Rapid determination of the active pharmaceutical Ingredient (API) content of suspension formulations using Broadband acoustic resonance dissolution spectroscopy (BARDS).

Abstract

Oral suspension formulations are advantageous over other drug dosage methods due to ease of administration, swallowability and taste masking. A large market exists for this particular form of drug introduction, particularly among paediatric and geriatric patients. This paper highlights a proof of concept approach to an alternative quality control test for oral suspension formulations using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS). BARDS measurements are based on reproducible changes in the compressibility of a solvent during the dispersion of a formulation, which is monitored acoustically via associated changes in the frequency of induced acoustic resonances. This study offers a new approach to tracking the loading of oral suspension formulations. Suspension formulations containing various Active Pharmaceutical Ingredients (APIs) and excipients were investigated to examine the effect of API dosage and formulation on their overall dissolution. The data shows oral suspension formulations have an intrinsic acoustic signature specific to their manufacturing and formulation composition. It was also found that the level of API present determines the acoustic response. BARDS represents a possible future surrogate for In-Process Control (IPC) testing as a Process Analytical Technology (PAT) method. It also offers an alternative approach to assessing patient compliance and for determining drug precipitation. This study represents a greener, cost-effective, and time-efficient product testing method with no requirement for organic solvents or high-end instrumentation.