Date of Award
1-1-2024
Document Type
Thesis
Degree Name
M.S. in Pharmaceutical Science
First Advisor
Micheal A. Repka
Second Advisor
Mo Maniruzzaman
Third Advisor
Walt Chambliss
Relational Format
dissertation/thesis
Abstract
Granulation is one of the important unit operations in the manufacturing of solid dosage forms like tablets and capsules that regulate the quality of end products. It is a process of particle enlargement by agglomeration technique, which improves flow properties, compressibility, reduction of dust formation, drug content uniformity, dissolution rates, and overall product stability. Traditionally, it has been a batch process due to a better understanding. However, there has been a shift towards continuous manufacturing using a Twin-screw granulator, which is more robust, scalable, and versatile for various applications. This work presents the use of Twin screw wet granulation (TSWG) in the development of Quetiapine fumarate (QTF) immediate release tablets. Various process parameters (Screw configuration, liquid-to-solid (L/S) ratios), and binders (Klucel EXF and Kollidon 30) were evaluated to determine their effect on granule quality. Further, the obtained granules were tested for particle size distribution and flow properties. A higher percentage of uniform-sized granules were yielded with three mixing zones even with a lower liquid addition compared to that of one mixing zone with a higher liquid addition. These granules were further tableted and tested for their hardness, friability, disintegration, and dissolution. The tablets disintegrated and released the drug (~95%) rapidly within 5 minutes in 0.1N HCl due to QTF’s high solubility (17 mg/mL in 0.1N HCl) and porosity of granules. Overall, understanding process parameters and their influence on granule and tablet characteristics would help establish a more robust and continuous manufacturing of dosage.
Recommended Citation
Naguboyina, Tejaswini, "Evaluation of Process Parameters for Continuous Manufacturing of Quetiapine Fumarate Immediate Release Tablets Using Twin Screw Wet Granulation" (2024). Electronic Theses and Dissertations. 2849.
https://egrove.olemiss.edu/etd/2849