Development and evaluation of orally disintegrating tablets (ODTs) containing Ibuprofen granules prepared by hot melt extrusion

Colloids Surf B Biointerfaces. 2011 Sep 1;86(2):275-84. doi: 10.1016/j.colsurfb.2011.04.007. Epub 2011 Apr 13.

Abstract

In the current study Ibuprofen was embedded in a methacrylate copolymer (Eudragit® EPO) matrix to produce solid dispersions by hot-melt extrusion (HME) processing. The obtained granules were incorporated in orally disintegrating tablets (ODTs). The tablets were developed by varying the ratio of superdisintegrants such as sodium croscarmellose and crosslinked polyvinylpyrrolidone grades while a direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets which included porosity, hardness, friability and dissolution profiles were further evaluated and compared with Nurofen® Meltlet ODTs. The taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and improved tablet palatability.

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Carboxymethylcellulose Sodium / chemistry
  • Chemistry, Pharmaceutical / methods*
  • Chromatography, High Pressure Liquid
  • Drug Compounding / methods*
  • Female
  • Hardness
  • Hot Temperature
  • Humans
  • Ibuprofen / chemistry*
  • Male
  • Polymethacrylic Acids / chemistry
  • Povidone / chemistry
  • Pressure
  • Solubility
  • Tablets / chemistry*
  • Taste / physiology
  • X-Ray Diffraction

Substances

  • Polymethacrylic Acids
  • Tablets
  • methylmethacrylate-methacrylic acid copolymer
  • Povidone
  • Carboxymethylcellulose Sodium
  • Ibuprofen