HRP20191458T1 - Kompleksni spojevi željezo (iii) oksida s aktiviranim glukoznim sirupima i proces za pripremu istog - Google Patents
Kompleksni spojevi željezo (iii) oksida s aktiviranim glukoznim sirupima i proces za pripremu istog Download PDFInfo
- Publication number
- HRP20191458T1 HRP20191458T1 HRP20191458T HRP20191458T1 HR P20191458 T1 HRP20191458 T1 HR P20191458T1 HR P20191458 T HRP20191458 T HR P20191458T HR P20191458 T1 HRP20191458 T1 HR P20191458T1
- Authority
- HR
- Croatia
- Prior art keywords
- iii
- glucose syrup
- iron
- complex compound
- activated
- Prior art date
Links
- 239000006188 syrup Substances 0.000 title claims 16
- 235000020357 syrup Nutrition 0.000 title claims 16
- MSNWSDPPULHLDL-UHFFFAOYSA-K ferric hydroxide Chemical class [OH-].[OH-].[OH-].[Fe+3] MSNWSDPPULHLDL-UHFFFAOYSA-K 0.000 title claims 8
- 125000002791 glucosyl group Chemical class C1([C@H](O)[C@@H](O)[C@H](O)[C@H](O1)CO)* 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 150000001875 compounds Chemical class 0.000 claims 18
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims 10
- 239000008103 glucose Substances 0.000 claims 10
- 150000002303 glucose derivatives Chemical class 0.000 claims 8
- 238000000034 method Methods 0.000 claims 7
- 229920002245 Dextrose equivalent Polymers 0.000 claims 5
- MHAJPDPJQMAIIY-UHFFFAOYSA-N Hydrogen peroxide Chemical compound OO MHAJPDPJQMAIIY-UHFFFAOYSA-N 0.000 claims 4
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 claims 3
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims 2
- 229910021578 Iron(III) chloride Inorganic materials 0.000 claims 2
- 239000003054 catalyst Substances 0.000 claims 2
- RBTARNINKXHZNM-UHFFFAOYSA-K iron trichloride Chemical compound Cl[Fe](Cl)Cl RBTARNINKXHZNM-UHFFFAOYSA-K 0.000 claims 2
- 230000003647 oxidation Effects 0.000 claims 2
- 238000007254 oxidation reaction Methods 0.000 claims 2
- 239000011541 reaction mixture Substances 0.000 claims 2
- WKBOTKDWSSQWDR-UHFFFAOYSA-N Bromine atom Chemical compound [Br] WKBOTKDWSSQWDR-UHFFFAOYSA-N 0.000 claims 1
- 206010022971 Iron Deficiencies Diseases 0.000 claims 1
- 241001465754 Metazoa Species 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- GDTBXPJZTBHREO-UHFFFAOYSA-N bromine Substances BrBr GDTBXPJZTBHREO-UHFFFAOYSA-N 0.000 claims 1
- 229910052794 bromium Inorganic materials 0.000 claims 1
- 230000003197 catalytic effect Effects 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000005227 gel permeation chromatography Methods 0.000 claims 1
- 238000004442 gravimetric analysis Methods 0.000 claims 1
- 238000010438 heat treatment Methods 0.000 claims 1
- 238000004128 high performance liquid chromatography Methods 0.000 claims 1
- 150000007529 inorganic bases Chemical class 0.000 claims 1
- 229910052740 iodine Inorganic materials 0.000 claims 1
- 239000011630 iodine Substances 0.000 claims 1
- -1 iodine ions Chemical class 0.000 claims 1
- 229910052742 iron Inorganic materials 0.000 claims 1
- 239000006193 liquid solution Substances 0.000 claims 1
- 238000007911 parenteral administration Methods 0.000 claims 1
- 238000002360 preparation method Methods 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
- A61K31/28—Compounds containing heavy metals
- A61K31/295—Iron group metal compounds
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/26—Iron; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal 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
- A61K47/69—Medicinal 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
Claims (9)
1. Proces za pripremu kompleksnih spojeva željezo (III) hidroksida i aktiviranog glukoznog sirupa, pri čemu je molekularna težina kompleksa u rasponu od 100 kDa do 150 kDa, kako je izmjereno tekućinskom kromatografijom visokog učinka - gel permeacijskom kromatografijom (HPLC-GPC), naveden proces sadrži slijedeće korake:
(i) dobivanje tekuće otopine glukoznog sirupa, dekstroznog ekvivalenta (DE) od najmanje 21 i najviše 60, kao što je utvrđeno gravimetrijskom analizom, temperature raspona od 25°C do 80°C i pH vrijednosti raspona od 6 do 13;
(ii) dodavanje hidrogen peroksida, i, opcionalno, katalitičke količine oksidacijskog katalizatora, otopini u skladu s korakom (i), a istovremeno održavajući pH vrijednost i temperaturu u rasponu definiranom u prethodnom koraku (i), puštajući otopinu da se ohladi do temperature raspona od 10°C do 45°C, održavajući navedenu temperaturu otopine 5 min. do 24 sata, dobivajući time aktivirani glukozni sirup;
(iii) pretvaranje navedenog aktiviranog glukoznog sirupa u kompleksni spoj sa željezo (III) hidroksidom; i
(iv) dobivanje kompleksnog spoja željezo (III) hidroksida i aktiviranog glukoznog sirupa, pri čemu je korišteni hidrogen peroksid ukupne količine 0.0005-0.01 mol/g (glukozni sirup) pomnožen s faktorom korekcije: (dekstrozni ekvivalent glukoznog sirupa)/21, pri čemu kompleksni spoj ima sadržaj željeza raspona od 27 do 35%, temeljen na masi kompleksnog spoja; i pri čemu dobiveni kompleksni spoj željezo (III) hidroksida i aktivirani glukozni sirup imaju više od dvije –COOH grupe po molekuli glukoze i pri čemu glukozni sirup u skladu s korakom (i) nema nijednu –COOH grupu u molekuli glukoze.
2. Proces u skladu s patentnim zahtjevom 1,
pri čemu je dekstrozni ekvivalent (DE) aktiviranog glukoznog sirupa raspona od 0,1 do 1,0, preferabilno otprilike 0,3 i/ili dobiveni kompleksni spoj željezo (III) hidroksida i aktiviranog glukoznog sirupa ima najmanje tri –COOH grupe po molekuli glukoze, što ukazuje da je glukozni sirup aktiviran.
3. Proces u skladu s bilo kojim od patentnih zahtjeva 1-2,
pri čemu korak pretvaranja navedenog aktiviranog glukoznog sirupa u kompleksni spoj s željezovim (III) hidroksidom sadrži korake:
(iii)(a) dodavanje otopine FeCl3 otopini u skladu s korakom (ii) temperature unutar raspona od 10 do 30°C; količina FeCl3 raspona od 30% masenog udjela do 120% masenog udjela količine glukoznog sirupa.
(iii)(b) dodavanje anorganske baze reakcijskoj mješavini u skladu s korakom (iii)(a) dok pH vrijednost nije raspona od 1,5 do 2,5; i
(iii)(c) zagrijavanje reakcijske mješavine u skladu s korakom (iii)(b) do temperature unutar raspona od 40 do 60°C.
4. Proces u skladu s bilo kojim od patentnih zahtjeva 1-3,
pri čemu katalizator oksidacije uključuje ione broma i joda.
5. Kompleksni spoj željezo (III) hidroksida i glukoznog sirupa može se dobiti ili se dobiva procesom u skladu s bilo kojim od patentnih zahtjeva 1-4.
6. Farmaceutski spoj koji sadrži kompleksni spoj u skladu s patentnim zahtjevom 5.
7. Kompleksni spoj u skladu s patentnim zahtjevom 5 ili farmaceutski spoj u skladu s patentnim zahtjevom 6 za uporabu kao lijek.
8. Kompleksni spoj u skladu s patentnim zahtjevom 5 ili farmaceutski spoj u skladu s patentnim zahtjevom 6 za uporabu u metodi liječenja deficijencije željeza kod ljudi i životinja.
9. Kompleksni spoj ili farmaceutski spoj za uporabu u skladu s patentnim zahtjevom 8, pri čemu liječenje sadrži parenteralnu primjenu navedenog kompleksnog spoja u skladu s patentnim zahtjevom 5 ili farmaceutski spoj u skladu s patentnim zahtjevom 6.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14386023.7A EP2997968A1 (en) | 2014-09-22 | 2014-09-22 | Iron (III) hydroxide complexes with activated glucose syrups and process for preparing same |
| EP15739647.4A EP3197444B1 (en) | 2014-09-22 | 2015-07-28 | Iron (iii) hydroxide complexes with activated glucose syrups and process for preparing same |
| PCT/EP2015/067216 WO2016045826A1 (en) | 2014-09-22 | 2015-07-28 | Iron (iii) hydroxide complexes with activated glucose syrups and process for preparing same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20191458T1 true HRP20191458T1 (hr) | 2019-11-29 |
Family
ID=51730477
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20191458 HRP20191458T1 (hr) | 2014-09-22 | 2019-08-12 | Kompleksni spojevi željezo (iii) oksida s aktiviranim glukoznim sirupima i proces za pripremu istog |
Country Status (30)
| Country | Link |
|---|---|
| US (1) | US20170232040A1 (hr) |
| EP (3) | EP2997968A1 (hr) |
| AP (1) | AP2017009747A0 (hr) |
| AU (1) | AU2015320003C1 (hr) |
| BR (1) | BR112017005614A2 (hr) |
| CA (1) | CA2956870C (hr) |
| CL (1) | CL2017000690A1 (hr) |
| CO (1) | CO2017003488A2 (hr) |
| CY (1) | CY1122133T1 (hr) |
| DK (1) | DK3197444T3 (hr) |
| EA (1) | EA033807B1 (hr) |
| ES (1) | ES2740630T3 (hr) |
| GE (1) | GEP20197004B (hr) |
| HR (1) | HRP20191458T1 (hr) |
| HU (1) | HUE044803T2 (hr) |
| IL (1) | IL250615A0 (hr) |
| LT (1) | LT3197444T (hr) |
| MA (2) | MA50202A (hr) |
| MX (1) | MX368219B (hr) |
| MY (1) | MY187900A (hr) |
| PE (1) | PE20170689A1 (hr) |
| PH (1) | PH12017500316B1 (hr) |
| PL (1) | PL3197444T3 (hr) |
| PT (1) | PT3197444T (hr) |
| RS (1) | RS59246B1 (hr) |
| SA (2) | SA517381133B1 (hr) |
| SG (1) | SG11201701408TA (hr) |
| SI (1) | SI3197444T1 (hr) |
| WO (1) | WO2016045826A1 (hr) |
| ZA (1) | ZA201701899B (hr) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GR1009597B (el) | 2018-04-16 | 2019-09-16 | Ιουλια Κλεωνος Τσετη | Φαρμακευτικο σκευασμα για την ενισχυση των επιπεδων σιδηρου στο αιμα, που περιεχει πολυμαλτοζικο σιδηρο (ιιι) και μια δραστικη ουσια επιλεγμενη απο πενταϋδρικο φυλλινικο ασβεστιο, βιταμινη c ή συνδυασμο των δυο, που ενισχυει την απορροφηση σιδηρου |
| TWI784646B (zh) * | 2021-07-29 | 2022-11-21 | 台耀化學股份有限公司 | 製備羧基麥芽糖鐵的方法 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US2885393A (en) | 1956-02-24 | 1959-05-05 | R K Laros Company | Dextran-iron complex and process for making same |
| US3076798A (en) | 1961-02-23 | 1963-02-05 | Hausmann Lab Ltd | Process for preparing a ferric hydroxide polymaltose complex |
| DE1293144B (de) | 1964-11-04 | 1969-04-24 | Hausmann Ag Labor | Verfahren zur Herstellung von Komplexverbindungen des Eisens mit Sorbit, Gluconsaeure und einem Oligosaccharid |
| ZA711254B (en) | 1970-03-13 | 1971-11-24 | Fisons Ltd | Treatment of iron deficiency in piglets |
| US3908004A (en) | 1970-05-20 | 1975-09-23 | C L Basingstoke Limited | Process for making injectable iron compositions for treating iron-deficiency anemia |
| US4180567A (en) | 1977-09-02 | 1979-12-25 | Pharmachem Corporation | Iron preparations and methods of making and administering the same |
| DE3422249A1 (de) | 1984-06-15 | 1985-12-19 | Pfeifer & Langen, 5000 Köln | Wasserloesliches eisendextran und verfahren zu seiner herstellung |
| GB9514090D0 (en) | 1995-07-11 | 1995-09-13 | Cerestar Holding Bv | Non-catalysed oxidation of maltodextrin with an oxygen containing oxidant |
| JP4520748B2 (ja) | 2002-04-09 | 2010-08-11 | ファーマコスモス、ホールディング、アクティーゼルスカブ | 鉄欠乏性貧血の治療のための鉄デキストリン化合物 |
| DE10249552A1 (de) | 2002-10-23 | 2004-05-13 | Vifor (International) Ag | Wasserlösliche Eisen-Kohlenhydrat-Komplexe, deren Herstellung und diese enthaltende Arzneimittel |
| ITMO20050056A1 (it) | 2005-03-15 | 2006-09-16 | Biofer Spa | Processo per la preparazione di complessi del ferro trivalente con zuccheri mono-, di- e polisaccaridi. |
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2014
- 2014-09-22 EP EP14386023.7A patent/EP2997968A1/en not_active Withdrawn
-
2015
- 2015-07-28 EA EA201790673A patent/EA033807B1/ru unknown
- 2015-07-28 HU HUE15739647 patent/HUE044803T2/hu unknown
- 2015-07-28 GE GEAP201514478A patent/GEP20197004B/en unknown
- 2015-07-28 SG SG11201701408TA patent/SG11201701408TA/en unknown
- 2015-07-28 MY MYPI2017700471A patent/MY187900A/en unknown
- 2015-07-28 PT PT15739647T patent/PT3197444T/pt unknown
- 2015-07-28 PE PE2017000252A patent/PE20170689A1/es unknown
- 2015-07-28 MX MX2017003708A patent/MX368219B/es active IP Right Grant
- 2015-07-28 EP EP15739647.4A patent/EP3197444B1/en active Active
- 2015-07-28 SI SI201530847T patent/SI3197444T1/sl unknown
- 2015-07-28 MA MA050202A patent/MA50202A/fr unknown
- 2015-07-28 WO PCT/EP2015/067216 patent/WO2016045826A1/en active Application Filing
- 2015-07-28 AU AU2015320003A patent/AU2015320003C1/en active Active
- 2015-07-28 RS RSP20191009 patent/RS59246B1/sr unknown
- 2015-07-28 DK DK15739647.4T patent/DK3197444T3/da active
- 2015-07-28 MA MA40322A patent/MA40322B1/fr unknown
- 2015-07-28 CA CA2956870A patent/CA2956870C/en active Active
- 2015-07-28 LT LT15739647T patent/LT3197444T/lt unknown
- 2015-07-28 AP AP2017009747A patent/AP2017009747A0/en unknown
- 2015-07-28 BR BR112017005614A patent/BR112017005614A2/pt not_active Application Discontinuation
- 2015-07-28 EP EP19182379.8A patent/EP3583941A1/en active Pending
- 2015-07-28 US US15/513,006 patent/US20170232040A1/en not_active Abandoned
- 2015-07-28 ES ES15739647T patent/ES2740630T3/es active Active
- 2015-07-28 PL PL15739647T patent/PL3197444T3/pl unknown
-
2017
- 2017-02-15 IL IL250615A patent/IL250615A0/en active IP Right Grant
- 2017-02-21 PH PH12017500316A patent/PH12017500316B1/en unknown
- 2017-03-17 ZA ZA2017/01899A patent/ZA201701899B/en unknown
- 2017-03-19 SA SA517381133A patent/SA517381133B1/ar unknown
- 2017-03-19 SA SA518392070A patent/SA518392070B1/ar unknown
- 2017-03-22 CL CL2017000690A patent/CL2017000690A1/es unknown
- 2017-04-10 CO CONC2017/0003488A patent/CO2017003488A2/es unknown
-
2019
- 2019-08-09 CY CY20191100860T patent/CY1122133T1/el unknown
- 2019-08-12 HR HRP20191458 patent/HRP20191458T1/hr unknown
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