Study On The Formulation And Quality Of Gliclazide Sustained Release Tablet

In order to localize the sustained-release gliclazide tablet(GZ SR), and offer commercial opportunity through intellectual property to national pharmaceutical factory, we study the formulation of GZ SR. We attempted to obtain a sustained-release tablet that can be administered in a single daily administration. On the one hand this dosage form makes it easier for the diabetes patients to use, and enables better compliance with the treatment. On the other hand domestical GC SR can be used by more people because of it is cheaper than the Diamicron MR, We attempted to design a formulation to prolong GZ in vitro release. We selected HPMC as hydrophilic matrix system, PVP, lactose and MCC as the excipients. We investigated the effects of the type and amount of HPMC, the amount of HPMC, PVP, MCC and the tablets hardness on dissolution rates. The study by uniform design using form U5(54) with the drug accumulated release as the evaluation quota to decide the best preparing condition. The final formulation is:gliclazide 30mg, lactose 51.4mg, HPMCK4M 45mg, PVPK30 7.2mg, MCC 24mg, silicon dioxide 1.6mg, Mg stearate 0.8mg.According to the BP2000, we confirmed the quality standard of the GZ SR and investigated the tablets stability of 3 lots product. The result as following: (1) the GZ SR tablets have stability quality after 6 months accelerated test, 24 months long-term test. (2) the release behavior of tablets followed Higuchi kinetics(Y=29.83t1/2-9.920, r=0.9914). At last the study advanced the mechanism of the drug release, that is the drug was released by diffusion and corrosion mechanism according to Peppas equation (n=0.737).