In vitro and in vivo evaluation of gliclazide push-pull osmotic pump coated with aqueous colloidal polymer dispersions

Drug Development and Industrial Pharmacy
Xin TangWeisan Pan

Abstract

The objective of present work was to design and evaluate gliclazide push-pull osmotic pump (PPOP) coated with aqueous colloidal polymer dispersions-Eudragit(®) RL 30D and Eudragit(®) RS 30D. The influence of diacetin, diethyl phthalate (DEP), dibutyl sebacate (DBS) and triethyl citrate (TEC) on the free Eudragit(®) RL 30D and Eudragit(®) RS 30D films as plasticizers on drug release were studied. Among these four plasticizers, diacetin offered the smoothest surface of the cast films, and it displayed greatest water vapor transmission coefficient. Free RL and RS films with diacetin also exhibited greatest erosion compared with the other three plasticizers. On the other hand, TEC, DEP and DBS showed greater water absorption. When compared with CA-coated gliclazide PPOP, Eudragit-coated ones showed a f(2) factor of 71.7, indicating the similarity between the release profile of the two formulations. The prepared Eudragit-coated gliclazide PPOP showed typical Zero-order release characteristics, with R being 0.9953. In the in vivo evaluation, the mean relative oral bioavailability of Eudragit-coated PPOP compared to CA-coated ones was 106.9%, demonstrating good bioequivalence. Both of their in vitro-in vivo correlation (IVIVC) showed ...Continue Reading

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Citations

Oct 12, 2013·Drug Development and Industrial Pharmacy·Yan YangWei-san Pan
Jan 10, 2014·Drug Development and Industrial Pharmacy·Wei GongXing-Guo Mei
Jul 3, 2015·Drug Development and Industrial Pharmacy·Ignacio González-GarcíaMarival Bermejo
Dec 17, 2015·The AAPS Journal·Alison MargolskeeLeon Aarons
Mar 5, 2015·Biologicals : Journal of the International Association of Biological Standardization·R R JainM D Menon
Mar 17, 2020·International Journal of Pharmaceutics·Marcelo Gomes DavançoPatrícia de Oliveira Carvalho

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