007001563A (es) | 2004-08-04 | 2008-03-05 | Johnson & Johnson | Composicion para liberacion sostenida de farmaco que demuestra un patron de liberacion ascendente del orden cero, metodos para la elaboracion de dicha composicion. |
| US8852638B2 (en) * | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| RU2459824C2 (ru) | 2007-04-19 | 2012-08-27 | Юсинь ЛИ | Новые соединения для лечения психических расстройств, их получение и применение |
| MX354603B (es) * | 2007-05-25 | 2018-03-13 | Indivior Uk Ltd | Formulaciones de transferencia sostenida de compuestos de risperidona. |
| US20090036470A1 (en) | 2007-07-27 | 2009-02-05 | Jiri Bartl | Paliperidone derivatives |
| CN105560176A (zh) | 2007-12-19 | 2016-05-11 | 詹森药业有限公司 | 与长效注射用帕潘立酮酯相关的给药方案 |
| US8758780B2 (en) | 2009-10-06 | 2014-06-24 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| HRP20211853T1 (hr) * | 2010-05-31 | 2022-03-04 | Laboratorios Farmaceuticos Rovi, S.A. | Sastavi in situ injekcijskih biorazgradivih implantata |
| PL2394664T3 (pl) | 2010-05-31 | 2016-12-30 | Preparat przeciwpsychotyczny do wstrzykiwań o przedłużonym uwalnianiu | |
| ES2878112T3 (es) * | 2011-05-31 | 2021-11-18 | Farm Rovi Lab Sa | Formulación de implante de risperidona y/o paliperidona |
| ES2456917T3 (es) * | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
-
2012
- 2012-05-31 ES ES12170366.4T patent/ES2456917T3/es active Active
- 2012-05-31 EP EP12170366.4A patent/EP2529757B1/en active Active
- 2012-05-31 SI SI201230022T patent/SI2529757T1/sl unknown
- 2012-05-31 PL PL12170366T patent/PL2529757T3/pl unknown
- 2012-05-31 DK DK12170366.4T patent/DK2529757T3/en active
- 2012-05-31 PT PT121703664T patent/PT2529757E/pt unknown
-
2013
- 2013-05-31 JP JP2015514532A patent/JP6430933B2/ja active Active
- 2013-05-31 BR BR112014029208A patent/BR112014029208B1/pt active IP Right Grant
- 2013-05-31 MY MYPI2014703550A patent/MY181549A/en unknown
- 2013-05-31 KR KR1020147036778A patent/KR101892496B1/ko active IP Right Grant
- 2013-05-31 CA CA2874702A patent/CA2874702C/en active Active
- 2013-05-31 UA UAA201414185A patent/UA115987C2/uk unknown
- 2013-05-31 IN IN10673DEN2014 patent/IN2014DN10673A/en unknown
- 2013-05-31 WO PCT/EP2013/061319 patent/WO2013178811A1/en active Application Filing
- 2013-05-31 NZ NZ703319A patent/NZ703319A/en unknown
- 2013-05-31 SG SG11201407971QA patent/SG11201407971QA/en unknown
- 2013-05-31 CN CN201910004281.0A patent/CN109966239A/zh active Pending
- 2013-05-31 MX MX2014014484A patent/MX365097B/es active IP Right Grant
- 2013-05-31 AU AU2013269546A patent/AU2013269546B2/en active Active
- 2013-05-31 EA EA201401348A patent/EA029921B1/ru unknown
- 2013-05-31 CN CN201380028041.5A patent/CN104349792A/zh active Pending
-
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
Also Published As
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B06I | Publication of requirement cancelled [chapter 6.9 patent gazette] |
Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA. |
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| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] |
Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI |
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| B06T | Formal requirements before examination [chapter 6.20 patent gazette] | ||
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 31/05/2013, OBSERVADAS AS CONDICOES LEGAIS. |