Journal
INTERNATIONAL JOURNAL OF PHARMACEUTICS
Volume 495, Issue 1, Pages 290-301Publisher
ELSEVIER
DOI: 10.1016/j.ijpharm.2015.08.077
Keywords
Continuous manufacturing; Direct compression; Continuous mixing; Extended release; HPMC; Adaptive control
Categories
Funding
- PROMIS Centre consortium
- Finnish Funding Agency for Technology and Innovation (Tekes)
- Regional Council of Pohjois-Savo
- North Savo Centre for Economic Development, Transportation and Environment
Ask authors/readers for more resources
The aim of the current work was to explore continuous dry powder mixing and direct compression for manufacturing of extended release (ER) matrix tablets. The study was span out with a challenging formulation design comprising ibuprofen compositions with varying particle size and a relatively low amount of the matrix former hydroxypropyl methylcellulose (HPMC). Standard grade HPMC (CR) was compared to a recently developed direct compressible grade (DC2). The work demonstrate that ER tablets with desired quality attributes could be manufactured via integrated continuous mixing and direct compression. The most robust tablet quality (weight, assay, tensile strength) was obtained using high mixer speed and large particle size ibuprofen and HPMC DC2 due to good powder flow. At low mixer speed it was more difficult to achieve high quality low dose tablets. Notably, with HPMC DC2 the processing conditions had a significant effect on drug release. Longer processing time and/or faster mixer speed was needed to achieve robust release with compositions containing DC2 compared with those containing CR. This work confirms the importance of balancing process parameters and material properties to find consistent product quality. Also, adaptive control is proven a pivotal means for control of continuous manufacturing systems. (C) 2015 Elsevier B.V. All rights reserved.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available