Development and characterisation of orally disintegrating flurbiprofen tablets using SeDeM-ODT tool

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Drug Delivery Systems

Background:

• Orally disintegrating tablets (ODTs) offer improved patient compliance for certain drug formulations.
• Direct compression (DC) is an efficient manufacturing method for tablets, requiring excipients with specific compressibility properties.
• Flurbiprofen is a non-steroidal anti-inflammatory drug often formulated for rapid absorption.

Purpose of the Study:

• To assess ludipress as a directly compressible excipient for flurbiprofen ODTs.
• To optimize ODT formulations using design of experiments (DoE) and the SeDeM-ODT tool.
• To evaluate the physicochemical properties, stability, and dissolution of the developed flurbiprofen ODTs.

Main Methods:

• SeDeM-ODT parametric tests were employed for preformulation analysis of powder blends.
• Design of experiments (DoE) with a central composite design was used to optimize ludipress and croscarmellose sodium ratios.
• Differential scanning calorimetry-thermogravimetric analysis (DSC-TGA), hardness, friability, disintegration, dissolution, and stability studies (ICH guidelines) were performed.

Main Results:

• All powder blends exhibited an index of good compressibility and bucodispersibility (IGCB) above 5, indicating suitability for direct compression.
• Optimized formulations met all evaluation criteria, with an estimated shelf life of 51.144-56.186 months under accelerated conditions.
• Dissolution studies indicated that the formulations followed the Higuchi kinetic model.

Conclusions:

• Ludipress is a suitable excipient for developing flurbiprofen ODTs via direct compression.
• The SeDeM-ODT tool is effective in predicting and optimizing powder blend properties for direct compression tableting.
• The developed flurbiprofen ODTs are stable and exhibit predictable dissolution profiles.