HRP20180774T1 - Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom - Google Patents
Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom Download PDFInfo
- Publication number
- HRP20180774T1 HRP20180774T1 HRP20180774TT HRP20180774T HRP20180774T1 HR P20180774 T1 HRP20180774 T1 HR P20180774T1 HR P20180774T T HRP20180774T T HR P20180774TT HR P20180774 T HRP20180774 T HR P20180774T HR P20180774 T1 HRP20180774 T1 HR P20180774T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- desmopressin
- use according
- patient
- treatment
- Prior art date
Links
- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 title claims 16
- 229960004281 desmopressin Drugs 0.000 title claims 14
- NFLWUMRGJYTJIN-NXBWRCJVSA-N desmopressin Chemical compound C([C@H]1C(=O)N[C@H](C(N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSCCC(=O)N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)NCC(N)=O)=O)CCC(=O)N)C1=CC=CC=C1 NFLWUMRGJYTJIN-NXBWRCJVSA-N 0.000 title claims 14
- 206010029446 nocturia Diseases 0.000 title claims 7
- 230000007958 sleep Effects 0.000 title claims 4
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 6
- 239000012458 free base Substances 0.000 claims 5
- 210000002700 urine Anatomy 0.000 claims 5
- FIEYHAAMDAPVCH-UHFFFAOYSA-N 2-methyl-1h-quinazolin-4-one Chemical class C1=CC=C2NC(C)=NC(=O)C2=C1 FIEYHAAMDAPVCH-UHFFFAOYSA-N 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 4
- 230000000422 nocturnal effect Effects 0.000 claims 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 2
- 108010010803 Gelatin Proteins 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 235000015165 citric acid Nutrition 0.000 claims 2
- 229960002845 desmopressin acetate Drugs 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 229920000159 gelatin Polymers 0.000 claims 2
- 239000008273 gelatin Substances 0.000 claims 2
- 235000019322 gelatine Nutrition 0.000 claims 2
- 235000011852 gelatine desserts Nutrition 0.000 claims 2
- 235000010355 mannitol Nutrition 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims 1
- 210000002966 serum Anatomy 0.000 claims 1
- 229910052708 sodium Inorganic materials 0.000 claims 1
- 239000011734 sodium Substances 0.000 claims 1
Classifications
-
- 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
- A61K38/095—Oxytocins; Vasopressins; Related peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/10—Drugs for disorders of the urinary system of the bladder
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
Claims (18)
1. Pripravak, koji sadrži dezmopresin za uporabu kod liječenja muškog pacijenta koji ima nokturiju ili noćnu poliuriju, za smanjenje broja noćnih pražnjenja mjehura kod muškog pacijenta, koji treba takvo liječenje, te pripravak sadrži orodisperzibilnu dozu dezmopresina od 25 µg, naznačen time da se doza mjeri kao slobodna baza dezmopresina, za administraciju prije počinka.
2. Pripravak, koji sadrži dezmopresin za uporabu kod liječenja muškog pacijenta, koji ima nokturiju ili noćnu poliuriju, za smanjenje noćnog volumena urina kod muškog pacijenta, koji treba takvo liječenje, te pripravak sadrži orodisperzibilnu dozu dezmopresina od 25 µg, naznačen time da se doza mjeri kao slobodna baza dezmopresina, za administraciju prije počinka.
3. Pripravak za uporabu prema zahtjevu 1 ili 2, naznačen time da se doza uzima od 0,8 do 3 sata prije spavanja pacijenta; i/ili pri čemu se doza uzima jednom dnevno.
4. Pripravak za uporabu prema zahtjevu 1-3, naznačen time da je doza slobodne baze dezmopresina u obliku acetatne soli dezmopresina.
5. Pripravak za uporabu prema zahtjevu 1-3, naznačen time da je orodisperzibilna doza dezmopresina u obliku doziranja, koji sadrži acetat dezmopresina, želatinu, manitol i limunsku kiselinu.
6. Pripravak za uporabu prema zahtjevu 1-5, naznačen time da se liječenje odvija tijekom razdoblja liječenja.
7. Pripravak za uporabu prema zahtjevu 1-5, naznačen time da je razdoblje liječenja barem 28 dana.
8. Pripravak za uporabu prema zahtjevu 1-7, naznačen time da pacijent ima stopu proizvodnje urina tijekom spavanja veću od prosječne stope cjelodnevne proizvodnje urina pacijenta.
9. Pripravak za uporabu prema zahtjevu 1-8, naznačen time da je pacijent stariji od 65 godina.
10. Pripravak za uporabu prema zahtjevu 9, naznačen time da pacijent ima razinu natrija u serumu barem 135 mmol/L nakon administracije.
11. Pripravak, koji sadrži dezmopresin za uporabu kod liječenja ženskog pacijenta, koji ima nokturiju ili noćnu poliuriju, za smanjenje broja noćnih pražnjenja mjehura kod ženskog pacijenta, koji treba takvo liječenje, te pripravak sadrži orodisperzibilnu dozu dezmopresina od 10 µg za administraciju prije počinka, naznačen time da se doza mjeri kao slobodna baza dezmopresina.
12. Pripravak za uporabu prema zahtjevu 11 za liječenje ženskog pacijenta starijeg od 50 godina.
13. Pripravak za uporabu prema zahtjevu 11 za liječenje ženskog pacijenta starijeg od 65 godina.
14. Pripravak za uporabu prema zahtjevu 11-13, naznačen time da je doza slobodne baze dezmopresina u obliku acetatne soli dezmopresina.
15. Pripravak za uporabu prema zahtjevu 11-13, naznačen time da je orodisperzibilna doza dezmopresina u obliku doziranja, koji sadrži acetat dezmopresina, želatinu, manitol i limunsku kiselinu.
16. Pripravak za uporabu prema zahtjevu 11-15, naznačen time da se liječenje odvija tijekom razdoblja liječenja.
17. Pripravak za uporabu prema zahtjevu 11-15, naznačen time da je razdoblje liječenja barem 28 dana.
18. Pripravak za uporabu prema zahtjevu 11, naznačen time da pacijent ima stopu proizvodnje urina tijekom spavanja veću od prosječne stope cjelodnevne proizvodnje urina pacijenta.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US5512008P | 2008-05-21 | 2008-05-21 | |
| EP16165875.2A EP3085381B1 (en) | 2008-05-21 | 2009-05-21 | Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20180774T1 true HRP20180774T1 (hr) | 2018-08-10 |
Family
ID=41100519
Family Applications (4)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161066TT HRP20161066T1 (hr) | 2008-05-21 | 2016-08-22 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
| HRP20180774TT HRP20180774T1 (hr) | 2008-05-21 | 2018-05-17 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
| HRP20190114TT HRP20190114T1 (hr) | 2008-05-21 | 2019-01-18 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
| HRP20191854TT HRP20191854T1 (hr) | 2008-05-21 | 2019-10-14 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161066TT HRP20161066T1 (hr) | 2008-05-21 | 2016-08-22 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20190114TT HRP20190114T1 (hr) | 2008-05-21 | 2019-01-18 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
| HRP20191854TT HRP20191854T1 (hr) | 2008-05-21 | 2019-10-14 | Orodisperzibilni dezmopresin za povećanje početnog razdoblja sna neometanog s nokturijom |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US9974826B2 (hr) |
| EP (5) | EP3225250B1 (hr) |
| JP (5) | JP5767103B2 (hr) |
| CA (1) | CA2724653A1 (hr) |
| DK (5) | DK3225249T3 (hr) |
| ES (5) | ES2462465T5 (hr) |
| HR (4) | HRP20161066T1 (hr) |
| HU (5) | HUE039013T4 (hr) |
| LT (5) | LT3225250T (hr) |
| LU (1) | LUC00015I2 (hr) |
| NO (3) | NO2296686T3 (hr) |
| PL (5) | PL3085381T3 (hr) |
| PT (5) | PT3225249T (hr) |
| SI (4) | SI2712622T1 (hr) |
| TR (2) | TR201807224T4 (hr) |
| WO (1) | WO2009143356A1 (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NO2296686T3 (hr) * | 2008-05-21 | 2014-07-12 | ||
| US11963995B2 (en) | 2008-05-21 | 2024-04-23 | Ferring B.V. | Methods comprising desmopressin |
| US20100286045A1 (en) * | 2008-05-21 | 2010-11-11 | Bjarke Mirner Klein | Methods comprising desmopressin |
| WO2015063602A1 (en) * | 2013-10-29 | 2015-05-07 | Ferring B.V. | Desmopressin and blood glucose |
| KR20210078500A (ko) * | 2018-10-17 | 2021-06-28 | 닛뽕 케미파 가부시키가이샤 | 야간 다뇨의 치료 또는 예방제 |
| AU2021257176A1 (en) * | 2020-04-14 | 2022-11-10 | Nippon Chemiphar Co., Ltd. | Sleep quality improver |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
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