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HRP20231613T1 - Pripravci koji sadrže sredstvo za unošenje i njihova priprava - Google Patents

Pripravci koji sadrže sredstvo za unošenje i njihova priprava Download PDF

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Publication number
HRP20231613T1
HRP20231613T1 HRP20231613TT HRP20231613T HRP20231613T1 HR P20231613 T1 HRP20231613 T1 HR P20231613T1 HR P20231613T T HRP20231613T T HR P20231613TT HR P20231613 T HRP20231613 T HR P20231613T HR P20231613 T1 HRP20231613 T1 HR P20231613T1
Authority
HR
Croatia
Prior art keywords
preparation according
pharmaceutical preparation
glp
pharmaceutical
lubricant
Prior art date
Application number
HRP20231613TT
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English (en)
Inventor
Thomas Vilhelmsen
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Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49221869&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20231613(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of HRP20231613T1 publication Critical patent/HRP20231613T1/hr

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    • 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
    • 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
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/609—Amides, e.g. salicylamide
    • 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
    • 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
    • A61K9/2013—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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2095—Tabletting 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
    • 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
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Obesity (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Child & Adolescent Psychology (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Claims (17)

1. Pripravak koji sadrži granulu koja sadrži sol N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline i mazivo, naznačen time što se navedenu granulu proizvodi suhim granuliranjem, te dobiva miješanjem navedene soli N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline s navedenim mazivom u trajanju od više od 5 minuta prije suhog granuliranja, što je količina navedenog maziva najmanje 2% (tež./tež.) od navedene granule, što pripravak sadrži jedan ili više intragranularnih dijelova i ekstragranularni dio, što su jedan ili više intragranularnih dijelova granulirani, te što se ekstragranularni dio doda nakon granuliranja.
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što navedeno miješanje traje 10, 20 ili 30 minuta.
3. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeno miješanje traje najmanje 30 minuta ili najmanje 40 minuta, primjerice najmanje 50 minuta.
4. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je količina navedenog maziva najviše 10 % (tež./tež.), primjerice najviše 8, 7 ili 6 % (tež./tež.), od navedene granule.
5. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je mazivo magnezijev stearat.
6. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeno miješanje traje najviše 12 sata, primjerice najviše 10, 8, 6, 4 ili 2 sata.
7. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedene granule se proizvodi komprimiranjem valjcima.
8. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedena sol N-(8-(2-hidroksibenzoil)amino)kaprilne kiseline natrijev N-(8-(2-hidroksibenzoil)amino)kaprilat (SNAC).
9. Farmaceutski pripravak comprising a pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što pripravak sadrži jedan ili više intragranularnih dijelova i ekstragranularni dio, što su jedan ili više intragranularnih dijelova granulirani, te što se ekstragranularni dio doda nakon granuliranja.
10. Farmaceutski pripravak u skladu s patentnim zahtjevom 9, naznačen time što farmaceutski pripravak dodatno sadrži farmaceutski aktivni sastojak, poput peptida GLP-1.
11. Farmaceutski pripravak u skladu s patentnim zahtjevom 10, naznačen time što navedeni peptid GLP-1 sadrži skupinu kojem se veže na albumin.
12. Farmaceutski pripravak u skladu s patentnim zahtjevom 10, naznačen time što navedeni peptid GLP-1 sadrži supstituent, kovalentno vezan na peptid, poput masne kiseline ili masne dikiseline.
13. Farmaceutski pripravak u skladu s patentnim zahtjevom 10, naznačen time što je navedeni peptid GLP-1 semaglutid, poznat i kao Nε26-[2-(2-{2-[2-(2-{2-[(S)-4-karboksi-4-(17-karboksiheptadekanoilamino)butirilamino]etoksi}etoksi)acetilamino]etoksi}etoksi)acetil][Aib8,Arg34]GLP-1(7-37).
14. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva 9-13, naznačen time što navedeni farmaceutski pripravak dodatno sadrži jedno ili više farmaceutski prihvatljivih pomoćnih sredstava, poput jednog ili više sastojaka, koje se bira iz skupine koju čine punilo, poput mikrokristalne celuloze, te veziva, poput povidona.
15. Farmaceutski pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva 9-14, naznačen time što je navedeni farmaceutski pripravak u obliku čvrstog oblika doziranja, poput tablete, kapsule ili vrećice.
16. Farmaceutski pripravak u skladu s patentnim zahtjevom 15, naznačen time što navedeni farmaceutski pripravak treba primijeniti oralno/oralnom primjenom.
17. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 9-16, naznačen time što je namijenjen upotrebi u medicini, primjerice u liječenju dijabetesa ili pretilosti.
HRP20231613TT 2012-03-22 2013-03-15 Pripravci koji sadrže sredstvo za unošenje i njihova priprava HRP20231613T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP12160742 2012-03-22
US201361748844P 2013-01-04 2013-01-04
EP13153422 2013-01-31
EP18212576.5A EP3542790B1 (en) 2012-03-22 2013-03-15 Compositions comprising a delivery agent and preparation thereof

Publications (1)

Publication Number Publication Date
HRP20231613T1 true HRP20231613T1 (hr) 2024-03-15

Family

ID=49221869

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20231613TT HRP20231613T1 (hr) 2012-03-22 2013-03-15 Pripravci koji sadrže sredstvo za unošenje i njihova priprava

Country Status (11)

Country Link
US (1) US10335369B2 (hr)
EP (3) EP4331667A3 (hr)
JP (1) JP6356660B2 (hr)
CN (3) CN104203221A (hr)
ES (1) ES2965469T3 (hr)
HR (1) HRP20231613T1 (hr)
HU (1) HUE064694T2 (hr)
PL (2) PL3542790T3 (hr)
RS (2) RS64942B1 (hr)
SI (1) SI2827845T1 (hr)
WO (1) WO2013139695A1 (hr)

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