Blend uniformity analysis of pharmaceutical products by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Fitzpatrick, Dara; Scanlon, Eoin; Krüse, Jacob; Vos, Bastiaan; Evans-Hurson, Rachel; Fitzpatrick, Eileen; McSweeney, Sean

doi:10.1016/j.ijpharm.2012.07.073

Cited by 14 publications

(14 citation statements)

References 3 publications

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“…Results from BARDS analysis indicated that water transfer into MPC powder particles became inhibited as the protein content of the MPC powders increased (Figures 2, 3, Table 1). For example, rehydration of MPC35 yielded a minimal BARDS response and a rapid return to steady-state (<400 s), while the time (60 min) required to reach steady-state for MPC90 (0.2%) (Figure 2) is unprecedented in its length compared to previous BARDS studies (Fitzpatrick et al, 2012a(Fitzpatrick et al, , 2012b(Fitzpatrick et al, , 2013(Fitzpatrick et al, , 2014. Release of gas from powders can be used to indirectly investigate water transfer in dairy powders (Richard et al, 2012;Hauser and Amamcharla, 2016;).…”

Section: Discussionmentioning

confidence: 95%

“…Thus, in this study, a new form of acoustic spectroscopy, Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS), was used to monitor water transfer related phenomena in a range of MPC powders for the first time. BARDS is an analytical platform technology with multiple applications, such as blend uniformity analysis, discrimination of polymorphs and drug loading on sugar spheres for controlled release formulations (Fitzpatrick et al, 2012a(Fitzpatrick et al, , 2012b(Fitzpatrick et al, , 2014. ).…”

Section: Accepted Manuscriptmentioning

confidence: 99%

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New insights into the mechanism of rehydration of milk protein concentrate powders determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

et al. 2016

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Section: Discussionmentioning

confidence: 95%

Section: Accepted Manuscriptmentioning

confidence: 99%

New insights into the mechanism of rehydration of milk protein concentrate powders determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

et al. 2016

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“…A custom prototype spectrometer was built and used to investigate the BARDS responses (12,13). It consists of a chamber with a glass dissolution vessel, a microphone (Sony ECM-CS10, range 100-16 kHz), a magnetic stirrer, and a stir bar.…”

Section: Instrumentationmentioning

confidence: 99%

pH Dependence of the Dissolution Rate of EntericCoated Drug Spheres Determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Evans-Hurson¹,

McSweeney²,

Vos³

et al. 2016

Dissolution Technol.

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Enteric coatings are widely used in formulations of drug delivery spheres. The coating protects an active pharmaceutical ingredient (API) from acidic conditions in the low pH environment of the stomach. The coating breaks down readily at higher pH in the lower intestine to allow absorption of the API. The thickness of the enteric coating is one of the factors that determine the release rate of the drug in the gastrointestinal tract. It is difficult to determine the loading of the drug layer and enteric coating on the core support sphere without conventional dissolution testing during and post manufacture. Broadband acoustic resonance dissolution spectroscopy (BARDS) potentially offers a new, rapid approach to characterizing enteric coatings during their manufacture. BARDS applications are based on reproducible changes in the compressibility of a solvent during dissolution, which is monitored acoustically via associated changes in the frequency of induced acoustic resonances. Two drug sphere formulations that yield characteristic and reproducible data were investigated. A steady-state acoustic lag time is associated with the disintegration of the enteric coating and drug layer in basic solution. This lag time is pH dependent and is indicative of the rate at which the coating and layers dissolve. BARDS analysis has the potential to characterize drug sphere formulations at-line in very short timescales. BARDS represents a complementary technique to conventional dissolution testing that could be used in precompliance testing for quality assurance during manufacture. BARDS data, in the future, may also be indicative of the likely performance of a formulation under USP dissolution testing. KEYWORDS:Hypromellose; enteric-coated spheres; dissolution; BARDS.

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“…Substandard medicines, both due to within-factory errors and due to degradation in supply chains, are expected to produce different BARDS spectra compared to control spectra with the correct formulation. Small percentage changes of the excipients can cause statistical changes in the spectra 34 .…”

Section: Discussion/conclusionmentioning

confidence: 99%

Sounding out falsified medicines from genuine medicines using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Alfarsi

Caillet

Fawbert

et al. 2021

Sci Rep

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The trade in falsified medicine has increased significantly and it is estimated that global falsified sales have reached $100 billion in 2020. The EU Falsified Medicines Directive states that falsified medicines do not only reach patients through illegal routes but also via the legal supply chain. Falsified medicines can contain harmful ingredients. They can also contain too little or too much active ingredient or no active ingredient at all. BARDS (Broadband Acoustic Resonance Dissolution Spectroscopy) harnesses an acoustic phenomenon associated with the dissolution of a sample (tablet or powder). The resulting acoustic spectrum is unique and intrinsic to the sample and can be used as an identifier or signature profile. BARDS was evaluated in this study to determine whether a product is falsified or genuine in a rapid manner and at lower cost than many existing technologies. A range of genuine and falsified medicines, including falsified antimalarial tablets from south-east Asia, were tested, and compared to their counterpart genuine products. Significant differences between genuine and falsified doses were found in their acoustic signatures as they disintegrate and dissolve. Principal component analysis was employed to differentiate between the genuine and falsified medicines. This demonstrates that the tablets and capsules included here have intrinsic acoustic signatures which could be used to screen the quality of medicines.

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Blend uniformity analysis of pharmaceutical products by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Cited by 14 publications

References 3 publications

New insights into the mechanism of rehydration of milk protein concentrate powders determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

New insights into the mechanism of rehydration of milk protein concentrate powders determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

pH Dependence of the Dissolution Rate of EntericCoated Drug Spheres Determined by Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

Sounding out falsified medicines from genuine medicines using Broadband Acoustic Resonance Dissolution Spectroscopy (BARDS)

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