Open AccessDesign and in vivo Evaluation of Controlled Release Gliclazide Trilayer Matrix Tablets in the Management of Diabetes Mellitus
Author(s) -
D V R N Bhikshapathi,
B. Ram Prasad
Publication year - 2018
Publication title -
international journal of pharmaceutical sciences and drug research
Language(s) - English
Resource type - Journals
ISSN - 0975-248X
DOI - 10.25004/ijpsdr.2018.100508
Subject(s) - gliclazide , bioavailability , cmax , immediate release , controlled release , pharmacology , drug , dosage form , chromatography , drug delivery , in vivo , matrix (chemical analysis) , chemistry , materials science , diabetes mellitus , biomedical engineering , medicine , nanotechnology , microbiology and biotechnology , endocrinology , biology
The purpose of the present study was to develop and optimize multi-layered matrix tablets of Gliclazide trilayer tablets to achieve zero-order drug release for sustained plasma concentration. Gliclazide tablets were prepared by directcompression and consist of middle active layer with different grades of hydroxypropyl methylcellulose (HPMC K 4M, K 15M and K100M), Guar gum and Eudragit L 100. The tablets were also evaluated for physicochemical characteristics and release kinetics.The physicochemical characteristics of the prepared tablets were satisfactory. The developed drug delivery systems showed prolonged drug release rates over a period of 24 h. In vivo bioavailability studies were carried out on the optimizedformulation (EF14), mean time to attain peak drug concentration (Tmax) was 6.00 ± 0.14 and 4.02 ± 0.12 h for the optimized and marketed product respectively, while mean maximum drug concentration (Cmax) was 124.80 ± 1.02 ng/ml and 95.12 ± 1.05 ng/mlrespectively. AUC0-α and AUC0-t for optimized formulation was significantly higher (p less than 0.05) as compared to marketed product. A fair correlation between the dissolution profile and bioavailability for the optimized formulation was observed.The results indicate that the approach used could lead to a successful development of a controlled release formulation of the drug. The EF14 was shown significant plasma concentration with controlled release and maintained for 24 hours with patientcompliance by reducing the dosage frequency, when compared with marketed product in the efficient management of Diabetes mellitus.