Nagar Vineet*, Goyal Kumar Anil, Satraval P.C.
Mahatma Gandhi College of Pharmaceutical Sciences, Jaipur, Rajasthan, India
A B S T R A C T
The main objective of the present work was to develop sustained release tablets of quetiapine fumarate using different polymers hydroxy propyl methyl cellulose (HPMC) and PVP K30. Varying ratios of drug and polymer like were selected for the study. Used in Cross Carmellose Sodium super disintegration agent. Quetiapine fumarate used in the treatment of schizophrenia. Quetiapine Fumarate was prepared by using direct compression method. IR spectral analysis study showed that there was no drug interaction with formulation additives of the tablet. The blend was examined for the pre- compression parameters results were within prescribed limits and indicated good free flowing property. The prepared tablets formulations were evaluated for post-compression parameters. Evaluation of physical properties of tablet, the in vitro release study was performed in 0.1 N HCl pH 1.2 for 2 hrs and in phosphate buffer pH 6.8 up to 14 hrs. QFSRT/07 was comparable with the prepared batch products. Stability studies (300±20C and 60±5% RH) for 1 months indicated that quetiapine fumarate was stable in the tablets. The FTIR study revealed that there was no chemical interaction between drug and excipients. All the post-compression parameter are evaluated were prescribed limits and results were within IP acceptable limits. Formulation F7 in-vitro drug release showed 98.82 within 14 hours. Formulation F1 to F4 showed 78.64, 81.68, 94.41, 85.42 release after 14 hours.F5, F6, F8 showed 78.56, 84.51, 90.71.drug release in release in 14 hours. The stability study conducted as per the ICH guidelines and the formulations were found to be stable. Microbiology study not found any bacteria.
Keywords: Quetiapine Fumarate, Microcrystalline cellulose, Cross Carmellose sodium, Poly vinyl pyrrolidone k 30, hydroxy propyl methyl cellulose.