DK2174652T3 - Oral, farmaceutisk desmopressin-sammensætning - Google Patents
Oral, farmaceutisk desmopressin-sammensætning Download PDFInfo
- Publication number
- DK2174652T3 DK2174652T3 DK08805367.3T DK08805367T DK2174652T3 DK 2174652 T3 DK2174652 T3 DK 2174652T3 DK 08805367 T DK08805367 T DK 08805367T DK 2174652 T3 DK2174652 T3 DK 2174652T3
- Authority
- DK
- Denmark
- Prior art keywords
- desmopressin
- pharmaceutical composition
- oral
- composition
- effective amount
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims description 46
- 108010000437 Deamino Arginine Vasopressin Proteins 0.000 title claims description 44
- 229960004281 desmopressin Drugs 0.000 title claims description 40
- 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 6
- 239000008194 pharmaceutical composition Substances 0.000 claims description 26
- 239000003755 preservative agent Substances 0.000 claims description 15
- 239000007788 liquid Substances 0.000 claims description 12
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 10
- 239000006188 syrup Substances 0.000 claims description 8
- 235000020357 syrup Nutrition 0.000 claims description 8
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 7
- 239000004292 methyl p-hydroxybenzoate Substances 0.000 claims description 6
- 235000010270 methyl p-hydroxybenzoate Nutrition 0.000 claims description 6
- 210000004877 mucosa Anatomy 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 6
- 208000032843 Hemorrhage Diseases 0.000 claims description 5
- 201000010064 diabetes insipidus Diseases 0.000 claims description 5
- 230000002496 gastric effect Effects 0.000 claims description 5
- 229960002216 methylparaben Drugs 0.000 claims description 5
- 210000002200 mouth mucosa Anatomy 0.000 claims description 5
- FJKROLUGYXJWQN-UHFFFAOYSA-N 4-hydroxybenzoic acid Chemical compound OC(=O)C1=CC=C(O)C=C1 FJKROLUGYXJWQN-UHFFFAOYSA-N 0.000 claims description 4
- QFOHBWFCKVYLES-UHFFFAOYSA-N Butylparaben Chemical compound CCCCOC(=O)C1=CC=C(O)C=C1 QFOHBWFCKVYLES-UHFFFAOYSA-N 0.000 claims description 4
- 208000008967 Enuresis Diseases 0.000 claims description 4
- 201000003542 Factor VIII deficiency Diseases 0.000 claims description 4
- 208000003450 Neurogenic Diabetes Insipidus Diseases 0.000 claims description 4
- 206010051077 Post procedural haemorrhage Diseases 0.000 claims description 4
- 208000028235 central diabetes insipidus Diseases 0.000 claims description 4
- 201000010099 disease Diseases 0.000 claims description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 4
- 201000005119 neurohypophyseal diabetes insipidus Diseases 0.000 claims description 4
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 4
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 4
- FIEYHAAMDAPVCH-UHFFFAOYSA-N 2-methyl-1h-quinazolin-4-one Chemical compound C1=CC=C2NC(C)=NC(=O)C2=C1 FIEYHAAMDAPVCH-UHFFFAOYSA-N 0.000 claims description 3
- 239000002253 acid Substances 0.000 claims description 3
- 150000007513 acids Chemical class 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 3
- 230000000844 anti-bacterial effect Effects 0.000 claims description 3
- 239000003429 antifungal agent Substances 0.000 claims description 3
- 229940121375 antifungal agent Drugs 0.000 claims description 3
- 229960002845 desmopressin acetate Drugs 0.000 claims description 3
- 229960003415 propylparaben Drugs 0.000 claims description 3
- MOZDKDIOPSPTBH-UHFFFAOYSA-N Benzyl parahydroxybenzoate Chemical compound C1=CC(O)=CC=C1C(=O)OCC1=CC=CC=C1 MOZDKDIOPSPTBH-UHFFFAOYSA-N 0.000 claims description 2
- XPJVKCRENWUEJH-UHFFFAOYSA-N Isobutylparaben Chemical compound CC(C)COC(=O)C1=CC=C(O)C=C1 XPJVKCRENWUEJH-UHFFFAOYSA-N 0.000 claims description 2
- 229940034794 benzylparaben Drugs 0.000 claims description 2
- 229940067596 butylparaben Drugs 0.000 claims description 2
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 2
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims description 2
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- NFLWUMRGJYTJIN-PNIOQBSNSA-N desmopressin Chemical group 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-PNIOQBSNSA-N 0.000 description 35
- 238000010521 absorption reaction Methods 0.000 description 8
- 230000002335 preservative effect Effects 0.000 description 7
- 239000007921 spray Substances 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 239000003795 chemical substances by application Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 239000002357 osmotic agent Substances 0.000 description 5
- 239000007787 solid Substances 0.000 description 5
- 208000034158 bleeding Diseases 0.000 description 4
- 230000000740 bleeding effect Effects 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- 102100026735 Coagulation factor VIII Human genes 0.000 description 3
- 208000009292 Hemophilia A Diseases 0.000 description 3
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 3
- 239000013543 active substance Substances 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 230000002708 enhancing effect Effects 0.000 description 3
- 210000002850 nasal mucosa Anatomy 0.000 description 3
- 239000006174 pH buffer Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 150000001412 amines Chemical group 0.000 description 2
- 230000002686 anti-diuretic effect Effects 0.000 description 2
- 239000012752 auxiliary agent Substances 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 239000002775 capsule Substances 0.000 description 2
- 108700021293 carbetocin Proteins 0.000 description 2
- 229960001118 carbetocin Drugs 0.000 description 2
- NSTRIRCPWQHTIA-DTRKZRJBSA-N carbetocin Chemical group C([C@H]1C(=O)N[C@H](C(N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSCCCC(=O)N1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)=O)[C@@H](C)CC)C1=CC=C(OC)C=C1 NSTRIRCPWQHTIA-DTRKZRJBSA-N 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 210000004400 mucous membrane Anatomy 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 230000009747 swallowing Effects 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- CMHMMKSPYOOVGI-UHFFFAOYSA-N Isopropylparaben Chemical compound CC(C)OC(=O)C1=CC=C(O)C=C1 CMHMMKSPYOOVGI-UHFFFAOYSA-N 0.000 description 1
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 1
- 101800000989 Oxytocin Proteins 0.000 description 1
- 102100026383 Vasopressin-neurophysin 2-copeptin Human genes 0.000 description 1
- 239000002250 absorbent Substances 0.000 description 1
- 230000002745 absorbent Effects 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 229940124538 antidiuretic agent Drugs 0.000 description 1
- 239000003160 antidiuretic agent Substances 0.000 description 1
- 229960000686 benzalkonium chloride Drugs 0.000 description 1
- CADWTSSKOVRVJC-UHFFFAOYSA-N benzyl(dimethyl)azanium;chloride Chemical compound [Cl-].C[NH+](C)CC1=CC=CC=C1 CADWTSSKOVRVJC-UHFFFAOYSA-N 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- BBBFJLBPOGFECG-VJVYQDLKSA-N calcitonin Chemical compound N([C@H](C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC=1NC=NC=1)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC=1C=CC(O)=CC=1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N1[C@@H](CCC1)C(N)=O)C(C)C)C(=O)[C@@H]1CSSC[C@H](N)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)O)C(=O)N1 BBBFJLBPOGFECG-VJVYQDLKSA-N 0.000 description 1
- 229960003773 calcitonin (salmon synthetic) Drugs 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000006184 cosolvent Substances 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 229940113094 isopropylparaben Drugs 0.000 description 1
- 239000002502 liposome Substances 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 239000004530 micro-emulsion Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 210000003928 nasal cavity Anatomy 0.000 description 1
- 229910017604 nitric acid Inorganic materials 0.000 description 1
- 239000008203 oral pharmaceutical composition Substances 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
- 235000005985 organic acids Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000007911 parenteral administration Methods 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 108010068072 salmon calcitonin Proteins 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 229920001187 thermosetting polymer Polymers 0.000 description 1
- 239000004634 thermosetting polymer Substances 0.000 description 1
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
- OIWCYIUQAVBPGV-DAQGAKHBSA-N {1-O-hexadecanoyl-2-O-[(Z)-octadec-9-enoyl]-sn-glycero-3-phospho}serine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP(O)(=O)OC[C@H](N)C(O)=O)OC(=O)CCCCCCC\C=C/CCCCCCCC OIWCYIUQAVBPGV-DAQGAKHBSA-N 0.000 description 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0065—Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
-
- 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
- A61K9/08—Solutions
-
- 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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/12—Antidiuretics, e.g. drugs for diabetes insipidus
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Diabetes (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Zoology (AREA)
- Obesity (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Urology & Nephrology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Claims (9)
1. Farmaceutisk sammensætning, bestående af en terapeutisk virksom mængde af desmopressin eller et farmaceutisk acceptabelt salt af samme, et eller flere konserveringsmidler, antibakterielle og svampedræbende midler, udvalgt blandt parabener og salte eller blandinger af samme, en eller flere syrer til indstilling af sammensætningens pH-værdi og vand, udvalgt fra gruppen, som udgøres af saltsyre, salpetersyre, phosphorsyre, svovlsyre, eddikesyre og citronsyre samt blandinger af samme, hvorved den farmaceutiske sammensætning er en stabil og flydende sammensætning med fleksibel dosering og med en pH-værdi mellem 3,5 og 5,0, og hvilken sammensætning indgives oralt.
2. Farmaceutisk sammensætning ifølge krav 1, hvorved den terapeutisk virksomme mængde af desmopressin indgives i form af desmopressinacetat.
3. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 eller 2, hvorved den terapeutisk virksomme mængde af desmopressin er mellem 0,001 mg/ml og 5 mg/ml.
4. Farmaceutisk sammensætning ifølge krav 3, hvorved den terapeutisk virksomme mængde af desmopressin er mellem 0,01 mg/ml og 2 mg/ml.
5. Farmaceutisk sammensætning ifølge krav 4, hvorved den terapeutisk virksomme mængde af desmopressin er mellem 0,1 mg/ml og 1 mg/ml.
6. Farmaceutisk sammensætning ifølge krav 1, hvorved parabenerne udvælges blandt methylparaben, ethylparaben, propylparaben, butylparaben, isobutylpara-ben, benzylparaben, salt eller blandinger af samme.
7. Farmaceutisk sammensætning ifølge et hvilket som helst af de foregående krav, hvorved præsentationsformen er dråber til oral indgivelse, hvilke dråber absorberes gennem mundslimhinden og/eller den sublinguale slimhinde.
8. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 7, hvorved præsentationsformen er sirup med henblik på oral gastrointestinal indgivelse eller sirup til oral indgivelse, og som absorberes gennem mund- og/eller sublingual slimhinde.
9. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 1 til 8 med henblik på sammensætningens anvendelse ved behandling af central diabetes insipidus, primær enuresis nocturna, blødninger hos patienter med hæmophili A, patienter med Willebrand-Jiirgens sygdom og postoperativ blødning.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES200702215A ES2319054B1 (es) | 2007-08-06 | 2007-08-06 | Composicion farmaceutica oral de desmopresina. |
| PCT/ES2008/000539 WO2009027561A2 (es) | 2007-08-06 | 2008-08-01 | Composición farmacéutica oral de desmopresina |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2174652T3 true DK2174652T3 (da) | 2017-01-23 |
Family
ID=40032884
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08805367.3T DK2174652T3 (da) | 2007-08-06 | 2008-08-01 | Oral, farmaceutisk desmopressin-sammensætning |
Country Status (18)
| Country | Link |
|---|---|
| US (1) | US8993521B2 (da) |
| EP (1) | EP2174652B1 (da) |
| JP (1) | JP5626682B2 (da) |
| CN (2) | CN101808621A (da) |
| AR (1) | AR068337A1 (da) |
| BR (1) | BRPI0814835B8 (da) |
| CY (1) | CY1118459T1 (da) |
| DK (1) | DK2174652T3 (da) |
| ES (2) | ES2319054B1 (da) |
| HR (1) | HRP20161676T1 (da) |
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| RU (1) | RU2474414C2 (da) |
| SI (1) | SI2174652T1 (da) |
| WO (1) | WO2009027561A2 (da) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JO3400B1 (ar) * | 2010-09-30 | 2019-10-20 | Ferring Bv | مركب صيدلاني من كاربيتوسين |
| WO2024211393A2 (en) | 2023-04-04 | 2024-10-10 | Tulex Pharmaceuticals Inc. | Desmopressin oral compositions |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE8306367L (sv) | 1983-11-18 | 1985-05-19 | Ferring Ab | Antidiuretiskt verkande farmaceutiskt preparat |
| DE69010518T2 (de) * | 1989-01-30 | 1994-11-03 | Corint Ltd | Wässerige Desmopressin-CMC enthaltende Arzneizubereitung. |
| JP2653255B2 (ja) * | 1990-02-13 | 1997-09-17 | 武田薬品工業株式会社 | 長期徐放型マイクロカプセル |
| AU653026B2 (en) | 1991-06-07 | 1994-09-15 | Teikoku Seiyaku Kabushiki Kaisha | Physiologically active polypeptide-containing pharmaceutical composition |
| US5298256A (en) | 1992-04-28 | 1994-03-29 | Corint, Ltd. | Desmopressin buccal patch composition |
| IT1255460B (it) | 1992-07-28 | 1995-11-02 | Poli Ind Chimica Spa | Composizioni farmaceutiche in forma di microemulsioni o di dispersioni liposomiali bioadesive per la somministrazione transmucosale di sostanze peptidiche e di proteine farmacologicamente attive |
| SE9300937L (sv) | 1993-03-19 | 1994-09-20 | Anne Fjellestad Paulsen | Komposition för oral administrering av peptider |
| US5482931A (en) * | 1993-06-29 | 1996-01-09 | Ferring Ab | Stabilized pharmaceutical peptide compositions |
| SE9400918L (sv) | 1994-03-18 | 1995-09-19 | Anne Fjellstad Paulsen | Stabiliserad komposition för oral administrering av peptider |
| US5763398A (en) * | 1996-06-20 | 1998-06-09 | Ferring B.V. | Nasal administration of desmopressin |
| US20030095926A1 (en) * | 1997-10-01 | 2003-05-22 | Dugger Harry A. | Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the gastrointestinal tract or urinary tract |
| AU766913B2 (en) * | 1998-11-02 | 2003-10-23 | Alza Corporation | Electrotransport device including a compatible antimicrobial agent |
| US6894026B1 (en) | 2000-01-11 | 2005-05-17 | Atossa Healthcare, Inc. | Long-acting oxytocin analogues for the treatment and prevention of breast cancer and psychiatric disorders |
| EP1121935B1 (en) * | 2000-02-04 | 2008-08-13 | Patents Exploitation Company B.V. | Pharmaceutical composition containing a small or medium size peptide |
| AT409081B (de) * | 2000-02-16 | 2002-05-27 | Gebro Pharma Gmbh | Stabile, nasal, oral oder sublingual anwendbare pharmazeutische zubereitung |
| GB0210397D0 (en) | 2002-05-07 | 2002-06-12 | Ferring Bv | Pharmaceutical formulations |
| WO2003097080A1 (en) * | 2002-05-15 | 2003-11-27 | Sun Pharmaceutical Industries Limited | A stable aqueous composition of a peptide |
| ITMI20021684A1 (it) | 2002-07-29 | 2004-01-29 | Therapicon Srl | Composizione farmaceutica di peptide nasale |
| EP1617823B1 (en) * | 2003-01-24 | 2019-01-09 | Nicachet AB | A pouch comprising a nicotine composition for transmucosal delivery |
| EP1473029B1 (en) | 2003-04-30 | 2005-03-23 | Ferring B.V. | Solid dosage form comprising desmopressin |
| ATE301990T1 (de) | 2003-07-25 | 2005-09-15 | Ferring Bv | Pharmazeutische desmopressin-zubereitung als feste darreichungsform und methode zu ihrer herstellung |
| EP2322195A2 (en) | 2003-11-10 | 2011-05-18 | Reprise Biopharmaceutics, LLC | Pharmaceutical compositions including low dosages of desmopressin |
| GB0406048D0 (en) | 2004-03-18 | 2004-04-21 | Ardana Bioscience Ltd | Drug formulations |
| US20050244502A1 (en) | 2004-04-28 | 2005-11-03 | Mathias Neil R | Composition for enhancing absorption of a drug and method |
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2007
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2008
- 2008-08-01 SI SI200831737A patent/SI2174652T1/sl unknown
- 2008-08-01 HU HUE08805367A patent/HUE032667T2/en unknown
- 2008-08-01 LT LTEP08805367.3T patent/LT2174652T/lt unknown
- 2008-08-01 BR BRPI0814835A patent/BRPI0814835B8/pt not_active IP Right Cessation
- 2008-08-01 ES ES08805367.3T patent/ES2608816T3/es active Active
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- 2008-08-01 RU RU2010105031/15A patent/RU2474414C2/ru active
- 2008-08-01 CN CN200880105631A patent/CN101808621A/zh active Pending
- 2008-08-01 HR HRP20161676TT patent/HRP20161676T1/hr unknown
- 2008-08-01 DK DK08805367.3T patent/DK2174652T3/da active
- 2008-08-01 US US12/672,255 patent/US8993521B2/en active Active
- 2008-08-01 PL PL08805367T patent/PL2174652T3/pl unknown
- 2008-08-01 JP JP2010519481A patent/JP5626682B2/ja not_active Expired - Fee Related
- 2008-08-01 WO PCT/ES2008/000539 patent/WO2009027561A2/es not_active Ceased
- 2008-08-01 CN CN201610700664.8A patent/CN106265494A/zh active Pending
- 2008-08-01 PT PT88053673T patent/PT2174652T/pt unknown
- 2008-08-01 EP EP08805367.3A patent/EP2174652B1/en active Active
- 2008-08-06 AR ARP080103430A patent/AR068337A1/es not_active Application Discontinuation
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2017
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Also Published As
| Publication number | Publication date |
|---|---|
| WO2009027561A3 (es) | 2009-07-16 |
| CN101808621A (zh) | 2010-08-18 |
| EP2174652A2 (en) | 2010-04-14 |
| BRPI0814835B1 (pt) | 2020-10-27 |
| US8993521B2 (en) | 2015-03-31 |
| SI2174652T1 (sl) | 2017-04-26 |
| BRPI0814835A2 (pt) | 2015-03-31 |
| ES2319054A1 (es) | 2009-05-01 |
| CY1118459T1 (el) | 2017-07-12 |
| PL2174652T3 (pl) | 2017-06-30 |
| EP2174652B1 (en) | 2016-10-05 |
| JP5626682B2 (ja) | 2014-11-19 |
| LT2174652T (lt) | 2017-02-27 |
| AR068337A1 (es) | 2009-11-11 |
| RU2474414C2 (ru) | 2013-02-10 |
| RU2010105031A (ru) | 2011-09-20 |
| MX2010001456A (es) | 2010-06-02 |
| ES2608816T3 (es) | 2017-04-17 |
| WO2009027561A2 (es) | 2009-03-05 |
| PT2174652T (pt) | 2016-12-23 |
| BRPI0814835B8 (pt) | 2021-05-25 |
| HRP20161676T1 (hr) | 2017-02-24 |
| HUE032667T2 (en) | 2017-10-30 |
| ES2319054B1 (es) | 2010-02-12 |
| JP2010535745A (ja) | 2010-11-25 |
| CN106265494A (zh) | 2017-01-04 |
| US20110251123A1 (en) | 2011-10-13 |
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