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
Links
- ADEBPBSSDYVVLD-UHFFFAOYSA-N donepezil Chemical compound O=C1C=2C=C(OC)C(OC)=CC=2CC1CC(CC1)CCN1CC1=CC=CC=C1 ADEBPBSSDYVVLD-UHFFFAOYSA-N 0.000 title abstract 12
- 229960003530 donepezil Drugs 0.000 title abstract 6
- 238000010521 absorption reaction Methods 0.000 title abstract 5
- 238000002360 preparation method Methods 0.000 title abstract 5
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 abstract 5
- WMBWREPUVVBILR-WIYYLYMNSA-N (-)-Epigallocatechin-3-o-gallate Chemical compound O([C@@H]1CC2=C(O)C=C(C=C2O[C@@H]1C=1C=C(O)C(O)=C(O)C=1)O)C(=O)C1=CC(O)=C(O)C(O)=C1 WMBWREPUVVBILR-WIYYLYMNSA-N 0.000 abstract 4
- 230000007774 longterm Effects 0.000 abstract 3
- 238000003860 storage Methods 0.000 abstract 3
- 229930013915 (+)-catechin Natural products 0.000 abstract 2
- 235000007219 (+)-catechin Nutrition 0.000 abstract 2
- PFTAWBLQPZVEMU-DZGCQCFKSA-N (+)-catechin Chemical compound C1([C@H]2OC3=CC(O)=CC(O)=C3C[C@@H]2O)=CC=C(O)C(O)=C1 PFTAWBLQPZVEMU-DZGCQCFKSA-N 0.000 abstract 2
- WMBWREPUVVBILR-UHFFFAOYSA-N GCG Natural products C=1C(O)=C(O)C(O)=CC=1C1OC2=CC(O)=CC(O)=C2CC1OC(=O)C1=CC(O)=C(O)C(O)=C1 WMBWREPUVVBILR-UHFFFAOYSA-N 0.000 abstract 2
- 235000010323 ascorbic acid Nutrition 0.000 abstract 2
- 229960005070 ascorbic acid Drugs 0.000 abstract 2
- 239000011668 ascorbic acid Substances 0.000 abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 2
- 229940030275 epigallocatechin gallate Drugs 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- CIWBSHSKHKDKBQ-DUZGATOHSA-N D-isoascorbic acid Chemical compound OC[C@@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-DUZGATOHSA-N 0.000 abstract 1
- 206010012289 Dementia Diseases 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 238000000354 decomposition reaction Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 235000010350 erythorbic acid Nutrition 0.000 abstract 1
- 239000012535 impurity Substances 0.000 abstract 1
- 230000002401 inhibitory effect Effects 0.000 abstract 1
- 229940026239 isoascorbic acid Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- PJUIMOJAAPLTRJ-UHFFFAOYSA-N monothioglycerol Chemical compound OCC(O)CS PJUIMOJAAPLTRJ-UHFFFAOYSA-N 0.000 abstract 1
- 238000004321 preservation Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 150000003567 thiocyanates Chemical class 0.000 abstract 1
Classifications
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal 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
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal 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
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs 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
-
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/20—Organic 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
-
- 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
- A61K47/22—Heterocyclic 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.
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)
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)
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 |
-
2020
- 2020-05-13 KR KR1020200057402A patent/KR102218593B1/ko active IP Right Grant
-
2021
- 2021-05-12 MA MA58444A patent/MA58444B1/fr unknown
- 2021-05-12 EP EP21805158.9A patent/EP4149442A4/en active Pending
- 2021-05-12 PE PE2022002555A patent/PE20240490A1/es unknown
- 2021-05-12 WO PCT/KR2021/005930 patent/WO2021230647A1/en active Application Filing
- 2021-05-12 CA CA3181045A patent/CA3181045C/en active Active
- 2021-05-12 MX MX2022013702A patent/MX2022013702A/es unknown
- 2021-05-12 US US17/924,781 patent/US20230201131A1/en active Pending
- 2021-05-12 JP JP2022568614A patent/JP7419565B2/ja active Active
- 2021-05-12 CN CN202180034892.5A patent/CN115666536A/zh active Pending
- 2021-05-12 AU AU2021270155A patent/AU2021270155B2/en active Active
- 2021-05-12 BR BR112022023127A patent/BR112022023127A2/pt unknown
-
2022
- 2022-10-26 ZA ZA2022/11680A patent/ZA202211680B/en unknown
- 2022-10-27 CL CL2022002984A patent/CL2022002984A1/es unknown
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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