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MX2022016155A - Soluciones de esteroide neuroactivo y sus metodos de uso. - Google Patents

Soluciones de esteroide neuroactivo y sus metodos de uso.

Info

Publication number
MX2022016155A
MX2022016155A MX2022016155A MX2022016155A MX2022016155A MX 2022016155 A MX2022016155 A MX 2022016155A MX 2022016155 A MX2022016155 A MX 2022016155A MX 2022016155 A MX2022016155 A MX 2022016155A MX 2022016155 A MX2022016155 A MX 2022016155A
Authority
MX
Mexico
Prior art keywords
solution
neuroactive steroid
methods
months
weeks
Prior art date
Application number
MX2022016155A
Other languages
English (en)
Inventor
Francesco G Salituro
William Hunke
Albert Jean Robichaud
Paul Watson
Original Assignee
Sage Therapeutics Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57546448&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2022016155(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sage Therapeutics Inc filed Critical Sage Therapeutics Inc
Publication of MX2022016155A publication Critical patent/MX2022016155A/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/724Cyclodextrins
    • 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
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
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    • 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
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    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
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    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
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    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
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    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
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    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0006Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
    • C08B37/0009Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
    • C08B37/0012Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
    • C08B37/0015Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/04Preparation or injection of sample to be analysed
    • G01N30/06Preparation
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02Column chromatography
    • G01N30/88Integrated analysis systems specially adapted therefor, not covered by a single one of the groups G01N30/04 - G01N30/86
    • A61L2103/05

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Abstract

Se proporcionan en la presente soluciones acuosas farmacéuticamente aceptables que comprenden un esteroide neuroactivo, una sulfobutil éter beta ciclodextrina y una solución amortiguadora; en donde: la solución es una solución estable entre un pH de alrededor de 3 y alrededor de 9, por ejemplo, a temperatura ambiente, por al menos 1, 2, 3, 4 semanas; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 meses; 1, 2, 3 años o más; la solución amortiguadora se presenta a una concentración de al menos 0.1 nM; o la solución se mantiene sustancialmente libre de impurezas (por ejemplo, la solución está sustancialmente libre de impurezas a temperatura ambiente por al menos 1, 2, 3, 4 semanas; 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 meses; 1, 2, 3 años o más).
MX2022016155A 2015-06-18 2017-12-18 Soluciones de esteroide neuroactivo y sus metodos de uso. MX2022016155A (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201562181550P 2015-06-18 2015-06-18

Publications (1)

Publication Number Publication Date
MX2022016155A true MX2022016155A (es) 2023-02-22

Family

ID=57546448

Family Applications (3)

Application Number Title Priority Date Filing Date
MX2017016660A MX2017016660A (es) 2015-06-18 2016-06-17 Soluciones de esteroide neuroactivo y sus metodos de uso.
MX2022012383A MX2022012383A (es) 2015-06-18 2017-12-18 Soluciones de esteroide neuroactivo y sus metodos de uso.
MX2022016155A MX2022016155A (es) 2015-06-18 2017-12-18 Soluciones de esteroide neuroactivo y sus metodos de uso.

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Application Number Title Priority Date Filing Date
MX2017016660A MX2017016660A (es) 2015-06-18 2016-06-17 Soluciones de esteroide neuroactivo y sus metodos de uso.
MX2022012383A MX2022012383A (es) 2015-06-18 2017-12-18 Soluciones de esteroide neuroactivo y sus metodos de uso.

Country Status (21)

Country Link
US (3) US20190008873A1 (es)
EP (1) EP3310394A4 (es)
JP (3) JP2018521987A (es)
KR (1) KR20180018730A (es)
CN (2) CN113181112A (es)
AR (1) AR105044A1 (es)
AU (2) AU2016279000A1 (es)
BR (1) BR112017026909A2 (es)
CA (1) CA2988262A1 (es)
CO (1) CO2018000137A2 (es)
HK (1) HK1246676A1 (es)
IL (3) IL315367A (es)
JO (1) JO3759B1 (es)
MA (1) MA45276A (es)
MX (3) MX2017016660A (es)
PE (2) PE20180489A1 (es)
PH (2) PH12021552011A1 (es)
SG (1) SG10202012285QA (es)
TW (2) TWI805540B (es)
WO (1) WO2016205721A1 (es)
ZA (1) ZA201708412B (es)

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