HRP20161066T1 - 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
- HRP20161066T1 HRP20161066T1 HRP20161066TT HRP20161066T HRP20161066T1 HR P20161066 T1 HRP20161066 T1 HR P20161066T1 HR P20161066T T HRP20161066T T HR P20161066TT HR P20161066 T HRP20161066 T HR P20161066T HR P20161066 T1 HRP20161066 T1 HR P20161066T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- desmopressin
- use according
- patient
- dose
- Prior art date
Links
- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 title claims 14
- 229960004281 desmopressin Drugs 0.000 title claims 11
- 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 11
- 206010029446 nocturia Diseases 0.000 title claims 5
- 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
- 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 5
- 210000002966 serum Anatomy 0.000 claims 5
- 229910052708 sodium Inorganic materials 0.000 claims 5
- 239000011734 sodium Substances 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
- 210000002700 urine Anatomy 0.000 claims 4
- 229960002845 desmopressin acetate Drugs 0.000 claims 3
- 239000012458 free base Substances 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
- 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
- 238000005259 measurement Methods 0.000 claims 2
- 230000000422 nocturnal effect Effects 0.000 claims 2
- 238000000034 method Methods 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Epidemiology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Diabetes (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Anesthesiology (AREA)
- Endocrinology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Claims (14)
1. Pripravak, koji sadrži dezmopresin za uporabu kod liječenja nokturije ili noćne poliurije, za smanjenje broja noćnih pražnjenja mjehura kod pacijentice, koja treba takvo liječenje, te pripravak sadrži orodisperzibilnu dozu dezmopresina u količini od 25 µg za administraciju prije počinka, naznačen time da se doza mjeri kao slobodna baza dezmopresina.
2. Pripravak za uporabu prema zahtjevu 1 naznačen time da je za liječenje pacijentice starije od 50 godina.
3. Pripravak za uporabu prema zahtjevu 1 naznačen time da je za liječenje pacijentice starije od 65 godina.
4. Pripravak za uporabu prema zahtjevu 1, 2 ili 3, naznačen time da je doza slobodne baze dezmopresina u obliku acetatne soli dezmopresina.
5. Pripravak za uporabu prema zahtjevu 1, 2 ili 3, naznačen time da orodisperzibilna doza dezmopresina je oblik doziranja, koji sadrži acetat dezmopresina, želatinu, manitol i limunsku kiselinu.
6. Pripravak za uporabu prema zahtjevu 1, naznačen time da je razdoblje liječenja 28 dana.
7. Pripravak za uporabu prema zahtjevu 3, naznačen time da pacijent ima stopu proizvodnje urina tijekom spavanja veću od stope cjelodnevne proizvodnje urina kod pacijenta.
8. Pripravak, naznačen time da sadrži dezmopresin za uporabu kod liječenja nokturije ili noćne poliurije, za smanjenje broja noćnih pražnjenja mjehura kod muškog pacijenta, koji treba takvo liječenje, te pripravak sadrži orodisperzibilnu dozu dezmopresina (npr. dezmopresin acetat) od 50 µg, naznačen time da se doza mjeri kao slobodna baza dezmopresina, za administraciju prije počinka.
9. Pripravak naznačen time da je za uporabu prema zahtjevu 8 u postupku koji sadrži:
- mjerenje razine natrija u serumu kod pacijenta;
- administraciju pripravka pacijentu, koji ima razinu natrija u serumu barem 135 mmol/L;
- mjerenje razine natrija u serumu u vremenskom intervalu nakon administracije;
- nastavak administracije doze dezmopresina pacijentu, koji ima razinu natrija u serumu od barem 130 mmol/L.
10. Pripravak za uporabu prema zahtjevu 9, naznačen time da je vremenski period u rasponu od 4 dana do 28 dana, na primjer, pri čemu je vremenski period 4 dana ili 28 dana.
11. Pripravak za uporabu prema zahtjevu 8, naznačen time da se doza uzima od 0,8 do 3 sata prije spavanja pacijenta; i/ili pri čemu se doza uzima jednom dnevno.
12. Pripravak za uporabu prema zahtjevu 8, naznačen time da je orodisperzibilna doza dezmopresina u obliku doziranja, koji sadrži acetat dezmopresina, želatinu, manitol i limunsku kiselinu.
13. Pripravak za uporabu prema zahtjevu 8, naznačen time da je razdoblje liječenja 28 dana.
14. Pripravak za uporabu prema zahtjevu 8, naznačen time da pacijent ima stopu proizvodnje urina tijekom spavanja veću od stope cjelodnevne proizvodnje urina pacijenta; i/ili pri čemu je pacijent stariji od 65 godina s razinom natrija u serumu, nakon administracije, od barem 135.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US5512008P | 2008-05-21 | 2008-05-21 | |
| EP13181216.6A EP2712622B1 (en) | 2008-05-21 | 2009-05-21 | Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia |
| PCT/US2009/044860 WO2009143356A1 (en) | 2008-05-21 | 2009-05-21 | Orodispersible desmopressin for increasing initial period of sleep undisturbed by nocturia |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161066T1 true HRP20161066T1 (hr) | 2016-10-21 |
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 After (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
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) | HUE046050T2 (hr) |
| LT (5) | LT2712622T (hr) |
| LU (1) | LUC00015I2 (hr) |
| NO (3) | NO2296686T3 (hr) |
| PL (5) | PL2712622T3 (hr) |
| PT (5) | PT3225249T (hr) |
| SI (4) | SI2712622T1 (hr) |
| TR (2) | TR201819189T4 (hr) |
| WO (1) | WO2009143356A1 (hr) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20100286045A1 (en) | 2008-05-21 | 2010-11-11 | Bjarke Mirner Klein | Methods comprising desmopressin |
| US11963995B2 (en) | 2008-05-21 | 2024-04-23 | Ferring B.V. | Methods comprising desmopressin |
| NO2296686T3 (hr) | 2008-05-21 | 2014-07-12 | ||
| WO2015063602A1 (en) * | 2013-10-29 | 2015-05-07 | Ferring B.V. | Desmopressin and blood glucose |
| CA3116290A1 (en) | 2018-10-17 | 2020-04-23 | Nippon Chemiphar Co., Ltd. | Therapeutic or prophylactic agent for nocturnal polyuria |
| WO2021210565A1 (ja) * | 2020-04-14 | 2021-10-21 | 日本ケミファ株式会社 | 睡眠の質の改善剤 |
| US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
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