Impact of β-Cyclodextrin and Hydroxypropyl-β-Cyclodextrin Inclusion Complexes on Quality Attributes of Flurbiprofen Orally Disintegrating Tablets

Background/Objectives: Cyclodextrin inclusion complexation is widely used to improve the dissolution of poorly water-soluble drugs, but its effects on the manufacturability and quality of orally disintegrating tablets (ODTs) remain insufficiently understood. This study investigated how β-cyclodextrin (β-CD) and hydroxypropyl-β-cyclodextrin (HP-β-CD) inclusion complexes affect the powder properties, tablet quality attributes, and dissolution performance of flurbiprofen ODTs. Methods: Flurbiprofen inclusion complexes with β-CD and HP-β-CD were prepared by freeze-drying and characterized using scanning electron microscopy (SEM), Fourier-transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), and X-ray diffraction (XRD). ODTs containing pure flurbiprofen, inclusion complexes, or corresponding physical mixtures were manufactured by direct compression. Powder flowability and compressibility were assessed using the Hausner ratio and Carr’s index. Tablets were evaluated for weight variation, content uniformity, hardness, friability, disintegration, and dissolution at pH 1.2, 4.5, and 6.8. Results: Physicochemical characterization studies confirmed successful inclusion complex formation. β-CD formulations exhibited poorer flowability and compressibility than HP-β-CD formulations and pure drug blends. All ODTs complied with pharmacopeial requirements for weight variation and content uniformity. Inclusion complex-based tablets showed lower hardness and higher friability, whereas physical mixture-based tablets demonstrated greater mechanical strength. HP-β-CD inclusion complexes enhanced dissolution at pH 1.2 and 4.5. At pH 6.8, all formulations released more than 95% of flurbiprofen within 30 min. Conclusions: Cyclodextrin complexation influenced both the quality attributes and dissolution performance of flurbiprofen ODTs, highlighting the importance of cyclodextrin selection during formulation development.