PE20211479A1 - Composicion farmaceutica y metodo de fabricacion - Google Patents

Composicion farmaceutica y metodo de fabricacion

Info

Publication number
PE20211479A1
PE20211479A1 PE2020001435A PE2020001435A PE20211479A1 PE 20211479 A1 PE20211479 A1 PE 20211479A1 PE 2020001435 A PE2020001435 A PE 2020001435A PE 2020001435 A PE2020001435 A PE 2020001435A PE 20211479 A1 PE20211479 A1 PE 20211479A1
Authority
PE
Peru
Prior art keywords
range
pharmaceutical composition
metaarsenite
enteric
approximately
Prior art date
Application number
PE2020001435A
Other languages
English (en)
Inventor
Yong-Jin Yang
Original Assignee
Komipharm Int Australia Pty Ltd
Panaphix 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
Priority claimed from AU2018900954A external-priority patent/AU2018900954A0/en
Application filed by Komipharm Int Australia Pty Ltd, Panaphix Inc filed Critical Komipharm Int Australia Pty Ltd
Publication of PE20211479A1 publication Critical patent/PE20211479A1/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
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/24Heavy metals; Compounds thereof
    • A61K33/36Arsenic; Compounds thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/18Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/04Antineoplastic agents specific for metastasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/2063Proteins, e.g. gelatin
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Immunology (AREA)
  • Oncology (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Neurology (AREA)
  • Emergency Medicine (AREA)
  • Endocrinology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Neurosurgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Rheumatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

La presente solicitud se refiere a una composicion farmaceutica adecuada para la administracion oral que comprende: a) un nucleo solido compuesto por metaarsenito de sodio o metaarsenito de potasio y excipientes farmaceuticos tales como: i) un material de relleno o diluyente en un rango de aproximadamente 5 a 95% p/p, ii) un desintegrante en un rango de 10 y 90% p/p, iii) un deslizante en un rango de aproximadamente 0,1 a 5% p/p, iv) un lubricante en un rango de aproximadamente 0,1 a 5% p/p, y v) opcionalmente, un aglutinante en un rango de 0 a aproximadamente 30% p/p; y b) un cubierta enterica que comprende un polimero enterico; donde los excipientes de uso farmaceutico aceptable estan seleccionados de tal forma que la oxidacion de metaarsenito a metaarseniato esta minimizada, donde el porcentaje en peso de la cubierta enterica es de 6% p/p a 20% p/p con respecto al peso total de la composicion farmaceutica, y donde el grosor de la cubierta es de 6,5% a 15% del grosor de la composicion farmaceutica.
PE2020001435A 2018-03-22 2019-03-21 Composicion farmaceutica y metodo de fabricacion PE20211479A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2018900954A AU2018900954A0 (en) 2018-03-22 Pharmaceutical composition and method of manufacture
PCT/AU2019/050249 WO2019178643A1 (en) 2018-03-22 2019-03-21 Pharmaceutical composition comprising meta arsenite and method of manufacture

Publications (1)

Publication Number Publication Date
PE20211479A1 true PE20211479A1 (es) 2021-08-05

Family

ID=67988234

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2020001435A PE20211479A1 (es) 2018-03-22 2019-03-21 Composicion farmaceutica y metodo de fabricacion

Country Status (20)

Country Link
US (1) US20210000746A1 (es)
EP (1) EP3768247A4 (es)
JP (1) JP7419333B2 (es)
KR (1) KR20210016513A (es)
CN (1) CN112135608A (es)
AR (1) AR114596A1 (es)
AU (1) AU2019239671A1 (es)
BR (1) BR112020019425A2 (es)
CA (1) CA3094115A1 (es)
CL (1) CL2020002407A1 (es)
CO (1) CO2020012963A2 (es)
EA (1) EA202092186A1 (es)
IL (1) IL277456A (es)
JO (1) JOP20200238A1 (es)
MA (1) MA52088A (es)
MX (1) MX2020009756A (es)
PE (1) PE20211479A1 (es)
PH (1) PH12020551518A1 (es)
SG (1) SG11202009174WA (es)
WO (1) WO2019178643A1 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230123135A1 (en) * 2020-02-16 2023-04-20 Komipharm International Australia Pty Ltd Method of treatment using meta-arsenite

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5162117A (en) * 1991-11-22 1992-11-10 Schering Corporation Controlled release flutamide composition
US5318973A (en) * 1993-06-07 1994-06-07 Vyzkumny Ustav Pro Farmacii A Biochemii Neuroprotective composition for preventing or treating of central nervous system impairment
JP4036936B2 (ja) * 1997-10-22 2008-01-23 古河機械金属株式会社 排酸の処理法
US6262086B1 (en) * 1999-08-26 2001-07-17 Robert R. Whittle Pharmaceutical unit dosage form
KR20020083678A (ko) * 2001-04-28 2002-11-04 주식회사 한국미생물연구소 아르세닉산나트륨 염, 소디움 메타아르세나이트 또는 이의혼합물을 함유한 항암제 조성물
CA2471715A1 (en) * 2001-12-28 2003-07-17 Teva Pharmaceutical Industries Ltd. A stable pharmaceutical formulation of paroxetine hydrochloride anhydrous and a process for preparation thereof
US20090061022A1 (en) * 2004-10-08 2009-03-05 Sang Bong Lee Pharmaceutical composition comprising arsenite for the treatment of malignancy
WO2006104292A1 (en) * 2005-03-31 2006-10-05 Komipharm International Co., Ltd. Pharmaceutical composition comprising arsenic acid, meta-arsenite, and pharmaceutically acceptable salts
EP1721615A1 (en) * 2005-05-09 2006-11-15 Komipharm International Co., Ltd. Pharmaceutical compositions comprising sodium or potassium arsenite for the treatment of urogenital cancer and its metastasis
US8945505B2 (en) * 2007-02-02 2015-02-03 Panaphix, Inc. Use of arsenic compounds for treatment of pain and inflammation
KR20090058423A (ko) * 2007-12-04 2009-06-09 심형섭 소디움 메타아르세나이트를 함유하는 c형 바이러스성 간염치료용 조성물
US20090246291A1 (en) * 2008-03-27 2009-10-01 Angelika Burger Method and compositions for treatment of cancer
US20120045520A1 (en) * 2008-08-21 2012-02-23 Sang Bong Lee Pharmaceutical composition comprising arsenite for the treatment of malignancy
MX2012002922A (es) * 2009-09-18 2012-09-07 Kominox Inc Metodos para tratar tumores del cerebro.

Also Published As

Publication number Publication date
JP2021518434A (ja) 2021-08-02
AU2019239671A1 (en) 2020-10-01
JP7419333B2 (ja) 2024-01-22
CO2020012963A2 (es) 2020-10-30
EA202092186A1 (ru) 2020-12-16
JOP20200238A1 (ar) 2020-09-20
IL277456A (en) 2020-11-30
CL2020002407A1 (es) 2021-04-09
CN112135608A (zh) 2020-12-25
SG11202009174WA (en) 2020-10-29
EP3768247A1 (en) 2021-01-27
CA3094115A1 (en) 2019-09-26
PH12020551518A1 (en) 2021-07-12
MX2020009756A (es) 2021-01-29
WO2019178643A1 (en) 2019-09-26
KR20210016513A (ko) 2021-02-16
AR114596A1 (es) 2020-09-23
BR112020019425A2 (pt) 2020-12-29
US20210000746A1 (en) 2021-01-07
EP3768247A4 (en) 2021-12-29
MA52088A (fr) 2021-01-27

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