Date of Award
1-1-2023
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Michael A. Repka
Second Advisor
Dr. Walter Chambliss
Third Advisor
Eman Ashour
School
University of Mississippi
Relational Format
dissertation/thesis
Abstract
Twin screw melt granulation is a versatile continuous manufacturing process extensively investigated for the production of oral solid dosage forms. The aim of this study was to prepare and compare the dissolution & tableting properties of compressed quetiapine fumarate tablets processed through twin screw melt granulation with commercially available quetiapine fumarate tablets. As an alternative to wet and dry granulation techniques, twin-screw melt granulation has several advantages. In the past few years, twin screw melt granulation has seen a sharp increase in interest from the pharmaceutical industry as it is time & cost effective, solvent free, continuous process. Twin screw melt granulation creates products with higher levels of consistency than batch processing since it is a fundamentally continuous process with controlled temperature and shear history. Industry estimates that more than 50% of active pharmaceutical ingredients fall under the biopharmaceutical classification system II i.e., BCS class II, which is characterized as a group of poorly water-soluble compounds that produce formulations with low bioavailability. Therefore, it is imperative that the pharmaceutical industry create formulations that will improve these chemicals solubility and ultimately, their bioavailability. This is an efficient, solvent-free, continuous process that is easily automatable and compatible to produce pharmaceutical products with high solubility and bioavailability. The novel combination of the drug quetiapine fumarate and polymer HPMC HME LV15 (Hypromellose) and bulking agent Ludiflash were selected. The selected final formulation was then produced by twin screw melt granulation using the 16mm twin screw configuration. Produced tablets were subjected to flow properties, DSC and FTIR characterizations, content uniformity, evaluation of tableting parameters including weight variation, hardness test, friability test, disintegration time and finally the comparative dissolution studies of the final formulation with the commercially available quetiapine fumarate tablets were performed.
Recommended Citation
Chavan, Salonee, "Formulation and Evaluation of Quetiapine Fumarate Tablets using Twin Screw Melt Granulation" (2023). Electronic Theses and Dissertations. 2487.
https://egrove.olemiss.edu/etd/2487