MA37661B1 - Formulation pour implant contenant de la palipéridone - Google Patents
Formulation pour implant contenant de la palipéridoneInfo
- Publication number
- MA37661B1 MA37661B1 MA37661A MA37661A MA37661B1 MA 37661 B1 MA37661 B1 MA 37661B1 MA 37661 A MA37661 A MA 37661A MA 37661 A MA37661 A MA 37661A MA 37661 B1 MA37661 B1 MA 37661B1
- Authority
- MA
- Morocco
- Prior art keywords
- paliperidone
- weeks
- lactic acid
- formulation containing
- glycolic acid
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- PMXMIIMHBWHSKN-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCC(O)C4=NC=3C)=NOC2=C1 PMXMIIMHBWHSKN-UHFFFAOYSA-N 0.000 title abstract 3
- 229960001057 paliperidone Drugs 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title abstract 2
- 239000007943 implant Substances 0.000 title abstract 2
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 abstract 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 abstract 4
- 235000014655 lactic acid Nutrition 0.000 abstract 2
- 239000004310 lactic acid Substances 0.000 abstract 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 abstract 1
- 229920001577 copolymer Polymers 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000001727 in vivo Methods 0.000 abstract 1
- 238000011065 in-situ storage Methods 0.000 abstract 1
- 238000007918 intramuscular administration Methods 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000007787 solid Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 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
- 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)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- General Chemical & Material Sciences (AREA)
- Psychiatry (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (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
Cette invention concerne une composition retard injectable par voie intramusculaire adaptée à former in situ un implant solide dans un corps. La composition comprend de la palipéridone (médicament) et/ou ses sels pharmaceutiques acceptables, quelle que soit leur combinaison, un copolymère biocompatible à base d'acide lactique et d'acide glycolique dont le rapport monomère acide lactique sur acide glycolique se situe dans la plage 50:50, et du dmso pour solvant. La composition libère la palipéridone immédiatement et en continu pendant au moins 8 semaines, son profil pharmacocinétique in vivo permettant que la formulation soit administrée toutes les 8 semaines ou sur des périodes plus longues.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP12170366.4A EP2529757B1 (fr) | 2011-05-31 | 2012-05-31 | Formulation d'implant de Paliperidone |
| PCT/EP2013/061319 WO2013178811A1 (fr) | 2012-05-31 | 2013-05-31 | Formulation pour implant contenant de la palipéridone |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MA37661A1 MA37661A1 (fr) | 2016-03-31 |
| MA37661B1 true MA37661B1 (fr) | 2016-12-30 |
Family
ID=47074463
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MA37661A MA37661B1 (fr) | 2012-05-31 | 2014-12-16 | Formulation pour implant contenant de la palipéridone |
Country Status (29)
| Country | Link |
|---|---|
| EP (1) | EP2529757B1 (fr) |
| JP (1) | JP6430933B2 (fr) |
| KR (1) | KR101892496B1 (fr) |
| CN (2) | CN109966239A (fr) |
| AU (1) | AU2013269546B2 (fr) |
| BR (1) | BR112014029208B1 (fr) |
| CA (1) | CA2874702C (fr) |
| CL (1) | CL2014003215A1 (fr) |
| CO (1) | CO7160109A2 (fr) |
| CY (1) | CY1114975T1 (fr) |
| DK (1) | DK2529757T3 (fr) |
| EA (1) | EA029921B1 (fr) |
| ES (1) | ES2456917T3 (fr) |
| HR (1) | HRP20140158T1 (fr) |
| IL (1) | IL235850A0 (fr) |
| IN (1) | IN2014DN10673A (fr) |
| MA (1) | MA37661B1 (fr) |
| MX (1) | MX365097B (fr) |
| MY (1) | MY181549A (fr) |
| NZ (1) | NZ703319A (fr) |
| PH (1) | PH12014502668B1 (fr) |
| PL (1) | PL2529757T3 (fr) |
| PT (1) | PT2529757E (fr) |
| SG (1) | SG11201407971QA (fr) |
| SI (1) | SI2529757T1 (fr) |
| SM (1) | SMT201400044B (fr) |
| UA (1) | UA115987C2 (fr) |
| WO (1) | WO2013178811A1 (fr) |
| ZA (1) | ZA201409297B (fr) |
Families Citing this family (28)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
| 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 |
| PL2394664T3 (pl) | 2010-05-31 | 2016-12-30 | Preparat przeciwpsychotyczny do wstrzykiwań o przedłużonym uwalnianiu | |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| PL2394663T3 (pl) | 2010-05-31 | 2022-02-21 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozycje do wstrzykiwania implantów biodegradowalnych in-situ |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| ES2456917T3 (es) * | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
| PT2529756T (pt) * | 2011-05-31 | 2021-07-28 | Farm Rovi Lab Sa | Formulação de implante de risperidona e/ou paliperidona |
| RS65024B1 (sr) * | 2015-04-07 | 2024-01-31 | Janssen Pharmaceutica Nv | Dozni režim za propuštene doze injektibilnih estara paliperidona sa produženim delovanjem |
| 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 |
| CN109982712A (zh) * | 2016-08-31 | 2019-07-05 | Mapi医药公司 | 包含醋酸格拉替雷的储库系统 |
| CN110382052A (zh) | 2017-03-26 | 2019-10-25 | Mapi医药公司 | 用于治疗进展型形式的多发性硬化症的格拉替雷储库系统 |
| ES3036965T3 (en) * | 2017-10-27 | 2025-09-25 | Geneora Pharma Shijiazhuang Co Ltd | Dosage regimen of paliperidone palmitate extended-release injectable suspension |
| KR20260007295A (ko) | 2018-05-24 | 2026-01-13 | 셀라니즈 이브이에이 퍼포먼스 폴리머스 엘엘씨 | 거대 분자 약물 화합물의 지속적인 방출을 위한 이식가능 장치 |
| MX2020012459A (es) | 2018-05-24 | 2021-04-28 | Celanese Eva Performance Polymers Llc | Dispositivo implantable para liberacion sostenida de un compuesto de farmaco macromolecular. |
| EP3803866A4 (fr) | 2018-05-24 | 2022-03-16 | Nureva Inc. | Procédé, appareil et supports lisibles par ordinateur pour gérer des sources sonores semi-constantes (persistantes) dans des zones de capture/foyer de microphones |
| PE20210047A1 (es) | 2018-06-12 | 2021-01-08 | Farm Rovi Lab Sa | Composicion inyectable |
| MX2023006370A (es) | 2020-11-30 | 2023-08-07 | Janssen Pharmaceutica Nv | Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada. |
| KR102794804B1 (ko) | 2020-11-30 | 2025-04-10 | 얀센 파마슈티카 엔브이 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 |
| ES2981035T3 (es) | 2020-11-30 | 2024-10-07 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada |
| BR112023022439A2 (pt) | 2021-04-26 | 2023-12-26 | Celanese Eva Performance Polymers Llc | Dispositivo implantável para liberação sustentada de um composto de fármaco macromolecular |
| US12318387B2 (en) | 2021-07-16 | 2025-06-03 | Laboratorios Farmaceuticos Rovi, S.A. | Method of treating acute exacerbation of schizophrenia with long-acting injectable depot composition |
| US12594236B2 (en) | 2021-07-16 | 2026-04-07 | Laboratorios Farmaceuticos Rovi, S.A. | Method of treating acute exacerbation of schizophrenia with long-acting injectable depot composition |
| MX2024002215A (es) | 2021-08-20 | 2024-05-10 | Janssen Pharmaceutica Nv | Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada. |
| 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 |
| CA3248062A1 (fr) | 2022-05-18 | 2025-07-10 | Laboratorios Farmacéuticos Rovi, S.A. | Compositions injectables à libération prolongée destinées à être utilisées dans le traitement avec la rispéridone conjointement avec des inhibiteurs de l’enzyme cyp2d6 |
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 |
| BRPI0513089B8 (pt) | 2004-08-04 | 2021-05-25 | Alza Corp | forma de dosagem para liberação controlada de um fármaco de ordem ascendente de zero |
| US8852638B2 (en) * | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| BRPI0809837A2 (pt) | 2007-04-19 | 2014-11-11 | Youxin Li | "composto para tratamento de distúrbios mentais, saldo do composto para tratamento de distúrbios mentais, composição farmacéutica e uso do composto para tratamento de distúrbios mentais" |
| ES2562878T3 (es) * | 2007-05-25 | 2016-03-08 | Indivior Uk Limited | Formulaciones de liberación sostenida de compuestos de risperidona |
| WO2009015828A1 (fr) | 2007-07-27 | 2009-02-05 | Synthon B.V. | Dérivés de palipéridone |
| KR102318070B1 (ko) | 2007-12-19 | 2021-10-27 | 얀센 파마슈티카 엔.브이. | 장기 작용성 주사가능 팔리페리돈 에스테르와 관련된 투여 요법 |
| WO2011042453A1 (fr) | 2009-10-06 | 2011-04-14 | Ascendis Pharma As | Composition sous-cutanée de palipéridone |
| PL2394664T3 (pl) * | 2010-05-31 | 2016-12-30 | Preparat przeciwpsychotyczny do wstrzykiwań o przedłużonym uwalnianiu | |
| PL2394663T3 (pl) * | 2010-05-31 | 2022-02-21 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozycje do wstrzykiwania implantów biodegradowalnych in-situ |
| PT2529756T (pt) * | 2011-05-31 | 2021-07-28 | Farm Rovi Lab Sa | Formulação de implante de risperidona e/ou 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 PL PL12170366T patent/PL2529757T3/pl unknown
- 2012-05-31 SI SI201230022T patent/SI2529757T1/sl unknown
- 2012-05-31 DK DK12170366.4T patent/DK2529757T3/en active
- 2012-05-31 EP EP12170366.4A patent/EP2529757B1/fr active Active
- 2012-05-31 PT PT121703664T patent/PT2529757E/pt unknown
-
2013
- 2013-05-31 BR BR112014029208-6A patent/BR112014029208B1/pt not_active IP Right Cessation
- 2013-05-31 JP JP2015514532A patent/JP6430933B2/ja active Active
- 2013-05-31 KR KR1020147036778A patent/KR101892496B1/ko active Active
- 2013-05-31 NZ NZ703319A patent/NZ703319A/en not_active IP Right Cessation
- 2013-05-31 CN CN201910004281.0A patent/CN109966239A/zh active Pending
- 2013-05-31 CA CA2874702A patent/CA2874702C/fr active Active
- 2013-05-31 SG SG11201407971QA patent/SG11201407971QA/en unknown
- 2013-05-31 WO PCT/EP2013/061319 patent/WO2013178811A1/fr not_active Ceased
- 2013-05-31 CN CN201380028041.5A patent/CN104349792A/zh active Pending
- 2013-05-31 MY MYPI2014703550A patent/MY181549A/en unknown
- 2013-05-31 EA EA201401348A patent/EA029921B1/ru unknown
- 2013-05-31 IN IN10673DEN2014 patent/IN2014DN10673A/en unknown
- 2013-05-31 MX MX2014014484A patent/MX365097B/es active IP Right Grant
- 2013-05-31 UA UAA201414185A patent/UA115987C2/uk unknown
- 2013-05-31 AU AU2013269546A patent/AU2013269546B2/en active Active
-
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/PH12014502668B1/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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