TY - JOUR
T1 - General and mechanistic optimal relationships for tensile strength of doubly convex tablets under diametrical compression
AU - Razavi, Sonia M.
AU - Gonzalez, Marcial
AU - Cuitiño, Alberto M.
N1 - Funding Information:
This material is based upon work supported by the National Science Foundation under Grant number IIP-1237873 , Industry-Academia Research Partnership for Developing & Implementing Non-Destructive Characterization and Assessment of Pharmaceutical Oral Dosages in Continuous Manufacturing. The authors also gratefully acknowledge the support received from the NSF ERC grant number EEC-0540855 , ERC for Structured Organic Particulate Systems.
Publisher Copyright:
© 2015 Elsevier B.V. All rights reserved.
PY - 2015/4/30
Y1 - 2015/4/30
N2 - We propose a general framework for determining optimal relationships for tensile strength of doubly convex tablets under diametrical compression. This approach is based on the observation that tensile strength is directly proportional to the breaking force and inversely proportional to a non-linear function of geometric parameters and materials properties. This generalization reduces to the analytical expression commonly used for flat faced tablets, i.e., Hertz solution, and to the empirical relationship currently used in the pharmaceutical industry for convex-faced tablets, i.e., Pitt's equation. Under proper parametrization, optimal tensile strength relationship can be determined from experimental results by minimizing a figure of merit of choice. This optimization is performed under the first-order approximation that a flat faced tablet and a doubly curved tablet have the same tensile strength if they have the same relative density and are made of the same powder, under equivalent manufacturing conditions. Furthermore, we provide a set of recommendations and best practices for assessing the performance of optimal tensile strength relationships in general. Based on these guidelines, we identify two new models, namely the general and mechanistic models, which are effective and predictive alternatives to the tensile strength relationship currently used in the pharmaceutical industry.
AB - We propose a general framework for determining optimal relationships for tensile strength of doubly convex tablets under diametrical compression. This approach is based on the observation that tensile strength is directly proportional to the breaking force and inversely proportional to a non-linear function of geometric parameters and materials properties. This generalization reduces to the analytical expression commonly used for flat faced tablets, i.e., Hertz solution, and to the empirical relationship currently used in the pharmaceutical industry for convex-faced tablets, i.e., Pitt's equation. Under proper parametrization, optimal tensile strength relationship can be determined from experimental results by minimizing a figure of merit of choice. This optimization is performed under the first-order approximation that a flat faced tablet and a doubly curved tablet have the same tensile strength if they have the same relative density and are made of the same powder, under equivalent manufacturing conditions. Furthermore, we provide a set of recommendations and best practices for assessing the performance of optimal tensile strength relationships in general. Based on these guidelines, we identify two new models, namely the general and mechanistic models, which are effective and predictive alternatives to the tensile strength relationship currently used in the pharmaceutical industry.
KW - Diametrical compression test
KW - Doubly convex tablets
KW - Optimal tensile strength relationships
KW - Tensile strength
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U2 - 10.1016/j.ijpharm.2015.02.030
DO - 10.1016/j.ijpharm.2015.02.030
M3 - Article
C2 - 25683146
AN - SCOPUS:84923586798
SN - 0378-5173
VL - 484
SP - 29
EP - 37
JO - International Journal of Pharmaceutics
JF - International Journal of Pharmaceutics
IS - 1-2
ER -