DOP2019000307A - Una composición de nanoemulsión de clobetasol de aceite en agua - Google Patents

Una composición de nanoemulsión de clobetasol de aceite en agua

Info

Publication number
DOP2019000307A
DOP2019000307A DO2019000307A DO2019000307A DOP2019000307A DO P2019000307 A DOP2019000307 A DO P2019000307A DO 2019000307 A DO2019000307 A DO 2019000307A DO 2019000307 A DO2019000307 A DO 2019000307A DO P2019000307 A DOP2019000307 A DO P2019000307A
Authority
DO
Dominican Republic
Prior art keywords
oil
clobetasol
nanoemulsion
water
weight ratio
Prior art date
Application number
DO2019000307A
Other languages
English (en)
Inventor
Sanagustin Aquilue Javier
Del Carmen Lendinez Gris Maria
Maria Delgado Gañan Isabel
Original Assignee
Salvat Lab 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 Salvat Lab Sa filed Critical Salvat Lab Sa
Publication of DOP2019000307A publication Critical patent/DOP2019000307A/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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (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)
  • Organic Chemistry (AREA)
  • Ophthalmology & Optometry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Rheumatology (AREA)
  • Pain & Pain Management (AREA)
  • Biophysics (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Otolaryngology (AREA)
  • Physiology (AREA)
  • Nutrition Science (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 nanoemulsión de aceite en agua que tiene una fase acuosa continua y gotas de aceite dispersas, donde la nanoemulsión comprende: (a) clobetasol; (b) uno o más componentes oleosos; y (c) uno o más tensioactivos; junto con uno o más excipientes o vehículos donde: la osmolalidad de la nanoemulsión es desde 100 hasta 500 mOsm/kg; el tamaño promedio de gota es desde 1 hasta 500 nm; la relación en peso entre los componentes oleosos y la suma de los componentes oleosos y uno o más tensioactivos es desde 0,001 hasta 0,5; la relación en peso entre el componente oleoso y el clobetasol es desde 1:1 hasta 200:1; y la relación en peso entre el tensioactivo y el clobetasol es desde 2:1 hasta 200:1. También se refiere a procedimientos para su preparación, a su uso como medicamento y para la profilaxis y/o tratamiento de la inflamación.
DO2019000307A 2017-06-23 2019-12-05 Una composición de nanoemulsión de clobetasol de aceite en agua DOP2019000307A (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
DOP2019000307A true DOP2019000307A (es) 2020-03-15

Family

ID=59285129

Family Applications (1)

Application Number Title Priority Date Filing Date
DO2019000307A DOP2019000307A (es) 2017-06-23 2019-12-05 Una composición de nanoemulsión 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

Family Cites Families (14)

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ZA966579B (en) * 1995-08-04 1998-02-02 Wakamoto Pharma Co Ltd O/W emulsion composition for eye drops.
US8449867B2 (en) * 2004-08-31 2013-05-28 Stiefel Research Australia Pty Ltd Microemulsion and sub-micron emulsion process and compositions
ES2429040T5 (es) * 2004-08-31 2017-06-13 Stiefel Research Australia Pty Ltd Método y composiciones de microemulsión y emulsión submicrónica
FR2889662B1 (fr) * 2005-08-11 2011-01-14 Galderma Res & Dev Emulsion de type huile-dans-eau pour application topique en dermatologie
CN102026623B (zh) * 2008-05-14 2013-08-14 奥德纳米有限公司 用于治疗耳部病症的控制释放皮质类固醇组合物和方法
US20110045050A1 (en) * 2009-08-24 2011-02-24 Atrium Medical Corporation Nanoemulsion formulations for direct delivery
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.
US9789123B2 (en) 2010-10-21 2017-10-17 Cadila Healthcare Limited Topical pharmaceutical compositions containing nanodroplets for the treatment of psoriasis
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
KR20170113568A (ko) * 2015-02-06 2017-10-12 알.피.쉐러 테크놀러지즈 엘엘씨 폴리머 안정화된 약학 제제용 수중 유 에멀전의 제조
CA2976952A1 (en) 2015-03-05 2016-09-09 Allergan, Inc. Self-emulsifying drug delivery system (sedds) for ophthalmic drug delivery
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
WO2016205001A1 (en) * 2015-06-18 2016-12-22 Valeant Pharmaceuticals North America Topical compositions comprising a corticosteroid and a retinoid for treating psoriasis
WO2017037663A1 (en) * 2015-09-02 2017-03-09 Cadila Healthcare Limited Topical compositions comprising corticosteroids

Also Published As

Publication number Publication date
ZA202000128B (en) 2021-01-27
CA3067657A1 (en) 2018-12-27
SI3641728T1 (sl) 2021-08-31
US20190298737A1 (en) 2019-10-03
CY1124193T1 (el) 2022-05-27
DK3641728T3 (da) 2021-06-07
TWI768056B (zh) 2022-06-21
CO2020000026A2 (es) 2020-04-24
JP2020524672A (ja) 2020-08-20
SG11201912393XA (en) 2020-01-30
HRP20210865T1 (hr) 2021-08-20
RU2019144015A (ru) 2021-07-23
EP3641728B9 (en) 2021-06-30
ES2875851T3 (es) 2021-11-11
AU2018288256A1 (en) 2020-01-30
CL2019003707A1 (es) 2020-06-05
CR20200024A (es) 2020-03-12
WO2018233878A1 (en) 2018-12-27
JP7065895B2 (ja) 2022-05-12
TW201904562A (zh) 2019-02-01
PE20200736A1 (es) 2020-07-23
RU2019144015A3 (es) 2021-07-23
ECSP19089679A (es) 2020-05-29
AU2018288256B2 (en) 2023-09-28
CN110944625A (zh) 2020-03-31
RU2759901C2 (ru) 2021-11-18
US10857160B2 (en) 2020-12-08
IL271474A (en) 2020-01-30
EP3641728B1 (en) 2021-03-10
IL271474B (en) 2022-09-01
LT3641728T (lt) 2021-08-10
PH12019550291A1 (en) 2021-01-11
HUE055016T2 (hu) 2021-10-28
SA519410841B1 (ar) 2022-06-05
CN110944625B (zh) 2022-05-03
EP3641728A1 (en) 2020-04-29
MY190953A (en) 2022-05-24
KR20200019945A (ko) 2020-02-25
PL3641728T3 (pl) 2021-09-20
KR102571107B1 (ko) 2023-08-25
MX2019015410A (es) 2021-09-30
PT3641728T (pt) 2021-06-14

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