MX2022013702A - Preparacion de absorcion percutanea que comprende donepezil con estabilidad mejorada. - Google Patents

Preparacion de absorcion percutanea que comprende donepezil con estabilidad mejorada.

Info

Publication number
MX2022013702A
MX2022013702A MX2022013702A MX2022013702A MX2022013702A MX 2022013702 A MX2022013702 A MX 2022013702A MX 2022013702 A MX2022013702 A MX 2022013702A MX 2022013702 A MX2022013702 A MX 2022013702A MX 2022013702 A MX2022013702 A MX 2022013702A
Authority
MX
Mexico
Prior art keywords
donepezil
percutaneous absorption
absorption preparation
catechin
long
Prior art date
Application number
MX2022013702A
Other languages
English (en)
Inventor
Hyun-Jung Kim
Sun - Woo Jang
Chang - Yell Shin
Hae - Sun KIM
Kwang - Ho Cha
Masaoki Goto
Sang - Min HYUN
Original Assignee
Dong A St Co Ltd
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 Dong A St Co Ltd filed Critical Dong A St Co Ltd
Publication of MX2022013702A publication Critical patent/MX2022013702A/es

Links

Classifications

    • 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
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • 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
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • A61K9/703Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
    • A61K9/7038Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
    • A61K9/7046Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
    • A61K9/7053Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • 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
    • 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
    • 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
    • A61K47/08Organic 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
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • 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
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La presente invención se relaciona a una preparación de absorción percutánea para el tratamiento de demencia en donde la capa que contiene fármaco comprende donepezil o una sal farmacéuticamente aceptable del mismo como un ingrediente activo y un estabilizador que es ya sea (i) una mezcla de una sal de tiocianato y un compuesto seleccionado del grupo que consiste de catequina de té, (+)-catequina, galato de epigalocatequina, ácido ascórbico y ácido isoascórbico, o (ii) una mezcla de monotioglicerol y un compuesto seleccionado del grupo que consiste de catequina de té, (+)-catequina, galato de epigalocatequina y ácido ascórbico. La presente invención proporciona una preparación de absorción percutánea que comprende donepezil que cumple los criterios del Procedimiento 1 y Procedimiento 2 presentados en la Farmacopea de los Estados Unidos en la prueba de estrés a corto plazo (70ºC 48 horas de almacenamiento), prueba 1 acelerada a largo plazo (40ºC humedad relativa 75% 1 mes de almacenamiento) y prueba 2 acelerada a largo plazo (40ºC humedad relativa 75% 3 meses de almacenamiento). La preparación de absorción percutánea que contiene donepezil reduce la producción de impurezas al inhibir la descomposición de donepezil, para de esta manera hacerlo posible para hacer una preparación de absorción percutánea que comprende donepezil con estabilidad mejorada para conservación a largo plazo.
MX2022013702A 2020-05-13 2021-05-12 Preparacion de absorcion percutanea que comprende donepezil con estabilidad mejorada. MX2022013702A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020200057402A KR102218593B1 (ko) 2020-05-13 2020-05-13 안정성이 향상된 도네페질 함유 경피 흡수제제
PCT/KR2021/005930 WO2021230647A1 (en) 2020-05-13 2021-05-12 Percutaneous absorption preparation comprising donepezil with improved stability

Publications (1)

Publication Number Publication Date
MX2022013702A true MX2022013702A (es) 2022-12-07

Family

ID=74687455

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022013702A MX2022013702A (es) 2020-05-13 2021-05-12 Preparacion de absorcion percutanea que comprende donepezil con estabilidad mejorada.

Country Status (14)

Country Link
US (1) US20230201131A1 (es)
EP (1) EP4149442A4 (es)
JP (1) JP7419565B2 (es)
KR (1) KR102218593B1 (es)
CN (1) CN115666536A (es)
AU (1) AU2021270155B2 (es)
BR (1) BR112022023127A2 (es)
CA (1) CA3181045C (es)
CL (1) CL2022002984A1 (es)
MA (1) MA58444B1 (es)
MX (1) MX2022013702A (es)
PE (1) PE20240490A1 (es)
WO (1) WO2021230647A1 (es)
ZA (1) ZA202211680B (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102218593B1 (ko) * 2020-05-13 2021-02-22 동아에스티 주식회사 안정성이 향상된 도네페질 함유 경피 흡수제제

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8481565B2 (en) * 2004-12-27 2013-07-09 Eisai R&D Management Co., Ltd. Method for stabilizing anti-dementia drug
WO2008066185A1 (fr) 2006-12-01 2008-06-05 Nitto Denko Corporation Procédé destiné à prévenir la décoloration provoquée par le temps d'une préparation d'adhésif cutané contenant du donépézil
WO2008066180A1 (fr) 2006-12-01 2008-06-05 Nitto Denko Corporation Préparation d'adhésif cutané comprenant du donépézil stabilisé
KR101454362B1 (ko) * 2008-03-24 2014-10-23 아이큐어 주식회사 도네페질을 유효성분으로 함유하는 치매 치료용경피흡수제제
KR100907660B1 (ko) * 2009-01-22 2009-07-13 (주)바이오제닉스 코팅된 항산화제 입자, 이를 포함하는 조성물 및 그 제조 방법
KR101485822B1 (ko) * 2014-01-22 2015-01-23 주식회사 대웅제약 도네페질 또는 그의 염을 함유하는 경피흡수제제
KR102024996B1 (ko) * 2017-12-27 2019-09-25 동아에스티 주식회사 도네페질을 함유하는 치매 치료용 경피흡수제제
KR102115102B1 (ko) 2018-12-21 2020-05-26 동아에스티 주식회사 안정화된 도네페질 함유 경피 흡수제제
KR102218593B1 (ko) * 2020-05-13 2021-02-22 동아에스티 주식회사 안정성이 향상된 도네페질 함유 경피 흡수제제

Also Published As

Publication number Publication date
CA3181045C (en) 2024-05-21
BR112022023127A2 (pt) 2022-12-20
CL2022002984A1 (es) 2023-05-12
ZA202211680B (en) 2023-07-26
AU2021270155A1 (en) 2022-11-24
CA3181045A1 (en) 2021-11-18
MA58444A1 (fr) 2023-03-31
JP2023525533A (ja) 2023-06-16
AU2021270155B2 (en) 2023-11-09
WO2021230647A1 (en) 2021-11-18
EP4149442A1 (en) 2023-03-22
CN115666536A (zh) 2023-01-31
MA58444B1 (fr) 2023-09-27
EP4149442A4 (en) 2024-05-29
JP7419565B2 (ja) 2024-01-22
PE20240490A1 (es) 2024-03-15
KR102218593B1 (ko) 2021-02-22
US20230201131A1 (en) 2023-06-29

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