Monthly Spotlight - BARDS

Troubleshooting Tablet Dissolution Processes using BARDS

The present industrial and regulatory practice for the quality control of oral formulations is centred around tablet dissolution, i.e. the process that follows disintegration, yet the vast majority of problems that are found in formulation dissolution testing can be traced back to the erratic disintegration behaviour of the medicinal product. It is only due to the distinct lack of quantitative measurement techniques for disintegration analysis that this situation arises. Current methods involve costly, and time-consuming test equipment, resulting in a need for more simple, green and efficient methods which have the potential to enable rapid development and to accelerate routine solid drug formulation dissolution and disintegration testing.

Image 1: BARDS Benchtop and Portable Instrument

A novel approach to track sequential tablet dissolution processes, including coating erosion, disintegration, deaggregation and dissolution is Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS) (Image 1. BARDS, in combination with minimal usage of UV spectroscopy, can effectively track these processes (Image 2). BARDS data results from reproducible changes in the compressibility of dissolution media (during tablet dissolution) which results in changes in the resonant frequency of the dissolution vessel. BARDS data shows that solid oral dosage formulations have intrinsic and reproducible acoustic signatures which are specific to the method of manufacture and excipient composition. This allows for a rapid upstream test to demonstrate the quality of batch formulations pre-dissolution testing or to determine the end point of enteric coating processes at-line. BARDS can also be used to determine counterfeit product given the uniqueness of the acoustic signature during dissolution. Stability testing is another application for which BARDS can be routinely used.

Image2: BARDS spectra showing the coating erosion (initial 300 s) followed by tablet disintegration (200-500 s), followed by deaggregation (500-1500 s). Note the UV data in red shows no drug release during the coating erosion and approx. 50% release by the frequency minima of the BARDS sepctra.

As a platform technology, BARDS has many other applications in the powder characterisation space including the tracking of agglomeration, the hydration of proteins and even end point determination of the milling of co-crystals. Biotech applications include tracking cell vitality and viability and new research is harnessing BARDS to help in the search for the most efficient materials for conversion of solar energy to hydrogen through the electrolysis of water.

If you’d like to learn more, please contact Dr. Dara Fitzpatrick (Director, BARDS Acoustic Science Labs Ltd.) at d.fitzpatrick@ucc.ie

Take a further look at some recent publications relating to Tablet Dissolution Processes using BARDS;