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AR065827A2 - Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina, composicion farmaceutica, procedimiento y preparacion y su uso en terapia - Google Patents

Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina, composicion farmaceutica, procedimiento y preparacion y su uso en terapia

Info

Publication number
AR065827A2
AR065827A2 ARP060100016A ARP060100016A AR065827A2 AR 065827 A2 AR065827 A2 AR 065827A2 AR P060100016 A ARP060100016 A AR P060100016A AR P060100016 A ARP060100016 A AR P060100016A AR 065827 A2 AR065827 A2 AR 065827A2
Authority
AR
Argentina
Prior art keywords
sertraline
dosage form
release
sustained release
usp
Prior art date
Application number
ARP060100016A
Other languages
English (en)
Original Assignee
Pfizer
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 Pfizer filed Critical Pfizer
Publication of AR065827A2 publication Critical patent/AR065827A2/es

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/04—Anorexiants; Antiobesity agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Addiction (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

Una forma de dosificacion de liberacion sostenida apropiada para la administracion oral a un mamífero, que contiene sertralina, o una sal farmacéuticamente aceptable de la misma y un vehículo farmacéuticamente aceptable, liberando la forma de dosificacion la sertralina a una velocidad no inferior a 4mgA/h in vitro, cuando se ensaya la disolucion en un aparato USP-2, que contiene 900 ml de tampon acetato, con un pH 4,0, que es 0,075 M en NaCl, de la siguiente forma: (1) si dicha forma de dosificacion es un comprimido de liberacion sostenida o una cápsula de liberacion sostenida no disgregable, dicho aparato USP-2 está equipado con una pala que se agita a una velocidad de 50rpm; o (2) si dicha forma de dosificacion es un sistema multiparticular, dicho aparato USP-2 está equipado con una pala que se agita a 10 rpm; siempre que dicha forma de dosificacion (a) no libere más del 70% de sertralina contenida en la misma en la primera hora después del comienzo del ensayo y (b) libere la sertralina al menos a 1 mgA/h. Reivindicacion 55: Un compuesto util para una forma de dosificacion de acuerdo con cualquiera de las reivindicaciones precedentes, caracterizado porque es acetato de sertralina. Reivindicacion 61: Un compuesto util para una forma de dosificacion de acuerdo con cualquiera de las reivindicaciones precedentes, caracterizado porque es L-lactato de sertralina.
ARP060100016A 1997-07-01 2006-01-03 Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina, composicion farmaceutica, procedimiento y preparacion y su uso en terapia AR065827A2 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US5142097P 1997-07-01 1997-07-01
US5149897P 1997-07-01 1997-07-01
US5140297P 1997-07-01 1997-07-01
US5141497P 1997-07-01 1997-07-01

Publications (1)

Publication Number Publication Date
AR065827A2 true AR065827A2 (es) 2009-07-08

Family

ID=27489408

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP980103148A AR015919A1 (es) 1997-07-01 1998-06-29 Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina ,composicion farmaceutica, procedimiento depreparacion y su uso en terapias.
ARP060100016A AR065827A2 (es) 1997-07-01 2006-01-03 Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina, composicion farmaceutica, procedimiento y preparacion y su uso en terapia

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP980103148A AR015919A1 (es) 1997-07-01 1998-06-29 Formas de dosificacion de liberacion sostenida de sertralina, sales de sertralina ,composicion farmaceutica, procedimiento depreparacion y su uso en terapias.

Country Status (32)

Country Link
US (1) US6517866B1 (es)
EP (1) EP0999830A1 (es)
JP (1) JP2000514101A (es)
KR (2) KR100446366B1 (es)
CN (1) CN1256085C (es)
AP (1) AP1526A (es)
AR (2) AR015919A1 (es)
AU (1) AU739261B2 (es)
BG (1) BG103915A (es)
BR (1) BR9810403A (es)
CA (1) CA2290966C (es)
CO (1) CO4940402A1 (es)
DZ (1) DZ2546A1 (es)
EA (1) EA002482B1 (es)
HR (1) HRP980379B1 (es)
HU (1) HUP0002296A3 (es)
ID (1) ID23503A (es)
IL (2) IL133080A0 (es)
IS (1) IS5265A (es)
MY (1) MY129175A (es)
NO (1) NO996518L (es)
NZ (2) NZ501251A (es)
OA (1) OA11245A (es)
PA (1) PA8454401A1 (es)
PE (1) PE88699A1 (es)
PL (1) PL337806A1 (es)
SK (1) SK180499A3 (es)
TN (1) TNSN98125A1 (es)
TR (1) TR199903280T2 (es)
TW (1) TWI241188B (es)
UY (1) UY25067A1 (es)
WO (1) WO1999001121A1 (es)

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