HRP20220271T1 - Čvrsti oralni pripravci sa sporim otpuštanjem - Google Patents
Čvrsti oralni pripravci sa sporim otpuštanjem Download PDFInfo
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- HRP20220271T1 HRP20220271T1 HRP20220271TT HRP20220271T HRP20220271T1 HR P20220271 T1 HRP20220271 T1 HR P20220271T1 HR P20220271T T HRP20220271T T HR P20220271TT HR P20220271 T HRP20220271 T HR P20220271T HR P20220271 T1 HRP20220271 T1 HR P20220271T1
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- 239000007787 solid Substances 0.000 title claims 7
- 239000000203 mixture Substances 0.000 title claims 4
- 238000002360 preparation method Methods 0.000 claims 19
- 150000003839 salts Chemical class 0.000 claims 13
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims 12
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims 8
- 229920001800 Shellac Polymers 0.000 claims 7
- 239000011248 coating agent Substances 0.000 claims 7
- 238000000576 coating method Methods 0.000 claims 7
- 229940113147 shellac Drugs 0.000 claims 7
- 235000013874 shellac Nutrition 0.000 claims 7
- 239000004208 shellac Substances 0.000 claims 7
- 235000019359 magnesium stearate Nutrition 0.000 claims 6
- 229940014144 folate Drugs 0.000 claims 5
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 claims 5
- 235000019152 folic acid Nutrition 0.000 claims 5
- 239000011724 folic acid Substances 0.000 claims 5
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 claims 5
- 239000000546 pharmaceutical excipient Substances 0.000 claims 5
- 238000000034 method Methods 0.000 claims 4
- ZNOVTXRBGFNYRX-STQMWFEESA-N (6S)-5-methyltetrahydrofolic acid Chemical group C([C@@H]1N(C=2C(=O)N=C(N)NC=2NC1)C)NC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 ZNOVTXRBGFNYRX-STQMWFEESA-N 0.000 claims 3
- 239000002417 nutraceutical Substances 0.000 claims 3
- 235000021436 nutraceutical agent Nutrition 0.000 claims 3
- 239000007864 aqueous solution Substances 0.000 claims 2
- 125000000637 arginyl group Chemical class N[C@@H](CCCNC(N)=N)C(=O)* 0.000 claims 2
- 239000012752 auxiliary agent Substances 0.000 claims 2
- 239000007888 film coating Substances 0.000 claims 2
- 238000009501 film coating Methods 0.000 claims 2
- 239000000825 pharmaceutical preparation Substances 0.000 claims 2
- 239000000243 solution Substances 0.000 claims 2
- VHPOFDUCFKOUHV-XKGORWRGSA-N (2s)-2-amino-4-[[(2s,3s,4r,5r)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl-methylsulfonio]butanoate;4-methylbenzenesulfonic acid Chemical compound CC1=CC=C(S([O-])(=O)=O)C=C1.O[C@@H]1[C@H](O)[C@@H](C[S+](CC[C@H](N)C(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1 VHPOFDUCFKOUHV-XKGORWRGSA-N 0.000 claims 1
- XDCFCHNAIMYBAZ-XQVUROGGSA-N (2s)-2-amino-4-[[(2s,3s,4r,5r)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl-methylsulfonio]butanoate;4-methylbenzenesulfonic acid;sulfuric acid Chemical group OS(O)(=O)=O.OS([O-])(=O)=O.CC1=CC=C(S(O)(=O)=O)C=C1.O[C@@H]1[C@H](O)[C@@H](C[S+](CC[C@H](N)C(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1 XDCFCHNAIMYBAZ-XQVUROGGSA-N 0.000 claims 1
- RTQLMSZMCBAZIX-UHFFFAOYSA-N 4-methylbenzenesulfonic acid;sulfuric acid Chemical compound OS(O)(=O)=O.CC1=CC=C(S(O)(=O)=O)C=C1 RTQLMSZMCBAZIX-UHFFFAOYSA-N 0.000 claims 1
- TVEIQLLFQONHOA-FFSFXTILSA-N [(3S)-3-amino-3-carboxypropyl]-[[(2S,3S,4R,5R)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl]-methylsulfanium sulfate Chemical compound S(=O)(=O)([O-])[O-].N[C@@H](CC[S+](C[C@@H]1[C@H]([C@H]([C@H](N2C=NC3=C2N=CN=C3N)O1)O)O)C)C(O)=O.N[C@@H](CC[S+](C[C@@H]1[C@H]([C@H]([C@H](N3C=NC2=C3N=CN=C2N)O1)O)O)C)C(O)=O TVEIQLLFQONHOA-FFSFXTILSA-N 0.000 claims 1
- NWVICASORGOGDW-FFSFXTILSA-N [(3s)-3-amino-3-carboxypropyl]-[[(2s,3s,4r,5r)-5-(6-aminopurin-9-yl)-3,4-dihydroxyoxolan-2-yl]methyl]-methylsulfanium;butane-1,4-disulfonate Chemical compound [O-]S(=O)(=O)CCCCS([O-])(=O)=O.O[C@@H]1[C@H](O)[C@@H](C[S+](CC[C@H](N)C(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1.O[C@@H]1[C@H](O)[C@@H](C[S+](CC[C@H](N)C(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1 NWVICASORGOGDW-FFSFXTILSA-N 0.000 claims 1
- 230000001476 alcoholic effect Effects 0.000 claims 1
- 150000003863 ammonium salts Chemical class 0.000 claims 1
- 239000008346 aqueous phase Substances 0.000 claims 1
- 150000001638 boron Chemical class 0.000 claims 1
- 238000007906 compression Methods 0.000 claims 1
- 230000006835 compression Effects 0.000 claims 1
- LEUIUWYZAHKPSE-UHFFFAOYSA-L disodium;butane-1,4-disulfonate Chemical compound [Na+].[Na+].[O-]S(=O)(=O)CCCCS([O-])(=O)=O LEUIUWYZAHKPSE-UHFFFAOYSA-L 0.000 claims 1
- 150000002301 glucosamine derivatives Chemical class 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims 1
- 210000002784 stomach Anatomy 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- A—HUMAN NECESSITIES
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- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
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- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
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- A61K31/7076—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines containing purines, e.g. adenosine, adenylic acid
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- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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Claims (13)
1. Čvrsti oralni nutraceutski i/ili farmaceutski pripravak sa sporim otpuštanjem, koji se sastoji od:
a) jezgre koja sadrži donor metilnih skupina, naznačen time što se navedeni donor metilnih skupina bira između SAMe, ili njegove farmaceutski prihvatljive soli, folata, reduciranog folata ili njihove smjese, i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo, te
b) vanjske obloge koja sadrži šelak, i/ili njegovu farmaceutski prihvatljivu sol, magnezijev stearat i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo, naznačen time što je šelak, i/ili njegova farmaceutski prihvatljiva sol, prisutan u pripravku u količini rasponu između 0.5% i 10%, težinski na osnovi ukupne težine pripravka, te naznačen time što je magnezijev stearat prisutan u vanjskoj oblozi u količini rasponu između 10% i 20%, težinski na osnovi vanjske obloge;
i naznačen time što je navedeni čvrsti oralni oblik tableta.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što se sastoji od:
a) jezgre koja sadrži donor metilnih skupina i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo, te
b) vanjske obloge koja sadrži šelak, i/ili njegovu farmaceutski prihvatljivu sol, magnezijev stearat i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo.
3. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što je navedena vanjska obloga želučanootporna obloga.
4. Pripravak u skladu s patentnim zahtjevom 3, naznačen time što se navedenu SAMe-ovu farmaceutski prihvatljivu sol bira između S-adenozilmetionin-sulfat-p-toluensulfonata, S-adenozilmetionin-1,4-butanedisulfonata, S-adenozilmetionin-sulfata, S-adenozilmetionin-tosilata i S-adenozilmetionin-fitata, a po mogućnosti je sulfat-p-toluensulfonat ili 1,4-butanedisulfonat.
5. Pripravak u skladu s patentnim zahtjevom 3, naznačen time što se navedeni reducirani folat bira između (6S)-5-metiltetrahidrofolne kiseline, ili njezine farmaceutski prihvatljive soli, po mogućnosti je sol (6S)-5-metiltetrahidrofolne kiseline, a poželjnije je glukozaminska sol (6S)-5-metiltetrahidrofolne kiseline.
6. Pripravak u skladu s bilo kojim od patentnih zahtjeva 1-2, naznačen time što se navedenu sol šelaka bira između argininske soli, amonijeve soli, borne soli i kalijeve soli, a po mogućnosti je argininska sol.
7. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je šelak, i/ili njegova farmaceutski prihvatljiva sol, u obliku otopine, po mogućnosti u obliku vodene otopine ili u obliku alkoholne otopine, poželjnije u obliku vodene otopine.
8. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je SAMe, i/ili njegova farmaceutski prihvatljiva sol, prisutan u pripravku prema ovom izumu u količini rasponu između 50% i 90%, težinski, po mogućnosti između 60% i 85%, težinski, na osnovi ukupne težine pripravka.
9. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je šelak, i/ili njegova farmaceutski prihvatljiva sol, prisutan u pripravku prema ovom izumu u količini rasponu između 1% i 5%, težinski, na osnovi ukupne težine pripravka.
10. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je magnezijev stearat prisutan u pripravku prema ovom izumu u količini rasponu između 0,2% i 1%, težinski, na osnovi ukupne težine pripravka.
11. Postupak priprave čvrstog oralnog nutraceutskog i/ili farmaceutskog pripravka sa sporim otpuštanjem u skladu s patentnim zahtjevom 1, koji se sastoji u sljedećim koracima:
a) miješanja donora metilnih skupina, naznačenog time što se navedeni donor metilnih skupina bira između SAMe, ili njegove farmaceutski prihvatljive soli, folata, reduciranog folata ili njihove smjese, s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
b) predkomprimiranja, za kojim slijedi granuliranje, smjese dobivene u koraku a);
c) miješanja granuliranog materijala dobivenog u koraku b) s najmanje jednim farmaceutski prihvatljivim pomoćnim sredstvom;
d) oblaganja filmom čvrstog oralnog oblika dobivenog u koraku c) vodenom fazom koja sadrži šelak, i/ili njegovu farmaceutski prihvatljivu sol, magnezijev stearat i najmanje jedno farmaceutski prihvatljivo pomoćno sredstvo, gdje je navedeni postupak naznačen time što je šelak, i/ili njegova farmaceutski prihvatljiva sol, prisutan u nutraceutskom i/ili farmaceutskom čvrstom oralnom pripravku sa sporim otpuštanjem u količini rasponu između 0,5% i 10%, težinski na osnovi ukupne težine pripravka i naznačen time što je magnezijev stearat prisutan u vanjskoj oblozi u količini rasponu između 10% i 20%, težinski na osnovi težine vanjske obloge.
12. Postupak u skladu s patentnim zahtjevom 11, naznačen time što se tijekom oblaganja filmom d) navedeni čvrsti oralni oblik održava na temperaturi u rasponu između 30 °C i 60 °C, po mogućnosti između 40 °C i 55 °C, poželjnije na otprilike 48 °C.
13. Postupak u skladu s patentnim zahtjevom 12, naznačen time što se navedenu temperaturu održava u vremenskom periodu u rasponu između 10 minuta i 2 sata, po mogućnosti u trajanju od otprilike 1 sat.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001906A ITMI20131906A1 (it) | 2013-11-18 | 2013-11-18 | Composizioni solide orali a lento rilascio |
| US201461989645P | 2014-05-07 | 2014-05-07 | |
| EP14812619.6A EP3071191B1 (en) | 2013-11-18 | 2014-11-06 | Slow-release solid oral compositions |
| PCT/IB2014/065852 WO2015071806A1 (en) | 2013-11-18 | 2014-11-06 | Slow-release solid oral compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20220271T1 true HRP20220271T1 (hr) | 2022-05-13 |
Family
ID=49780196
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20220271TT HRP20220271T1 (hr) | 2013-11-18 | 2014-11-06 | Čvrsti oralni pripravci sa sporim otpuštanjem |
Country Status (26)
| Country | Link |
|---|---|
| US (1) | US10702482B2 (hr) |
| EP (1) | EP3071191B1 (hr) |
| JP (1) | JP6401270B2 (hr) |
| KR (1) | KR102224087B1 (hr) |
| CN (1) | CN105764493B (hr) |
| AU (1) | AU2014349782B2 (hr) |
| BR (1) | BR112016011142B1 (hr) |
| CA (1) | CA2929426C (hr) |
| DK (1) | DK3071191T3 (hr) |
| EA (1) | EA039558B1 (hr) |
| ES (1) | ES2908924T3 (hr) |
| GE (1) | GEP20186884B (hr) |
| HR (1) | HRP20220271T1 (hr) |
| HU (1) | HUE058086T2 (hr) |
| IL (1) | IL245167B (hr) |
| IT (1) | ITMI20131906A1 (hr) |
| LT (1) | LT3071191T (hr) |
| MX (1) | MX367664B (hr) |
| NZ (1) | NZ719000A (hr) |
| PH (1) | PH12016500693A1 (hr) |
| PL (1) | PL3071191T3 (hr) |
| PT (1) | PT3071191T (hr) |
| RS (1) | RS62916B1 (hr) |
| UA (1) | UA119856C2 (hr) |
| WO (1) | WO2015071806A1 (hr) |
| ZA (1) | ZA201602659B (hr) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT201700074957A1 (it) * | 2017-07-04 | 2019-01-04 | Gnosis Spa | Sale di (ss)-adenosil metionina con inositolo esafosfato e procedimento per ottenerlo |
| CN109939077B (zh) * | 2017-12-04 | 2022-07-22 | 深圳奥萨制药有限公司 | 一种含有5-甲基四氢叶酸的控释制剂 |
| CN111990674B (zh) * | 2020-01-14 | 2021-07-02 | 青岛圣邦健康食品有限公司 | 肠溶包衣材料及其制备方法和肠溶制品 |
| IT202000006127A1 (it) * | 2020-03-23 | 2021-09-23 | Fmc S R L | Formulazione farmaceutica, dietetica e/o alimentare a base ademetionina e processo di realizzazione di detta formulazione |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IT1200589B (it) * | 1985-02-14 | 1989-01-27 | Gibipharma Spa | Derivati naturali attivita farmagologica |
| ITMI20012462A1 (it) * | 2001-11-22 | 2003-05-22 | Gnosis Srl | Processo per la preparazione di compresse comprendenti s-adenosilmetionina |
| US20050181047A1 (en) * | 2004-02-18 | 2005-08-18 | Jaime Romero | Compositions and methods for timed release of water-soluble nutritional supplements |
| WO2006052227A1 (en) | 2004-11-05 | 2006-05-18 | Fabre-Kramer Holdings, Inc. | High-dosage extended-release formulation of gepirone |
| ITMI20060629A1 (it) * | 2006-03-31 | 2007-10-01 | Daniele Giovannone | Composizioni solide orali a base di s-adenosilmetionina e processo per il loro ottenimento |
| US20090088404A1 (en) | 2007-01-31 | 2009-04-02 | Methylation Sciences International Srl | Extended Release Pharmaceutical Formulations of S-Adenosylmethionine |
| KR20070093972A (ko) * | 2007-06-05 | 2007-09-19 | 파브르-크래머 홀딩스. 인크 | 게피론의 고용량 서방성 제제 |
| US7947662B2 (en) * | 2008-02-20 | 2011-05-24 | Gnosis S.P.A. | Folates, compositions and uses thereof |
| US20110027342A1 (en) | 2009-07-28 | 2011-02-03 | Msi Methylation Sciences, Inc. | S-adenosylmethionine formulations with enhanced bioavailability |
| US8329208B2 (en) | 2009-07-28 | 2012-12-11 | Methylation Sciences International Srl | Pharmacokinetics of S-adenosylmethionine formulations |
| IT1401146B1 (it) * | 2010-07-27 | 2013-07-12 | Gnosis Spa | Composizione comprendente shellac e/o un suo sale e sodio amido glicolato |
-
2013
- 2013-11-18 IT IT001906A patent/ITMI20131906A1/it unknown
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2014
- 2014-11-06 JP JP2016532105A patent/JP6401270B2/ja active Active
- 2014-11-06 BR BR112016011142-7A patent/BR112016011142B1/pt active IP Right Grant
- 2014-11-06 HR HRP20220271TT patent/HRP20220271T1/hr unknown
- 2014-11-06 US US15/037,149 patent/US10702482B2/en active Active
- 2014-11-06 PT PT148126196T patent/PT3071191T/pt unknown
- 2014-11-06 PL PL14812619T patent/PL3071191T3/pl unknown
- 2014-11-06 RS RS20220156A patent/RS62916B1/sr unknown
- 2014-11-06 NZ NZ719000A patent/NZ719000A/en unknown
- 2014-11-06 KR KR1020167011680A patent/KR102224087B1/ko active IP Right Grant
- 2014-11-06 CA CA2929426A patent/CA2929426C/en active Active
- 2014-11-06 DK DK14812619.6T patent/DK3071191T3/da active
- 2014-11-06 AU AU2014349782A patent/AU2014349782B2/en active Active
- 2014-11-06 ES ES14812619T patent/ES2908924T3/es active Active
- 2014-11-06 LT LTEPPCT/IB2014/065852T patent/LT3071191T/lt unknown
- 2014-11-06 UA UAA201605352A patent/UA119856C2/uk unknown
- 2014-11-06 WO PCT/IB2014/065852 patent/WO2015071806A1/en active Application Filing
- 2014-11-06 EA EA201691034A patent/EA039558B1/ru unknown
- 2014-11-06 CN CN201480062634.8A patent/CN105764493B/zh active Active
- 2014-11-06 MX MX2016006442A patent/MX367664B/es active IP Right Grant
- 2014-11-06 GE GEAP201414177A patent/GEP20186884B/en unknown
- 2014-11-06 HU HUE14812619A patent/HUE058086T2/hu unknown
- 2014-11-06 EP EP14812619.6A patent/EP3071191B1/en active Active
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2016
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- 2016-04-17 IL IL245167A patent/IL245167B/en active IP Right Grant
- 2016-04-19 ZA ZA2016/02659A patent/ZA201602659B/en unknown
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