AR040681A1 - Composicion de tabletas de liberacion sostenida de pramipexol - Google Patents

Composicion de tabletas de liberacion sostenida de pramipexol

Info

Publication number
AR040681A1
AR040681A1 AR20030102666A ARP030102666A AR040681A1 AR 040681 A1 AR040681 A1 AR 040681A1 AR 20030102666 A AR20030102666 A AR 20030102666A AR P030102666 A ARP030102666 A AR P030102666A AR 040681 A1 AR040681 A1 AR 040681A1
Authority
AR
Argentina
Prior art keywords
tablet
weight
amount
composition
sustained release
Prior art date
Application number
AR20030102666A
Other languages
English (en)
Inventor
Gregory Amidon
Loksidh Ganorkar
John Heimlich
Ernest Lee
Robert Noack
Joseph Reo
Connie Skoug
Original Assignee
Pharmacia Corp
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 Pharmacia Corp filed Critical Pharmacia Corp
Publication of AR040681A1 publication Critical patent/AR040681A1/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
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • 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
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

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

Abstract

Reivindicación 1: Una composición farmacéutica de liberación sostenida en forma de una tableta administrable por vía oral que comprende una sal de pramipexol soluble en agua, dispersada de una matriz que comprende una polímero hidrófilo y un almidón que tiene una resistencia a la tensión de al menos aproximadamente 0,15 KN cm-2, preferiblemente al menos aproximadamente 0,175 KN cm-2 y más preferiblemente al menos aproximadamente 0,2 KN cm-2 en una fracción sólida representativa de la tableta. Reivindicación 14: Una composición farmacéutica en forma de una tableta administrable por vía oral que tiene un núcleo que comprende diclorhidrato de pramipexol monohidrato en una cantidad de aproximadamente 0,375, 0,75, 1,5, 3 ó 4,5 mg, dispersado en una matriz que comprende (a) HPMC tipo 2208 en una cantidad de aproximadamente un 35% a aproximadamente un 50% en peso de la tableta y (b) un almidón pregelatinizado que tiene una resistencia a la tensión de al menos aproximadamente 0,15 KN cm-2 en un fracción sólida de 0,8, en una cantidad de aproximadamente un 45% a aproximadamente un 65% en peso de la tableta; estando dicho núcleo encerrado sustancialmente en un recubrimiento que constituye de aproximadamente un 2% a aproximadamente un 7% del peso de la tableta, comprendiendo dicho recubrimiento un componente hidrófobo a base de etilcelulosa o un componente insoluble en agua y un componente formador de poros de base de HPMC en una cantidad de aproximadamente un 10% a aproximadamente un 40% en peso del componente a base de etilcelulosa. Reivindicación 15: Un método de tratamiento de un paciente que tenga una enfermedad o un trastorno para el cual está indicado un agonista de los receptores D2 de la dopamina, comprendiendo el método la administración al paciente por vía oral de la composición farmacéutica de cualquiera de las reivindicaciones que anteceden.
AR20030102666A 2002-07-25 2003-07-24 Composicion de tabletas de liberacion sostenida de pramipexol AR040681A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39842702P 2002-07-25 2002-07-25
US39844702P 2002-07-25 2002-07-25
US47951303P 2003-06-18 2003-06-18

Publications (1)

Publication Number Publication Date
AR040681A1 true AR040681A1 (es) 2005-04-13

Family

ID=31192087

Family Applications (1)

Application Number Title Priority Date Filing Date
AR20030102666A AR040681A1 (es) 2002-07-25 2003-07-24 Composicion de tabletas de liberacion sostenida de pramipexol

Country Status (41)

Country Link
US (2) US20050226926A1 (es)
EP (2) EP1987832A1 (es)
JP (1) JP4700963B2 (es)
KR (1) KR100712832B1 (es)
CN (1) CN1313092C (es)
AP (1) AP2201A (es)
AR (1) AR040681A1 (es)
AT (1) ATE406162T1 (es)
AU (1) AU2003261241B2 (es)
BR (1) BR0312960A (es)
CA (1) CA2492854C (es)
CR (1) CR7661A (es)
CU (1) CU23440B7 (es)
CY (1) CY1110408T1 (es)
DE (1) DE60323235D1 (es)
DK (1) DK1531814T3 (es)
EA (2) EA009663B1 (es)
EC (1) ECSP055568A (es)
ES (1) ES2310673T3 (es)
GE (1) GEP20074048B (es)
HK (1) HK10777456A1 (es)
HR (1) HRP20041235B1 (es)
IL (1) IL166078A0 (es)
IS (1) IS7623A (es)
MA (1) MA27328A1 (es)
ME (1) MEP52308A (es)
MX (1) MXPA05001054A (es)
MY (1) MY138846A (es)
NO (1) NO334298B1 (es)
NZ (1) NZ537790A (es)
OA (1) OA13303A (es)
PA (1) PA8578301A1 (es)
PE (1) PE20040130A1 (es)
PL (1) PL215587B1 (es)
PT (1) PT1531814E (es)
RS (1) RS51719B (es)
SI (1) SI1531814T1 (es)
TW (1) TWI347849B (es)
UY (1) UY27912A1 (es)
WO (1) WO2004010997A1 (es)
ZA (1) ZA200500439B (es)

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