Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system

The aim of this work was to develop a pulsatile release system with metoprolol for chronotherapeutical use by coating swellable mini-tablets with Eudragit RS. To study the influence of the formulation factors (amount of coating polymer, plasticizer percentage in film coating and swelling agent perce...

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Main Authors: Vonica-Gligor Andreea Loredana, Tomuţă Ioan, Leucuţa Sorin E.
Format: Article
Language:English
Published: Sciendo 2016-06-01
Series:Acta Pharmaceutica
Subjects:
Online Access:https://doi.org/10.1515/acph-2016-0025
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author Vonica-Gligor Andreea Loredana
Tomuţă Ioan
Leucuţa Sorin E.
author_facet Vonica-Gligor Andreea Loredana
Tomuţă Ioan
Leucuţa Sorin E.
author_sort Vonica-Gligor Andreea Loredana
collection DOAJ
description The aim of this work was to develop a pulsatile release system with metoprolol for chronotherapeutical use by coating swellable mini-tablets with Eudragit RS. To study the influence of the formulation factors (amount of coating polymer, plasticizer percentage in film coating and swelling agent percentage in mini-tablets), a Box-Behnken design of experiment (DoE) was used. To evaluate the influence of the studied factors on the sigmoid shape of the dissolution profile, piecewise function parameters were used as the responses of DoE. The results show that higher concentrations of coating polymer and higher concentrations of plasticizer polymer led to a thicker and more elastic polymeric film, which led to a delay in drug release. Using the parameters of the piecewise function as DoE responses, an optimum formulation with a sigmoid shape dissolution profile and a 2.5-h lag time followed by rapid drug release were obtained.
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series Acta Pharmaceutica
spelling doaj-art-dbe4041a78bb414281446bc1e3d0d23d2025-02-02T21:49:41ZengSciendoActa Pharmaceutica1846-95582016-06-0166217318910.1515/acph-2016-0025acph-2016-0025Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical systemVonica-Gligor Andreea LoredanaTomuţă Ioan0Leucuţa Sorin E.1 Department of Pharmaceutical, Technology and Biopharmacy, Faculty of Pharmacy University of Medicine and Pharmacy, “Iuliu Haţieganu”, 40012 – Cluj-Napoca, Romania Department of Pharmaceutical, Technology and Biopharmacy, Faculty of Pharmacy University of Medicine and Pharmacy, “Iuliu Haţieganu”, 40012 – Cluj-Napoca, RomaniaThe aim of this work was to develop a pulsatile release system with metoprolol for chronotherapeutical use by coating swellable mini-tablets with Eudragit RS. To study the influence of the formulation factors (amount of coating polymer, plasticizer percentage in film coating and swelling agent percentage in mini-tablets), a Box-Behnken design of experiment (DoE) was used. To evaluate the influence of the studied factors on the sigmoid shape of the dissolution profile, piecewise function parameters were used as the responses of DoE. The results show that higher concentrations of coating polymer and higher concentrations of plasticizer polymer led to a thicker and more elastic polymeric film, which led to a delay in drug release. Using the parameters of the piecewise function as DoE responses, an optimum formulation with a sigmoid shape dissolution profile and a 2.5-h lag time followed by rapid drug release were obtained.https://doi.org/10.1515/acph-2016-0025pulsatile releasechronopharmaceutical systempiecewise functiondesign of experimenteudragit rsmetoprolol
spellingShingle Vonica-Gligor Andreea Loredana
Tomuţă Ioan
Leucuţa Sorin E.
Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
Acta Pharmaceutica
pulsatile release
chronopharmaceutical system
piecewise function
design of experiment
eudragit rs
metoprolol
title Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
title_full Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
title_fullStr Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
title_full_unstemmed Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
title_short Piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
title_sort piecewise function parameters as responses of the design of experiment in the development of a pulsatile release chronopharmaceutical system
topic pulsatile release
chronopharmaceutical system
piecewise function
design of experiment
eudragit rs
metoprolol
url https://doi.org/10.1515/acph-2016-0025
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