DK2167039T3 - Forbedrede depotformuleringer - Google Patents
Forbedrede depotformuleringer Download PDFInfo
- Publication number
- DK2167039T3 DK2167039T3 DK08767765.4T DK08767765T DK2167039T3 DK 2167039 T3 DK2167039 T3 DK 2167039T3 DK 08767765 T DK08767765 T DK 08767765T DK 2167039 T3 DK2167039 T3 DK 2167039T3
- Authority
- DK
- Denmark
- Prior art keywords
- formulation
- weight
- polymer
- saib
- formulations
- Prior art date
Links
Classifications
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0012—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- 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
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Dispersion Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Polyesters Or Polycarbonates (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Biological Depolymerization Polymers (AREA)
Claims (12)
1. Formulering, der omfatter: (i) sucroseacetatisobutyrat (SAIB); (ii) fra 15 til 45 vægt-%, baseret på formuleringens samlede vægt, af et lineært poly(lactid-co-glycolid), der har en vægtmiddelmolekylvægt på mindre end eller lig med 15.000 Dalton, og som har et forhold R mellem lactid-repeat-enheder og samlede repeat-enheder, hvor R opfylder følgende: 0,55 < R < 0,95; og (iii) N-methylpyrrolidon, hvor N-methylpyrrolidon er til stede i en mængde, der er større end 20 vægt-%, baseret på formuleringens samlede vægt, når 0,55 < R < 0,85 and hvor the N-methylpyrrolidon er til stede i en mængde, der er større end eller lig med 10 vægt-%, baseret på formuleringens samlede vægt, når 0,85 < R < 0,95.
2. Formulering ifølge krav 1, hvor poly(lactid-co-glycolid) er til stede i en mængde på fra 15 til 35 vægt-% baseret på formuleringens samlede vægt.
3. Formulering ifølge krav 1 eller 2, hvor R er fra 0,55 til 0,85.
4. Formulering ifølge krav 1 eller 2, hvor R er fra større end 0,85 til 0,95.
5. Formulering ifølge et hvilket som helst af de foregående krav, hvor N- methylpyrrolidon er til stede i en mængde, der er større end eller lig med 25 vægt-% baseret på formuleringens samlede vægt.
6. Formulering ifølge krav 3, hvor N-methylpyrrolidon er til stede i en mængde, der er større end eller lig med 35 vægt-% baseret på formuleringens samlede vægt.
7. Farmaceutisk sammensætning, der omfatter en formulering som defineret i et hvilket som helst af de foregående krav og et biologisk aktivt stof.
8. Sammensætning ifølge krav 7, hvor det biologisk aktive stof omfatter et atypisk antipsykotikum.
9. Sammensætning ifølge krav8, hvor det atypiske antipsykotikum omfatter risperidon eller et farmaceutisk acceptabelt salt eller en polymorf deraf.
10. Sammensætning ifølge et hvilket som helst af kravene 7 til 9, hvor det biologisk aktive stof er til stede i en mængde, der ligger i intervallet fra 1 vægt-% til 20 vægt-% baseret på formuleringens samlede vægt.
11. Sammensætning ifølge et hvilket som helst af kravene 7 til 10, hvor det biologisk aktive stof er til stede i en mængde, der ligger i intervallet fra 2 vægt-% til 20 vægt-% baseret på formuleringens samlede vægt.
12. Sammensætning ifølge et hvilket som helst af kravene 7 til 11, hvor det biologisk aktive stof er til stede i en mængde, der ligger i intervallet fra 2 vægt-% til 10 vægt-% baseret på formuleringens samlede vægt.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US93073907P | 2007-05-18 | 2007-05-18 | |
PCT/US2008/006320 WO2008143992A2 (en) | 2007-05-18 | 2008-05-16 | Improved depot formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2167039T3 true DK2167039T3 (da) | 2017-01-09 |
Family
ID=39708928
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK08767765.4T DK2167039T3 (da) | 2007-05-18 | 2008-05-16 | Forbedrede depotformuleringer |
Country Status (12)
Country | Link |
---|---|
US (8) | US20080287464A1 (da) |
EP (2) | EP3115038A1 (da) |
JP (4) | JP5599705B2 (da) |
CN (2) | CN103007288B (da) |
AU (1) | AU2008254538B2 (da) |
CA (1) | CA2686137C (da) |
DK (1) | DK2167039T3 (da) |
ES (1) | ES2606951T3 (da) |
HU (1) | HUE030789T2 (da) |
IL (1) | IL202181A (da) |
PL (1) | PL2167039T3 (da) |
WO (1) | WO2008143992A2 (da) |
Families Citing this family (27)
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US20070027105A1 (en) | 2005-07-26 | 2007-02-01 | Alza Corporation | Peroxide removal from drug delivery vehicle |
US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
MX2009010689A (es) * | 2007-04-03 | 2009-12-14 | Trimeris Inc | Formulaciones novedosas para el suministro de agentes terapeuticos de peptidos antivirales. |
EP3115038A1 (en) | 2007-05-18 | 2017-01-11 | DURECT Corporation | Improved depot formulations |
CN101801415B (zh) | 2007-05-25 | 2015-09-23 | Rb医药品有限公司 | 利培酮化合物的持续递送制剂 |
US8524267B2 (en) | 2008-04-18 | 2013-09-03 | Warsaw Orthopedic, Inc. | Dexamethasone formulations in a biodegradable material |
US10335366B2 (en) | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
EP2394664B1 (en) * | 2010-05-31 | 2016-06-01 | Laboratorios Farmaceuticos Rovi, S.A. | Antipsychotic injectable depot composition |
US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
PL2394663T3 (pl) | 2010-05-31 | 2022-02-21 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozycje do wstrzykiwania implantów biodegradowalnych in-situ |
US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
MX347014B (es) * | 2010-11-24 | 2017-04-07 | Durect Corp | Composición para administración de fármaco biodegradable. |
DK2529756T3 (da) * | 2011-05-31 | 2021-08-02 | Farm Rovi Lab Sa | Risperidon- og/eller paliperidon-implantatformulering |
AU2012321101A1 (en) * | 2011-11-23 | 2013-06-06 | Durect Corporation | Radiation-sterilized biodegradable drug delivery compositions |
US20140308352A1 (en) * | 2013-03-11 | 2014-10-16 | Zogenix Inc. | Compositions and methods involving polymer, solvent, and high viscosity liquid carrier material |
CN109602692B (zh) | 2013-03-11 | 2022-11-04 | 度瑞公司 | 包含高粘度液体载体的可注射控制释放组合物 |
US20160303242A1 (en) | 2013-12-09 | 2016-10-20 | Durect Corporation | Pharmaceutically Active Agent Complexes, Polymer Complexes, and Compositions and Methods Involving the Same |
JP2016175900A (ja) | 2015-03-18 | 2016-10-06 | 参天製薬株式会社 | 徐放性医薬組成物 |
US10668011B2 (en) | 2016-06-30 | 2020-06-02 | Durect Corporation | Depot formulations |
US10682340B2 (en) | 2016-06-30 | 2020-06-16 | Durect Corporation | Depot formulations |
US20220257619A1 (en) * | 2019-07-18 | 2022-08-18 | Gilead Sciences, Inc. | Long-acting formulations of tenofovir alafenamide |
CA3146064A1 (en) * | 2019-07-18 | 2021-01-21 | Durect Corporation | Long-acting formulations and vehicles |
CN115666621A (zh) | 2020-01-13 | 2023-01-31 | 度勒科特公司 | 具有减少的杂质的持续释放药物递送系统及相关方法 |
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 |
CN117815172A (zh) * | 2024-01-08 | 2024-04-05 | 江苏诺和必拓新药研发有限公司 | 一种美洛昔康缓释注射液及其制备方法和用于关节炎镇痛的药物 |
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-
2008
- 2008-05-16 EP EP16182848.8A patent/EP3115038A1/en not_active Withdrawn
- 2008-05-16 US US12/152,764 patent/US20080287464A1/en not_active Abandoned
- 2008-05-16 EP EP08767765.4A patent/EP2167039B1/en not_active Not-in-force
- 2008-05-16 ES ES08767765.4T patent/ES2606951T3/es active Active
- 2008-05-16 JP JP2010508444A patent/JP5599705B2/ja not_active Expired - Fee Related
- 2008-05-16 AU AU2008254538A patent/AU2008254538B2/en not_active Ceased
- 2008-05-16 HU HUE08767765A patent/HUE030789T2/en unknown
- 2008-05-16 CN CN201210392622.4A patent/CN103007288B/zh not_active Expired - Fee Related
- 2008-05-16 DK DK08767765.4T patent/DK2167039T3/da active
- 2008-05-16 WO PCT/US2008/006320 patent/WO2008143992A2/en active Application Filing
- 2008-05-16 CA CA2686137A patent/CA2686137C/en active Active
- 2008-05-16 PL PL08767765T patent/PL2167039T3/pl unknown
- 2008-05-16 CN CN2008800208290A patent/CN101677952B/zh not_active Expired - Fee Related
-
2009
- 2009-11-17 IL IL202181A patent/IL202181A/en active IP Right Grant
-
2013
- 2013-03-08 US US13/790,902 patent/US10028957B2/en active Active
-
2014
- 2014-05-07 JP JP2014095775A patent/JP6018603B2/ja not_active Expired - Fee Related
-
2015
- 2015-07-16 US US14/801,141 patent/US20160045601A1/en not_active Abandoned
-
2016
- 2016-02-26 US US15/054,473 patent/US20160279131A1/en not_active Abandoned
- 2016-07-29 JP JP2016149343A patent/JP6339640B2/ja not_active Expired - Fee Related
-
2018
- 2018-05-10 JP JP2018091049A patent/JP2018158921A/ja active Pending
- 2018-06-25 US US16/017,477 patent/US20190030032A1/en not_active Abandoned
-
2019
- 2019-09-03 US US16/559,155 patent/US20200101073A1/en not_active Abandoned
-
2020
- 2020-10-05 US US17/063,095 patent/US20210121467A1/en not_active Abandoned
-
2023
- 2023-01-04 US US18/093,240 patent/US20230146925A1/en active Pending
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