HRP20190083T1 - Orodisperzibilan sastav filma sadržeći enalapril za tretman hipertenzije u pedijatrijskoj populaciji - Google Patents

Orodisperzibilan sastav filma sadržeći enalapril za tretman hipertenzije u pedijatrijskoj populaciji

Info

Publication number
HRP20190083T1
HRP20190083T1 HRP20190083TT HRP20190083T HRP20190083T1 HR P20190083 T1 HRP20190083 T1 HR P20190083T1 HR P20190083T T HRP20190083T T HR P20190083TT HR P20190083 T HRP20190083 T HR P20190083T HR P20190083 T1 HRP20190083 T1 HR P20190083T1
Authority
HR
Croatia
Prior art keywords
enalapril
hypertension
treatment
film composition
pediatric population
Prior art date
Application number
HRP20190083TT
Other languages
English (en)
Inventor
Evangelos Karavas
Efthymios Koutris
Vasiliki SAMARA
Ionna KOUTRI
Anastasia Kalaskani
Lida Kalantzi
Andreas KAKOURIS
Amalia DIAKIDOU
George GOTZAMANIS
Zaharias GEORGOUSIS
Louiza KONSTANTI
Original Assignee
Pharmathen S.A.
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.)
Filing date
Publication date
Application filed by Pharmathen S.A. filed Critical Pharmathen S.A.
Publication of HRP20190083T1 publication Critical patent/HRP20190083T1/hr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/05Dipeptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7007Drug-containing films, membranes or sheets

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
HRP20190083TT 2014-07-31 2019-01-15 Orodisperzibilan sastav filma sadržeći enalapril za tretman hipertenzije u pedijatrijskoj populaciji HRP20190083T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP2014002095 2014-07-31
PCT/EP2015/001243 WO2016015798A1 (en) 2014-07-31 2015-06-19 Orodispersible film composition comprising enalapril for the treatment of hypertension in a pediatric population
EP15732161.3A EP3193826B1 (en) 2014-07-31 2015-06-19 Orodispersible film composition comprising enalapril for the treatment of hypertension in a pediatric population

Publications (1)

Publication Number Publication Date
HRP20190083T1 true HRP20190083T1 (hr) 2019-03-08

Family

ID=53491483

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20190083TT HRP20190083T1 (hr) 2014-07-31 2019-01-15 Orodisperzibilan sastav filma sadržeći enalapril za tretman hipertenzije u pedijatrijskoj populaciji

Country Status (14)

Country Link
US (1) US20170165315A1 (hr)
EP (1) EP3193826B1 (hr)
CY (1) CY1121141T1 (hr)
DK (1) DK3193826T3 (hr)
ES (1) ES2705610T3 (hr)
HR (1) HRP20190083T1 (hr)
HU (1) HUE041705T2 (hr)
LT (1) LT3193826T (hr)
PL (1) PL3193826T3 (hr)
PT (1) PT3193826T (hr)
RS (1) RS58120B1 (hr)
SI (1) SI3193826T1 (hr)
TR (1) TR201819662T4 (hr)
WO (1) WO2016015798A1 (hr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201709141D0 (en) * 2017-06-08 2017-07-26 Klaria Pharma Holding Ab Pharmaceutical formulation
US20220249393A1 (en) * 2018-04-13 2022-08-11 Zim Laboratories Limited Composition of active ingredient loaded edible ink and methods of making suitable substrates for active ingredient printing on orodispersible films
GB201808462D0 (en) 2018-05-23 2018-07-11 Klaria Pharma Holding Ab Pharmaceutical formulation
GR20200100430A (el) * 2020-06-01 2022-01-13 Κυριακος Ηλια Κυπραιος Ταχεως διαλυομενες στοματικες ταινιες για τη χορηγηση δια της στοματικης οδου φαρμακων και λοιπων βιοδραστικων ουσιων σε ανθρωπους
WO2024107115A1 (en) * 2022-11-14 2024-05-23 National University Of Singapore Methods of compounding an injectable drug into a film or wafer and systems thereof

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL58849A (en) 1978-12-11 1983-03-31 Merck & Co Inc Carboxyalkyl dipeptides and derivatives thereof,their preparation and pharmaceutical compositions containing them
US4510083A (en) 1982-05-07 1985-04-09 Merck & Co., Inc. Process for preparing polypeptides
US4830853A (en) 1986-10-20 1989-05-16 Warner-Lambert Company Drug compositions stabilized against oxidation
US4743450A (en) 1987-02-24 1988-05-10 Warner-Lambert Company Stabilized compositions
YU48602B (sh) 1991-11-25 1998-12-23 Krka Tovarna Zdravil P.O. Postupak za dobijanje stabilne formulacije soli enalaprila
CA2128199C (en) 1994-07-15 1997-02-04 Bernard Charles Sherman Stable solid pharmaceutical compositions containing enalapril maleate
US7425292B2 (en) * 2001-10-12 2008-09-16 Monosol Rx, Llc Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
US20080220029A1 (en) * 2007-03-05 2008-09-11 Charlene Ng Fast-dissolving/disintegrating film preparation having high proportion of active
EP2732813A1 (en) * 2012-11-14 2014-05-21 Hexal AG Orodispersible film compositions

Also Published As

Publication number Publication date
WO2016015798A9 (en) 2016-03-31
DK3193826T3 (en) 2019-02-11
EP3193826A1 (en) 2017-07-26
RS58120B1 (sr) 2019-02-28
EP3193826B1 (en) 2018-10-17
CY1121141T1 (el) 2020-05-29
ES2705610T3 (es) 2019-03-26
SI3193826T1 (sl) 2019-02-28
WO2016015798A1 (en) 2016-02-04
US20170165315A1 (en) 2017-06-15
PT3193826T (pt) 2019-01-23
HUE041705T2 (hu) 2019-05-28
TR201819662T4 (tr) 2019-01-21
PL3193826T3 (pl) 2019-07-31
LT3193826T (lt) 2019-01-25

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