Studies in Solid Solution Formation between Acetaminophen and Povidone and Mouth mouth-dissolving Strip Formulation

Abstract

Introduction: This invention reports the solubilization of Acetaminophen (ACM) within the Povidone (PVP K30) in the solid state for the first time. First-generation solid dispersions (SDs) were attempted with a different ratio of PVP K:30:ACM. SDs prepared were transparent, suggesting a solid solution (SS) formation, which was a serendipitous discovery.

Methods: A minimum ratio of 1.25:1 PVP K30: ACM was required to form stable SS, suggesting discontinuous SS. A computational complex prediction tool, Fourier Transform Infrared Spectroscopy (FTIR), and Differential scanning calorimetry (DSC) confirmed the SS formation.

Results: The oral strip formulation was developed from the PVP K30: ACM SS using Polyvinyl alcohol as a film-former found to be optimum concerning physicochemical properties, offering rapid drug dissolution and taste masking. The developed strip is suitable for delivery of children's dose (100-150 mg).

Conclusion: The developed SS can also be formulated as tablets, capsules, and oral dissolving tablets to deliver adult doses with improved therapeutic benefits and patient compliance.

Keywords: Solid dispersion; mouth dissolving strip; paracetamol; solid solution.