PE20200736A1 - Una composicion de nanoemulsion de clobetasol de aceite en agua - Google Patents

Una composicion de nanoemulsion de clobetasol de aceite en agua

Info

Publication number
PE20200736A1
PE20200736A1 PE2019002570A PE2019002570A PE20200736A1 PE 20200736 A1 PE20200736 A1 PE 20200736A1 PE 2019002570 A PE2019002570 A PE 2019002570A PE 2019002570 A PE2019002570 A PE 2019002570A PE 20200736 A1 PE20200736 A1 PE 20200736A1
Authority
PE
Peru
Prior art keywords
oil
clobetasol
nanoemulsion
weight ratio
ranges
Prior art date
Application number
PE2019002570A
Other languages
English (en)
Inventor
Aquilue Javier Sanagustin
Maria Del Carmen Lendinez
Ganan Maria Isabel Delgado
Original Assignee
Laboratorios Salvat 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.)
Filing date
Publication date
Application filed by Laboratorios Salvat Sa filed Critical Laboratorios Salvat Sa
Publication of PE20200736A1 publication Critical patent/PE20200736A1/es

Links

Classifications

    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/0043—Nose
    • 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
    • A61K9/0046—Ear
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Rheumatology (AREA)
  • Biochemistry (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Colloid Chemistry (AREA)
  • Cosmetics (AREA)

Abstract

Se refiere a una composicion de nanoemulsion de aceite en agua que tiene una fase acuosa continua y gotas de aceite dispersas, en donde la nanoemulsion comprende: (a) clobetasol; (b) uno o mas componentes oleosos; y (e) uno o mas tensioactivos; junto con uno o mas excipientes o vehiculos farmaceuticamente aceptables en los que: la osmolalidad de la nanoemulsion esta comprendida desde 100 mOsm/kg hasta 500 mOsm/kg; el tamano promedio de gota medido por dispersion dinamica de luz esta comprendido desde1 nm hasta 500 nm; la relacion en peso entre los componentes oleosos y la suma de los componentes oleosos y uno o mas tensioactivos esta comprendida desde 0,001 hasta 0,5; la relacion en peso entre el componente oleoso y el clobetasol esta comprendida desde 1:1 hasta 200:1; y la relacion en peso entre el tensioactivo y el clobetasol esta comprendida desde 2:1 hasta 200:1. Tambien se refiere a procedimientos para su preparacion, a su uso como medicamento y en la profilaxis y/o tratamiento de enfermedades o afecciones inflamatorias.
PE2019002570A 2017-06-23 2018-01-18 Una composicion de nanoemulsion de clobetasol de aceite en agua PE20200736A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP17382393 2017-06-23
PCT/EP2018/051218 WO2018233878A1 (en) 2017-06-23 2018-01-18 OIL NANOEMULSION COMPOSITION IN CLOBETASOL WATER

Publications (1)

Publication Number Publication Date
PE20200736A1 true PE20200736A1 (es) 2020-07-23

Family

ID=59285129

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2019002570A PE20200736A1 (es) 2017-06-23 2018-01-18 Una composicion de nanoemulsion de clobetasol de aceite en agua

Country Status (32)

Country Link
US (1) US10857160B2 (es)
EP (1) EP3641728B9 (es)
JP (1) JP7065895B2 (es)
KR (1) KR102571107B1 (es)
CN (1) CN110944625B (es)
AU (1) AU2018288256B2 (es)
CA (1) CA3067657A1 (es)
CL (1) CL2019003707A1 (es)
CO (1) CO2020000026A2 (es)
CR (1) CR20200024A (es)
CY (1) CY1124193T1 (es)
DK (1) DK3641728T3 (es)
DO (1) DOP2019000307A (es)
EC (1) ECSP19089679A (es)
ES (1) ES2875851T3 (es)
HR (1) HRP20210865T1 (es)
HU (1) HUE055016T2 (es)
IL (1) IL271474B (es)
LT (1) LT3641728T (es)
MX (1) MX2019015410A (es)
MY (1) MY190953A (es)
PE (1) PE20200736A1 (es)
PH (1) PH12019550291A1 (es)
PL (1) PL3641728T3 (es)
PT (1) PT3641728T (es)
RU (1) RU2759901C2 (es)
SA (1) SA519410841B1 (es)
SG (1) SG11201912393XA (es)
SI (1) SI3641728T1 (es)
TW (1) TWI768056B (es)
WO (1) WO2018233878A1 (es)
ZA (1) ZA202000128B (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024005726A1 (en) * 2022-06-30 2024-01-04 Ilko Ilac Sanayi Ve Ticaret A.S. Storage stable topical composition comprising clobetasol

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ZA966579B (en) * 1995-08-04 1998-02-02 Wakamoto Pharma Co Ltd O/W emulsion composition for eye drops.
ES2429040T5 (es) * 2004-08-31 2017-06-13 Stiefel Research Australia Pty Ltd Método y composiciones de microemulsión y emulsión submicrónica
US8449867B2 (en) * 2004-08-31 2013-05-28 Stiefel Research Australia Pty Ltd Microemulsion and sub-micron emulsion process and compositions
FR2889662B1 (fr) * 2005-08-11 2011-01-14 Galderma Res & Dev Emulsion de type huile-dans-eau pour application topique en dermatologie
KR101534422B1 (ko) * 2008-05-14 2015-07-09 오토노미, 인코포레이티드 귀 질환 치료를 위한 제어 방출형 코르티코스테로이드 조성물 및 방법
US20110045050A1 (en) * 2009-08-24 2011-02-24 Atrium Medical Corporation Nanoemulsion formulations for direct delivery
US9789123B2 (en) * 2010-10-21 2017-10-17 Cadila Healthcare Limited Topical pharmaceutical compositions containing nanodroplets for the treatment of psoriasis
MX2013004296A (es) * 2010-10-21 2013-09-26 Cadila Healthcare Ltd Composiciones farmaceuticas topicas que contienen gotas de tamaño nanometrico para el tratamiento de soriasis.
CN102283850B (zh) * 2011-08-25 2013-04-10 西北农林科技大学 一种水包油型复方酮康唑纳米药物及其制备方法
ES2922815T3 (es) * 2015-02-06 2022-09-20 Woodstock Sterile Solutions Inc Preparación de una emulsión de aceite en agua para formulaciones farmacéuticas estabilizadas con polímeros
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TWI773641B (zh) * 2015-05-08 2022-08-11 日商活效製藥股份有限公司 含有糖皮質類固醇（ｇｌｕｃｏｃｏｒｔｉｃｏｉｄｓ）之奈米微粒子之水性懸浮液劑
AU2016279801B2 (en) * 2015-06-18 2021-09-09 Valeant Pharmaceuticals North America Topical compositions comprising a corticosteroid and a retinoid for treating psoriasis
US20180235882A1 (en) 2015-09-02 2018-08-23 Cadila Healthcare Limited Topical compositions comprising corticosteroids

Also Published As

Publication number Publication date
SG11201912393XA (en) 2020-01-30
JP2020524672A (ja) 2020-08-20
CO2020000026A2 (es) 2020-04-24
TWI768056B (zh) 2022-06-21
RU2019144015A3 (es) 2021-07-23
CN110944625A (zh) 2020-03-31
PH12019550291A1 (en) 2021-01-11
HRP20210865T1 (hr) 2021-08-20
CA3067657A1 (en) 2018-12-27
KR20200019945A (ko) 2020-02-25
CY1124193T1 (el) 2022-05-27
TW201904562A (zh) 2019-02-01
LT3641728T (lt) 2021-08-10
ECSP19089679A (es) 2020-05-29
EP3641728A1 (en) 2020-04-29
MY190953A (en) 2022-05-24
CN110944625B (zh) 2022-05-03
US10857160B2 (en) 2020-12-08
IL271474B (en) 2022-09-01
HUE055016T2 (hu) 2021-10-28
DOP2019000307A (es) 2020-03-15
AU2018288256A1 (en) 2020-01-30
AU2018288256B2 (en) 2023-09-28
SA519410841B1 (ar) 2022-06-05
IL271474A (en) 2020-01-30
RU2019144015A (ru) 2021-07-23
PL3641728T3 (pl) 2021-09-20
SI3641728T1 (sl) 2021-08-31
US20190298737A1 (en) 2019-10-03
WO2018233878A1 (en) 2018-12-27
PT3641728T (pt) 2021-06-14
EP3641728B1 (en) 2021-03-10
EP3641728B9 (en) 2021-06-30
ZA202000128B (en) 2021-01-27
RU2759901C2 (ru) 2021-11-18
DK3641728T3 (da) 2021-06-07
JP7065895B2 (ja) 2022-05-12
ES2875851T3 (es) 2021-11-11
CL2019003707A1 (es) 2020-06-05
KR102571107B1 (ko) 2023-08-25
CR20200024A (es) 2020-03-12
MX2019015410A (es) 2021-09-30

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