HRP20231200T1 - Kombinacija fiksne doze memantina i donepezila s trenutnim otpuštanjem - Google Patents
Kombinacija fiksne doze memantina i donepezila s trenutnim otpuštanjem Download PDFInfo
- Publication number
- HRP20231200T1 HRP20231200T1 HRP20231200TT HRP20231200T HRP20231200T1 HR P20231200 T1 HRP20231200 T1 HR P20231200T1 HR P20231200T T HRP20231200T T HR P20231200TT HR P20231200 T HRP20231200 T HR P20231200T HR P20231200 T1 HRP20231200 T1 HR P20231200T1
- Authority
- HR
- Croatia
- Prior art keywords
- preparation
- memantine
- pharmaceutically acceptable
- acceptable salt
- accordance
- Prior art date
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- ADEBPBSSDYVVLD-UHFFFAOYSA-N donepezil Chemical compound O=C1C=2C=C(OC)C(OC)=CC=2CC1CC(CC1)CCN1CC1=CC=CC=C1 ADEBPBSSDYVVLD-UHFFFAOYSA-N 0.000 title claims 10
- 229960004640 memantine Drugs 0.000 title claims 6
- 229960003530 donepezil Drugs 0.000 title claims 5
- 239000012729 immediate-release (IR) formulation Substances 0.000 title claims 2
- 229940000425 combination drug Drugs 0.000 title 1
- BUGYDGFZZOZRHP-UHFFFAOYSA-N memantine Chemical compound C1C(C2)CC3(C)CC1(C)CC2(N)C3 BUGYDGFZZOZRHP-UHFFFAOYSA-N 0.000 title 1
- 238000002360 preparation method Methods 0.000 claims 14
- 150000003839 salts Chemical class 0.000 claims 8
- LDDHMLJTFXJGPI-UHFFFAOYSA-N memantine hydrochloride Chemical compound Cl.C1C(C2)CC3(C)CC1(C)CC2(N)C3 LDDHMLJTFXJGPI-UHFFFAOYSA-N 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 6
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims 4
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 4
- 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 3
- 229930195725 Mannitol Natural products 0.000 claims 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 3
- 239000011230 binding agent Substances 0.000 claims 3
- 239000003085 diluting agent Substances 0.000 claims 3
- 239000008187 granular material Substances 0.000 claims 3
- 239000000314 lubricant Substances 0.000 claims 3
- 239000000594 mannitol Substances 0.000 claims 3
- 235000010355 mannitol Nutrition 0.000 claims 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 235000000346 sugar Nutrition 0.000 claims 3
- 150000008163 sugars Chemical class 0.000 claims 3
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 claims 2
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 229920002785 Croscarmellose sodium Polymers 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims 2
- 229920002472 Starch Polymers 0.000 claims 2
- VJHCJDRQFCCTHL-UHFFFAOYSA-N acetic acid 2,3,4,5,6-pentahydroxyhexanal Chemical compound CC(O)=O.OCC(O)C(O)C(O)C(O)C=O VJHCJDRQFCCTHL-UHFFFAOYSA-N 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 239000007884 disintegrant Substances 0.000 claims 2
- 229960003135 donepezil hydrochloride Drugs 0.000 claims 2
- XWAIAVWHZJNZQQ-UHFFFAOYSA-N donepezil hydrochloride Chemical compound [H+].[Cl-].O=C1C=2C=C(OC)C(OC)=CC=2CC1CC(CC1)CCN1CC1=CC=CC=C1 XWAIAVWHZJNZQQ-UHFFFAOYSA-N 0.000 claims 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 2
- 229960000967 memantine hydrochloride Drugs 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 2
- 239000008107 starch Substances 0.000 claims 2
- 235000019698 starch Nutrition 0.000 claims 2
- 229940032147 starch Drugs 0.000 claims 2
- 238000005550 wet granulation Methods 0.000 claims 2
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 claims 1
- IXPNQXFRVYWDDI-UHFFFAOYSA-N 1-methyl-2,4-dioxo-1,3-diazinane-5-carboximidamide Chemical compound CN1CC(C(N)=N)C(=O)NC1=O IXPNQXFRVYWDDI-UHFFFAOYSA-N 0.000 claims 1
- 208000024827 Alzheimer disease Diseases 0.000 claims 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims 1
- 239000004375 Dextrin Substances 0.000 claims 1
- 229920001353 Dextrin Polymers 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims 1
- 229920002774 Maltodextrin Polymers 0.000 claims 1
- 239000005913 Maltodextrin Substances 0.000 claims 1
- 229920000881 Modified starch Polymers 0.000 claims 1
- 239000002202 Polyethylene glycol Substances 0.000 claims 1
- 235000021355 Stearic acid Nutrition 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- RVNPCPLQENGXEO-UHFFFAOYSA-N [Na].CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO Chemical compound [Na].CCCCCCCCCCCCCCCCCCCCCC(=O)OCC(O)CO RVNPCPLQENGXEO-UHFFFAOYSA-N 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- CJZGTCYPCWQAJB-UHFFFAOYSA-L calcium stearate Chemical compound [Ca+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CJZGTCYPCWQAJB-UHFFFAOYSA-L 0.000 claims 1
- 239000008116 calcium stearate Substances 0.000 claims 1
- 235000013539 calcium stearate Nutrition 0.000 claims 1
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 1
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 1
- 229950008138 carmellose Drugs 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 229920001531 copovidone Polymers 0.000 claims 1
- 229960005168 croscarmellose Drugs 0.000 claims 1
- 229960000913 crospovidone Drugs 0.000 claims 1
- 239000001767 crosslinked sodium carboxy methyl cellulose Substances 0.000 claims 1
- 235000019425 dextrin Nutrition 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 239000008240 homogeneous mixture Substances 0.000 claims 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims 1
- 239000000905 isomalt Substances 0.000 claims 1
- 235000010439 isomalt Nutrition 0.000 claims 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 claims 1
- 239000000832 lactitol Substances 0.000 claims 1
- 235000010448 lactitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 1
- 229960003451 lactitol Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 235000019359 magnesium stearate Nutrition 0.000 claims 1
- 229940035034 maltodextrin Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims 1
- 239000008194 pharmaceutical composition Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 229920001223 polyethylene glycol Polymers 0.000 claims 1
- 229920000193 polymethacrylate Polymers 0.000 claims 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims 1
- 229940069328 povidone Drugs 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 235000010413 sodium alginate Nutrition 0.000 claims 1
- 239000000661 sodium alginate Substances 0.000 claims 1
- 229940005550 sodium alginate Drugs 0.000 claims 1
- RYYKJJJTJZKILX-UHFFFAOYSA-M sodium octadecanoate Chemical compound [Na+].CCCCCCCCCCCCCCCCCC([O-])=O RYYKJJJTJZKILX-UHFFFAOYSA-M 0.000 claims 1
- 229920003109 sodium starch glycolate Polymers 0.000 claims 1
- 239000008109 sodium starch glycolate Substances 0.000 claims 1
- 229940079832 sodium starch glycolate Drugs 0.000 claims 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims 1
- 239000000600 sorbitol Substances 0.000 claims 1
- 229960002920 sorbitol Drugs 0.000 claims 1
- 235000010356 sorbitol Nutrition 0.000 claims 1
- 239000008117 stearic acid Substances 0.000 claims 1
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- 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
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- 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
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (11)
1. Farmaceutski pripravak oralne fiksne doze s trenutnim otpuštanjem, za uporabu u liječenju ili terapiji umjerene do teške Alzheimerove bolesti, naznačeno time, da pripravak uključuje:
od 4,16 mg do 20 mg memantina ili farmaceutski prihvatljive soli; i
od 4,56 mg do 10 mg donepezila ili farmaceutski prihvatljive soli;
pri čemu su memantin ili farmaceutski prihvatljiva sol i donepezil ili farmaceutski prihvatljiva sol jedine djelatne tvari;
45,0 tež. % do 60,0 tež. % manitola;
pri čemu je farmaceutski pripravak bez laktoze;
i manje od 1,0 tež.% reducirajućih šećera u odnosu na ukupnu težinu pripravka.
2. Pripravak za uporabu u skladu s prethodnim patentnim zahtjevom, naznačeno time, da sadrži od 45,0 tež. % do 55,0 tež. % manitola.
3. Pripravak za uporabu u skladu s prethodnim patentnim zahtjevima, naznačeno time, što sadrži manje od 0,6 tež.% reducirajućih šećera u odnosu na ukupnu težinu pripravka, poželjno manje od 0,4 tež.%.
4. Pripravak za uporabu u skladu s prethodnim patentnim zahtjevima, naznačeno time, da sadrži manje od 0,3 tež.% reducirajućih šećera.
5. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je farmaceutski prihvatljiva sol za memantin memantin hidroklorid, poželjno u količinama od 5 mg do 20 mg po dozi.
6. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da je farmaceutski prihvatljiva sol za donepezil donepezil hidroklorid, poželjno u količinama od 5 mg do 10 mg po dozi.
7. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da sadrži manje od 2,5 tež. % memantin-laktoznog adukta (MLA) u odnosu na težinu memantina, poželjno manje od 1,4 tež. %, poželjnije manje od 1,0 tež. %.
8. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da nadalje sadrži:
jedan ili više dezintegratora;
jedno ili više veziva;
jedan ili više razrjeđivača;
jedno ili više lubrikanata;
po izboru jedan ili više sredstava za klizanje;
druge farmaceutski prihvatljive pomoćne tvari.
9. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time da pripravak sadrži
jedan ili više dezintegratora odabranih s popisa koji se sastoji od: škroba, karboksimetil celuloze (karmeloze), umrežene karboksimetil celuloze (kroskarmeloze), natrijevog škrobnog glikolata, nisko supstituirane hidroksipropil celuloze (L-HPC), karboksimetil škroba, polivinilpirolidona, krospovidona, i njihove smjese;
jedno ili više veziva odabranih s popisa koji se sastoji od: hidroksipropil celuloze (HPC), nisko supstituirane hidroksipropil celuloze (L-HPC), hidroksipropil metilceluloze (HPMC), metil celuloze, hidroksietil celuloze, etil celuloze, polietilen-glikol maltodekstrina, preželatiniziranog škroba, polimetakrilata, natrijevog alginata, polivinilpirolidona (povidona), vinilpirolidona/vinilacetat kopolimera (kopovidona) i njihove mješavine;
jedan ili više razrjeđivača odabranih s popisa koji se sastoji od: mikrokristalne celuloze (MCC), silicificirane mikrokristalne celuloze (SMCC), sorbitola, laktitola, ksilitola, izomalta, dekstrina i njihovih smjesa; poželjno mikrokristalne celuloze;
jedan ili više lubrikanata odabranih s liste koja se sastoji od: magnezijevog stearata, kalcijevog stearata, natrijevog stearata, stearinske kiseline, natrijevog gliceril behenata, natrijevog stearil fumarata i njihovih mješavina.
10. Pripravak za uporabu u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačeno time, da se pripravak može dobiti mokrom granulacijom.
11. Postupak za proizvodnju farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačeno time, što obuhvaća korake:
pripremanje homogene smjese koja sadrži
Donepezil ili farmaceutski prihvatljivu sol, posebno donepezil hidroklorid, memantin ili farmaceutski prihvatljivu sol, posebno memantin hidroklorid, 45,0 tež. % do 60,0 tež. % manitola;
jedan ili više dezintegranata, jedan ili više veziva i jedan ili više razrjeđivača;
dobivanje granula mokrom granulacijom; sušenje mokrih granula i prosijavanje; miješanje granula s jednim ili više lubrikanata; komprimiranje konačne smjese u tabletu; izborno oblaganje tablete filmom.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PT11555719 | 2019-05-31 | ||
| PCT/IB2020/055137 WO2020240505A1 (en) | 2019-05-31 | 2020-05-29 | Immediate release fixed-dose combination of memantine and donepezil |
| EP20732664.6A EP3843702B1 (en) | 2019-05-31 | 2020-05-29 | Immediate release fixed-dose combination of memantine and donepezil |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20231200T1 true HRP20231200T1 (hr) | 2024-01-19 |
Family
ID=71092565
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20231200TT HRP20231200T1 (hr) | 2019-05-31 | 2020-05-29 | Kombinacija fiksne doze memantina i donepezila s trenutnim otpuštanjem |
Country Status (15)
| Country | Link |
|---|---|
| EP (2) | EP4238555A3 (hr) |
| BR (1) | BR112021024054A2 (hr) |
| CL (1) | CL2021002911A1 (hr) |
| CO (1) | CO2021014967A2 (hr) |
| DK (1) | DK3843702T3 (hr) |
| FI (1) | FI3843702T3 (hr) |
| HR (1) | HRP20231200T1 (hr) |
| IL (1) | IL288505A (hr) |
| MX (1) | MX2021014673A (hr) |
| PE (1) | PE20220936A1 (hr) |
| PT (1) | PT3843702T (hr) |
| SA (1) | SA521430969B1 (hr) |
| SI (1) | SI3843702T1 (hr) |
| WO (1) | WO2020240505A1 (hr) |
| ZA (2) | ZA202110478B (hr) |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI95572C (fi) | 1987-06-22 | 1996-02-26 | Eisai Co Ltd | Menetelmä lääkeaineena käyttökelpoisen piperidiinijohdannaisten tai sen farmaseuttisen suolan valmistamiseksi |
| ES2059602T3 (es) | 1989-04-14 | 1994-11-16 | Merz & Co Gmbh & Co | Uso de derivados de adamantano para la prevencion y tratamiento de isquemia cerebral. |
| WO1997046526A1 (en) | 1996-06-07 | 1997-12-11 | Eisai Co., Ltd. | Stable polymorphs of donepezil (1-benzyl-4-[(5,6-dimethoxy-1-indanon)-2-yl]methylpiperidine) hydrochloride and process for production |
| SI1509232T1 (sl) | 2002-05-31 | 2009-04-30 | Lundbeck & Co As H | Kombinacija antagonista nmda in zaviralcev acetilholinesteraze za zdravljenje alzheimerjeve bolezni |
| US20040087658A1 (en) | 2002-10-24 | 2004-05-06 | Hans-Joerg Moebius | Combination therapy using 1-aminocyclohexane derivatives and acetylcholinesterase inhibitors |
| AU2005328701B2 (en) | 2004-06-17 | 2009-08-13 | Merz Pharma Gmbh & Co. Kgaa | Drinkable immediate release tablet made with direct compression of memantine or neramexane |
| MX2007007302A (es) | 2005-01-11 | 2008-02-11 | Teva Pharm Fine Chemicals Srl | Proceso para la preparacion de clorhidrato de 1-amino-3,5-dimetiladamantano. |
| KR101406456B1 (ko) | 2005-04-06 | 2014-06-20 | 아다마스 파마슈티칼스, 인코포레이티드 | Ｃｎｓ 장애의 치료를 위한 방법 및 조성물 |
| RU2445092C2 (ru) | 2005-04-28 | 2012-03-20 | Эйсай Ар Энд Ди Менеджмент Ко., Лтд. | Композиция, содержащая средство против деменции |
| DE102005060377A1 (de) | 2005-12-16 | 2007-06-21 | Ratiopharm Gmbh | Pharmazeutische Zusammensetzung enthaltend Donepezilhydrochlorid, Tablette hieraus und Verfahren zu deren Herstellung |
| WO2018062941A1 (ko) * | 2016-09-30 | 2018-04-05 | 주식회사 바이오파마티스 | 도네페질 또는 그의 약학적으로 허용 가능한 염 및 메만틴 또는 그의 약학적으로 허용 가능한 염을 함유하는 치매 및 인지기능 장애 예방 또는 치료용 약학 조성물 및 이의 제조방법 |
-
2020
- 2020-05-29 SI SI202030282T patent/SI3843702T1/sl unknown
- 2020-05-29 MX MX2021014673A patent/MX2021014673A/es unknown
- 2020-05-29 EP EP23177087.6A patent/EP4238555A3/en active Pending
- 2020-05-29 FI FIEP20732664.6T patent/FI3843702T3/fi active
- 2020-05-29 PE PE2021001939A patent/PE20220936A1/es unknown
- 2020-05-29 WO PCT/IB2020/055137 patent/WO2020240505A1/en active Application Filing
- 2020-05-29 HR HRP20231200TT patent/HRP20231200T1/hr unknown
- 2020-05-29 PT PT207326646T patent/PT3843702T/pt unknown
- 2020-05-29 EP EP20732664.6A patent/EP3843702B1/en active Active
- 2020-05-29 DK DK20732664.6T patent/DK3843702T3/da active
- 2020-05-29 BR BR112021024054A patent/BR112021024054A2/pt unknown
-
2021
- 2021-11-04 CL CL2021002911A patent/CL2021002911A1/es unknown
- 2021-11-05 CO CONC2021/0014967A patent/CO2021014967A2/es unknown
- 2021-11-29 SA SA521430969A patent/SA521430969B1/ar unknown
- 2021-11-29 IL IL288505A patent/IL288505A/en unknown
- 2021-12-15 ZA ZA2021/10478A patent/ZA202110478B/en unknown
-
2023
- 2023-12-18 ZA ZA2023/11560A patent/ZA202311560B/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| EP3843702B1 (en) | 2023-07-05 |
| SI3843702T1 (sl) | 2023-12-29 |
| CL2021002911A1 (es) | 2022-07-15 |
| BR112021024054A2 (pt) | 2022-01-11 |
| EP4238555A3 (en) | 2023-09-20 |
| IL288505A (en) | 2022-01-01 |
| EP3843702A1 (en) | 2021-07-07 |
| PT3843702T (pt) | 2023-10-13 |
| EP4238555A2 (en) | 2023-09-06 |
| WO2020240505A1 (en) | 2020-12-03 |
| FI3843702T3 (fi) | 2023-10-09 |
| PE20220936A1 (es) | 2022-05-31 |
| MX2021014673A (es) | 2022-01-11 |
| ZA202311560B (en) | 2024-07-31 |
| SA521430969B1 (ar) | 2023-12-05 |
| ZA202110478B (en) | 2024-08-28 |
| DK3843702T3 (da) | 2023-10-09 |
| CO2021014967A2 (es) | 2021-11-19 |
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