HRP20191243T1 - Topikalni antifugalni pripravak za liječenje onihomikoze - Google Patents

Topikalni antifugalni pripravak za liječenje onihomikoze Download PDF

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Publication number
HRP20191243T1
HRP20191243T1 HRP20191243T HRP20191243T1 HR P20191243 T1 HRP20191243 T1 HR P20191243T1 HR P20191243 T HRP20191243 T HR P20191243T HR P20191243 T1 HRP20191243 T1 HR P20191243T1
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HR
Croatia
Prior art keywords
preparation
mass
amount
treatment
terbinafine
Prior art date
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English (en)
Inventor
Federico Mailland
Michela Legora
Daniela Ceriani
Giuliana Iob
Original Assignee
Polichem Sa
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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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=50029007&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20191243(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Polichem Sa filed Critical Polichem Sa
Publication of HRP20191243T1 publication Critical patent/HRP20191243T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/30Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/02Local antiseptics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Oncology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Communicable Diseases (AREA)
  • Emergency Medicine (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (19)

1. Pripravak koji sadrži najmanje oko 9 % masenog udjela terbinafina ili njegove farmaceutski prihvatljive soli, hidroksipropil hitozan, niži alkanol i vodu za primjenu u liječenju onihomikoze kod pacijenta, naznačen time, što se spomenuti pripravak nanosi na pogođena područja pacijenta jednom tjedno.
2. Pripravak za primjenu prema patentnom zahtjevu 1, naznačen time, što razdoblje liječenja inicijalnom dozom prethodni tjednom nanošenju.
3. Pripravak za primjenu prema patentnom zahtjevu 2, naznačen time, što se razdoblje liječenja inicijalnom dozom sastoji od dnevnog nanošenja tijekom vremenskog razdoblja od dva tjedna do dva mjeseca.
4. Pripravak za primjenu prema patentnom zahtjevu 3, naznačen time, što se razdoblje liječenja inicijalnom dozom sastoji od dnevnog nanošenja tijekom mjesec dana.
5. Pripravak za primjenu prema patentnom zahtjevu 1, naznačen time, što je terbinafin ili njegova farmaceutski prihvatljiva sol prisutna u količini od 9,5 % do 10,5 % masenog udjela.
6. Pripravak za primjenu prema patentnom zahtjevu 1, naznačen time, što je spomenuti niži alkanol etanol.
7. Pripravak za primjenu prema patentnom zahtjevu 1, naznačen time, što je spomenuta farmaceutski prihvatljiva sol terbinafin HCl.
8. Pripravak koji se suštinski sastoji od: a) terbinafina i/ili najmanje njegove farmaceutski prihvatljive soli u količini od 9 do 11 % masenog udjela pripravka, b) hidroksipropil hitozan u količini od 0,1 do 0,6 % masenog udjela pripravka, c) vode u količini od 10,0 do 40,0 % masenog udjela pripravka, d) najmanje nižeg alkanola u količini od 60 do 80 % masenog udjela pripravka.
9. Pripravak prema patentnom zahtjevu 8, naznačen time, što je sastojak a) terbinafin HCl.
10. Pripravak prema patentnom zahtjevu 8, naznačen time, što je sastojak b) prisutan u količini od 0,2 do 0,4 % masenog udjela pripravka.
11. Pripravak prema patentnom zahtjevu 8, naznačen time, što je sastojak c) prisutan u količini od 18 do 30 % masenog udjela pripravka.
12. Pripravak prema patentnom zahtjevu 8, naznačen time, što je sastojak d) odabran iz etanola, propanola, izopropanola, butanola i njihovih smjesa.
13. Pripravak prema patentnom zahtjevu 12, naznačen time, što je sastojak d) etanol.
14. Pripravak prema patentnom zahtjevu 8, koji se sastoji od a) 9,5 do 10,5 % masenog udjela terbinafin HCl-a, b) 0,2 do 0,4 % masenog udjela hidroksipropil hitozana, c) 18 do 30 % masenog udjela pročišćene vode i d) 65 do 75 % masenog udjela etanola.
15. Pripravak prema patentnom zahtjevu 14, koji se sastoji od a) oko 10 % masenog udjela terbinafin HCl-a, b) oko 0,3 % masenog udjela hidroksipropil hitozana, c) oko 19,7 % masenog udjela pročišćene vode i d) oko 70 % masenog udjela etanola.
16. Pripravak prema patentnom zahtjevu 8, naznačen time, što je u obliku laka za nokte.
17. Pripravak prema bilo kojem patentnom zahtjevu od 8 do 16 za primjenu u liječenju onihomikoze.
18. Pripravak za primjenu prema patentnom zahtjevu 17, naznačen time, što se pripravak nanosi jednom tjedno.
19. Pripravak za primjenu prema patentnom zahtjevu 17, naznačen time, što se pripravak nanosi jednom dnevno tijekom prvih mjesec dana, a zatim jednom tjedno do kraja liječenja.
HRP20191243 2013-02-07 2019-07-11 Topikalni antifugalni pripravak za liječenje onihomikoze HRP20191243T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201361761953P 2013-02-07 2013-02-07
US201361781560P 2013-03-14 2013-03-14
PCT/EP2014/051288 WO2014122024A1 (en) 2013-02-07 2014-01-23 Topical antifungal composition for treating onychomycosis
EP14701713.1A EP2953621B1 (en) 2013-02-07 2014-01-23 Topical antifungal composition for treating onychomycosis

Publications (1)

Publication Number Publication Date
HRP20191243T1 true HRP20191243T1 (hr) 2019-11-01

Family

ID=50029007

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20191243 HRP20191243T1 (hr) 2013-02-07 2019-07-11 Topikalni antifugalni pripravak za liječenje onihomikoze

Country Status (35)

Country Link
US (3) US8697753B1 (hr)
EP (1) EP2953621B1 (hr)
JP (1) JP6420258B2 (hr)
KR (1) KR102200788B1 (hr)
CN (1) CN105050592B (hr)
AU (1) AU2014214166B2 (hr)
BR (1) BR112015018798B1 (hr)
CA (1) CA2900127C (hr)
CL (1) CL2015002191A1 (hr)
CR (1) CR20150377A (hr)
CY (1) CY1121841T1 (hr)
DK (1) DK2953621T3 (hr)
EA (1) EA036061B1 (hr)
EC (1) ECSP15033898A (hr)
ES (1) ES2729373T3 (hr)
HK (1) HK1212904A1 (hr)
HR (1) HRP20191243T1 (hr)
HU (1) HUE045000T2 (hr)
IL (1) IL240334B (hr)
LT (1) LT2953621T (hr)
ME (1) ME03507B (hr)
MX (1) MX361880B (hr)
NZ (1) NZ709668A (hr)
PE (1) PE20151300A1 (hr)
PH (1) PH12015501739B1 (hr)
PL (1) PL2953621T3 (hr)
PT (1) PT2953621T (hr)
RS (1) RS58990B1 (hr)
SG (1) SG11201505275YA (hr)
SI (1) SI2953621T1 (hr)
TN (1) TN2015000316A1 (hr)
TW (1) TWI658839B (hr)
UY (1) UY35307A (hr)
WO (1) WO2014122024A1 (hr)
ZA (1) ZA201504880B (hr)

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