HRP20211086T1 - Pomoćna farmaceutska sredstva s kontroliranim otpuštanjem i slojeviti kompleks za uključivanje ciklodekstrina - Google Patents

Pomoćna farmaceutska sredstva s kontroliranim otpuštanjem i slojeviti kompleks za uključivanje ciklodekstrina Download PDF

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HRP20211086T1
HRP20211086T1 HRP20211086TT HRP20211086T HRP20211086T1 HR P20211086 T1 HRP20211086 T1 HR P20211086T1 HR P20211086T T HRP20211086T T HR P20211086TT HR P20211086 T HRP20211086 T HR P20211086T HR P20211086 T1 HRP20211086 T1 HR P20211086T1
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Croatia
Prior art keywords
cyclodextrin
pharmaceutical agent
auxiliary pharmaceutical
guest molecule
molecule
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HRP20211086TT
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English (en)
Inventor
Al Czap
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Czap Research And Development, Llc
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Priority claimed from US15/232,647 external-priority patent/US20170224841A1/en
Priority claimed from US15/285,264 external-priority patent/US20170224842A1/en
Application filed by Czap Research And Development, Llc filed Critical Czap Research And Development, Llc
Publication of HRP20211086T1 publication Critical patent/HRP20211086T1/hr

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    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/69Medicinal 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
    • A61K47/6949Medicinal 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
    • A61K47/6951Medicinal 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
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40Cyclodextrins; Derivatives thereof
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    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/17Amino acids, peptides or proteins
    • A23L33/175Amino acids
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    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/164Amides, e.g. hydroxamic acids of a carboxylic acid with an aminoalcohol, e.g. ceramides
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    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
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    • A61K38/47Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
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    • A61K9/146Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
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    • C08B37/0012Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
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Claims (14)

1. Pomoćno farmaceutsko sredstvo za primjenu kompleksa koji uključuje ciklodekstrin, koje obuhvaća: alfa ciklodekstrin koji ima šupljinu; molekula maslačne kiseline, ili njen glicerid, koji je barem djelomično zadržan kao gost-molekula unutar šupljine ciklodekstrina, koja tvori kompleks koji uključuje ciklodekstrin; farmaceutski prihvatljiv nosač za kompleks koji uključuje ciklodekstrin, pri čemu je gost-molekula stabilno zadržana putem ciklodekstrina unutar farmaceutski prihvatljivog nosača; i, mikrobni enzim amilaze koji ima aktivnost razgradnje ciklodekstrina koji može razložiti ciklodekstrin a da pri tome zadržava gost-molekulu, pri čemu je mikrobni enzim amilaze ko-formuliran s kompleksom koji uključuje ciklodekstrin tako da je aktivnost razgradnje ciklodekstrina aktivirana na oralnoj primjeni pomoćnog farmaceutskog sredstva ljudskom pacijentu tako da se otpusti gost-molekula iz šupljine ciklodekstrina.
2. Pomoćno farmaceutsko sredstvo za primjenu sukladno patentnom zahtjevu 1, pri čemu je ta amilaza bakterijska amilaza.
3. Pomoćno farmaceutsko sredstvo za primjenu sukladno bilo kojem od patentnih zahtjeva 1 ili 2, pri čemu je taj ciklodekstrin hidrofobni alkilirani ciklodekstrin.
4. Pomoćno farmaceutsko sredstvo za primjenu sukladno bilo kojem od patentnih zahtjeva 1 do 3, pri čemu je taj ciklodekstrin mješoviti metilirani/etilirani ciklodekstrin.
5. Pomoćno farmaceutsko sredstvo za primjenu sukladno bilo kojem od patentnih zahtjeva 1 do 4, pri čemu je to pomoćno farmaceutsko sredstvo za primjenu formulirano za usporeno otpuštanje molekule maslačne kiseline ili njenog glicerida.
6. Pomoćno farmaceutsko sredstvo za primjenu sukladno patentnom zahtjevu 5, nadalje obuhvaća lipazu.
7. Pomoćno farmaceutsko sredstvo za primjenu sukladno bilo kojem od patentnih zahtjeva 1 do 6, za uporabu u liječenju gastrointestinalnog poremećaja.
8. Pomoćno farmaceutsko sredstvo za primjenu sukladno patentnom zahtjevu 7, pri čemu je taj poremećaj kolitis, divertikulitis, Chronova bolest, upalna bolest crijeva, sindrom nervoznih crijeva, upala povezana s otvorom za stomu ili granulacija povezana s otvorom za stomu.
9. Postupak formuliranja pomoćnog farmaceutskog sredstva za primjenu kompleksa koji uključuje ciklodiekstrin, koji sadrži: osiguravanje alfa ciklodekstrina koji ima šupljinu; osiguravanje molekule maslačne kiseline, ili njenog glicerida, koja je barem djelomično zadržana kao gost-molekula unutar šupljine ciklodekstrina, koja stvara kompleks koji uključuje ciklodekstrin; osiguravanje farmaceutski prihvatljivog nosača za kompleks koji uključuje ciklodekstrin, pri čemu je gost-molekula stabilno zadržana pomoću ciklodekstrina unutar farmaceutski prihvaltjivog nosača; i, osiguravanje mikrobnog enzima amilaze koji ima aktivnost razgradnje ciklodekstrina koja može razgraditi ciklodekstrin pri čemu zadržava gost-molekulu, pri čemu je mikrobni enzim amilaze ko-formuliran s kompleksom koji uključuje ciklodekstrin tako da je aktivnost razgradnje ciklodekstrina aktivirana na oralnoj primjeni pomoćnog farmaceutskog sredstva na ljudskom pacijentu tako da se otpusti gost-molekula iz šupljine ciklodekstrina.
10. Postupak sukladno patentnom zahtjevu 9, pri čemu je ta amilaza bakterijska amilaza.
11. Postupak sukladno bilo kojem od patentnih zahtjeva 9 ili 10, pri čemu je ciklodekstrin hidrofobni alkilirani ciklodekstrin.
12. Postupak sukladno bilo kojem od patentnih zahtjeva 9 do 11, pri čemu je ciklodekstrin mješoviti metilirani/etilirani ciklodekstrin.
13. Postupak sukladno bilo kojem od patentnih zahtjeva 9 do 12, pri čemu je pomoćno farmaceutsko sredstvo za primjenu formulirano za zadržano otpuštanje molekule maslačne kiseline ili njenog glicerida.
14. Pomoćno farmaceutsko sredstvo za primjenu sukladno bilo kojem od patentnih zahtjeva 1 do 6, za uporabu u liječenje poremećaja iz spektra autizma.
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