HRP20221105T1 - Farmaceutski sastav za anemiju - Google Patents

Farmaceutski sastav za anemiju Download PDF

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Publication number
HRP20221105T1
HRP20221105T1 HRP20221105TT HRP20221105T HRP20221105T1 HR P20221105 T1 HRP20221105 T1 HR P20221105T1 HR P20221105T T HRP20221105T T HR P20221105TT HR P20221105 T HRP20221105 T HR P20221105T HR P20221105 T1 HRP20221105 T1 HR P20221105T1
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Croatia
Prior art keywords
pharmaceutical composition
weight
ranges
composition according
vitamin
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HRP20221105TT
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English (en)
Inventor
Ankit Shyam Singh
Vedprakash Mishra
Neelima Tongra
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Frimline Private Limited
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Publication of HRP20221105T1 publication Critical patent/HRP20221105T1/hr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/40—Transferrins, e.g. lactoferrins, ovotransferrins
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • 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
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/18—Peptides; Protein hydrolysates
    • 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
    • A23L33/17—Amino acids, peptides or proteins
    • A23L33/19—Dairy proteins
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/07—Retinol compounds, e.g. vitamin A
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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
    • A61K31/7042—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
    • A61K31/7064—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
    • 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
    • A61K31/708—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 having oxo groups directly attached to the purine ring system, e.g. guanosine, guanylic acid
    • 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
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Biophysics (AREA)
  • Biomedical Technology (AREA)
  • Obesity (AREA)
  • Physiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Claims (15)

1. Farmaceutski sastav koji sadrži kombinaciju: a) laktoferina; i b) jednog ili više gvanozin nukleotida ili njegovu farmaceutski prihvatljivu sol; pri čemu se količina laktoferina kreće u rasponu od 5 do 50 % po tež. sastava i pri čemu se količina gvanozin nukleotida kreće u rasponu od 1 do 5 % tež. sastava.
2. Farmaceutski sastav sukladno patentnom zahtjevu 1, pri čemu je gvanozin nukleotid odabran između gvanozin monofosfata (GMP), gvanozin difosfata (GDP), gvanozin trifosfata (GTP) ili njihove kombinacije.
3. Farmaceutski sastav sukladno patentnom zahtjevu 1, pri čemu je farmaceutski prihvatljiva sol gvanozin nukleotida odabrana između hidroklorida, sulfata, fosfata, acetata, laktata, citrata, pantotenata, askorbata, sukcinata, maleata, fumarata, glukonata, magnezijeve soli, kalija, natrija, cinka, soli dietanolamina i njihove kombinacije.
4. Farmaceutski sastav sukladno bilo kojem od prethodnih patentnih zahtjeva, pri čemu taj sastav nadalje sadrži elementarno željezo, vitamin C, vitamin A, folnu kiselinu, folat, vitamin B ili njihovu kombinaciju.
5. Farmaceutski sastav sukladno patentnom zahtjevu 4, pri čemu se količina elementarnog željeza kreće u rasponu od 30 do 45 % tež. toga sastava.
6. Farmaceutski sastav sukladno patentnom zahtjevu 4, pri čemu se količina vitamina C kreće u rasponu od 5 do 65 % tež. toga sastava.
7. Farmaceutski sastav sukladno patentnom zahtjevu 4, pri čemu se količina vitamina A kreće u rasponu od 0,5 do 3 % tež. toga sastava.
8. Farmaceutski sastav sukladno patentnom zahtjevu 4, pri čemu se količina folne kiseline ili folata kreće u rasponu od 0,05 do 0,75 % tež. toga sastava.
9. Farmaceutski sastav sukladno patentnom zahtjevu 4, pri čemu se količina vitamina B kreće u rasponu od 1 do 5 % tež. toga sastava.
10. Farmaceutski sastav sukladno bilo kojem od prethodnih patentnih zahtjeva, koji nadalje sadrži farmaceutski prihvatljive pomoćne tvari.
11. Farmaceutski sastav sukladno patentnom zahtjevu 10, pri čemu se farmaceutski prihvatljiva pomoćna tvar odabire između razrjeđivača, veziva, sredstva za dezintegraciju, sredstva za podmazivanje, glidanta, sredstva za oblaganje, otapala i njihovih kombinacija.
12. Farmaceutski sastav sukladno patentnom zahtjevu 11, pri čemu se količina razrjeđivača kreće u rasponu od 5 % do 45 % tež. toga sastava, veziva kreće u rasponu od 1 % do 7 % tež. toga sastava, sredstva za dezintegraciju kreće u rasponu od 1 % do 25 % tež. toga sastava, sredstva za podmazivanje kreće u rasponu od 0,5 % do 5 % tež. toga sastava, glidanta kreće u rasponu od 0,5 % do 5 % tež. toga sastava, sredstva za oblaganje kreće u rasponu od 1 % do 15 % tež. toga sastava i/ili je količina otapala dovoljna.
13. Farmaceutski sastav sukladno patentnom zahtjevu 1, pri čemu je taj sastav u obliku tablete, kapsule, pilule, tvrde kapsule napunjene tekućinom ili krutom tvari, meke kapsule, praška, granule, vrećice, enterički obložene tablete ili kapsule, tablete ili kapsule s modificiranim oslobađanjem.
14. Postupak pripremanja sastava sukladno patentom zahtjevu 1 sadrži: a) pojedinačno vaganje svih sastojaka u zasebnim spremnicima; b) prosijavanje prethodno izvaganog laktoferina, gvanozin nukleotida ili njegove farmaceutski prihvatljive soli i izborno zasebno dodavanje elementarnog željeza, vitamina C, vitamina A, folne kiseline, folata ili vitamina B, razrjeđivača i sredstva za dezintegraciju; c) miješanje sadržaja iz koraka (b); d) po izboru, pripremanje otopine veziva u zasebnom spremniku i dodavanje sadržaja u koraku (c) i prosijavanje formirane granulirane vlažne mase da se dobiju granule; e) sušenje dobivenih granulata dok se razina suhoće (LOD) ne smanji do između 3,0 i 5,0 % masenog udjela (w/w), f) prosijavanje polusušenih granula kroz prikladno sito; i g) odvojeno prosijavanje prethodno izvaganog sredstva za podmazivanje i glidanta kroz prikladno sito i dodavanje sadržaja u koraku (f) da se dobije sastav.
15. Farmaceutski sastav sukladno patentnom zahtjevu 1 za liječenje anemije uzrokovane nedostatkom željeza (IDA), anemije uzrokovane upalom (AOI) i neurodegenerativnih poremećaja.
HRP20221105TT 2018-03-09 2019-03-04 Farmaceutski sastav za anemiju HRP20221105T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN201821008809 2018-03-09
PCT/IB2019/051706 WO2019171236A1 (en) 2018-03-09 2019-03-04 A pharmaceutical composition for anaemia
EP19721718.5A EP3661373B1 (en) 2018-03-09 2019-03-04 A pharmaceutical composition for anaemia

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HRP20221105T1 true HRP20221105T1 (hr) 2022-11-25

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US (1) US12016906B2 (hr)
EP (1) EP3661373B1 (hr)
AU (1) AU2019232621B2 (hr)
BR (1) BR112020018319A2 (hr)
CA (1) CA3073184C (hr)
CO (1) CO2020010193A2 (hr)
DK (1) DK3661373T3 (hr)
EA (1) EA202090276A1 (hr)
ES (1) ES2927216T3 (hr)
HR (1) HRP20221105T1 (hr)
HU (1) HUE059584T2 (hr)
LT (1) LT3661373T (hr)
MA (1) MA52154B1 (hr)
MD (1) MD3661373T2 (hr)
MY (1) MY183462A (hr)
PE (1) PE20201278A1 (hr)
PH (1) PH12019550263A1 (hr)
PL (1) PL3661373T3 (hr)
PT (1) PT3661373T (hr)
RS (1) RS63563B1 (hr)
SG (1) SG11202008732VA (hr)
SI (1) SI3661373T1 (hr)
UA (1) UA123852C2 (hr)
WO (1) WO2019171236A1 (hr)

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WO2024097926A1 (en) * 2022-11-03 2024-05-10 Nutrition & Biosciences Usa 1, Llc Oral biologic macromolecule delivery system
CN116530687A (zh) * 2023-06-03 2023-08-04 重庆医科大学 一种含乳酸亚铁口服溶液及其用途

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