ES2525720T3 - Forma de dosificación robusta de disolución rápida - Google Patents

Forma de dosificación robusta de disolución rápida Download PDF

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Publication number
ES2525720T3
ES2525720T3 ES09013477.6T ES09013477T ES2525720T3 ES 2525720 T3 ES2525720 T3 ES 2525720T3 ES 09013477 T ES09013477 T ES 09013477T ES 2525720 T3 ES2525720 T3 ES 2525720T3
Authority
ES
Spain
Prior art keywords
active ingredient
direct compression
less
direct
compression
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Lifetime
Application number
ES09013477.6T
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English (en)
Other versions
ES2525720T5 (es
Inventor
Rajendra K. Khankari
John Hontz
Sara J. Chastain
Leo Katzner
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Cima Labs Inc
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Cima Labs Inc
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.)
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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21926209&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2525720(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cima Labs Inc filed Critical Cima Labs Inc
Application granted granted Critical
Publication of ES2525720T3 publication Critical patent/ES2525720T3/es
Publication of ES2525720T5 publication Critical patent/ES2525720T5/es
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)

Abstract

Un procedimiento de fabricación de una forma de dosificación oralmente disgregable envasada, adaptada para una dosificación oral directa, que tiene una dureza de al menos 15 Newtons y una friabilidad del 2 % o menos cuando se ensaya de acuerdo con la Farmacopea de Estados Unidos, comprendiendo dicho procedimiento las etapas de: (a) formar una mezcla que incluye un ingrediente activo y una matriz que incluye una carga de compresión no directa y un lubricante; (b) comprimir dicha mezcla mediante compresión directa para formar una pluralidad de formas de dosificación rápidamente disgregables, duras y comprimidas que tienen dicho ingrediente activo distribuido en dicha matriz que se disuelve oralmente, estando adaptadas dichas formas de dosificación para disolverse espontáneamente en la boca de un paciente en menos de 60 segundos y liberar, por tanto, dicho ingrediente activo; y en el que dicha carga de compresión no directa es un azúcar o un alcohol de azúcar presente en una cantidad del 25 al 95 % en peso; dicho lubricante está presente en una cantidad de entre el 1 y el 2,5 % en peso; y el 85 % de las partículas de la carga de no compresión son de menos de 100 μm; en el que dicha carga de compresión no directa no está modificada físicamente para impartirle una mayor fluidez y compresibilidad antes de la compresión.

Description

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Claims (1)

  1. imagen1
ES09013477.6T 1997-04-16 1998-04-13 Forma de dosificación robusta de disolución rápida Expired - Lifetime ES2525720T5 (es)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US4324297P 1997-04-16 1997-04-16
US43242P 1997-04-16
US57884 1998-04-09
US09/057,884 US6024981A (en) 1997-04-16 1998-04-09 Rapidly dissolving robust dosage form

Publications (2)

Publication Number Publication Date
ES2525720T3 true ES2525720T3 (es) 2014-12-29
ES2525720T5 ES2525720T5 (es) 2018-04-05

Family

ID=21926209

Family Applications (2)

Application Number Title Priority Date Filing Date
ES09013477.6T Expired - Lifetime ES2525720T5 (es) 1997-04-16 1998-04-13 Forma de dosificación robusta de disolución rápida
ES10011802.5T Expired - Lifetime ES2647356T3 (es) 1997-04-16 1998-04-13 Forma de dosificación robusta de disolución rápida

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES10011802.5T Expired - Lifetime ES2647356T3 (es) 1997-04-16 1998-04-13 Forma de dosificación robusta de disolución rápida

Country Status (9)

Country Link
US (2) US6024981A (es)
EP (3) EP2147669B2 (es)
JP (3) JP2001524956A (es)
AU (1) AU726336B2 (es)
CA (1) CA2284663C (es)
DK (2) DK2266538T3 (es)
ES (2) ES2525720T5 (es)
PT (2) PT2147669E (es)
WO (1) WO1998046215A1 (es)

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CA2284663A1 (en) 1998-10-22
DK2147669T4 (en) 2018-03-12
EP2266538A2 (en) 2010-12-29
PT2147669E (pt) 2014-12-22
ES2525720T5 (es) 2018-04-05
US6024981A (en) 2000-02-15
EP2147669B1 (en) 2014-10-29
EP0975336A1 (en) 2000-02-02
DK2266538T3 (en) 2017-10-23
AU6896998A (en) 1998-11-11
JP2008001726A (ja) 2008-01-10
CA2284663C (en) 2003-06-17
WO1998046215A1 (en) 1998-10-22
US6221392B1 (en) 2001-04-24
ES2647356T3 (es) 2017-12-21
EP2147669A2 (en) 2010-01-27
PT2266538T (pt) 2017-11-20
EP2266538B1 (en) 2017-08-16
EP0975336A4 (en) 2006-02-01
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JP2001524956A (ja) 2001-12-04
EP2147669B2 (en) 2018-01-17
EP2147669A3 (en) 2010-03-10
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