Hydrophilic Polymers

The present study was undertaken with an aim formulation and evaluation of Bilayer Tablets containing Candesartan and Simvastatin by Direct compression and wet granulation method to formulate a stable, safe and convenience dosage form for the better management of most common cardiovascular disorders blood pressure. The formulations of Bilayer tablets showed good results in case of Candesartan immediate release layer physicochemical parameters and prepared using concentration of super disintegrant sodium starch glycolate for the fast release layer and sustained release layer of simvastatin containing HPMC K100 M and ethyl cellulose for the delay the drug release up to 10-12 hrs. The FTIR analysis indicates that the drug is pure. Pre compression and post compression parameters were found to be within the satisfactory limits and hence suitable to formulate Bilayer tablets. The data obtained from in vitro release study shows that there is a delay in release of drug simvastatin from the sustained layer that is just because of its hydrophobic characteristics of the polymer ethyl cellulose and the mechanism involved in the release of drug is due to erosion of polymer surface from the matrix.

Therapeutic efficacy and safety of pharmaceutical tablets largely depend on their uniformity and quality, especially during preclinical studies. This study will assess the use of Process Analytical Technology (PAT) to monitor granulation parameters in real time to enhance the consistency of tablets. During wet granulation, properties of the granules including particle size, moisture content, and bulk density are continuously measured using near-infrared spectroscopy (NIRS) and in-line particle size analyzers using animal-model-compatible formulations. GRS PAT granules are converted into tablets and examined concerning mass homogeneity, firmness, and friability and compared with non-PAT batches. Findings indicated that PAT-controlled production has led to a large decrease in the batch-to-batch variability resulting in tablets of uniform physical characteristics and mechanical strength. The statistical analysis revealed that batches approached by PAT is superior to conventional processes. The results indicate that the use of PAT in preclinical preparations improves process controls, variability, and stable tablet quality, which is a key to its usability as a standard method in early pharmaceutical development.