Application of polyvinyl acetate in an innovative formulation strategy for lyophilized orally disintegrating tablets.

Orally disintegrating tablets (ODTs) manufactured by freeze-drying, also called oral lyophilizates, are a patient-centred dosage form. They possess ultra-fast disintegration dynamics, have acceptable mechanical strength and have a smooth mouth texture. In this study, polyvinyl alcohol (PVA) was investigated as an alternative polymeric binder to gelatin for ODT formulations. A low- and high-dose formulation were in-scope with mannitol as filler and xanthan gum as a viscosity enhancer. Design of experiments (DoE) methodology was applied to study the formulation effects on several quality attributes. Sedimentation during the initial phases of freeze-drying was successfully measured using Raman spectroscopy and could be minimized by adjusting the xanthan gum concentration. Multiple linear regression models were subsequently applied to establish design spaces and robust optimised formulations. A 19 mg hydrochlorothiazide (HCT) as low-dose and 500 mg paracetamol as high-dose ODT were developed in this study. The work displayed the use of PVA as a viable polymeric binder, and alternative for gelatin, in lyophilized ODTs.