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Interfacial bonding in formulated bilayer tablets
Shao-Yu Chang1, Changquan Calvin Sun1
1Pharmaceutical Materials Science and Engineering Laboratory, Department of Pharmaceutics, College of Pharmacy, University of Minnesota, 9-127B Weaver-Densford Hall, 308 Harvard Street S.E., Minneapolis, MN 55455, USA.
Summary
This study investigated bilayer tablet interfacial bonding strength (IBS), finding that composition and compaction pressure significantly impact tablet integrity. Optimizing these factors is key for robust drug delivery systems.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
- Manufacturing Engineering
Background:
- Bilayer tablets offer drug delivery advantages but face manufacturing challenges.
- Weak interfacial bonding strength (IBS) is a critical issue in bilayer tablet production.
- Overcoming IBS is essential for realizing the full potential of bilayer drug delivery systems.
Purpose of the Study:
- To characterize the effects of layer composition and compaction pressure on bilayer tablet IBS.
- To understand the relationship between material properties and tablet interfacial integrity.
- To provide insights for optimizing bilayer tablet manufacturing processes.
Main Methods:
- Investigated mixtures of microcrystalline cellulose (MCC) and lactose in varying ratios, with and without hydroxypropyl methylcellulose (HPMC).
- Compacted the first layer at 20 and 100 MPa, followed by a second layer compaction at 200 MPa.
- Analyzed failure modes (at the interface or within a layer) to determine IBS.
Main Results:
- Bilayer tablet IBS is complexly influenced by MCC content, particle bonding strength, and interfacial bonding area.
- Both composition of individual layers and compaction pressure were identified as key factors affecting IBS.
- Failure modes were observed to occur either at the interface or within a layer, depending on the formulation and compaction parameters.
Conclusions:
- The interplay between particle bonding and bonding area at the interface explains the observed trends in bilayer tablet IBS.
- Understanding these relationships is crucial for designing and manufacturing stable bilayer tablets.
- This research provides a foundation for improving the manufacturing of bilayer drug delivery systems by addressing interfacial bonding.
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