DEVELOPMENT, OPTIMIZATION AND IN-VITRO CHARACTERIZATION OF GLICLAZIDE NANOSPONGE TABLETS FOR ORAL ADMINISTRATIONAbstract
Poor bioavailability by the oral route is noticeable with the majority of new active pharmaceutical ingredients due to its dissolution rate-limited absorption. Gliclazide is an oral anti-hyperglycemic drug, though it is a class II drug, results in poor oral bioavailability. The present investigation was undertaken to prepare polymeric nanosponges of an oral anti-hyperglycemic drug Gliclazide to achieve improved solubility. Nanosponges using ethyl cellulose as a polymer and glutarldehyde as a cross-linker were prepared successfully by the emulsion solvent diffusion method. Drug polymer compatibility study was performed by FTIR and DSC. To obtain optimized batch, 32 factorial designs were performed. Optimized batch exhibited particle size 398. 78 nm, % drug content 90.504 ± 0.296, % entrapment efficiency 81.25 ± 0.266, % drug release 97.725 ± 0.186. An SEM and TEM image of optimized batch shows the spongy and spherical nature of formulations were converted into tablets to achieve immediate release drug delivery for oral route. These tablets were prepared using crospovidone and A SEM and TEM image of the optimized batch shows spongy and spherical nature of nanosponges pregelatinized starch. All nine tablet batches of 32 factorial design yield sharpness (kg/cm-2) between 3.76 ± 0.115-4.2 ± 0.1, % friability between 0.4191-0.5571, drug content 98.41 ±1.1331-99.40 ± 0 .741, in-vitro disintegration time (min) 0.44 ± 0.043-1.4 ± 0.047 and % drug release between 83.803 ± 0.1866-98.269 ± 0.187. (kg/cm2) 4.03 ± 0.057, in-vitro disintegration time (min) 0.44 ± 0.043 and % drug release 98.269 ± 0.187. In-vitro dissolution studies indicate that percent cumulative drug release follows zero-order kinetics. Accelerated and long-term stability data revealed no significant change in % drug content and percent drug release.
S. S. Gedam * and G. D. Basarkar
SNJBS Shriman Sureshdada Jain College of Pharmacy, Chandwad, Nashik, Maharashtra, India.
03 April 2020
30 January 2021
22 March 2021
01 April 2021