ES2586412T3 - Formulaciones de rasagilina con uniformidad de contenido mejorada - Google Patents

Formulaciones de rasagilina con uniformidad de contenido mejorada Download PDF

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Publication number
ES2586412T3
ES2586412T3 ES06720975.9T ES06720975T ES2586412T3 ES 2586412 T3 ES2586412 T3 ES 2586412T3 ES 06720975 T ES06720975 T ES 06720975T ES 2586412 T3 ES2586412 T3 ES 2586412T3
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Prior art keywords
aminoindane
particles
content uniformity
improved content
uniformity
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Expired - Lifetime
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ES06720975.9T
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English (en)
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ES2586412T5 (es
Inventor
Tirtza Berger Peskin
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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    • 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
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/205—Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
    • 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
    • A61K9/2004—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
    • 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
    • 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

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

Abstract

Una composición sólida que comprende una cantidad terapéuticamente eficaz de una mezcla de partículas de una sal farmacéuticamente aceptable de R(+)-N-propargil-1-aminoindano que tiene una distribución de tamaños de partícula en la cual más de 90%, en volumen, de la cantidad total de partículas de sal de mesilato de R(+)-Npropargil- 1-aminoindano tienen un tamaño inferior a 200 micrómetros y al menos 90%, en volumen, de la cantidad total de las partículas de sal de R(+)-N-propargil-1-aminoindano tienen un tamaño superior a 6 micrómetros, siendo la distribución de tamaños de partícula resultado de la molienda de partículas de mayor tamaño, como lo determinan los valores de d(0,9) y d(0,1), en donde el tamaño de partícula se mide mediante difracción láser; y un vehículo farmacéuticamente aceptable .

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
La uniformidad de mezcla promedio de cada lote de granulado se determinó tomando 10 muestras que representaban la capa superior, la capa media y la capa inferior de cada lote de mezcla final (antes de la compresión), realizando un análisis por HPLC para medir la cantidad de ingrediente activo en las muestras y comparando la cantidad de ingrediente activo en cada muestra con la cantidad declarada de ingrediente activo. Después se determinaron la desviación típica y la desviación típica relativa según las siguientes fórmulas:
imagen7
En las fórmulas anteriores, s es la desviación típica; DTR es la desviación típica relativa; x1, x2, x3 ... xn son cantidades individuales de las muestras ensayadas, expresadas como porcentajes de la cantidad declarada de
10 sustancia medicamentosa en cada muestra; X(con barra) es la media de los valores obtenidos de las muestras analizadas, expresada como porcentaje de la cantidad declarada de sustancia medicamentosa en cada muestra; y n es el número de unidades analizadas.
La uniformidad de contenido de los comprimidos se determinó utilizando 10 comprimidos al azar, realizando un análisis HPLC para medir la cantidad de ingrediente activo en cada comprimido y comparando la cantidad de
15 ingrediente activo en cada comprimido con la cantidad declarada de ingrediente activo. La desviación típica y la desviación típica relativa se determinaron como antes.
Se determinaron d(0,1) y d(0,9) como en el Ejemplo 1. En la Tabla 2 se exponen los resultados.
Tabla 2
Número de lote de sustancia medicamentosa
100 200 300 300
Número de lote de producto medicamentoso
021 022 023 063
d(0,1) (micrómetros)
12,5 12,9 12,1 12,1
d(0,9) (micrómetros)
190,3 111,9 121,0 121,0
Uniformidad de mezcla/DTR (tanto por ciento)
98,2/1,7 99,8/0,8 98,7/1,1 98,1/0,7
Uniformidad de contenido/DTR (tanto por ciento)
99,3/1,6 99,0/1,4 98,6/1,3 100,6/1,2
20 Resultados:
La uniformidad del contenido de los lotes ensayados varió de 98,6% a 100,6%. La DTR (desviación típica relativa, expresada como porcentaje de la media) fue inferior a 2,0% para todos los lotes de comprimidos, lo que indica que la uniformidad de los comprimidos era elevada a pesar de la pequeña cantidad de ingrediente activo en cada comprimido. Así, estos resultados cumplirían los criterios de aceptación establecidos por la primera fase del ensayo
25 USP de uniformidad de contenido.
8

Claims (1)

  1. imagen1
    imagen2
ES06720975T 2005-02-23 2006-02-22 Formulaciones de rasagilina con uniformidad de contenido mejorada Expired - Lifetime ES2586412T5 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US65562205P 2005-02-23 2005-02-23
US655622P 2005-02-23
US72090805P 2005-09-27 2005-09-27
US720908P 2005-09-27
PCT/US2006/006252 WO2006091657A1 (en) 2005-02-23 2006-02-22 Rasagiline formulations of improved content uniformity

Publications (2)

Publication Number Publication Date
ES2586412T3 true ES2586412T3 (es) 2016-10-14
ES2586412T5 ES2586412T5 (es) 2019-05-16

Family

ID=36927751

Family Applications (1)

Application Number Title Priority Date Filing Date
ES06720975T Expired - Lifetime ES2586412T5 (es) 2005-02-23 2006-02-22 Formulaciones de rasagilina con uniformidad de contenido mejorada

Country Status (15)

Country Link
US (1) US7815942B2 (es)
EP (1) EP1848402B2 (es)
JP (2) JP5738509B2 (es)
KR (5) KR20070111534A (es)
AU (1) AU2006216696B2 (es)
BR (1) BRPI0608209A2 (es)
CA (2) CA2901244A1 (es)
ES (1) ES2586412T5 (es)
IL (2) IL184033A0 (es)
IS (1) IS8669A (es)
MX (1) MX2007010233A (es)
NO (1) NO20074823L (es)
NZ (1) NZ560660A (es)
RU (1) RU2404746C2 (es)
WO (1) WO2006091657A1 (es)

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Also Published As

Publication number Publication date
KR20170023211A (ko) 2017-03-02
WO2006091657A1 (en) 2006-08-31
EP1848402B2 (en) 2019-02-20
JP2008531572A (ja) 2008-08-14
IL244802A0 (en) 2016-04-21
ES2586412T5 (es) 2019-05-16
EP1848402A4 (en) 2012-01-18
US7815942B2 (en) 2010-10-19
KR20070111534A (ko) 2007-11-21
CA2901244A1 (en) 2006-08-31
RU2404746C2 (ru) 2010-11-27
IL244802A (en) 2016-08-31
EP1848402A1 (en) 2007-10-31
IS8669A (is) 2007-08-15
KR20180026580A (ko) 2018-03-12
NO20074823L (no) 2007-11-16
HK1103366A1 (zh) 2007-12-21
CA2600011A1 (en) 2006-08-31
RU2007135169A (ru) 2009-03-27
KR20140103356A (ko) 2014-08-26
BRPI0608209A2 (pt) 2010-11-09
AU2006216696A1 (en) 2006-08-31
US20060188581A1 (en) 2006-08-24
MX2007010233A (es) 2007-11-07
IL184033A0 (en) 2007-10-31
NZ560660A (en) 2010-11-26
EP1848402B1 (en) 2016-05-11
JP5738509B2 (ja) 2015-06-24
JP2013139452A (ja) 2013-07-18
AU2006216696B2 (en) 2011-08-18
KR20130129300A (ko) 2013-11-27
CA2600011C (en) 2015-11-10

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