HRP20160988T1 - Farmaceutski sastavi s dvostrukim djelovanjem na temelju superstruktura od antagonista/blokatora receptora angiotenzina (arb) i neutralnih inhibitora endopeptidaze (nep) - Google Patents
Farmaceutski sastavi s dvostrukim djelovanjem na temelju superstruktura od antagonista/blokatora receptora angiotenzina (arb) i neutralnih inhibitora endopeptidaze (nep) Download PDFInfo
- Publication number
- HRP20160988T1 HRP20160988T1 HRP20160988TT HRP20160988T HRP20160988T1 HR P20160988 T1 HRP20160988 T1 HR P20160988T1 HR P20160988T T HRP20160988T T HR P20160988TT HR P20160988 T HRP20160988 T HR P20160988T HR P20160988 T1 HRP20160988 T1 HR P20160988T1
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- oral dosage
- solid oral
- biphenyl
- ylmethyl
- Prior art date
Links
- 102000003729 Neprilysin Human genes 0.000 title 1
- 108090000028 Neprilysin Proteins 0.000 title 1
- 229940127282 angiotensin receptor antagonist Drugs 0.000 title 1
- 229940125364 angiotensin receptor blocker Drugs 0.000 title 1
- 239000003112 inhibitor Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 239000000463 material Substances 0.000 claims 8
- 239000006186 oral dosage form Substances 0.000 claims 8
- 239000000203 mixture Substances 0.000 claims 7
- 239000007787 solid Substances 0.000 claims 7
- 238000002156 mixing Methods 0.000 claims 4
- 150000001875 compounds Chemical class 0.000 claims 3
- 239000003826 tablet Substances 0.000 claims 3
- FERIUCNNQQJTOY-UHFFFAOYSA-M Butyrate Chemical compound CCCC([O-])=O FERIUCNNQQJTOY-UHFFFAOYSA-M 0.000 claims 2
- FERIUCNNQQJTOY-UHFFFAOYSA-N Butyric acid Natural products CCCC(O)=O FERIUCNNQQJTOY-UHFFFAOYSA-N 0.000 claims 2
- 239000002253 acid Substances 0.000 claims 2
- 238000005056 compaction Methods 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 239000004072 C09CA03 - Valsartan Substances 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- 239000007941 film coated tablet Substances 0.000 claims 1
- 239000007888 film coating Substances 0.000 claims 1
- 238000009501 film coating Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 238000000227 grinding Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000003825 pressing Methods 0.000 claims 1
- PYNXFZCZUAOOQC-UTKZUKDTSA-N sacubitril Chemical compound C1=CC(C[C@H](C[C@@H](C)C(=O)OCC)NC(=O)CCC(O)=O)=CC=C1C1=CC=CC=C1 PYNXFZCZUAOOQC-UTKZUKDTSA-N 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 claims 1
- 229960004699 valsartan Drugs 0.000 claims 1
Classifications
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
- A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
-
- 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
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Emergency Medicine (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Hospice & Palliative Care (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (5)
1. Čvrsti oralni dozni oblik, naznačen time, da obuhvaća sljedeće:
spoj trinatrij-[3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil)-propionat-(S)-3'-metil-2'-(pentanoil{2''-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat]hemipentahidrata u koncentraciji od 4 % do 90 % po masi sastava; i
najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo,
pri čemu je spoj prisutan u doznoj jačini od 100, 200 ili 400 mg u odnosu prema odgovarajućoj kombiniranoj količini kiseline bez valsartana i (2R,4S)-5-bifenil-4-il-4-(3-karboksi-propionilamino)-2-metil-pentanska kiselina-etil-estera u omjeru 1:1 po jediničnom doznom obliku, te time, da čvrsti oralni dozni oblik je tableta sabijena pomoću valjaka.
2. Čvrsti oralni dozni oblik prema zahtjevu 1, naznačen time, da spomenuta tableta je formulacija s brzim oslobađanjem.
3. Postupak priprave čvrstog oralnog doznog oblika prema zahtjevu 1, naznačen time, da obuhvaća sljedeće korake:
miješanje trinatrij-[3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil)-propionat-(S)-3'-metil-2'-(pentanoil{2''-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat]hemipentahidrata s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom u svrhu tvorbe smjese;
sabijanje navedene smjese pomoću tlačenja valjcima;
opcijski miješanje s dodatnim farmaceutski prihvatljivim pomoćnim sredstvima; i
stlačivanje konačne smjese u čvrsti oralni dozni oblik.
4. Postupak proizvodnje čvrstog oralnog doznog oblika prema zahtjevu 1, naznačen time, da obuhvaća sljedeće korake:
prosijavanje spoja i farmaceutskih prihvatljivih pomoćnih sredstava za tvorbu prosijanog materijala;
miješanje prosijanog materijala za tvorbu pomiješanog materijala;
sabijanje pomiješanog materijala valjcima za tvorbu sabijenog materijala;
mljevenje sabijenog materijala za tvorbu mljevenog materijala;
opcijski miješanje mljevenog materijala s dodatnim farmaceutski prihvatljivim pomoćnim sredstvima za tvorbu konačne smjese;
stlačivanje konačne smjese za tvorbu tablete;
opcijski nanošenje film-obloge, kako bi se dobile filmom obložene tablete.
5. Čvrsti oralni dozni oblik prema zahtjevu 1, naznačen time, da oralni dozni oblik omogućava brzinu resorpcije kiseline bez valsartana, koja iznosi tmax od 1 do 2,2 sata nakon davanja jednostruke doze navedenog doznog oblika.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US98566807P | 2007-11-06 | 2007-11-06 | |
| EP10173506.6A EP2295035B1 (en) | 2007-11-06 | 2008-11-04 | Dual-acting pharmaceutical compositions based on superstructures of angiotensin receptor antagonist/blocker (arb) and neutral endopeptidase (nep) inhibitor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20160988T1 true HRP20160988T1 (hr) | 2016-10-07 |
Family
ID=40451030
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230178TT HRP20230178T3 (hr) | 2007-11-06 | 2008-11-04 | Farmaceutski pripravci temeljeni na nadgradnjama antagonista/blokatora angiotenzinskog receptora (arb) i inhibitoru neutralne endopeptidaze (nep) |
| HRP20150459TT HRP20150459T1 (hr) | 2007-11-06 | 2015-04-28 | Farmaceutski pripravci na bazi superstruktura antagonista/blokatora angiontenzinskih receptora (arb) i inhibitora neutralne endopeptidaze (nep) |
| HRP20160988TT HRP20160988T1 (hr) | 2007-11-06 | 2016-08-02 | Farmaceutski sastavi s dvostrukim djelovanjem na temelju superstruktura od antagonista/blokatora receptora angiotenzina (arb) i neutralnih inhibitora endopeptidaze (nep) |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20230178TT HRP20230178T3 (hr) | 2007-11-06 | 2008-11-04 | Farmaceutski pripravci temeljeni na nadgradnjama antagonista/blokatora angiotenzinskog receptora (arb) i inhibitoru neutralne endopeptidaze (nep) |
| HRP20150459TT HRP20150459T1 (hr) | 2007-11-06 | 2015-04-28 | Farmaceutski pripravci na bazi superstruktura antagonista/blokatora angiontenzinskih receptora (arb) i inhibitora neutralne endopeptidaze (nep) |
Country Status (34)
| Country | Link |
|---|---|
| US (3) | US20100267786A1 (hr) |
| EP (4) | EP2295035B1 (hr) |
| JP (2) | JP5653218B2 (hr) |
| KR (2) | KR101700062B1 (hr) |
| CN (2) | CN103251587A (hr) |
| AR (1) | AR069184A1 (hr) |
| AU (1) | AU2008324878B2 (hr) |
| BR (1) | BRPI0823505A2 (hr) |
| CA (1) | CA2703598C (hr) |
| CL (1) | CL2008003298A1 (hr) |
| CY (2) | CY1116280T1 (hr) |
| DK (3) | DK2217205T3 (hr) |
| EC (1) | ECSP10010160A (hr) |
| ES (3) | ES2536514T3 (hr) |
| FI (1) | FI3067043T3 (hr) |
| GT (1) | GT201000131A (hr) |
| HK (3) | HK1143529A1 (hr) |
| HR (3) | HRP20230178T3 (hr) |
| HU (2) | HUE028866T2 (hr) |
| IL (3) | IL262990B2 (hr) |
| JO (1) | JOP20080499B1 (hr) |
| MA (1) | MA31797B1 (hr) |
| MX (1) | MX2010004930A (hr) |
| MY (1) | MY153730A (hr) |
| NZ (1) | NZ584686A (hr) |
| PE (2) | PE20141072A1 (hr) |
| PL (3) | PL2295035T3 (hr) |
| PT (3) | PT2295035T (hr) |
| RU (1) | RU2493844C3 (hr) |
| SG (1) | SG185951A1 (hr) |
| SI (3) | SI3067043T1 (hr) |
| TN (1) | TN2010000200A1 (hr) |
| TW (1) | TWI484982B (hr) |
| WO (1) | WO2009061713A1 (hr) |
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|---|---|---|---|---|
| HRP20230178T3 (hr) | 2007-11-06 | 2023-03-31 | Novartis Ag | Farmaceutski pripravci temeljeni na nadgradnjama antagonista/blokatora angiotenzinskog receptora (arb) i inhibitoru neutralne endopeptidaze (nep) |
| EP2435402B1 (en) | 2009-05-28 | 2016-04-13 | Novartis AG | Substituted aminobutyric derivatives as neprilysin inhibitors |
| NZ596304A (en) | 2009-05-28 | 2014-01-31 | Novartis Ag | Substituted aminopropionic derivatives as neprilysin inhibitors |
| JO2967B1 (en) | 2009-11-20 | 2016-03-15 | نوفارتس ايه جي | Acetic acid derivatives of carbamoyl methyl amino are substituted as new NEP inhibitors |
| US20130158088A1 (en) | 2010-08-24 | 2013-06-20 | Novartis Ag | Treatment of hypertension and/or prevention or treatment of heart failure in a mammal receiving anti-coagulant therapy |
| US8673974B2 (en) | 2010-11-16 | 2014-03-18 | Novartis Ag | Substituted amino bisphenyl pentanoic acid derivatives as NEP inhibitors |
| KR20200111822A (ko) | 2012-08-24 | 2020-09-29 | 노파르티스 아게 | 심방 확장 또는 재형성을 특징으로 하는 질환을 치료하기 위한 nep 억제제 |
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| KR102545274B1 (ko) | 2020-02-26 | 2023-06-20 | 에리슨제약(주) | 사쿠비트릴 및 발사르탄을 포함하는 심부전 치료용 서방성 제제, 및 이를 포함하는 다중방출 복합제제와 이의 제조방법 |
| KR20210120560A (ko) | 2020-03-27 | 2021-10-07 | 주식회사 유영제약 | 고함량의 주성분을 포함하는 정제 및 그 제조방법 |
| KR20210138510A (ko) | 2020-05-12 | 2021-11-19 | 에리슨제약(주) | 사쿠비트릴, 발사르탄 및 네비보롤을 포함하는 심부전 및 허혈성 심질환의 예방 또는 치료용 약제학적 조성물 및 이를 포함하는 약제학적 복합제제 |
| KR20220091767A (ko) | 2020-12-24 | 2022-07-01 | 주식회사 보령 | 사쿠비트릴 발사르탄 하이브리드 화합물 또는 그 약제학적으로 허용되는 염을 유효성분으로 포함하는 약제학적 조성물 |
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