HRP20240086T1 - Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem - Google Patents
Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem Download PDFInfo
- Publication number
- HRP20240086T1 HRP20240086T1 HRP20240086TT HRP20240086T HRP20240086T1 HR P20240086 T1 HRP20240086 T1 HR P20240086T1 HR P20240086T T HRP20240086T T HR P20240086TT HR P20240086 T HRP20240086 T HR P20240086T HR P20240086 T1 HRP20240086 T1 HR P20240086T1
- Authority
- HR
- Croatia
- Prior art keywords
- paliperidone palmitate
- dose
- paliperidone
- use according
- palmitate
- Prior art date
Links
- 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 claims 8
- 229960001057 paliperidone Drugs 0.000 title claims 8
- 238000013265 extended release Methods 0.000 title claims 5
- 239000007972 injectable composition Substances 0.000 title 1
- VOMKSBFLAZZBOW-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-2-methyl-4-oxo-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-9-yl hexadecanoate Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC3=C(C)N=C4N(C3=O)CCCC4OC(=O)CCCCCCCCCCCCCCC)=NOC2=C1 VOMKSBFLAZZBOW-UHFFFAOYSA-N 0.000 claims 37
- 229960000635 paliperidone palmitate Drugs 0.000 claims 37
- 229940102213 injectable suspension Drugs 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- 208000028017 Psychotic disease Diseases 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- 239000000872 buffer Substances 0.000 claims 3
- 210000003205 muscle Anatomy 0.000 claims 2
- 230000036470 plasma concentration Effects 0.000 claims 2
- 201000000980 schizophrenia Diseases 0.000 claims 2
- 239000000375 suspending agent Substances 0.000 claims 2
- 208000020925 Bipolar disease Diseases 0.000 claims 1
- YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 208000020186 Schizophreniform disease Diseases 0.000 claims 1
- 239000013011 aqueous formulation Substances 0.000 claims 1
- 239000003795 chemical substances by application Substances 0.000 claims 1
- 229960002303 citric acid monohydrate Drugs 0.000 claims 1
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 1
- 229940102215 extended release suspension Drugs 0.000 claims 1
- 239000003906 humectant Substances 0.000 claims 1
- 229940057838 polyethylene glycol 4000 Drugs 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 208000022610 schizoaffective disease Diseases 0.000 claims 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
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
- 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
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- 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
- A61K9/10—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
-
- 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)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dispersion Chemistry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (16)
1. Paliperidon palmitat, naznačen time, da je za uporabu u postupku liječenja psihoze, shizofrenije, shizoafektivnog poremećaja, shizofreniformnog poremećaja, ili bipolarnog poremećaja, pri čemu postupak obuhvaća davanje paliperidon palmitata pacijentu kojemu je to potrebno, kojemu je bila isporučena prva doza od injektibilne suspenzije paliperidon palmitata s produljenim oslobađanjem sa šestomjesečnim intervalom za doziranje (PP6M), gdje postupak obuhvaća primjenu druge doze od injektibilne suspenzije paliperidon palmitata s produljenim oslobađanjem u deltoidni ili glutealni mišić pacijenta, najviše dva tjedna prije ili tri tjedna nakon trenutka kada je prošlo šest mjeseci nakon primjene prve doze, pri čemu ne postoje interventne doze paliperidon palmitata između prve doze i druge doze,
pri čemu injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži oko 312 mg/mL paliperidon palmitata;
pri čemu je injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem vodeni pripravak koji nadalje sadrži sredstvo za suspenziju, pufer, i opcionalno jedan ili više konzervansa i sredstvo za izotonizaciju;
pri čemu prva doza sadrži oko 1092 mg paliperidon palmitata ili oko 1560 mg paliperidon palmitata; i
pri čemu druga doza sadrži oko 1092 mg paliperidon palmitata ili oko 1560 mg paliperidon palmitata.
2. Paliperidon palmitat za uporabu prema patentnom zahtjevu 1, naznačen time, da se druga doza daje u glutealni mišić.
3. Paliperidon palmitat za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da pacijent ima stabilno stanje koncentracije paliperidona u plazmi, u trenutku prve doze.
4. Paliperidon palmitat za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, da se kod postupka radi o postupku za liječenje shizofrenije.
5. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da svaka od prve doze i druge doze sadrži oko 1092 mg paliperidon palmitata.
6. Paliperidon palmitat za uporabu prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, da svaka od prve doze i druge doze sadrži oko 1560 mg paliperidon palmitata.
7. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija paliperidona u plazmi kod pacijenta iznosi oko 5 do oko 50 ng/mL u trenutku druge doze.
8. Paliperidon palmitat za uporabu prema patentnom zahtjevu 7, naznačen time, da kada prva doza sadrži 1092 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta iznosi oko 5 do oko 30 ng/mL u trenutku druge doze.
9. Paliperidon palmitat za uporabu prema patentnom zahtjevu 7, naznačen time, da kada prva doza sadrži 1560 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta iznosi oko 9 do oko 40 ng/mL u trenutku druge doze.
10. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija paliperidona u plazmi doseže maksimum od oko 10 do oko 150 ng/mL nakon primjene druge doze.
11. Paliperidon palmitat za uporabu prema patentnom zahtjevu 10, naznačen time, da kada prva doza iznosi 1092 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta doseže maksimum od oko 10 do oko 125 ng/mL nakon primjene druge doze.
12. Paliperidon palmitat za uporabu prema patentnom zahtjevu 10, naznačen time, da kada prva doza iznosi 1560 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta doseže maksimum od oko 35 do oko 145 ng/mL nakon primjene druge doze.
13. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži:
oko 312 mg/mL paliperidon palmitata;
oko 8 mg/mL do oko 12 mg/mL ovlaživača;
jedan ili više pufera;
oko 65 mg/mL do oko 85 mg/mL sredstva za suspenziju; i
vodu q.s. ad 100%.
14. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13, naznačen time, da je suspenzija na oko pH 6,0 do oko pH 8,0.
15. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13 ili zahtjevu 14, naznačen time, da jedan ili više pufera sadrže monohidrat limunske kiseline, natrijev dihidrogen fosfat monohidrat, bezvodni dinatrijev hidrogen fosfat, ili natrijev hidroksid.
16. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13, naznačen time, da injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži:
oko 312 mg/mL paliperidon palmitata;
oko 10 mg/mL polisorbata 20; i
oko 75 mg/mL polietilen glikola 4000.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063119382P | 2020-11-30 | 2020-11-30 | |
| PCT/EP2021/062144 WO2022111858A1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
| EP21724651.1A EP4025187B1 (en) | 2020-11-30 | 2021-05-07 | Dosing regimens associated with extended release paliperidone injectable formulations |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20240086T1 true HRP20240086T1 (hr) | 2024-03-29 |
Family
ID=75888042
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20240086TT HRP20240086T1 (hr) | 2020-11-30 | 2021-05-07 | Režimi za doziranje povezani s injektibilnim formulacijama paliperidona s produljenim oslobađanjem |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US11324751B1 (hr) |
| EP (1) | EP4025187B1 (hr) |
| JP (1) | JP2023552149A (hr) |
| KR (1) | KR20230116837A (hr) |
| CN (1) | CN116507320A (hr) |
| AU (2) | AU2021387679B2 (hr) |
| CA (1) | CA3203448A1 (hr) |
| DK (1) | DK4025187T3 (hr) |
| FI (1) | FI4025187T3 (hr) |
| HR (1) | HRP20240086T1 (hr) |
| IL (1) | IL303251A (hr) |
| LT (1) | LT4025187T (hr) |
| MX (1) | MX2023006370A (hr) |
| PL (1) | PL4025187T3 (hr) |
| PT (1) | PT4025187T (hr) |
| RS (1) | RS65133B1 (hr) |
| SI (1) | SI4025187T1 (hr) |
| WO (1) | WO2022111858A1 (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2023551007A (ja) | 2020-11-30 | 2023-12-06 | ヤンセン ファーマシューティカ エヌ．ベー． | パルミチン酸パリペリドン製剤の再懸濁を確実にする方法 |
| KR20240052810A (ko) * | 2021-08-30 | 2024-04-23 | 얀센 파마슈티카 엔브이 | 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5158952A (en) | 1988-11-07 | 1992-10-27 | Janssen Pharmaceutica N.V. | 3-[2-[4-(6-fluoro-1,2-benzisoxozol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9 tetrahydro-9-hydroxy-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one, compositions and method of use |
| US5254556A (en) | 1988-11-07 | 1993-10-19 | Janssen Pharmaceutica N.V. | 3-piperidinyl-1,2-benzisoxazoles |
| TW487572B (en) | 1996-05-20 | 2002-05-21 | Janssen Pharmaceutica Nv | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters |
| UA72189C2 (uk) | 1997-11-17 | 2005-02-15 | Янссен Фармацевтика Н.В. | Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот |
| WO2006114384A1 (en) | 2005-04-25 | 2006-11-02 | Janssen Pharmaceutica N.V. | Preparation of aseptic 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyridio[1,2-a]pyrimidin-4-one palmitate ester |
| EP2234617B1 (en) | 2007-12-19 | 2021-03-31 | Janssen Pharmaceutica NV | Dosing regimen associated with long acting injectable paliperidone esters |
| WO2011042453A1 (en) | 2009-10-06 | 2011-04-14 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| WO2011053829A1 (en) | 2009-10-30 | 2011-05-05 | Janssen Pharmaceutical Nv | Dosing regimen associated with long-acting injectable paliperidone esters |
| PL2529757T3 (pl) | 2011-05-31 | 2014-04-30 | Farm Rovi Lab Sa | Formulacja implantu zawierającego paliperydon |
| WO2016157061A1 (en) * | 2015-03-31 | 2016-10-06 | Wockhardt Limited | Aseptic wet milling process for paliperidone palmitate |
| EP4349323A2 (en) | 2015-04-07 | 2024-04-10 | JANSSEN Pharmaceutica NV | Dosing regimen for missed doses for long-acting injectable paliperidone esters |
| BR112020011614A2 (pt) | 2017-12-14 | 2020-12-08 | SpecGx LLC | Processo de moagem de uma etapa para preparar ésteres de paliperidona micronizada |
-
2021
- 2021-05-07 AU AU2021387679A patent/AU2021387679B2/en active Active
- 2021-05-07 WO PCT/EP2021/062144 patent/WO2022111858A1/en active Application Filing
- 2021-05-07 DK DK21724651.1T patent/DK4025187T3/da active
- 2021-05-07 EP EP21724651.1A patent/EP4025187B1/en active Active
- 2021-05-07 SI SI202130112T patent/SI4025187T1/sl unknown
- 2021-05-07 PT PT217246511T patent/PT4025187T/pt unknown
- 2021-05-07 PL PL21724651.1T patent/PL4025187T3/pl unknown
- 2021-05-07 CN CN202180080436.4A patent/CN116507320A/zh active Pending
- 2021-05-07 KR KR1020237021416A patent/KR20230116837A/ko not_active Application Discontinuation
- 2021-05-07 US US17/314,281 patent/US11324751B1/en active Active
- 2021-05-07 MX MX2023006370A patent/MX2023006370A/es unknown
- 2021-05-07 LT LTEPPCT/EP2021/062144T patent/LT4025187T/lt unknown
- 2021-05-07 CA CA3203448A patent/CA3203448A1/en active Pending
- 2021-05-07 JP JP2023532443A patent/JP2023552149A/ja active Pending
- 2021-05-07 IL IL303251A patent/IL303251A/en unknown
- 2021-05-07 FI FIEP21724651.1T patent/FI4025187T3/fi active
- 2021-05-07 RS RS20240087A patent/RS65133B1/sr unknown
- 2021-05-07 HR HRP20240086TT patent/HRP20240086T1/hr unknown
-
2022
- 2022-05-06 US US17/738,422 patent/US20230105276A1/en active Pending
-
2024
- 2024-04-10 AU AU2024202306A patent/AU2024202306A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| FI4025187T3 (fi) | 2024-02-13 |
| AU2021387679A1 (en) | 2023-07-20 |
| EP4025187A1 (en) | 2022-07-13 |
| CN116507320A (zh) | 2023-07-28 |
| AU2021387679B2 (en) | 2024-01-18 |
| AU2024202306A1 (en) | 2024-05-02 |
| EP4025187B1 (en) | 2024-01-03 |
| JP2023552149A (ja) | 2023-12-14 |
| CA3203448A1 (en) | 2022-06-02 |
| PL4025187T3 (pl) | 2024-04-29 |
| US11324751B1 (en) | 2022-05-10 |
| IL303251A (en) | 2023-07-01 |
| MX2023006370A (es) | 2023-08-07 |
| PT4025187T (pt) | 2024-02-28 |
| LT4025187T (lt) | 2024-02-12 |
| US20220168306A1 (en) | 2022-06-02 |
| SI4025187T1 (sl) | 2024-03-29 |
| DK4025187T3 (da) | 2024-03-04 |
| US20230105276A1 (en) | 2023-04-06 |
| TW202222318A (zh) | 2022-06-16 |
| KR20230116837A (ko) | 2023-08-04 |
| WO2022111858A1 (en) | 2022-06-02 |
| RS65133B1 (sr) | 2024-02-29 |
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