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BR9612801A - Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply. - Google Patents

Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply.

Info

Publication number
BR9612801A
BR9612801A BR9612801-1A BR9612801A BR9612801A BR 9612801 A BR9612801 A BR 9612801A BR 9612801 A BR9612801 A BR 9612801A BR 9612801 A BR9612801 A BR 9612801A
Authority
BR
Brazil
Prior art keywords
dosage form
coating layer
colon
enteric polymer
dissolve
Prior art date
Application number
BR9612801-1A
Other languages
Portuguese (pt)
Inventor
Gary Robert Kelm
Gary Lee Manring
Original Assignee
Procter & Gamble
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 Procter & Gamble filed Critical Procter & Gamble
Priority to BR9612801-1A priority Critical patent/BR9612801A/en
Priority claimed from PCT/US1996/018258 external-priority patent/WO1998022096A1/en
Publication of BR9612801A publication Critical patent/BR9612801A/en

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  • Medicinal Preparation (AREA)

Abstract

Patente de Invenção: <B>"FORMA DE DOSAGEM FARMACêUTICA COM MúLTIPLOS REVESTIMENTOS DE POLìMEROS ENTéRICOS PARA O FORNECIMENTO COLÈNICO"<D>. A presente invenção se refere a uma composição farmacêutica em uma forma de dosagem unitária para a administração peroral em um ser humano ou animal inferior, tendo um trato gastrointestinal compreendendo um intestino delgado e um cólon com um lúmen através do mesmo tendo uma entrada para o cólon a partir do intestino delgado, compreendendo: a. uma quantidade eficaz e segura de um agente terapeuticamente ativo incorporado na ou revestido sobre a superfície de uma forma de dosagem selecionada do grupo que comnsiste de um substrato esférico, um substrato elíptico, uma cápsula dura ou um comprimido comprimido, com um diâmetro máximo de cerca de 3 mm a cerca de 10 mm; e b. um material de revestimento de polímero entérico comprenendendo pelo menos uma camada de revestimento interna e uma camadaa de revestimento externa; em que a forma de dosagem tem uma superfície regular livre de arestas ou curvas acetuadas; o substrato elíptico e a cápsula dura têm uma razão dos diâmetros longos para diâmetros curtos de não mais do que cerca de 1,5; o agente terapeuticamente ativo é liberado em um ponto próximo da entrada do, ou dentro do cólon; cada (uma das) camada(s) de revestimento interno é (são) um polímero entérico que começa a se dissolver em meios aquosos em um pH entre cerca de 5 a cerca de 6,3; e a camada de revestimento externa é um polímero entérico que começa a se dissolver em meios aquosos em um pH entre cerca de 6,8 a cerca de 7,2.Invention Patent: <B> "PHARMACEUTICAL DOSAGE FORM WITH MULTIPLE ENTERETIC POLYMER COATINGS FOR COLLECTIVE SUPPLY" <D>. The present invention relates to a pharmaceutical composition in a unit dosage form for peroral administration in a human or lower animal, having a gastrointestinal tract comprising a small intestine and a colon with a lumen through it having an entrance to the colon. from the small intestine, comprising: a. an effective and safe amount of a therapeutically active agent incorporated into or coated on the surface of a dosage form selected from the group consisting of a spherical substrate, an elliptical substrate, a hard capsule or a compressed tablet, with a maximum diameter of about from 3 mm to about 10 mm; and b. an enteric polymer coating material comprising at least one inner coating layer and an outer coating layer; wherein the dosage form has a regular surface free of sharp edges or curves; the elliptical substrate and the hard capsule have a ratio of long diameters to short diameters of no more than about 1.5; the therapeutically active agent is released at a point near the entrance to, or into the colon; each (one) of the inner coating layer (s) is (are) an enteric polymer that begins to dissolve in aqueous media at a pH between about 5 to about 6.3; and the outer coating layer is an enteric polymer that begins to dissolve in aqueous media at a pH between about 6.8 to about 7.2.

BR9612801-1A 1996-11-15 1996-11-15 Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply. BR9612801A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
BR9612801-1A BR9612801A (en) 1996-11-15 1996-11-15 Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
PCT/US1996/018258 WO1998022096A1 (en) 1996-11-15 1996-11-15 Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery
BR9612801-1A BR9612801A (en) 1996-11-15 1996-11-15 Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply.

Publications (1)

Publication Number Publication Date
BR9612801A true BR9612801A (en) 2000-03-28

Family

ID=25664824

Family Applications (1)

Application Number Title Priority Date Filing Date
BR9612801-1A BR9612801A (en) 1996-11-15 1996-11-15 Pharmaceutical dosage form with multiple coatings of enteric polymers for colonic supply.

Country Status (1)

Country Link
BR (1) BR9612801A (en)

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Legal Events

Date Code Title Description
B25A Requested transfer of rights approved

Free format text: MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH (US)

B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 7A,8A,9A E 9A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 1886 DE 27/02/2007.