Characterisation of pharmaceutical formulations using broadband acoustic resonance dissolution spectroscopy (BARDS) Niamh O'Mahoney University College Cork, Ireland In this study, Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS) characterises several pharmaceutical formulations, including enteric-coated microspheres, tablets and multiple-unit pellet systems (MUPS). Effervescent tablets, chewable tablets and liquid formulations were also analysed. BARDS is a novel approach based on reproducible changes in a solvent's compressibility as a sample dissolves. It is a rapid and straightforward method that utilises a magnetic stir bar to mix added solute and induce a vessel's acoustic resonance containing a fixed volume of solvent. Adding a solute to a solvent is known to reduce the solubility of dissolved gases in solution, leading to gas oversaturation and outgassing of the solvent, changing the solvent system's compressibility, and reducing the velocity of sound in the solvent. As a sample is wetted and subsequently dissolved, gas is released from the solvent, altering the resonance frequency. A single replicate BARDS measurement can provide data relevant to multiple dissolution processes in a time-efficient manner by tracking the Erosion of the enteric coating, Disintegration, Deaggregation and overall Dissolution of the formulations while assessing the formulation's integrity using an EDDDI Plot [1]. BARDS can determine the thickness of the drug and enteric coatings. UV-Vis Spectroscopy and High-Performance Liquid Chromatography have been used in the cross-validation of the technique [2]. BARDS can enable the rapid development of solid drug formulation dissolution and disintegration testing as an in-process control test and drug stability analysis. The data shows that a dosage formulation has an intrinsic acoustic signature specific to the method of manufacture, excipient composition and elapsed time since the production of a product [3]. This study will highlight BARDS as a rapid characterisation technique to track the chemical reaction associated with effervescent dosage forms. BARDS can also be used as an analytical tool to quantify the dissolution of liquid formulations. This has been demonstrated by a test model using two different liquid formulation types, suspension formulations and syrup formulations. Similarities between different brands were apparent when tested. BARDS can qualitatively discriminate between API dosage, API types, and discriminate whether an API has been partially dissolved in the suspension media before addition to the BARDS instrument. In addition, BARDS is a time-efficient, cost-effective and green approach to formulation characterisation. References 1. O'MAHONEY, N., KEATING, J. J., MCSWEENEY, S., HILL, S., LAWRENCE, S. & FITZPATRICK, D. 2020a. The sound of tablets during coating erosion, disintegration, deaggregation and dissolution. International journal of pharmaceutics, 580, 119216-119216. 2. ALFARSI, A., O'MAHONEY, N., ARNDT, M., KUNTZ, T., MCSWEENEY, S., KRÜ SE, J., SKALSKY, B. & FITZPATRICK, D. 2019a. A rapid in-process control (IPC) test to monitor the functionality of taste masking polymer coatings using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS). International Journal of Pharmaceutics, 568, 118559. 3. O'MAHONEY, N., ALFARSI, A., O'SULLIVAN, H., MCSWEENEY, S., CREAN, A. & FITZPATRICK, D. 2021b. Sounding out stability of enteric coated dosage forms using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS). International journal of pharmaceutics, 602, 120614-120614.
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