HRP20201923T1 - Farmaceutske formulacije loratadina za kapsuliranje i njihove kombinacije - Google Patents

Farmaceutske formulacije loratadina za kapsuliranje i njihove kombinacije Download PDF

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Publication number
HRP20201923T1
HRP20201923T1 HRP20201923TT HRP20201923T HRP20201923T1 HR P20201923 T1 HRP20201923 T1 HR P20201923T1 HR P20201923T T HRP20201923T T HR P20201923TT HR P20201923 T HRP20201923 T HR P20201923T HR P20201923 T1 HRP20201923 T1 HR P20201923T1
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HR
Croatia
Prior art keywords
amount
fatty acids
formulation
medium
weight
Prior art date
Application number
HRP20201923TT
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English (en)
Inventor
Beth Okutan
Peter Draper
Original Assignee
Catalent Ontario Limited
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
Application filed by Catalent Ontario Limited filed Critical Catalent Ontario Limited
Publication of HRP20201923T1 publication Critical patent/HRP20201923T1/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
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (9)

1. Farmaceutska formulacija loratadina, naznačena time da sadrži: loratadin u količini u rasponu od 3% do 7% masenog udjela; jednu ili više mono- i di-gliceridinih masnih kiselina srednjeg lanca u količini od 33% do 83% masenog udjela, pri ćemu mono- i di-gliceridne masne kiseline srednjeg lanca su gliceril mono- & dikaprat; jednu ili više masnih kiselina srednjeg lanca triglicerida u količini od 8% do 50% masenog udjela; disperzent je povidon; i surfaktant u količini od 2% do 5% masenog udjela, pri čemu je surfaktant polioksietilen sorbitan ester masne kiseline, koji je polisorbat 80; pri čemu je omjer količine disperzenata u količini surfaktanata 1,75:1 do 2,5:1; pri čemu je tekuća formulacija pogodna za kapsuliranje u obliku doziranja mekane gel-kapsule ispunjene tekućinom; a gdje je povidon povidon K-12.
2. Formulacija prema zahtjevu 1, naznačena time da nadalje sadrži vodu.
3. Formulacija u skladu s patentnim zahtjevom 2, naznačena time da se količina vode kreće od 1% do 4% masenog udjela.
4. Formulacija u skladu s patentnim zahtjevom 1, naznačena time da su masne kiseline srednjeg lanca triglicerida odabrane iz skupine koja se sastoji od gliceril trikaprilata/kaprata, glicerol kaprilata kaprata i kapril/kapri triglicerida.
5. Formulacija prema zahtjevu 1, naznačena time da formulacija ima vrijednost hidrofilne lipofilne ravnoteže (HLB) između 3 i 7, posebno između 5 i 6.
6. Formulacija u skladu s patentnim zahtjevom 1, naznačena time da masne kiseline srednjeg monoglicerida imaju vrijednost HLB između 5 i 6, a masne kiseline srednjeg lanca triglicerida imaju vrijednost HLB od 11.
7. Formulacija prema zahtjevu 1, naznačena time da površinsko aktivno sredstvo ima HLB vrijednost između 14 i 17.
8. Oblik doziranja loratadina za oralnu primjenu, naznačen time da sadrži: nosač za davanje lijeka; i formulaciju za punjenje prema bilo kojem od zahtjeva 1 do 7 smještenu u nosaču za dostavu lijeka.
9. Oblik doziranja prema zahtjevu 8, naznačen time da je sredstvo za davanje lijeka kapsula, mekana želatinska kapsula ili kapsula koja se uglavnom sastoji od želatine.
HRP20201923TT 2010-01-19 2020-12-02 Farmaceutske formulacije loratadina za kapsuliranje i njihove kombinacije HRP20201923T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CA2690490A CA2690490C (en) 2010-01-19 2010-01-19 Pharmaceutical formulations of loratadine for encapsulation and combinations thereof
EP11734280.8A EP2525827B1 (en) 2010-01-19 2011-01-18 Pharmaceutical formulations of loratadine for encapsulation and combinations thereof
PCT/CA2011/000052 WO2011088550A1 (en) 2010-01-19 2011-01-18 Pharmaceutical formulations of loratadine for encapsulation and combinations thereof

Publications (1)

Publication Number Publication Date
HRP20201923T1 true HRP20201923T1 (hr) 2021-02-05

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20201923TT HRP20201923T1 (hr) 2010-01-19 2020-12-02 Farmaceutske formulacije loratadina za kapsuliranje i njihove kombinacije

Country Status (17)

Country Link
US (1) US20120301544A1 (hr)
EP (2) EP2525827B1 (hr)
JP (1) JP5328992B2 (hr)
AU (1) AU2011207058B2 (hr)
CA (1) CA2690490C (hr)
CY (1) CY1123895T1 (hr)
DK (1) DK2525827T3 (hr)
ES (1) ES2843351T3 (hr)
HR (1) HRP20201923T1 (hr)
HU (1) HUE053412T2 (hr)
LT (1) LT2525827T (hr)
MX (1) MX344163B (hr)
PL (1) PL2525827T3 (hr)
PT (1) PT2525827T (hr)
RS (1) RS61362B1 (hr)
SI (1) SI2525827T1 (hr)
WO (1) WO2011088550A1 (hr)

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CN103784446B (zh) * 2014-03-05 2016-01-06 大连金石滩药业有限公司 氯雷他定组合物
CN103784399B (zh) * 2014-03-05 2015-09-30 大连金石滩药业有限公司 氯雷他定液体组合物
JP7065562B2 (ja) * 2015-09-04 2022-05-12 ロート製薬株式会社 医薬組成物
KR101746500B1 (ko) 2016-05-26 2017-06-14 (주)알피바이오 연질캡슐 제제용 로라타딘 조성물 및 이를 함유하는 연질캡슐
WO2019113461A1 (en) 2017-12-08 2019-06-13 Western University Of Health Sciences Lipid emulsified drug delivery systems for chemoprevention and treatment
CA3100314A1 (en) 2018-05-16 2019-11-21 Bayer Healthcare Llc High concentration suspension formulation for cold and flu soft gel capsule medications
CN112426404B (zh) * 2020-10-29 2023-02-28 太阳升(亳州)生物医药科技有限公司 用于制备富马酸卢帕他定口服液的方法

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Also Published As

Publication number Publication date
MX344163B (es) 2016-12-07
SI2525827T1 (sl) 2021-02-26
HUE053412T2 (hu) 2021-06-28
RS61362B1 (sr) 2021-02-26
US20120301544A1 (en) 2012-11-29
EP2525827A4 (en) 2014-04-30
AU2011207058A1 (en) 2012-09-06
AU2011207058B2 (en) 2015-04-23
PL2525827T3 (pl) 2021-05-04
EP3653204A1 (en) 2020-05-20
ES2843351T3 (es) 2021-07-16
PT2525827T (pt) 2021-01-20
WO2011088550A1 (en) 2011-07-28
EP2525827B1 (en) 2020-11-18
MX2012008301A (es) 2012-09-28
DK2525827T3 (da) 2020-12-14
CA2690490C (en) 2012-06-26
LT2525827T (lt) 2021-03-25
JP2013517303A (ja) 2013-05-16
JP5328992B2 (ja) 2013-10-30
CA2690490A1 (en) 2011-07-19
CY1123895T1 (el) 2022-05-27
EP2525827A1 (en) 2012-11-28

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