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Minimum Interfacial Bonding Strength for Bilayer Tablets Determined Using a Survival Test
Shao-Yu Chang1, Changquan Calvin Sun2
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, Minnesota, 55455, USA.
A minimum interfacial bonding strength (IBS) of 0.26 MPa is sufficient for bilayer tablets to withstand manufacturing and handling stresses. This IBS value ensures tablet integrity across various formulations and sizes, preventing quality issues.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Bilayer tablets offer advantages in drug delivery but are susceptible to interfacial delamination.
- Understanding the minimum interfacial bonding strength (IBS) is crucial for ensuring tablet integrity during processing and distribution.
Purpose of the Study:
- To determine the minimum interfacial bonding strength (IBS) necessary for bilayer tablets to withstand mechanical stresses.
- To establish a tentative criterion for adequate IBS in bilayer tablet formulations.
Main Methods:
- Bilayer tablets with varying IBS were fabricated and subjected to simulated manufacturing and handling stresses using a friabilator.
- Tablet integrity was assessed after repeated drops, and the minimum IBS required to maintain interface integrity after 1000 drops was identified.
Main Results:
- The required minimum IBS is influenced by layer composition and tablet size, with more brittle materials or larger tablets needing higher IBS.
- Incorporating HPMC into the formulation reduced the minimum IBS requirement.
- An IBS of 0.26 MPa was found to be sufficient for all tested bilayer tablet formulations and sizes to survive 1000 drops.
Conclusions:
- A minimum IBS of 0.26 MPa is proposed as a tentative standard for bilayer tablets.
- This criterion can help prevent quality defects related to insufficient interfacial bonding in pharmaceutical manufacturing.
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