HRP20200315T1 - Čvrsti oralni pripravci na bazi soli s-adenozilmetionina i postupak njihove priprave - Google Patents

Čvrsti oralni pripravci na bazi soli s-adenozilmetionina i postupak njihove priprave Download PDF

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Publication number
HRP20200315T1
HRP20200315T1 HRP20200315TT HRP20200315T HRP20200315T1 HR P20200315 T1 HRP20200315 T1 HR P20200315T1 HR P20200315T T HRP20200315T T HR P20200315TT HR P20200315 T HRP20200315 T HR P20200315T HR P20200315 T1 HRP20200315 T1 HR P20200315T1
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Croatia
Prior art keywords
weight
preparation
adenosylmethionine
relation
mixture
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HRP20200315TT
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English (en)
Inventor
Daniele Giovannone
Carlo De Angelis
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Gnosis S.P.A.
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Application filed by Gnosis S.P.A. filed Critical Gnosis S.P.A.
Publication of HRP20200315T1 publication Critical patent/HRP20200315T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706Compounds 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
    • A61K31/7064Compounds 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
    • A61K31/7076Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7084Compounds having two nucleosides or nucleotides, e.g. nicotinamide-adenine dinucleotide, flavine-adenine dinucleotide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Saccharide Compounds (AREA)

Claims (17)

1. Pripravak, naznačen time što sadrži S-adenozilmetionin-sulfat-para-toluensulfonat ili S-adenozilmetionin-1,4-butan-disulfonat u smjesi s kalcijevim oksidom i izborno farmaceutski prihvatljive pomoćne tvari.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je S-adenozilmetionin-sulfat-para-toluensulfonat ili S-adenozilmetionin-1,4-butan-disulfonat u njemu prisutan u količini koja se kreće od 30 do 90%, težinski, u odnosu na težinu pripravka, po mogućnosti od 50 do 85%, težinski, u odnosu na težinu pripravka.
3. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je kalcijev oksid u njemu prisutan u količini koja se kreće od 1 do 40%, težinski, u odnosu na težinu pripravka, po mogućnosti od 2 do 20%, težinski, u odnosu na težinu pripravka.
4. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što sadrži najmanje jedan dodatni aktivni sastojak, kojeg se po mogućnosti bira između l-melatonina, l-teanina i/ili l-triptofana i/ili 5-hidroksitriptofana ili njihove smjese.
5. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je najmanje jedna od farmaceutski prihvatljivih pomoćnih tvari kalcijev sulfat hemihidrat i/ili glukono-δ-lakton.
6. Pripravak u skladu s prethodnim patentnim zahtjevima, naznačen time što je u obliku izravne smjese, tablete, kapsule, granulata ili praha, po mogućnosti u obliku tablete, poželjnije obične, obložene, filmom obložene i/ili želučanootporne tablete.
7. Postupak priprave tablete u skladu s patentnim zahtjevom 6, naznačen time što se sastoji u sljedećim koracima: a) miješanja S-adenozilmetionin-sulfat-para-toluensulfonata ili S-adenozilmetionin-1,4-butan-disulfonata s kalcijevim oksidom i farmaceutski prihvatljivim pomoćnim tvarima, b) predkomprimiranja i naknadno granuliranje smjese dobivene u koraku a), c) miješanja granulata dobivenog u koraku b) s farmaceutski prihvatljivim pomoćnim tvarima, poput kalcijevog sulfata hemihidrata, ksilitola, jabučne kiseline, glutaminske kiseline, glukono-δ-laktona, magnezijevog oksida, hidrogeniranih masnih kiselina, istaloženog silicijevog dioksida, magnezijevog stearata, saharoze, glicerol-behenata, d) komprimiranja smjese dobivene u koraku c), uz izborno dodavanje sladila i/ili aroma, e) izbornog oblaganja tablete dobivene u koraku d) hidrogeniranim masnim kiselina, f) izbornog oblaganja tablete dobivene u koraku e) filmom u vodenoj fazi.
8. Postupak u skladu s patentnim zahtjevom 7, naznačen time što se u koraku c) najmanje jedan dodatni aktivni sastojak, kojeg se po mogućnosti bira između l-melatonina, l-teanina i/ili l-triptofana i/ili 5-hidroksitriptofana i/ili njihovih smjesa može dodati u smjesu.
9. Postupak u skladu s patentnim zahtjevom 7, naznačen time što se oblaganje spomenuto u koraku e) primijenjuje upotrebom hidrogeniranih masnih kiselina u količini između 0,4 i 1,5%, težinski, u odnosu na težinu tablete.
10. Postupak u skladu s patentnim zahtjevom 7, naznačen time što se stvaranje filma u vodenoj fazi spomenuto u koraku f) provodi uz upotrebu laka, kojeg se po mogućnosti bira između gumenog laka i/ili njegovih soli (Shellac™), metakriline kiseline, celuloznih acetoftalata, titanijevog dioksida, talka, trietil-citrata, PVP K30, kurkumina, luteina, hidroksipropilceluloze, hidroksipropilmetilceluloze i/ili njihovih smjesa.
11. Pripravci, naznačeni time što ih se može pripraviti postupkom u skladu s patentnim zahtjevima 7-10.
12. Upotreba S-adenozilmetionin-sulfat-para-toluensulfonata ili S-adenozilmetionin-1,4-butan-disulfonata u smjesi s kalcijevim oksidom, naznačena time što je navedena smjesa namijenjena pripravi pripravka za liječenje depresivnih stanja.
13. Upotreba u skladu s patentnim zahtjevom 12, naznačen time što se magnezijev oksid dodatno dodaje navedenom kalcijevom oksidu.
14. Postupak stabiliziranja pripravka na bazi S-adenozilmetionin-sulfat-para-toluensulfonata ili S-adenozilmetionin-1,4-butan-disulfonata, naznačen time što se sastoji u upotrebi smjese S-adenozilmetionin-sulfat-para-toluensulfonata ili S-adenozilmetionin-1,4-butan-disulfonata s kalcijevim oksidom.
15. Postupak u skladu s patentnim zahtjevom 14, naznačen time što je S-adenozilmetionin-sulfat-para-toluensulfonat ili S-adenozilmetionin-1,4-butan-disulfonat u njemu prisutan u količini između 30 i 90%, težinski, izračunato u odnosu na težinu pripravka, po mogućnosti između 50 i 85%, težinski, izračunato u odnosu na težinu pripravka.
16. Postupak u skladu s patentnih zahtjeva 14-15, naznačen time što je kalcijev oksid u njemu prisutan u količini koja se kreće od 1 do 40%, težinski, u odnosu na težinu pripravka, po mogućnosti od 2 do 20%, težinski, u odnosu na težinu pripravka.
17. Postupak u skladu s patentnim zahtjevom 16, naznačen time što se sastoji u dodavanju farmaceutski prihvatljivih pomoćnih tvari.
HRP20200315TT 2006-03-31 2020-02-25 Čvrsti oralni pripravci na bazi soli s-adenozilmetionina i postupak njihove priprave HRP20200315T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IT000629A ITMI20060629A1 (it) 2006-03-31 2006-03-31 Composizioni solide orali a base di s-adenosilmetionina e processo per il loro ottenimento
PCT/IT2006/000610 WO2007113885A2 (en) 2006-03-31 2006-08-08 Solid oral compositions based on s-adenosyl methionine and/or nadh and process for obtaining them
EP06780609.1A EP2007479B1 (en) 2006-03-31 2006-08-08 Solid oral compositions based on S-adenosyl methionine salt and process for obtaining them

Publications (1)

Publication Number Publication Date
HRP20200315T1 true HRP20200315T1 (hr) 2020-06-12

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Application Number Title Priority Date Filing Date
HRP20200315TT HRP20200315T1 (hr) 2006-03-31 2020-02-25 Čvrsti oralni pripravci na bazi soli s-adenozilmetionina i postupak njihove priprave

Country Status (22)

Country Link
US (2) US20090110729A1 (hr)
EP (1) EP2007479B1 (hr)
JP (1) JP5562632B2 (hr)
CN (1) CN101415464B (hr)
AU (1) AU2006341243B2 (hr)
BR (1) BRPI0621556B8 (hr)
CA (1) CA2645767C (hr)
DK (1) DK2007479T3 (hr)
EA (1) EA017895B1 (hr)
ES (1) ES2774913T3 (hr)
HR (1) HRP20200315T1 (hr)
HU (1) HUE047955T2 (hr)
IL (1) IL194254A (hr)
IT (1) ITMI20060629A1 (hr)
ME (2) MEP22708A (hr)
MX (1) MX2008012491A (hr)
NZ (1) NZ571240A (hr)
PL (1) PL2007479T3 (hr)
RS (2) RS59995B1 (hr)
SI (1) SI2007479T1 (hr)
WO (1) WO2007113885A2 (hr)
ZA (1) ZA200808118B (hr)

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US20090110729A1 (en) 2009-04-30
MX2008012491A (es) 2009-03-02
JP2009532344A (ja) 2009-09-10
RS59995B1 (sr) 2020-04-30
EP2007479B1 (en) 2019-12-04
NZ571240A (en) 2011-08-26
HUE047955T2 (hu) 2020-05-28
DK2007479T3 (da) 2020-02-24
EP2007479A2 (en) 2008-12-31
BRPI0621556A2 (pt) 2012-10-09
WO2007113885A3 (en) 2008-01-24
AU2006341243B2 (en) 2012-02-23
EA200802095A1 (ru) 2009-02-27
US10471088B2 (en) 2019-11-12
BRPI0621556B8 (pt) 2021-05-25
MEP22708A (en) 2010-06-10
ME00115B (me) 2010-10-10
WO2007113885A8 (en) 2008-11-13
ZA200808118B (en) 2009-12-30
CN101415464B (zh) 2013-10-30
IL194254A0 (en) 2009-09-22
ITMI20060629A1 (it) 2007-10-01
CN101415464A (zh) 2009-04-22
PL2007479T3 (pl) 2020-09-21
IL194254A (en) 2015-07-30
JP5562632B2 (ja) 2014-07-30
ES2774913T3 (es) 2020-07-23
RS20080441A (en) 2009-07-15
CA2645767A1 (en) 2007-10-11
BRPI0621556B1 (pt) 2020-09-29
CA2645767C (en) 2015-03-17
AU2006341243A1 (en) 2007-10-11
US20150306126A1 (en) 2015-10-29
WO2007113885A2 (en) 2007-10-11
SI2007479T1 (sl) 2020-04-30
EA017895B1 (ru) 2013-04-30

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