Chan Sulthana, S.M (2012) Formulation and Evaluation of Sorafenib Tosylate Immediate Release Tablets. Masters thesis, Adhiparasakthi College of Pharmacy, Melmaruvathur.
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Abstract
The present work is to develop a solid oral dosage form of Sorafenib tosylate and it‟s comparision with innovator drug (Nexavar). The formulation of tablets were done to match the in-vitro drug release with respect to the reference drug and carry out the stability studies as per the ICH guidelines. Sorafenib tosylate posses Longer half life and hence it was a good candidate for Immediate release drug delivery system. The identification of drug was carried out by HPLC and melting point. The physicochemical parameters such as appearance, solubility study were performed by suitable methods. The analytical profile of drug was evaluated for development of standard curve and percentage purity of drug. Compatibility of drug and ingredients was done by performing HPLC and DSC study. It was concluded that there was no interaction between the drug and disintegrants as the Impurities present in the drug were found unaltered in the HPLC chromatogram and peaks in the DSC thermogram of drug disintegrant physical mixture. The powder blend was prepared by blending the various ingredients in mortar and pestle for 20 min and evaluated for bulk density, tapped density, carr‟s index, hausner‟s ratio and angle of repose the immediate release tablets of Sorafenib tosylate was feasible and may be manufactured with reproducible characteristics with the aid of Croscarmellose sodium as super disintegrants. From the above all trials we conclude that formulation-5 obeys all the results within the Standard limits as that of innovator product. However it needs further in depth animal studies on suitable animal models with statistical clinical data for a dependable and successful pharmaceutical marketing formulation.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Sorafenib Tosylate; Immediate Release Tablets |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 03 Oct 2017 04:52 |
| Last Modified: | 03 Oct 2017 04:52 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3365 |
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