ArticleDEVELOPMENT OF RAPID DISINTEGRATING MODIFIED RELEASE TABLET BY USING NOVEL PARTICLE COATING TECHNOLOGY
Chattar Singh Yadav , *, Narendra Lariya
Chattar Singh Yadav
The objective of present sturdy is to formulate rapid disintegrating modified release (RDMR) tablet of carbamazepine by using drug particle coating technology. Fluid bed granulation technology is most emerging and upcoming face of granulation technology of pharmaceuticals. The technology is used for granulation/agglomeration, layering, coating and drying of a wide range of particle size. The development of a polymer-based RDMR tablet was undertaken to produce a rapid disintegrating modified release dosage form of carbamazepine. Granulation and drug particle coating were performed by using fluidized bed technology using different polymeric combination (Eudragit RS 30D and HPMC P55) and retard the release rate of drug. Uniform particle coating was achieved by using the particle coating technology and Release rate was retarded. Rapid disintegration of tablet were achieved by using the extra-granular material with drug portion. Finally the Granular portion and extra granular portion with drug was blended and compressed, this was produced the RDMR tablet. Final compressed tablets were tested for Inprocess test and dissolution test based on the pharmacopoeial specifications. Shapes of the tablets were round, Weight variation, hardness, % friability, thickness, diameter, disintegration and dissolution tests were carried out for all the formulation and found within the pharmacopoeial specifications. Accelerated stability studies of the selected formulated tablets were carried out by keeping the tablets at 40°C ± 2°C / 75 ± 5% RH and 60°C ± 2°C / 75 ± 5% RH in stability ovens for 1 and 2 months.. All the parameters were checked and found within the limit after stability period. Selected formulations were compared with the marketed product and dissolution comparison study was performed with marketed formulation, found comparable. Nevertheless, the innovation of this article is to optimize all the Critical process parameters with respect to their quality attribute.
Fluid-bed Technology, Top spray granulation, Process variables, Process analytical technologies