HRP20230716T1 - Farmaceutski sastav poboljšane stabilnosti - Google Patents
Farmaceutski sastav poboljšane stabilnosti Download PDFInfo
- Publication number
- HRP20230716T1 HRP20230716T1 HRP20230716TT HRP20230716T HRP20230716T1 HR P20230716 T1 HRP20230716 T1 HR P20230716T1 HR P20230716T T HRP20230716T T HR P20230716TT HR P20230716 T HRP20230716 T HR P20230716T HR P20230716 T1 HRP20230716 T1 HR P20230716T1
- Authority
- HR
- Croatia
- Prior art keywords
- lactide
- lactate
- based polymer
- less
- preparation
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 claims 21
- JVTAAEKCZFNVCJ-UHFFFAOYSA-M Lactate Chemical compound CC(O)C([O-])=O JVTAAEKCZFNVCJ-UHFFFAOYSA-M 0.000 claims 16
- 229920000642 polymer Polymers 0.000 claims 16
- 239000002253 acid Substances 0.000 claims 6
- 238000000034 method Methods 0.000 claims 6
- 239000000178 monomer Substances 0.000 claims 6
- 239000000579 Gonadotropin-Releasing Hormone Substances 0.000 claims 4
- 101000857870 Squalus acanthias Gonadoliberin Proteins 0.000 claims 4
- XLXSAKCOAKORKW-UHFFFAOYSA-N gonadorelin Chemical compound C1CCC(C(=O)NCC(N)=O)N1C(=O)C(CCCN=C(N)N)NC(=O)C(CC(C)C)NC(=O)CNC(=O)C(NC(=O)C(CO)NC(=O)C(CC=1C2=CC=CC=C2NC=1)NC(=O)C(CC=1NC=NC=1)NC(=O)C1NC(=O)CC1)CC1=CC=C(O)C=C1 XLXSAKCOAKORKW-UHFFFAOYSA-N 0.000 claims 4
- XLXSAKCOAKORKW-AQJXLSMYSA-N gonadorelin Chemical compound C([C@@H](C(=O)NCC(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 XLXSAKCOAKORKW-AQJXLSMYSA-N 0.000 claims 4
- 229940035638 gonadotropin-releasing hormone Drugs 0.000 claims 4
- 230000000975 bioactive effect Effects 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- JJTUDXZGHPGLLC-ZXZARUISSA-N (3r,6s)-3,6-dimethyl-1,4-dioxane-2,5-dione Chemical compound C[C@H]1OC(=O)[C@H](C)OC1=O JJTUDXZGHPGLLC-ZXZARUISSA-N 0.000 claims 2
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 claims 2
- 101000904173 Homo sapiens Progonadoliberin-1 Proteins 0.000 claims 2
- 102100024028 Progonadoliberin-1 Human genes 0.000 claims 2
- 101000996723 Sus scrofa Gonadotropin-releasing hormone receptor Proteins 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 230000000996 additive effect Effects 0.000 claims 2
- 239000000556 agonist Substances 0.000 claims 2
- 239000005557 antagonist Substances 0.000 claims 2
- 238000013270 controlled release Methods 0.000 claims 2
- 239000003960 organic solvent Substances 0.000 claims 2
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims 2
- 108010000817 Leuprolide Proteins 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 claims 1
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- GFIJNRVAKGFPGQ-LIJARHBVSA-N leuprolide Chemical compound CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)CC1=CC=C(O)C=C1 GFIJNRVAKGFPGQ-LIJARHBVSA-N 0.000 claims 1
- 229960004338 leuprorelin Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
-
- 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
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/593—Polyesters, e.g. PLGA or polylactide-co-glycolide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P13/00—Preparation of nitrogen-containing organic compounds
- C12P13/04—Alpha- or beta- amino acids
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Reproductive Health (AREA)
- Endocrinology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Microbiology (AREA)
- Pregnancy & Childbirth (AREA)
- Biotechnology (AREA)
- Gynecology & Obstetrics (AREA)
- Biochemistry (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (13)
1. Postupak za izradu injektibilnog pripravka za kontrolirano otpuštanje lijeka koji uključuje
kombiniranje polimera na bazi laktata čija je prosječna molekularnu težinu između 5.000 i 50.000 daltona i kiselinski broj manji od 3 mgKOH/g i sadržaj zaostalih monomera laktida u tome polimeru na bazi laktata koji je manji od oko 0,3% težine; s
farmaceutski prihvatljivim organskim otapalom; i
bioaktivni pripravak je izabran iz skupina koju čine gonadotropin-otpuštajući hormon (LHRH), analozi gonadotropin-otpuštajućeg hormona (LHRH), agonisti, antagonisti, i njihove soli,
uz uvjet da se prilikom pripreme ovog pripravka ne dodaje nikakav kiselinski aditiv.
2. Postupak sukladno patentnom zahtjevu 1 pri čemu je laktid u polimeru na bazi laktata D laktid, D, L laktid, L, D laktid, L laktid, (R, R) laktid, (S,S) laktid i mezo laktid ili bilo koja kombinacija navedenih.
3. Postupak sukladno patentnom zahtjevu 1 pri čemu polimer na bazi laktata ima sadržaj zaostalih monomera laktida manji od oko 0,2% težine.
4. Postupak sukladno patentnom zahtjevu 1 pri čemu polimer na bazi laktata ima sadržaj zaostalih monomera laktida manji od oko 0,1% težine.
5. Postupak sukladno patentnom zahtjevu 1 pri čemu polimer na bazi laktata ima kiselinski broj manji od 2 mgKOG/g.
6. Postupak sukladno patentnom zahtjevu 1, pri čemu je polimer na bazi laktata poli(laktid-koglikolid) (PLGA) koji ima odnos laktida/glikolida od 50/50 do 100/0.
7. Injektibilni pripravak za kontrolirano otpuštanje za isporuku lijeka uključuje:
a. polimer na bazi laktata koji ima prosječnu molekularnu težinu između 5.000 i 50.000 daltona, kiselinski broj manji od 3 mgKOH/g i sadržaj zaostalih monomera laktida u polimeru na bazi laktata manji od oko 0,3% težine;
b. farmaceutski prihvatljivo organsko otapalo; i
c. bioaktivni pripravak odabran iz skupine koju čine gonadotropin-otpuštajući hormon (LHRH), analozi gonadotropin-otpuštajućeg hormona (LHRH), agonisti, antagonisti, i njihove soli, uz uvjet da se nikakav kiselinski aditiv ne dodaje u proizvodnju toga pripravka, i taj pripravak smanjuje stvaranje konjugata.
8. Injektibilni pripravak sukladno patentnom zahtjevu 7 pri čemu je laktid u polimeru na bazi laktata D laktid, D,L laktid, D,L laktid, L,D laktid, L laktid, (R,R)-laktid, (S,S)-laktid i mezolaktid ili bilo koja kombinacija navedenih.
9. Injektibilni pripravak sukladno patentnom zahtjevu 7 pri čemu polimer na bazi laktata ima kiselinski broj manji od 2 mgKOH/g.
10. Injektibilni pripravak sukladno patentnom zahtjevu 7 pri čemu polimer na bazi laktata ima sadržaj zaostalih monomera laktida u polimeru za na bazi laktata manji od oko 0,2% težine.
11. Injektibilni pripravak sukladno patentnom zahtjevu 7 pri čemu polimer na bazi laktata ima sadržaj zaostalih monomera laktida u polimeru na bazi laktata manji od oko 0,1% težine.
12. Injektibilni pripravak sukladno patentnom zahtjevu 7, pri čemu je polimer na bazi laktata poli(laktid-koglikolid) (PLGA) sa odnosom laktida/glikolida od 50/50 do 100/0.
13. Injektibilni pripravak sukladno patentnom zahtjevu 7 pri čemu je bioaktivni pripravak leuprolid ili njegova sol.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462064008P | 2014-10-15 | 2014-10-15 | |
PCT/US2015/055634 WO2016061296A1 (en) | 2014-10-15 | 2015-10-15 | Pharmaceutical composition with improved stability |
EP15850568.5A EP3207149B1 (en) | 2014-10-15 | 2015-10-15 | Pharmaceutical composition with improved stability |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20230716T1 true HRP20230716T1 (hr) | 2023-10-13 |
Family
ID=55747307
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230716TT HRP20230716T1 (hr) | 2014-10-15 | 2015-10-15 | Farmaceutski sastav poboljšane stabilnosti |
Country Status (20)
Country | Link |
---|---|
US (2) | US20160106804A1 (hr) |
EP (1) | EP3207149B1 (hr) |
JP (2) | JP6717839B2 (hr) |
KR (2) | KR102274420B1 (hr) |
CN (2) | CN107075541B (hr) |
AU (2) | AU2015332456A1 (hr) |
BR (1) | BR112017007669A2 (hr) |
CA (1) | CA2964475C (hr) |
ES (1) | ES2949827T3 (hr) |
HR (1) | HRP20230716T1 (hr) |
HU (1) | HUE062326T2 (hr) |
IL (1) | IL251703B (hr) |
MX (2) | MX2017005235A (hr) |
NZ (1) | NZ730538A (hr) |
PL (1) | PL3207149T3 (hr) |
RS (1) | RS64339B1 (hr) |
RU (1) | RU2728786C2 (hr) |
SA (1) | SA517381298B1 (hr) |
SG (1) | SG11201702535QA (hr) |
WO (1) | WO2016061296A1 (hr) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20160106804A1 (en) * | 2014-10-15 | 2016-04-21 | Yuhua Li | Pharmaceutical composition with improved stability |
US11046810B2 (en) * | 2017-01-04 | 2021-06-29 | Pharmathen S.A. | Process for preparing biodegradable polymers of high molecular weight |
US20200282008A1 (en) * | 2017-01-31 | 2020-09-10 | Veru Inc. | COMPOSITIONS AND METHODS FOR LONG TERM RELEASE OF GONADOTROPIN-RELEASING HORMONE (GnRH) ANTAGONISTS |
HUE058207T2 (hu) * | 2017-01-31 | 2022-07-28 | Veru Inc | Készítmények és módszerek gonadotropin felszabadító hormon (GNRH) antagonisták elnyújtott idejû felszabadítására |
CN111511385B (zh) * | 2017-12-18 | 2024-05-03 | 逸达生物科技股份有限公司 | 具有选定的释放持续时间的药物组合物 |
BR112024002231A2 (pt) | 2021-08-05 | 2024-04-30 | Medincell S A | Composição farmacêutica |
Family Cites Families (34)
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US4443340A (en) | 1981-10-09 | 1984-04-17 | Betz Laboratories, Inc. | Control of iron induced fouling in water systems |
JPS60100516A (ja) * | 1983-11-04 | 1985-06-04 | Takeda Chem Ind Ltd | 徐放型マイクロカプセルの製造法 |
DE3708916A1 (de) | 1987-03-19 | 1988-09-29 | Boehringer Ingelheim Kg | Verfahren zur reinigung resorbierbarer polyester |
US5702716A (en) | 1988-10-03 | 1997-12-30 | Atrix Laboratories, Inc. | Polymeric compositions useful as controlled release implants |
US4938763B1 (en) | 1988-10-03 | 1995-07-04 | Atrix Lab Inc | Biodegradable in-situ forming implants and method of producing the same |
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US5487897A (en) | 1989-07-24 | 1996-01-30 | Atrix Laboratories, Inc. | Biodegradable implant precursor |
CA2040141C (en) | 1990-04-13 | 2002-05-14 | Minoru Yamada | Biodegradable high-molecular polymers, production and use therof |
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AU2605592A (en) | 1991-10-15 | 1993-04-22 | Atrix Laboratories, Inc. | Polymeric compositions useful as controlled release implants |
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EP0560014A1 (en) | 1992-03-12 | 1993-09-15 | Atrix Laboratories, Inc. | Biodegradable film dressing and method for its formation |
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FR2776516B1 (fr) * | 1998-03-25 | 2001-05-25 | Pharma Biotech | Compositions presentant une liberation prolongee et leur procede de preparation |
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ES2234325T3 (es) | 1998-12-15 | 2005-06-16 | Takeda Pharmaceutical Company Limited | Procedimiento para producir poliesteres biodegradables. |
US6355657B1 (en) | 1998-12-30 | 2002-03-12 | Atrix Laboratories, Inc. | System for percutaneous delivery of opioid analgesics |
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CA2915574C (en) * | 2003-07-18 | 2017-02-07 | Oakwood Laboratories, L.L.C. | Prevention of molecular weight reduction of the polymer, impurity formation and gelling in polymer compositions |
US8313763B2 (en) | 2004-10-04 | 2012-11-20 | Tolmar Therapeutics, Inc. | Sustained delivery formulations of rapamycin compounds |
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US20160106804A1 (en) * | 2014-10-15 | 2016-04-21 | Yuhua Li | Pharmaceutical composition with improved stability |
-
2015
- 2015-10-14 US US14/883,183 patent/US20160106804A1/en not_active Abandoned
- 2015-10-15 CN CN201580055836.4A patent/CN107075541B/zh active Active
- 2015-10-15 HR HRP20230716TT patent/HRP20230716T1/hr unknown
- 2015-10-15 ES ES15850568T patent/ES2949827T3/es active Active
- 2015-10-15 RU RU2017111079A patent/RU2728786C2/ru not_active Application Discontinuation
- 2015-10-15 EP EP15850568.5A patent/EP3207149B1/en active Active
- 2015-10-15 BR BR112017007669A patent/BR112017007669A2/pt not_active Application Discontinuation
- 2015-10-15 CA CA2964475A patent/CA2964475C/en active Active
- 2015-10-15 RS RS20230541A patent/RS64339B1/sr unknown
- 2015-10-15 WO PCT/US2015/055634 patent/WO2016061296A1/en active Application Filing
- 2015-10-15 CN CN202110616661.7A patent/CN113209009A/zh active Pending
- 2015-10-15 PL PL15850568.5T patent/PL3207149T3/pl unknown
- 2015-10-15 KR KR1020197007340A patent/KR102274420B1/ko active IP Right Grant
- 2015-10-15 JP JP2017539512A patent/JP6717839B2/ja active Active
- 2015-10-15 SG SG11201702535QA patent/SG11201702535QA/en unknown
- 2015-10-15 KR KR1020177013085A patent/KR102134873B1/ko active IP Right Grant
- 2015-10-15 HU HUE15850568A patent/HUE062326T2/hu unknown
- 2015-10-15 MX MX2017005235A patent/MX2017005235A/es unknown
- 2015-10-15 NZ NZ730538A patent/NZ730538A/en unknown
- 2015-10-15 AU AU2015332456A patent/AU2015332456A1/en not_active Abandoned
-
2017
- 2017-04-12 IL IL251703A patent/IL251703B/en active IP Right Grant
- 2017-04-12 SA SA517381298A patent/SA517381298B1/ar unknown
- 2017-04-21 MX MX2022003939A patent/MX2022003939A/es unknown
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2019
- 2019-12-09 AU AU2019279929A patent/AU2019279929B2/en active Active
-
2020
- 2020-06-11 JP JP2020101632A patent/JP6928695B2/ja active Active
-
2021
- 2021-12-16 US US17/552,748 patent/US20220160817A1/en active Pending
Also Published As
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Publication | Publication Date | Title |
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