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PE20030399A1 - Formas de administracion de propiverina o sus sales farmaceuticamente aceptables con liberacion prolongada de la sustancia activa - Google Patents

Formas de administracion de propiverina o sus sales farmaceuticamente aceptables con liberacion prolongada de la sustancia activa

Info

Publication number
PE20030399A1
PE20030399A1 PE2002000989A PE2002000989A PE20030399A1 PE 20030399 A1 PE20030399 A1 PE 20030399A1 PE 2002000989 A PE2002000989 A PE 2002000989A PE 2002000989 A PE2002000989 A PE 2002000989A PE 20030399 A1 PE20030399 A1 PE 20030399A1
Authority
PE
Peru
Prior art keywords
hours
prolonged release
administration
propiverine
forms
Prior art date
Application number
PE2002000989A
Other languages
English (en)
Inventor
Thomas Gramatte
Peter Gruber
Peter Guldner
Wolfgang Wehner
Dirk Pamperin
Jan Ploen
Steffen Scheithauer
Michael Heschel
Original Assignee
Apogepha Arzneimittel Gmbh
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 Apogepha Arzneimittel Gmbh filed Critical Apogepha Arzneimittel Gmbh
Publication of PE20030399A1 publication Critical patent/PE20030399A1/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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • 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
    • 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
    • A61K31/45Non condensed piperidines, e.g. piperocaine having oxo groups directly attached to the heterocyclic ring, e.g. cycloheximide
    • 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
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/06Anti-spasmodics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/10Drugs for disorders of the urinary system of the bladder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (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)
  • Urology & Nephrology (AREA)
  • Inorganic Chemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

SE REFIERE A UNA COMPOSICION PARA ADMINISTRACION ORAL CON LIBERACION PROLONGADA, QUE COMPRENDE: i)DE 4 mg A 60 mg DE PROPIVERINA O LA CANTIDAD EQUIVALENTE DE UNA DE SUS SALES O UNA MEZCLA DE LAS MISMAS; ii)UNA O VARIAS SUSTANCIAS ACIDAS QUE TIENEN UN VALOR pKa INFERIOR A 6,65, PREFERENTEMENTE DE 1,8 A 6,5; TAL COMO: ACIDO CITRICO, ACIDO TARTARICO; Y, iii)UNA SUSTANCIA RETARDANTE, TAL COMO POLIMEROS Y COPOLIMEROS DE DERIVADOS DE ACIDO ACRILICO Y/O METACRILICO. PRESENTANDO DICHA COMPOSICION LAS SIGUIENTES TASAS DE LIBERACION DE PROPIVERINA IN VITRO MEDIDAS EN 750 ml DE HCl 0,1 N, DURANTE LA PRIMERA HORA Y A CONTINUACION MEDIDAS EN 750 ml BUFFER USP, pH IGUAL A 5,8 USANDO EL METODO DE CANASTILLA GIRATORIA Ph. Eur. A 100 rpm Y 37 °C: DE 0% A 20% AL CABO DE UNA HORA; DE 10% A 45% AL CABO DE 3 HORAS; DE 30% A 75% AL CABO DE 5 HORAS; DE 40% A 85% AL CABO DE 7 HORAS; DE 45% A 95% AL CABO DE 9 HORAS Y MAYOR A 60% AL CABO DE 12 HORAS
PE2002000989A 2001-10-09 2002-10-04 Formas de administracion de propiverina o sus sales farmaceuticamente aceptables con liberacion prolongada de la sustancia activa PE20030399A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE10149674A DE10149674A1 (de) 2001-10-09 2001-10-09 Orale Darreichungsformen für Propiverin oder seinen pharmazeutisch annehmbaren Salzen mit verlängerter Wirkstoffreisetzung

Publications (1)

Publication Number Publication Date
PE20030399A1 true PE20030399A1 (es) 2003-05-08

Family

ID=7701848

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2002000989A PE20030399A1 (es) 2001-10-09 2002-10-04 Formas de administracion de propiverina o sus sales farmaceuticamente aceptables con liberacion prolongada de la sustancia activa

Country Status (33)

Country Link
US (1) US7943176B2 (es)
EP (1) EP1435915B1 (es)
JP (1) JP4192096B2 (es)
KR (1) KR100723964B1 (es)
CN (1) CN100473382C (es)
AR (1) AR036768A1 (es)
AT (1) ATE401865T1 (es)
AU (1) AU2002346973B8 (es)
CA (1) CA2462482C (es)
CY (1) CY1108426T1 (es)
DE (2) DE10149674A1 (es)
DK (1) DK1435915T3 (es)
EA (1) EA008862B1 (es)
EG (1) EG25542A (es)
ES (2) ES2299287B1 (es)
HK (1) HK1067310A1 (es)
HR (1) HRP20040323C1 (es)
HU (1) HU227878B1 (es)
IL (2) IL160977A0 (es)
IS (1) IS2571B (es)
JO (1) JO2555B1 (es)
ME (2) MEP44308A (es)
MX (1) MXPA04003132A (es)
MY (1) MY142403A (es)
PE (1) PE20030399A1 (es)
PL (1) PL208229B1 (es)
PT (1) PT1435915E (es)
RS (1) RS50924B (es)
SI (1) SI1435915T1 (es)
TW (1) TWI315204B (es)
UA (1) UA75727C2 (es)
WO (1) WO2003030869A1 (es)
ZA (1) ZA200402437B (es)

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