Article Sidebar
Published:
Mar 12, 2024DOI:
10.4314/tjpr.v23i2.1Keywords:
Article Details
Submission of a manuscript to this journal is a representation that the manuscript has not been published previously and is not under consideration for publication elsewhere.
All authors named in each manuscript would be required to sign a form (to be supplied by the Editor) so that they may retain their copyright in the article but to assign to us (the Publishers) and its licensees in perpetuity, in all forms, formats and media (whether known or created in the future) to (i) publish, reproduce, distribute, display and store the contribution, (ii) translate the contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the contribution, (iii) create any other derivative works(s) based on the contribution, (iv) to exploit all subsidiary rights in the contribution, (v) the inclusion of electronic links from the contribution to third party material where-ever it may be located, and (vi) license any thrid party to do any or all of the above.
Main Article Content
Optimization of ticagrelor tablet for gastro-retentive drug delivery using full factorial design
Abstract
Purpose: To identify the optimized region of formulation using quality by design for developing ticagrelor gastro-retentive (GR) tablets.
Methods: A 23 + 3 full factorial design of experiments study was used to identify three factors (polyethylene oxide (PEO), compression, and volume of granulating fluid) involved in the wet granulation and compression process of ticagrelor GR tablets. Hardness, friability, content, dosage unit uniformity, and pH 1.2 dissolution rate (at 4, 8, and 12 h) were evaluated as critical quality attributes via analysis of variance using Design Expert software.
Results: All seven models were significantly influenced based on analysis of variance results (p < 0.05). Hardness and friability were significantly affected by compression (p < 0.0001). Content uniformity was significantly affected by the interaction between compression and granulating water volume for wet granulation (p < 0.05), and dosage unit uniformity was significantly affected by the volume of granulating fluid for wet granulation (p < 0.05). However, all results were within acceptable ranges. Polyethylene oxide (PEO) (4 h, p < 0.05; 8 h, p < 0.05; 12 h, p < 0.05) and compression (4 h, p < 0.05; 8 h, p < 0.05; 12 h, p < 0.05) had negative effect on pH 1.2 dissolution rate.
Conclusion: Design of experiment (DoE) approach has been used to optimize region of PEO, compression, and volume of granulating fluid for formulation development. This outcome is expected to be a basis for further research to develop TCG GR tablets on a large production scale.
