ES2499541T3 - Implantes intraoculares de liberación sostenida que comprenden un antagonista de receptores beta adrenérgicos y métodos para tratar neuropatías oculares - Google Patents

Implantes intraoculares de liberación sostenida que comprenden un antagonista de receptores beta adrenérgicos y métodos para tratar neuropatías oculares Download PDF

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Publication number
ES2499541T3
ES2499541T3 ES11161473.1T ES11161473T ES2499541T3 ES 2499541 T3 ES2499541 T3 ES 2499541T3 ES 11161473 T ES11161473 T ES 11161473T ES 2499541 T3 ES2499541 T3 ES 2499541T3
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Spain
Prior art keywords
implant
beta
receptor antagonist
adrenergic receptor
methods
Prior art date
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Expired - Lifetime
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ES11161473.1T
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English (en)
Inventor
Glenn T. Huang
Thierry Nivaggioli
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Allergan Inc
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Allergan Inc
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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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts or implants
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/06—Antiglaucoma agents or miotics
    • 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

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un implante para administración de fármacos para su utilización en un método de tratamiento de glaucoma, implante que comprende: un antagonista de receptores beta adrenérgicos asociado a una matriz polimérica biodegradable que libera fármacos a una velocidad eficaz para la liberación sostenida de una cantidad de antagonista de receptores beta adrenérgicos procedente del implante durante un tiempo eficaz para reducir la presión intraocular en un ojo en el que se coloca el implante, siendo el tiempo al menos aproximadamente una semana después de colocar el implante en el ojo, en donde el antagonista de receptores beta adrenérgicos se selecciona del grupo consistente en timolol, sus sales y sus mezclas; y en donde el método incluye la colocación del implante en la cámara anterior del ojo.

Description

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E11161473
05-09-2014
Tabla 6. Presión Intraocular de referencia – Antes de intervención quirúrgica (mm Hg)
Cámara Anterior
Conejo
Día 1 2 3 4 5 8 Promedio DT
1682-OD
23,5 18,5 19,0 18,0 18,5 19,5 19,5 2,0
1682-OS
23,0 18,0 21,0 21,0 20,5 17,5 20,2 2,1
1697-OD
19,0 19,0 18,0 17,5 18,5 15,0 17,8 1,5
1697-OS
16,5 18,0 17,0 18,5 17,5 16,5 17,3 0,8
1689-OD
16,0 18,0 20,0 19,0 19,0 18,5 18,4 1,4
1689-OS
16,5 19,0 17,0 16,5 17,0 17,5 17,3 0,9
Segmento Posterior
Conejo
Día 1 2 3 4 5 8 Promedio DT
1696-OD
15,0 19,5 15,0 16,5 15,0 16,0 16,2 1,8
1696-OS
18,0 15,5 17,0 15,0 16,0 15,5 16,2 1,1
1698-OD
19,5 18,5 19,5 20,0 19,5 19,5 19,4 0,5
1698-OS
19,5 17,5 16,0 16,0 17,0 16,5 17,1 1,3
1683-OD
20,5 21,0 20,0 20,5 19,0 20,0 20,2 0,7
1683-OS
16,5 16,0 16,0 17,0 16,5 17,5 16,6 0,6
Conjuntiva
Conejo
Día 1 2 3 4 5 8 Promedio DT
1694-OD
22,5 21,5 21,0 18,5 18,5 17,0 19,8 2,1
1694-OS
16,5 19,0 18,0 19,0 18,0 16,5 17,8 1,1
1693-OD
15,5 15,0 15,0 14,5 15,0 15,0 15,0 0,3
1693-OS
16,0 19,5 16,5 16,5 16,0 17,5 17,0 1,3
1685-OD
18,0 14,5 16,0 18,5 18,0 14,5 16,6 1,8
1685-OS
16,0 16,0 14,5 16,5 16,5 14,5 15,7 0,9
Como era de esperar, la IOP de cada animal fluctuó día a día, pero en un período de 8 días tiende a equilibrarse en torno a los adolescentes con una desviación típica que va desde baja de 0,3 a alta de 2,1. El día 15, se encontró uno que estaba enfermo y, por tanto, se sacrificó en el día 17 y los restantes se recuperaron para el análisis de contenido total. El día 35 el animal nº 1693 (conjuntiva), el animal nº 1697 (cámara anterior) y el animal nº 1698 (segmento posterior) se sacrificaron, y el día 69, los cinco animales restantes se sacrificaron y los restantes se retiraron para el análisis de contenido total. Los resultados se presentan en la Tabla 7 y los perfiles de liberación basadas en los restantes recuperados en cada punto de tiempo se muestran en la Fig. 7.
19
E11161473
05-09-2014
Tabla 7. Contenido total de maleato de timolol in vivo
Animal nº
Peso de DDS Cantidad teórica de timolol, (μg) Sacrificado el día Timolol recuperado (μg) Recuperación de timolol (%) Liberación de timolol (%)
1696 (SP)
809 150,47 17 105,50 70,11 28,89
1693 (Conj)
791 147,92 35 67,75 45,80 54,20
1697 (CA)
769 143,80 35 55,00 38,25 61,75
1698 (SP)
781 146,05 35 52,50 39,95 64,05
1694 (Conj)
770 143,22 69 36,00 25,14 74,86
1689 (CA)
763 141,92 69 29,00 20,43 79,57
1685 (Conj)
807 150,10 69 33,50 22,32 77,68
1683 (SP)
829 154,19 69 29,25 18,97 81,03
1682 (CA)
765 142,29 69 30,25 21,26 78,74
Como se muestra en la Fig. 7, los datos presentaban características de liberación similares de los tres lugares, cámara anterior, segmento posterior y conjuntiva.
En la comparación de los perfiles in vivo con los perfiles in vitro, mostrada en la Fig. 8, puede reconocerse una buena correlación entre los perfiles de liberación.
Se midió la presión intraocular de ambos ojos derecho e izquierdo de los nueve animales los días indicados, como se muestra en la Tabla 8.
Tabla 8 Programa de IOP con maleato de timolol
Animal nº
Día
1696
1, 2, 3, 6, 7, 8, 9, 13,15
1693,1697,1698
1, 2, 3, 6, 7, 8, 9, 13, 15, 17, 20, 22, 24, 27, 29, 31, 34
1682, 1683, 1685, 1689, 1695
1, 2, 3, 6, 7, 8, 9, 13, 15, 17, 20, 22, 24, 27, 29, 31, 34, 38, 42, 45, 48, 52, 56, 60, 64
10 Los datos se recogieron en orden para compensar las variaciones de IOP de ojo a ojo de cada animal, tanto
preoperatoria como posopertoria, los cambios de IOP se calcularon de la manera siguiente: ΔΔ IOP = Δ IOP -Δ IOPreferencia (1) Δ IOP = Δ IOPtratada -Δ IOPontrolada (2)
15
20
imagen18
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Claims (1)

  1. imagen1
ES11161473.1T 2004-04-30 2005-04-21 Implantes intraoculares de liberación sostenida que comprenden un antagonista de receptores beta adrenérgicos y métodos para tratar neuropatías oculares Expired - Lifetime ES2499541T3 (es)

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US836880 2004-04-30
US10/836,880 US20050244458A1 (en) 2004-04-30 2004-04-30 Sustained release intraocular implants and methods for treating ocular neuropathies

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AU (1) AU2005244211B2 (es)
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CA (1) CA2565347C (es)
DK (1) DK2361617T3 (es)
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WO (1) WO2005110380A1 (es)

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AU2005244211A1 (en) 2005-11-24
US20110091520A1 (en) 2011-04-21
EP2361617A1 (en) 2011-08-31
US20140199366A1 (en) 2014-07-17
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