PE20220936A1 - Composiciones farmaceuticas de combinacion a dosis fijas de liberacion inmediata, metodos y usos de las mismas - Google Patents

Composiciones farmaceuticas de combinacion a dosis fijas de liberacion inmediata, metodos y usos de las mismas

Info

Publication number
PE20220936A1
PE20220936A1 PE2021001939A PE2021001939A PE20220936A1 PE 20220936 A1 PE20220936 A1 PE 20220936A1 PE 2021001939 A PE2021001939 A PE 2021001939A PE 2021001939 A PE2021001939 A PE 2021001939A PE 20220936 A1 PE20220936 A1 PE 20220936A1
Authority
PE
Peru
Prior art keywords
composition
memantine
donepezil
dose combination
methods
Prior art date
Application number
PE2021001939A
Other languages
English (en)
Inventor
Machuco Estevens Maria Catarina Oliveira
Marques Da Costa Ricardo Manuel Silva
Serra João Pedro Silva
Filipe Augusto Eugenio Pardal
Original Assignee
Tecnimede Soc Tecnico Medicinal 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 Tecnimede Soc Tecnico Medicinal Sa filed Critical Tecnimede Soc Tecnico Medicinal Sa
Publication of PE20220936A1 publication Critical patent/PE20220936A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Hospice & Palliative Care (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

La presente invencion se refiere a una composicion farmaceutica de combinacion que comprende: desde 4,16 mg hasta 20 mg de memantina o una sal farmaceuticamente aceptable; y desde 4,56 mg hasta 10 mg de donepezilo o una sal farmaceuticamente aceptable; en donde la memantina y el donepezilo son los unicos principios activos; en donde la composicion farmaceutica esta libre de lactosa y menos del 1,0% en peso de azucares reductores en relacion con el peso total de la composicion. La composicion ademas comprende desde 45,0% hasta 70,0% en peso de manitol. Tambien se refiere a un procedimiento de fabricacion. Dicha composicion farmaceutica posee una tasa de disolucion de memantina y donepezilo a pH 1 mayor a 91% en el plazo de 5 minutos, siendo considerada una combinacion a dosis fija oral de liberacion inmediata util en el tratamiento o terapia de la enfermedad de Alzheimer de moderada a grave.
PE2021001939A 2019-05-31 2020-05-29 Composiciones farmaceuticas de combinacion a dosis fijas de liberacion inmediata, metodos y usos de las mismas PE20220936A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PT11555719 2019-05-31
PCT/IB2020/055137 WO2020240505A1 (en) 2019-05-31 2020-05-29 Immediate release fixed-dose combination of memantine and donepezil

Publications (1)

Publication Number Publication Date
PE20220936A1 true PE20220936A1 (es) 2022-05-31

Family

ID=71092565

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2021001939A PE20220936A1 (es) 2019-05-31 2020-05-29 Composiciones farmaceuticas de combinacion a dosis fijas de liberacion inmediata, metodos y usos de las mismas

Country Status (13)

Country Link
EP (2) EP3843702B1 (es)
BR (1) BR112021024054A2 (es)
CL (1) CL2021002911A1 (es)
CO (1) CO2021014967A2 (es)
DK (1) DK3843702T3 (es)
FI (1) FI3843702T3 (es)
HR (1) HRP20231200T1 (es)
IL (1) IL288505A (es)
MX (1) MX2021014673A (es)
PE (1) PE20220936A1 (es)
PT (1) PT3843702T (es)
SI (1) SI3843702T1 (es)
WO (1) WO2020240505A1 (es)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI95572C (fi) 1987-06-22 1996-02-26 Eisai Co Ltd Menetelmä lääkeaineena käyttökelpoisen piperidiinijohdannaisten tai sen farmaseuttisen suolan valmistamiseksi
EP0392059B1 (de) 1989-04-14 1993-09-15 Merz & Co. GmbH & Co. Verwendung von Adamantan-Derivaten zur Prävention und Behandlung der cerebralen Ischämie
AU1153097A (en) 1996-06-07 1998-01-05 Eisai Co. Ltd. Stable polymorphs of donepezil (1-benzyl-4-{(5,6-dimethoxy-1-indanon)-2-yl}methylpiperidine ) hydrochloride and process for production
JP2005528431A (ja) 2002-05-31 2005-09-22 ハー・ルンドベック・アクチエゼルスカベット アルツハイマー病を治療するためのnmda−アンタゴニスト及びアセチルコリンエステラーゼ阻害剤の組み合わせ物
AU2003274353B2 (en) 2002-10-24 2007-04-05 Merz Pharma Gmbh & Co. Kgaa Combination therapy using 1-aminocyclohexane derivatives and acetylcholinesterase inhibitors
EP1836157B1 (en) 2005-01-11 2009-10-07 Teva Pharmaceutical Fine Chemicals S.R.L. Process for the preparation of 1-amino-3,5-dimethyladamantane hydrochloride
PL1874282T3 (pl) 2005-04-06 2011-04-29 Adamas Pharmaceuticals Inc Sposoby i kompozycje do leczenia zaburzeń OUN
WO2018062941A1 (ko) * 2016-09-30 2018-04-05 주식회사 바이오파마티스 도네페질 또는 그의 약학적으로 허용 가능한 염 및 메만틴 또는 그의 약학적으로 허용 가능한 염을 함유하는 치매 및 인지기능 장애 예방 또는 치료용 약학 조성물 및 이의 제조방법

Also Published As

Publication number Publication date
EP4238555A2 (en) 2023-09-06
DK3843702T3 (da) 2023-10-09
SI3843702T1 (sl) 2023-12-29
MX2021014673A (es) 2022-01-11
HRP20231200T1 (hr) 2024-01-19
CL2021002911A1 (es) 2022-07-15
EP3843702A1 (en) 2021-07-07
PT3843702T (pt) 2023-10-13
BR112021024054A2 (pt) 2022-01-11
WO2020240505A1 (en) 2020-12-03
CO2021014967A2 (es) 2021-11-19
IL288505A (en) 2022-01-01
EP4238555A3 (en) 2023-09-20
EP3843702B1 (en) 2023-07-05
FI3843702T3 (fi) 2023-10-09

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