HRP20201802T1 - Kruti pripravak koji sadrži željezo za uporabu u uvjetima nedostatka željeza - Google Patents

Kruti pripravak koji sadrži željezo za uporabu u uvjetima nedostatka željeza Download PDF

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Publication number
HRP20201802T1
HRP20201802T1 HRP20201802TT HRP20201802T HRP20201802T1 HR P20201802 T1 HRP20201802 T1 HR P20201802T1 HR P20201802T T HRP20201802T T HR P20201802TT HR P20201802 T HRP20201802 T HR P20201802T HR P20201802 T1 HRP20201802 T1 HR P20201802T1
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Croatia
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lecithin
weight
iron
starch
amount
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HRP20201802TT
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English (en)
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Andrea Lacorte
Germano Tarantino
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Alesco S.R.L.
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Publication of HRP20201802T1 publication Critical patent/HRP20201802T1/hr

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    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/24Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/26Iron; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/42Phosphorus; Compounds thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
  • Pretreatment Of Seeds And Plants (AREA)
  • Solid-Sorbent Or Filter-Aiding Compositions (AREA)

Claims (14)

1. Kruti pripravak koji sadrži: (i) željeznu (III) sol koja je željezni pirofosfat, u količini od 30 do 70%; (ii) estere saharoze ili sukrestere E473 u količini sastavljenoj od 10 do 30%; (iii) lecitin koji je lecitin E322, pri čemu je navedeni lecitin odabran iz skupine koja sadrži kukuruzni, suncokretov ili sojin lecitin, i nalazi se u količini sastavljenoj od 0.1% do 1.5% težine.
2. Pripravak prema zahtjevu 1, naznačen time što navedeni pripravak nadalje sadrži želatinizirani ili preželatinizirani škrob.
3. Pripravak prema zahtjevima 1 ili 2, naznačen time što je navedena željezna (III) sol u količini sastavljenoj od 40 do 60% težine.
4. Pripravak prema zahtjevima 1-3, naznačen time što su navedeni esteri saharoze ili sukresteri E473 u količini sastavljenoj od 15 do 25 % težine.
5. Pripravak prema bilo kojem od zahtjeva 1-4, naznačen time što je navedeni lecitin u količini sastavljenoj od 0.4% do 1% težine.
6. Pripravak prema bilo kojem od zahtjeva 1-5, naznačen time što su navedeni ester saharoze ili sukrester i navedeni lecitin u pripravku u težinskom omjeru od 25: 1 do 20: 1; poželjno u težinskom omjeru od 20: 1 do 15: 1.
7. Pripravak prema bilo kojem od zahtjeva 1-6, naznačen time što je navedeni želatinizirani ili preželatinizirani škrob odabran iz skupine koja sadrži rižin škrob ili kukuruzni škrob; navedeni škrob je u količini sastavljenoj od 15 do 40%, poželjno od 20 do 35 % težine.
8. Pripravak prema bilo kojem od zahtjeva 1-7, naznačen time što je željezni pirofosfat u količini sastavljenoj od 50 do 55% težine; količina lecitina suncokreta je sastavljena od 0.5 do 0.8 težine; sukrester E473 je u količini sastavljenoj od 16 do 20% težine; želatinizirani ili preželatinizirani rižin škrob je u količini sastavljenoj od 25 do 30% težine.
9. Postupak za pripremu krutog pripravka - na primjer prema bilo kojem od prethodnih zahtjeva - koji sadrži: (i) željeznu (III) sol koja je željezni pirofosfat, u količini sastavljenoj od 30 do 70%; (ii) estere saharoze ili sukrestere E473, u količini sastavljenoj od 10 do 30%; (iii) lecitin koji je lecitin E322, pri čemu je navedeni lecitin odabran iz skupine koja sadrži kukuruzni, suncokretov ili sojin lecitin, i u količini je sastavljenoj od 0.1% do 1.5% težine; i (iv) neobavezni želatinizirani ili preželatinizirani biljni škrob; navedeni postupak sadrži niz koraka obrade kroz koje je željezna (III) sol presvučena ili inkapsulirana navedenim lecitinom i navedenim esterom saharoze ili sukresterom i navedenim neobaveznim biljnim škrobom.
10. Postupak prema zahtjevu 9, sadrži - u nizu - korake: i) dovođenje u kontakt željezne (III) soli u krutom stanju s navedenim lecitinom tako da se ovaj ravnomjerno rasporedi preko navedene soli; ii) dovođenje u kontakt proizvoda iz koraka i) sa navedenim esterom saharoze ili sukresterom i navedenim neobaveznim biljnim škrobom.
11. Postupak prema bilo kojem od zahtjeva 9 ili 10, naznačen time što kruti pripravak ima sadržaj željeza (III) od 60 mg / g do 140 mg / g, poželjno od 80 mg / g do 120 mg / g, još poželjnije od 90 do 110 mg / g.
12. Postupak prema bilo kojem od zahtjeva 9-11, naznačen time što: - željezna (III) sol se upotrebljava u količini od 40 do 60%, poželjno od 50 do 55%; - lecitin u krutom pripravku je u količini sastavljenoj od 0.4 do 1% težine, poželjno od 0.50 do 0.8%, ili je lecitin u krutom pripravku u količini sastavljenoj od 0.48 do 0.62% težine i esteri saharoze ili sukresteri koriste se u količini sastavljenoj od 16.5 do 18.5% težine; i - neobavezni škrob je u krutom pripravku u količini sastavljenoj od 15 do 40%, poželjno od 20 do 35%, još poželjnije od 25 do 30% težine, pri čemu se navedeni škrob na primjer bira između rižinog ili kukuruznog škroba, poželjno želatinizirani ili preželatinizirani domaći rižin škrob.
13. Postupak prema bilo kojem od zahtjeva 9-12, naznačen time što je lecitin nehidrolizirani ili enzimatski hidrolizirani lecitin.
14. Postupak prema bilo kojem od zahtjeva 9-13, naznačen time što je lecitin praškasti suncokretov lecitin E322.
HRP20201802TT 2012-07-31 2020-11-11 Kruti pripravak koji sadrži željezo za uporabu u uvjetima nedostatka željeza HRP20201802T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT001350A ITMI20121350A1 (it) 2012-07-31 2012-07-31 Composizione solido a base di ferro per uso nelle condizioni di deficienza di ferro.
EP19151902.4A EP3498265B1 (en) 2012-07-31 2013-07-30 Solid composition comprising iron for use in iron deficient conditions

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HRP20201802T1 true HRP20201802T1 (hr) 2021-03-19

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HRP20190461TT HRP20190461T1 (hr) 2012-07-31 2019-03-08 Čvrsti pripravak koji sadrži željezo, namijenjen upotrebi kod stanja s nedostatkom željeza
HRP20201802TT HRP20201802T1 (hr) 2012-07-31 2020-11-11 Kruti pripravak koji sadrži željezo za uporabu u uvjetima nedostatka željeza

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US (2) US10183077B2 (hr)
EP (2) EP3498265B1 (hr)
JP (1) JP6232426B2 (hr)
CN (2) CN111265546A (hr)
BR (2) BR122022015143B1 (hr)
CA (1) CA2879681C (hr)
CY (2) CY1121435T1 (hr)
DK (2) DK3498265T3 (hr)
EA (1) EA027684B1 (hr)
ES (2) ES2719252T3 (hr)
HR (2) HRP20190461T1 (hr)
HU (2) HUE052036T2 (hr)
IL (2) IL236793A0 (hr)
IN (1) IN2015MN00127A (hr)
IT (1) ITMI20121350A1 (hr)
LT (2) LT3498265T (hr)
MA (1) MA20150375A1 (hr)
ME (1) ME03349B (hr)
PL (2) PL3498265T3 (hr)
PT (2) PT3498265T (hr)
RS (2) RS58647B1 (hr)
SI (2) SI3498265T1 (hr)
TR (1) TR201903899T4 (hr)
WO (1) WO2014009806A1 (hr)

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IT201900020300A1 (it) 2019-11-04 2021-05-04 Alesco Srl Uso di berberina sucrosomiale® e sue composizioni nel trattamento di dislipidemie
IT201900020316A1 (it) 2019-11-04 2021-05-04 Alesco Srl Uso di berberina sucrosomiale® e sue composizioni nel trattamento di alterazioni del metabolismo glucidico
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US20190105393A1 (en) 2019-04-11
US20150250885A1 (en) 2015-09-10
ITMI20121350A1 (it) 2014-02-01
HUE052036T2 (hu) 2021-04-28
EP3498265B1 (en) 2020-09-30
EA027684B1 (ru) 2017-08-31
CN111265546A (zh) 2020-06-12
CY1123610T1 (el) 2022-03-24
DK2879667T3 (en) 2019-04-15
BR112015002072B1 (pt) 2022-11-01
CY1121435T1 (el) 2020-05-29
IL265561B (en) 2021-02-28
PT3498265T (pt) 2020-11-16
EP3498265A1 (en) 2019-06-19
RS61069B1 (sr) 2020-12-31
IL236793A0 (en) 2015-03-31
LT3498265T (lt) 2021-01-25
EA201590204A1 (ru) 2015-06-30
SI3498265T1 (sl) 2021-02-26
ME03349B (me) 2019-10-20
ES2830428T3 (es) 2021-06-03
PL3498265T3 (pl) 2021-03-08
HUE042698T2 (hu) 2019-07-29
ES2719252T3 (es) 2019-07-09
EP2879667A1 (en) 2015-06-10
US10183077B2 (en) 2019-01-22
TR201903899T4 (tr) 2019-04-22
BR112015002072A2 (pt) 2017-07-04
DK3498265T3 (da) 2020-11-16
MA20150375A1 (fr) 2015-10-30
PT2879667T (pt) 2019-04-15
CN104602674A (zh) 2015-05-06
WO2014009806A1 (en) 2014-01-16
JP6232426B2 (ja) 2017-11-15
PL2879667T3 (pl) 2019-07-31
SI2879667T1 (sl) 2019-07-31
CA2879681A1 (en) 2014-01-16
BR122022015143B1 (pt) 2023-05-09
LT2879667T (lt) 2019-05-10
US10765752B2 (en) 2020-09-08
CA2879681C (en) 2022-06-21
IL265561A (en) 2019-05-30
EP2879667B1 (en) 2019-01-16
HRP20190461T1 (hr) 2019-06-14
IN2015MN00127A (hr) 2015-10-16
RS58647B1 (sr) 2019-05-31
JP2015523409A (ja) 2015-08-13

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