Quality by Design (QbD) Approach and Application of Preformulation Studies for a Poorly Water Soluble Model Drug, Nimesulid

Özalp Y., Khamis H., Jiwa N., Mesut B., Aksu N. B.

ACTA FARMACEUTICA BONAERENSE, vol.42, no.1, pp.1-8, 2023 (SCI-Expanded)

  • Publication Type: Article / Article
  • Volume: 42 Issue: 1
  • Publication Date: 2023
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, EMBASE, International Pharmaceutical Abstracts
  • Page Numbers: pp.1-8
  • Istanbul University Affiliated: Yes


Formulating poorly water-soluble medications is one of the most crucial challenges encountered in the pharmaceutical industry. Due to this obstacle, the model drug chosen for this research was Nimesulide. The primary goal of this research was to obtain information on the drug’s physical and chemical properties, either alone or in combination with excipients, in order design a formulation and create a stable and bioavailable dosage form. Formulations were designed using Flowlac®100 and Avicel®102 as fillers, Kollidon®30 as a binder, Magnesium stearate as a lubricant, and variable concentrations of Kollidon®CL and Primojel as superdisintegrants. The tableting process was conducted using using a compaction simulator. The Quality by Design (QbD) approach allows formulators to enhance product development with built-in product quality. In this study, to understand the relationship between excipients and compaction force differences on tablet properties, the QbD approach was applied by using a compaction simulator.