HRP20161222T1 - Postupci liječenja koristeći lijekove za izbacivanje amonijaka - Google Patents
Postupci liječenja koristeći lijekove za izbacivanje amonijaka Download PDFInfo
- Publication number
- HRP20161222T1 HRP20161222T1 HRP20161222TT HRP20161222T HRP20161222T1 HR P20161222 T1 HRP20161222 T1 HR P20161222T1 HR P20161222T T HRP20161222T T HR P20161222TT HR P20161222 T HRP20161222 T HR P20161222T HR P20161222 T1 HRP20161222 T1 HR P20161222T1
- Authority
- HR
- Croatia
- Prior art keywords
- phenylbutyrate
- hpn
- glyceryl tri
- patient
- urinary
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 12
- 239000003814 drug Substances 0.000 title 1
- 229940079593 drug Drugs 0.000 title 1
- ZSDBFLMJVAGKOU-UHFFFAOYSA-N glycerol phenylbutyrate Chemical compound C=1C=CC=CC=1CCCC(=O)OCC(OC(=O)CCCC=1C=CC=CC=1)COC(=O)CCCC1=CC=CC=C1 ZSDBFLMJVAGKOU-UHFFFAOYSA-N 0.000 claims 50
- JFLIEFSWGNOPJJ-JTQLQIEISA-N N(2)-phenylacetyl-L-glutamine Chemical compound NC(=O)CC[C@@H](C(O)=O)NC(=O)CC1=CC=CC=C1 JFLIEFSWGNOPJJ-JTQLQIEISA-N 0.000 claims 22
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 18
- 230000002485 urinary effect Effects 0.000 claims 18
- 238000004519 manufacturing process Methods 0.000 claims 12
- 229910052757 nitrogen Inorganic materials 0.000 claims 9
- 238000006243 chemical reaction Methods 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 6
- 230000014759 maintenance of location Effects 0.000 claims 6
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 claims 4
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 claims 4
- 239000004202 carbamide Substances 0.000 claims 4
- OBKXEAXTFZPCHS-UHFFFAOYSA-N 4-phenylbutyric acid Chemical compound OC(=O)CCCC1=CC=CC=C1 OBKXEAXTFZPCHS-UHFFFAOYSA-N 0.000 claims 3
- 102000015781 Dietary Proteins Human genes 0.000 claims 3
- 108010010256 Dietary Proteins Proteins 0.000 claims 3
- IPBVNPXQWQGGJP-UHFFFAOYSA-N acetic acid phenyl ester Natural products CC(=O)OC1=CC=CC=C1 IPBVNPXQWQGGJP-UHFFFAOYSA-N 0.000 claims 3
- 230000015572 biosynthetic process Effects 0.000 claims 3
- 235000021245 dietary protein Nutrition 0.000 claims 3
- 229940049953 phenylacetate Drugs 0.000 claims 3
- WLJVXDMOQOGPHL-UHFFFAOYSA-N phenylacetic acid Chemical compound OC(=O)CC1=CC=CC=C1 WLJVXDMOQOGPHL-UHFFFAOYSA-N 0.000 claims 3
- 229950009215 phenylbutanoic acid Drugs 0.000 claims 3
- 238000003786 synthesis reaction Methods 0.000 claims 3
- 229910021529 ammonia Inorganic materials 0.000 claims 2
- DDRJAANPRJIHGJ-UHFFFAOYSA-N creatinine Chemical compound CN1CC(=O)NC1=N DDRJAANPRJIHGJ-UHFFFAOYSA-N 0.000 claims 2
- 208000028547 Inborn Urea Cycle disease Diseases 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 229940109239 creatinine Drugs 0.000 claims 1
- 208000007386 hepatic encephalopathy Diseases 0.000 claims 1
- 238000012544 monitoring process Methods 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 230000007704 transition Effects 0.000 claims 1
- 208000030954 urea cycle disease Diseases 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
- G01N33/6806—Determination of free amino acids
- G01N33/6812—Assays for specific amino acids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
- G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/08—Hepato-biliairy disorders other than hepatitis
- G01N2800/085—Liver diseases, e.g. portal hypertension, fibrosis, cirrhosis, bilirubin
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/34—Genitourinary disorders
- G01N2800/347—Renal failures; Glomerular diseases; Tubulointerstitial diseases, e.g. nephritic syndrome, glomerulonephritis; Renovascular diseases, e.g. renal artery occlusion, nephropathy
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2800/00—Detection or diagnosis of diseases
- G01N2800/52—Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
Claims (9)
1. Postupak određivanja efektivne početne doze gliceril tri-[4-fenilbutirata] (HPN-100) za pacijenta kojem je potrebno liječenje poremećaja zadržavanja dušika koji sadrži:
određivanje ciljane proizvodnje urinarnog fenilacetil glutamina (PAGN) zasnovano na ciljanoj proizvodnji dušika; te računanje efektivne početne doze gliceril tri-[4-fenilbutirata] (HPN-100) kako bi se proizvela ciljana proizvodnja PAGN, pri čemu je efektivna početna doza računata zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%.
2. Postupak prema zahtjevu 1, pri čemu se primjenjuje jedno ili više od slijedećeg:
a) proizvodnja urinarnog PAGN određena je kao omjer koncentracije urinarnog PAGN prema urinarnom kreatininu; b) poremećaj zadržavanja dušika je kronična hepatična encefalopatija ili poremećaj kruženja uree; te c) administracija efektivne doze gliceril tri-[4-fenilbutirata] (HPN-100) pacijentu dovodi do normalnih razina amonijaka u plazmi kod pacijenta.
3. Postupak određivanja efektivne doze gliceril tri-[4-fenilbutirata] (HPN-100) za pacijenta koji ima poremećaj zadržavanja dušika koji sadrži računanje doze gliceril tri-[4-fenilbutirata] (HPN-100) potrebne da se postigne ciljana razina proizvodnje urinarnog fenilacetil glutamina (PAGN) zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%.
4. Postupak prema zahtjevu 1, pri čemu ciljana proizvodnja dušika uzima u obzir jedan ili oboje od pacijentovog dijetalnog uzimanja proteina i kapaciteta sinteze rezidualne uree.
5. Postupak za određivanje efektivne doze gliceril tri-[4-fenilbutirata] (HPN-100) za pacijente koji ima poremećaj zadržavanja dušika, koji sadrži:
a) određivanje pacijentovog kapaciteta sinteze rezidualne uree;
b) određivanje pacijentovog dijetalnog uzimanja proteina;
c) procjenjivanje iz a) i b) pacijentove ciljane proizvodnje urinarnog fenilacetil glutamina (PAGN); te
d) određivanje količine gliceril tri-[4-fenilbutirata] (HPN-100) potrebne kako bi se proizvela ciljana proizvodnja urinarnog PAGN zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%.
6. Gliceril tri-[4-fenilbutirat] (HPN-100) za upotrebu u postupku liječenja pacijenta koji ima poremećaj zadržavanja amonijaka prikladnom dozom gliceril tri-[4-fenilbutirata] (HPN-100), gdje metoda sadrži:
a) određivanje pacijentovog kapaciteta sinteze rezidualne uree;
b) određivanje pacijentovog dijetalnog uzimanja proteina;
c) procjenjivanje iz a) i b) pacijentove ciljane proizvodnje urinarnog fenilacetil glutamina (PAGN); i
d) određivanje količine gliceril tri-[4-fenilbutirata] (HPN-100) potrebne kako bi se proizvela ciljana količina urinarnog PAGN zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%; te
e) administriranje pacijentu prikladne doze gliceril tri-[4-fenilbutirata] (HPN-100).
7. Postupak tranzicije pacijenta koji prima terapiju početnom količinom fenilacetata ili fenilbutirata na zamjensku količinu gliceril tri-[4-fenilbutirata] (HPN-100), koji sadrži:
određivanje zamjenske količine gliceril tri-[4-fenilbutirata] (HPN-100) da zamijeni urinarnu proizvodnju dušika u barem dijelu fenilacetata ili fenilbutirata, gdje je zamjenska količina računata zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%;
supstituiranje zamjenske količine gliceril tri-[4-fenilbutirata] (HPN-100) za fenilacetat ili fenilbutirat; te, opcionalno
monitoriranje količine urinarnog PAGN izlučenog od pacijenta kako bi se procijenila efikasnost zamjenske količine gliceril tri-[4-fenilbutirata] (HPN-100).
8. Gliceril tri-[4-fenilbutirat] (HPN-100) za upotrebu u postupku liječenja pacijenta sa poremećajem zadržavanja dušika, pri čemu postupak sadrži:
a) određivanje ciljane proizvodnje urinarnog fenilacetil glutamina (PAGN) zasnovano na ciljanoj proizvodnji dušika;
b) računanje efektivne doze gliceril tri-[4-fenilbutirata] (HPN-100) zasnovano na srednjoj pretvorbi gliceril tri-[4-fenilbutirata] (HPN-100) u urinarni PAGN od 60% do 75%; te
c) administriranje efektivne doze gliceril tri-[4-fenilbutirata] (HPN-100) pacijentu.
9. Postupak prema zahtjevu 6, pri čemu pacijent je pacijent sa klinički značajnim kapacitetom rezidualne uree, te se gliceril tri-[4-fenilbutirat] (HPN-100) administrira u dvije ili tri doze po danu.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US9323408P | 2008-08-29 | 2008-08-29 | |
| PCT/US2009/030362 WO2009134460A1 (en) | 2008-04-29 | 2009-01-07 | Methods of treatment using ammonia-scavenging drugs |
| EP09739263.3A EP2330892B1 (en) | 2008-04-29 | 2009-01-07 | Methods of treatment using ammonia-scavenging drugs |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161222T1 true HRP20161222T1 (hr) | 2017-02-10 |
Family
ID=45604478
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161222TT HRP20161222T1 (hr) | 2008-08-29 | 2016-09-26 | Postupci liječenja koristeći lijekove za izbacivanje amonijaka |
| HRP20181877TT HRP20181877T1 (hr) | 2008-08-29 | 2018-11-08 | Postupci za liječenje lijekovima koji uklanjaju amonijak |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20181877TT HRP20181877T1 (hr) | 2008-08-29 | 2018-11-08 | Postupci za liječenje lijekovima koji uklanjaju amonijak |
Country Status (10)
| Country | Link |
|---|---|
| JP (3) | JP5577341B2 (hr) |
| DK (1) | DK3133396T3 (hr) |
| ES (2) | ES2695534T3 (hr) |
| HR (2) | HRP20161222T1 (hr) |
| HU (2) | HUE029912T2 (hr) |
| LT (2) | LT2330892T (hr) |
| PL (1) | PL2330892T3 (hr) |
| PT (2) | PT2330892T (hr) |
| SI (1) | SI3133396T1 (hr) |
| TR (1) | TR201816616T4 (hr) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK2760479T3 (en) | 2011-09-30 | 2017-07-17 | Horizon Therapeutics Llc | Nitrogen-removing drug for use in a method of treating a nitrogen retention disorder |
| CN113995743A (zh) * | 2012-04-20 | 2022-02-01 | 伊梅尔迪卡制药公司 | 苯乙酸前药的治疗性监测方法 |
| US9289406B2 (en) * | 2012-11-21 | 2016-03-22 | Horizon Therapeutics, Inc. | Methods of administering and evaluating nitrogen scavenging drugs for the treatment of hepatic encephalopathy |
| US9914692B2 (en) | 2016-05-25 | 2018-03-13 | Horizon Therapeutics, Llc | Procedure for the preparation of 4-phenyl butyrate and uses thereof |
| US10668040B2 (en) | 2017-09-11 | 2020-06-02 | Horizon Therapeutics, Llc | Treatment of urea cycle disorders in neonates and infants |
| JP6797456B2 (ja) * | 2018-10-04 | 2020-12-09 | アトナープ株式会社 | 生体情報取得システム、健康管理サーバーおよびシステム |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4284647A (en) * | 1980-03-31 | 1981-08-18 | The Johns Hopkins University | Process for waste nitrogen removal |
| ES2157422T3 (es) * | 1995-02-07 | 2001-08-16 | Brusilow Entpr Llc | Trigliceridos y esteres etilicos de acido fenilalcanoico y acido fenilalquenoico utiles en el tratamiento de diversos trastornos. |
| US20070004805A1 (en) * | 2005-07-01 | 2007-01-04 | Navinta Llc | Process for preparation of liquid dosage form containing sodium 4-phenylbutyrate |
-
2009
- 2009-01-07 PT PT97392633T patent/PT2330892T/pt unknown
- 2009-01-07 ES ES16176456T patent/ES2695534T3/es active Active
- 2009-01-07 ES ES09739263.3T patent/ES2593378T3/es active Active
- 2009-01-07 LT LTEP09739263.3T patent/LT2330892T/lt unknown
- 2009-01-07 PT PT16176456T patent/PT3133396T/pt unknown
- 2009-01-07 DK DK16176456.8T patent/DK3133396T3/en active
- 2009-01-07 HU HUE09739263A patent/HUE029912T2/en unknown
- 2009-01-07 PL PL09739263T patent/PL2330892T3/pl unknown
- 2009-01-07 TR TR2018/16616T patent/TR201816616T4/tr unknown
- 2009-01-07 SI SI200931886T patent/SI3133396T1/sl unknown
- 2009-01-07 LT LTEP16176456.8T patent/LT3133396T/lt unknown
- 2009-01-07 JP JP2011525021A patent/JP5577341B2/ja active Active
- 2009-01-07 HU HUE16176456A patent/HUE040503T2/hu unknown
- 2009-08-27 JP JP2011525214A patent/JP2012501451A/ja not_active Withdrawn
-
2014
- 2014-01-07 JP JP2014000920A patent/JP2014102255A/ja not_active Withdrawn
-
2016
- 2016-09-26 HR HRP20161222TT patent/HRP20161222T1/hr unknown
-
2018
- 2018-11-08 HR HRP20181877TT patent/HRP20181877T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| LT3133396T (lt) | 2018-11-26 |
| LT2330892T (lt) | 2016-11-25 |
| ES2695534T3 (es) | 2019-01-08 |
| HUE029912T2 (en) | 2017-03-28 |
| JP5577341B2 (ja) | 2014-08-20 |
| PL2330892T3 (pl) | 2017-05-31 |
| JP2012501329A (ja) | 2012-01-19 |
| JP2014102255A (ja) | 2014-06-05 |
| ES2593378T3 (es) | 2016-12-09 |
| DK3133396T3 (en) | 2018-12-03 |
| HRP20181877T1 (hr) | 2019-01-11 |
| HUE040503T2 (hu) | 2019-03-28 |
| PT3133396T (pt) | 2018-12-07 |
| JP2012501451A (ja) | 2012-01-19 |
| SI3133396T1 (sl) | 2018-12-31 |
| PT2330892T (pt) | 2016-09-05 |
| TR201816616T4 (tr) | 2018-11-21 |
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