Date of Award
1-1-2024
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Michael A. Repka
Second Advisor
Walter G. Chambliss
Third Advisor
Eman A. Ashour
Relational Format
dissertation/thesis
Abstract
Quetiapine fumarate (QF) is an antipsychotic drug, and it has a plasma half-life of 6 hours. The chemical structure of QF has nitrogen groups making it highly soluble in acidic pH and slightly soluble in alkaline pH. This study aimed to develop the QF gastroretentive tablets by TSMG technology comprising floating and mucoadhesive approach by using different viscosity grades of HPMC to improve absorption by prolonging its gastric residence time. The floating tablets were prepared using the Twin screw melt granulation (TSMG) technology, and the impact of polymer concentration and viscosity grades of HPMC on the floating ability and drug release profile was investigated. This study focused on preparing gastroretentive floating quetiapine fumarate tablets using TSMG using an 11mm co rotating extruder (Thermo Fisher Scientific, Waltham, MA, USA). The produced granules were analyzed for flow properties and characterized using DSC technique. Additionally, the tablets were evaluated for content uniformity and various tableting parameters such as weight variation, hardness, friability, dissolution studies and mucoadhesive test conducted for the lead formulation. From the in vitro dissolution studies, the tablets prepared using granules obtained from the Process 11 extruder (Thermo Fisher Scientific, Waltham, MA, USA) at the processing temperature of 170 °C, met the requirements of the USP dissolution test 11 specifications (NMT 25% at 1hr 40-60% at 4hr 65-85% at 8hr NLT 80% at 16 hrs.) of QF extended-release tablets. However, the tablets prepared using direct compression method have failed to exhibit desired release as per Usp Specification for QF extended-release tablets. In conclusion, preparing QF gastroretentive floating tablets using TSMG has significant value as it is a continuous manufacturing process.
Recommended Citation
Kolipaka, Ajay Reddy, "Formulation and Characterization of Quetiapine Fumarate Floating Bioadhesive Tablets" (2024). Electronic Theses and Dissertations. 2756.
https://egrove.olemiss.edu/etd/2756