Rohini, G (2017) Development and Evaluation of Mouth Dissolving Tablet of Tianeptine Sodium. Masters thesis, J.K.K. Nattraja College of Pharmacy, Kumarapalayam.
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Abstract
AIM & OBJECTIVE: The main aim of the current study was to formulate Tianeptine sodium tablets and to evaluate. Immediate release tablets are most widely used dosage forms. These products are designed to disintegrate in the stomach followed by their dissolution in the fluids of the gastro intestinal tract. Tianeptine is a selective serotonin reuptake enhancer (SSRE) drug used for treating major depressive episodes (mild, moderate, or severe). It is having a half-life of 2.5 h and used at a dose of 12.5 mg. Currently, Tianeptine is approved in France and manufactured and marketed by Laboratoires Servier SA, it is also marketed in a number of other European countries under the trade name "Coaxil" as well as in Asia and Latin America as "Stablon" and "Tatinol" but it is not available in the UK. The objective of the study was, To develop tianeptine sodium immediate release tablets to achieve faster dissolution to match the innovator product Stablon 12.5 mg. Another objective of the study is to evaluate dissolution profiles of these tablets in discriminating dissolution mediums to ensure its bioequivalence. SUMMARY: The main objective of the study is to develop tianeptine IR tablets using various super disintegrants in different concentrations to achieve faster dissolution to match the innovator product Stablon-170 mg. Tablets were prepared by incorporating the super disintegrants at 3, 5, 6 % w/w. Tablet blends were prepared and micromeritic studies were carried out for those blends. Pure and formulated products of tianeptine were evaluated by HPLC at a wave length of 220 nm using inertsil ODS column. From the results obtained by HPLC, the calibration curve was constructed having regression value of 0.997. Assay values of the formulations were observed in the range of 99.3 to 101%. Compatibility studies were performed and it was observed that all the super disintegrants used were compatible with the drug. Dissolution studies were performed and it was found that formulation F6 have shown best results and comparable with the innovator (Stablon). CONCLUSION: From the above experimental results it can be concluded that: Immediate release tablets of tianeptine sodium can be prepared by using CCS, CP and SSG at different concentrations. Immediate release tablets showed release depending on the concentration of the super disintegrant and also on the type of mechanism of disintegration of the super disintegrants CCS, SSG and CP. Tablet dimensions, weight and breaking force have no significant difference between tablets with different disintegrants. The DSC, XRD spectra’s revealed that, there was no interaction between the drug and the disintegrants. From the study it is evident that a promising immediate release tablet formulation can be developed. Further in vivo investigation is required to establish efficacy of this formulations. The study indicated that the dissolution rate increased with an increase in the super disintegrant concentration and significant results were observed with CCS even in discriminating media’s and apparent difference in dissolution rate was not observed between tablets formulated with CP and SSG.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Mouth Dissolving Tablet ; Tianeptine Sodium |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 19 Dec 2017 07:21 |
| Last Modified: | 19 Dec 2017 07:21 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/4471 |
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