A Simple and Inexpensive Image Analysis Technique to Study the Effect of Disintegrants Concentration and Diluents Type on Disintegration

J Pharm Sci. 2018 Oct;107(10):2643-2652. doi: 10.1016/j.xphs.2018.06.008. Epub 2018 Jun 20.

Abstract

Tablets disintegration is often the result of a size expansion of the tablets. In this study, we quantified the extent and direction of size expansion of tablets during disintegration, using readily available techniques, that is, a digital camera and public domain image analysis software. After validating the method, the influence of disintegrants concentration and diluents type on kinetics and mechanisms of disintegration were studied. Tablets containing diluent, disintegrant (sodium starch glycolate, crospovidone, or croscarmellose sodium), and lubricant were prepared by direct compression. Projected area and aspect ratio of the tablets were monitored using image analysis techniques. The developed method could describe the kinetics and mechanisms of disintegration qualitatively and quantitatively. Sodium starch glycolate and crospovidone acted purely by swelling and shape recovery mechanisms. Instead, croscarmellose sodium worked by a combination of both mechanisms, the extent of which changed depending on its concentration and the diluent type. We anticipate that the method described here could provide a framework for the routine screening of tablets disintegration using readily available equipment.

Keywords: burst release; excipient(s); formulation; hydration; imaging method(s); tablet(s).

MeSH terms

  • Carboxymethylcellulose Sodium / chemistry
  • Chemistry, Pharmaceutical / methods
  • Excipients / chemistry
  • Kinetics
  • Povidone / chemistry
  • Software
  • Solubility
  • Starch / analogs & derivatives
  • Starch / chemistry
  • Tablets / chemistry*
  • Technology, Pharmaceutical / methods*
  • Water / chemistry

Substances

  • Excipients
  • Tablets
  • Water
  • Starch
  • sodium starch glycolate
  • Povidone
  • Carboxymethylcellulose Sodium