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1249977 
Journal Article 
In vitro and in vivo evaluation of gliclazide push-pull osmotic pump coated with aqueous colloidal polymer dispersions 
Tang, X; Tai, LY; Yang, XG; Chen, F; Xu, HM; Pan, WS 
2013 
Yes 
Drug Development and Industrial Pharmacy
ISSN: 0363-9045
EISSN: 1520-5762 
39 
67-76 
English 
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 linear relationship, with R(2) being 0.9955 (Eudragit-coated PPOP) and 0.9987 (CA-coated PPOP), respectively. These results suggested that PPOP coated with Eudragit(®) RL 30D and RS 30D could overcome drawbacks of organic solution coating and promote the development of PPOP. 
Push-pull osmotic pump (PPOP); gliclazide; Eudragit; plasticizers; cast film; in vitro-in vivo correlation (IVIVC) 
• Diethyl phthalate (DEP)
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OPPT
• Dibutyl sebacate
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