Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies

The objective of the present study was to develop an oral timed-released press-coated tablet containing theophylline as a model drug. A D-optimal design of experiment was employed to systematically study the effect of ternary blend of ethylcellulose (X<sub>1</sub>), hydroxypropylcellulos...

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Autores principales: Narendra, Chikkanna, Srinath, Mayasandra S.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2011
Materias:
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8273
http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_1_15.pdf
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id I19-R120-10915-8273
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
D-optimal design, In vivo studies; in vitro-in vivo correlation; optimization; press-coated tablets; stability studies
spellingShingle Farmacia
D-optimal design, In vivo studies; in vitro-in vivo correlation; optimization; press-coated tablets; stability studies
Narendra, Chikkanna
Srinath, Mayasandra S.
Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
topic_facet Farmacia
D-optimal design, In vivo studies; in vitro-in vivo correlation; optimization; press-coated tablets; stability studies
description The objective of the present study was to develop an oral timed-released press-coated tablet containing theophylline as a model drug. A D-optimal design of experiment was employed to systematically study the effect of ternary blend of ethylcellulose (X<sub>1</sub>), hydroxypropylcellulose (X<sub>2</sub>), and Mg stearate (X<sub>3</sub>) as independent variables. The design was quantitatively evaluated by quadratic model and the results from the statistical analysis revealed that interaction factors X<sub>1</sub>X<sub>2</sub> and X<sub>2</sub>X<sub>3</sub> were found to be highly significant on the studied response variables; percent drug release at 8 h (Y<sub>1</sub>), percent drug release at 10 h (Y<sub>2</sub>) and lag time (Y<sub>3</sub>). A numerical optimization technique by desirability function was used to optimize the response variables each having a different target and the observed responses were highly agreed with experimental values. The dissolution profiles of the optimal formulation before and after stability studies were evaluated by using similarity factor (ƒ2 ) and were found to be similar. The results of in vivo studies showed an increased T<sub>max</sub> and MRT values with high statistical significant difference between optimal press-coated and core tablets. The time point at which the drug first appeared in the plasma for the optimal press-coated tablet was found to be longer than that of core tablet, indicating a time controlled release profile. Moreover, a good linear relationship was observed between the fraction dissolved and fraction absorbed.
format Articulo
Articulo
author Narendra, Chikkanna
Srinath, Mayasandra S.
author_facet Narendra, Chikkanna
Srinath, Mayasandra S.
author_sort Narendra, Chikkanna
title Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
title_short Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
title_full Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
title_fullStr Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
title_full_unstemmed Formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
title_sort formulation development of oral timed-release press-coated tablets: optimization and in vivo studies
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8273
http://www.latamjpharm.org/resumenes/30/6/LAJOP_30_6_1_15.pdf
work_keys_str_mv AT narendrachikkanna formulationdevelopmentoforaltimedreleasepresscoatedtabletsoptimizationandinvivostudies
AT srinathmayasandras formulationdevelopmentoforaltimedreleasepresscoatedtabletsoptimizationandinvivostudies
bdutipo_str Repositorios
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