HRP20210034T1 - Farmaceutski pripravci koji sadrže meloksikam i rizatriptan - Google Patents
Farmaceutski pripravci koji sadrže meloksikam i rizatriptan Download PDFInfo
- Publication number
- HRP20210034T1 HRP20210034T1 HRP20210034TT HRP20210034T HRP20210034T1 HR P20210034 T1 HRP20210034 T1 HR P20210034T1 HR P20210034T T HRP20210034T T HR P20210034TT HR P20210034 T HRP20210034 T HR P20210034T HR P20210034 T1 HRP20210034 T1 HR P20210034T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- solid dosage
- meloxicam
- sbeβcd
- rizatriptan
- Prior art date
Links
- ZRVUJXDFFKFLMG-UHFFFAOYSA-N Meloxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=NC=C(C)S1 ZRVUJXDFFKFLMG-UHFFFAOYSA-N 0.000 title claims 11
- 229960001929 meloxicam Drugs 0.000 title claims 11
- TXHZXHICDBAVJW-UHFFFAOYSA-N rizatriptan Chemical compound C=1[C]2C(CCN(C)C)=CN=C2C=CC=1CN1C=NC=N1 TXHZXHICDBAVJW-UHFFFAOYSA-N 0.000 title claims 4
- 229960000425 rizatriptan Drugs 0.000 title claims 4
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000007909 solid dosage form Substances 0.000 claims 16
- 239000002552 dosage form Substances 0.000 claims 5
- 239000006186 oral dosage form Substances 0.000 claims 5
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims 3
- 241000282412 Homo Species 0.000 claims 3
- 208000002193 Pain Diseases 0.000 claims 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims 2
- ZISSAWUMDACLOM-UHFFFAOYSA-N triptane Chemical compound CC(C)C(C)(C)C ZISSAWUMDACLOM-UHFFFAOYSA-N 0.000 claims 2
- PVPBHKCSQBLDEW-ZQOBQRRWSA-N (1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31S,33R,35R,36R,37R,38R,39R,40R,41R,42R,43R,44R,45R,46R,47R,48R,49R)-5,10,15,20,25,30,35-heptakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.23,6.28,11.213,16.218,21.223,26.228,31]nonatetracontane-36,37,38,39,40,41,42,43,44,45,46,47,48,49-tetradecol 4-hydroxybutane-1-sulfonic acid Chemical compound OCCCCS(O)(=O)=O.OC[C@H]1O[C@@H]2O[C@@H]3[C@@H](CO)O[C@H](O[C@@H]4[C@@H](CO)O[C@H](O[C@@H]5[C@@H](CO)O[C@H](O[C@@H]6[C@@H](CO)O[C@H](O[C@@H]7[C@@H](CO)O[C@H](O[C@@H]8[C@@H](CO)O[C@H](O[C@H]1[C@H](O)[C@H]2O)[C@H](O)[C@H]8O)[C@H](O)[C@H]7O)[C@H](O)[C@H]6O)[C@H](O)[C@H]5O)[C@H](O)[C@H]4O)[C@H](O)[C@H]3O PVPBHKCSQBLDEW-ZQOBQRRWSA-N 0.000 claims 1
- NZAQRZWBQUIBSF-UHFFFAOYSA-N 4-(4-sulfobutoxy)butane-1-sulfonic acid Chemical group OS(=O)(=O)CCCCOCCCCS(O)(=O)=O NZAQRZWBQUIBSF-UHFFFAOYSA-N 0.000 claims 1
- 229920000858 Cyclodextrin Polymers 0.000 claims 1
- 239000001116 FEMA 4028 Substances 0.000 claims 1
- 206010065390 Inflammatory pain Diseases 0.000 claims 1
- 208000019695 Migraine disease Diseases 0.000 claims 1
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims 1
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 1
- 235000011175 beta-cyclodextrine Nutrition 0.000 claims 1
- 229960004853 betadex Drugs 0.000 claims 1
- 206010027599 migraine Diseases 0.000 claims 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims 1
- 235000017557 sodium bicarbonate Nutrition 0.000 claims 1
Classifications
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- 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
- A61K47/69—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
-
- 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
- A61P25/06—Antimigraine agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Rheumatology (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Claims (15)
1. Čvrsti oblik doziranja koji sadrži:
inkluzijski kompleks od 5 mg do 50 mg meloksikama i 50 mg do 200 mg sulfobutil etera β-ciklodekstrina (SBEβCD);
400 mg do 1000 mg bikarbonata; i
5 mg do 50 mg rizatriptana;
pri čemu je čvrsti oblik doziranja oralni oblik doziranja koji ima srednju vrijednost Tmax meloksikama kraću od 3 sata, što je kraće od referentnog oblika doziranja koji: 1) sadrži istu količinu meloksikama, 2) ne sadrži rizatriptan, 3) ne sadrži SBEβCD i 4) ne sadrži bikarbonat, kada se daje čovjeku.
2. Čvrsti oblik doziranja prema zahtjevu 1, koji sadrži inkluzijski kompleks 1) meloksikama ili triptana i 2) SBEβCD.
3. Čvrsti oblik doziranja prema zahtjevu 1 ili 2, sadrži 10 mg do 20 mg meloksikama.
4. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što SBEβCD ima 6 ili 7 sulfobutil eterskih skupina za svaku molekulu β-ciklodekstrina.
5. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što sadrži 80 mg do 120 mg SBEβCD.
6. Čvrsti oblik doziranja prema bilo kojem prethodnom zahtjevu, naznačen time što oblik doziranja sadrži 100 mg SBEβCD.
7. Čvrsti oblik doziranja prema patentnom zahtjevu 6, sadrži 8 mg do 13 mg rizatriptana.
8. Čvrsti oblik doziranja prema patentnom zahtjevu 6, naznačen time što bikarbonat sadrži natrij bikarbonat, a u obliku doziranja je od 400 mg do 600 mg natrij bikarbonata.
9. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što se pokazalo da oralni oblik doziranja ima srednju vrijednost Tmax meloksikama koja je manja od 2 sata kod čovjeka.
10. Čvrsti oblik doziranja prema bilo kojem od prethodnih zahtjeva, naznačen time što oralni oblik doziranja ima povećanu bioraspoloživost meloksikama u usporedbi s referentnim oblikom doziranja kada se daje čovjeku, i pri čemu se pokazalo da oralni oblik doziranja ima srednju Cmax meloksikama od 1600-2500 ng / ml.
11. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što se pokazalo da oralni oblik doziranja ima prosječni Tmax meloksikam od oko 1 sata, koji je kraći od referentnog oblika doziranja kada se daje čovjeku.
12. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što meloksikam i SBEβCD imaju molarni odnos od 0.8 do 1.2.
13. Čvrsti oblik doziranja iz bilo kojeg prethodnog zahtjeva, naznačen time što se koristi u liječenju boli kod čovjeka kojem je to potrebno.
14. Čvrsti oblik doziranja za uporabu prema zahtjevu 13, naznačen time što je bol migrena.
15. Čvrsti oblik doziranja za uporabu prema zahtjevu 13, naznačen time što je bol upalna bol.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762442136P | 2017-01-04 | 2017-01-04 | |
US201762504105P | 2017-05-10 | 2017-05-10 | |
US201762536466P | 2017-07-25 | 2017-07-25 | |
EP18736278.5A EP3565550B1 (en) | 2017-01-04 | 2018-01-04 | Pharmaceutical compositions comprising meloxicam and rizatriptan |
PCT/US2018/012433 WO2018129220A1 (en) | 2017-01-04 | 2018-01-04 | Pharmaceutical compositions comprising meloxicam |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20210034T1 true HRP20210034T1 (hr) | 2021-04-02 |
Family
ID=62791365
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20210034TT HRP20210034T1 (hr) | 2017-01-04 | 2021-01-08 | Farmaceutski pripravci koji sadrže meloksikam i rizatriptan |
Country Status (20)
Country | Link |
---|---|
US (4) | US10137131B2 (hr) |
EP (2) | EP3565550B1 (hr) |
JP (3) | JP6870867B2 (hr) |
KR (4) | KR20240013848A (hr) |
CN (1) | CN110621314A (hr) |
AU (3) | AU2018205790B2 (hr) |
CA (2) | CA3049229C (hr) |
CO (1) | CO2019008364A2 (hr) |
CY (1) | CY1123820T1 (hr) |
DK (1) | DK3565550T3 (hr) |
ES (1) | ES2845566T3 (hr) |
HR (1) | HRP20210034T1 (hr) |
HU (1) | HUE052749T2 (hr) |
LT (1) | LT3565550T (hr) |
MX (2) | MX2019008127A (hr) |
PL (1) | PL3565550T3 (hr) |
PT (1) | PT3565550T (hr) |
RS (1) | RS61346B1 (hr) |
SI (1) | SI3565550T1 (hr) |
WO (1) | WO2018129220A1 (hr) |
Families Citing this family (68)
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US10512692B2 (en) | 2015-02-10 | 2019-12-24 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
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US10821181B2 (en) | 2015-02-10 | 2020-11-03 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US11607456B2 (en) | 2015-02-10 | 2023-03-21 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
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US11602563B2 (en) | 2015-02-10 | 2023-03-14 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US10933137B2 (en) | 2015-02-10 | 2021-03-02 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US11013806B2 (en) | 2015-02-10 | 2021-05-25 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US11045549B2 (en) | 2015-02-10 | 2021-06-29 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US10537642B1 (en) | 2015-02-10 | 2020-01-21 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US10780165B2 (en) | 2015-02-10 | 2020-09-22 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
US10653777B2 (en) | 2015-02-10 | 2020-05-19 | Axsome Therapeutics, Inc. | Pharmaceutical compositions comprising meloxicam |
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CN110621314A (zh) | 2017-01-04 | 2019-12-27 | 艾克萨姆治疗公司 | 包含美洛昔康的药物组合物 |
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