INVESTIGATION ON THE IMPACT OF CORE AND BARRIER LAYER COMPOSITION ON THE DRUG RELEASE FROM A TRIPLE LAYER TABLETAbstract
In this study, Monolayer matrix (MLM) tablet and triple layer matrix (TLM) tablet formulation of metoprolol succinate were fabricated by using Hydroxypropyl-methylcellulose and Polymethacrylates (Eudragit) as the matrix forming agent in both the tablet core layer and barrier layers. The prepared tablets were analyzed for their drug content and in-vitro drug release studies. In-vitro evaluation and comparison of the MLM dosage form and TLM dosage form was done. The role of impermeable barrier layer in controlling the drug release from the core was studied. The in-vitro dissolution studies were carried out and showed a significant difference statistically (P value > 0.05 by ANOVA tool). Mean dissolution time (MDT) increased, while dissolution efficiency (DE %) decreased, indicating that the release of metoprolol succinate is slower from triple layer matrix tablets. The thermal analysis studies (DSC) performed on the initial TLM formulation and three month old accelerated stability sample of the same showed no variation in the thermograph, indicating TLM as stable formulation. The finding of the study indicated that the MLM tablets may prolonged the drug release, but a non linear drug release profile was observed with an initial burst release. In TLM tablets, layering with Hydroxypropyl-methylcellulose and Polymethacrylates (Eudragit) as impermeable barrier on the matrix core, resulted in linear/zero order drug release kinetics. The initial burst release was not observed in TLM tablets.TLM tablets showed significant and marked controlled release of a freely water soluble drug as compared to MLM tablets.
Kanwarpreet Singh Bakshi*, K. Vivek, Rajan K. Verma, Murali Krishna B., Sreekanth Narravula, Romi Barat Singh and Ajay K. Singla
NDDS Department, Ranbaxy Laboratories Ltd., (R & D-2), Plot No 20; Sec 18, Sarhaul, Udyog-Vihar, Gurgaon- 122015, Haryana, India
11 March, 2012
18 April, 2012
22 June, 2012 INVESTIGATION ON THE IMPACT OF CORE AND BARRIER LAYER COMPOSITION
01 July 2012