A semi-empirical model for estimation of flaw size in internally defective tablets.

Capping is a mechanical defect in tablets, which is attributed to multiple factors including intrinsic material properties and tableting conditions. A suitable non-destructive approach using acoustically derived elastic modulus has showed distinctive features between a defective tablet and a defect-free tablet. In this work, a semi-empirical model was developed to estimate flaw size in an internally defective tablet from the relationship among elastic modulus, tablet density, and time of flight (acoustic wave to traverse through the tablet). The model was found fundamentally consistent where the derived flaw size showed clear dependence on powder mechanical properties of seven diverse formulations studied. Furthermore, the flaw size was reasonably correlated with the internal tablet microstructure illustrated by X-ray micro-tomography findings, both qualitatively and quantitatively. This model could thus be efficiently implemented for risk-based evaluation of internal defects in visibly intact tablets to ensure robustness of drug products.

• Publication year

  2021

• Venue

  Journal of Pharmacy and Science

• Publication date

  2021-03-01

• Fields of study

  Medicine, Materials Science, Engineering

• Identifiers
  DOI 10.1016/j.xphs.2021.02.032PMID 33662393
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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