Minimum Interfacial Bonding Strength for Bilayer Tablets Determined Using a Survival Test

Purpose To identify the minimum interfacial bonding strength (IBS) required for bilayer tablets to sustain the stresses experienced during manufacturing, transportation, and handling. Methods Bilayer tablets of a number of formulations with systematically varied IBS were prepared on a materials test...

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Bibliographic Details
Published in:Pharmaceutical research 2019-10, Vol.36 (10), p.139-7, Article 139
Main Authors: Chang, Shao-Yu, Sun, Changquan Calvin
Format: Article
Language:English
Subjects:
Biochemistry
Biomedical and Life Sciences
Biomedical Engineering and Bioengineering
Biomedicine
Brittle materials
Formulations
Friability
Interfacial bonding
Materials testing
Medical Law
Pharmacology/Toxicology
Pharmacy
Research Paper
Survival
Tablets
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Summary:Purpose To identify the minimum interfacial bonding strength (IBS) required for bilayer tablets to sustain the stresses experienced during manufacturing, transportation, and handling. Methods Bilayer tablets of a number of formulations with systematically varied IBS were prepared on a materials testing macine. Five bilayer tablets with the same IBS were repeatedly dropped at a fixed height in a friabilator and integrity of the interface was periodically examined. The number of tablets free from observable defects at the interface was plotted as a function of the number of drops. The IBS for all five tablets to remain intact after 1000 drops was taken as the minimum IBS for a given formulation. Results The minimum IBS depends on both layer composition and tablet size. For bilayer tablets made with more brittle materials or a larger size, a higher minimum IBS is required to pass the survival test. The incorporation of HPMC leads to a lower minimum IBS. An IBS of 0.26 MPa is sufficient for all bilayer tablet formulations and sizes to pass the survival test in this work. Conclusions A minimum IBS of 0.26 MPa is recommended as a tentative criterion for bilayer tablets of most materials to avoid quality issues arising from inadequate IBS.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-019-2675-7