Tamilselvan, P (2019) Formulation and Evaluation of Quetiapine Fumarate Extended Release Tablets. Masters thesis, PGP College of Pharmaceutical Science and Research Institute, Namakkal.
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Abstract
There was no significant changes in the levels of known and unknown impurities between initial and 6 months stability loaded product ASSAY,DISSOLUTION AND WATER CONTENT: There was no significant difference in all the values between initial and 3 months stability samples. DISCUSSION: From the above stability data, it was clear that there were no significant changes in the physical and chemical parameters of quetiapinefumarate extended release tablet 200mg in both bottle and blister packs during the stability studies at intermediate (30ºC+2ºC/65%RH+5%RH) and accelerated conditions (40±2ºC/75±5%RH) during 3 months period. Hence the qualitative composition of trail-008 has been proposed as best to take up further batches. Present work focuses on development of Extended Release Tablet of Quetiapinefumarate Quetiapinefumarate is an antipsychotic drug and is used for schizophrenia and bipolar disorder In the market it is available as SEROQUEL XR® (Quetiapinefumarate) tablets It is available in different strengths like 50mg,150mg,200mg,300mg and 400mg In this work , Quetiapinefumarate extended release tablet 200mg (which is the reference listed drug product (RLD) in orange book , FDA ) was formulated by wet granulation method Totally 10 formulation trails were carried out Among all the formulations, trail-008 was found to be satisfactory. Hence on the basis of compression parameter results and in vitro release data, it can be concluded as best formulation The optimized formula was subjected to stability studies as per ICH guidelines There was no significant changes observed in stability studies after 3 months and hence trail-008 has been considered to take up further batches.
| Item Type: | Thesis (Masters) |
|---|---|
| Additional Information: | 261711454 |
| Uncontrolled Keywords: | Formulation, Evaluation, Quetiapine Fumarate Extended Release Tablets |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ramakrishnan J |
| Date Deposited: | 13 May 2022 05:27 |
| Last Modified: | 13 May 2022 05:27 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/20026 |
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