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

Abstract:

:Blend uniformity analysis (BUA) is a routine and highly regulated aspect of pharmaceutical production. In most instances, it involves quantitative determination of individual components of a blend in order to ascertain the mixture ratio. This approach often entails the use of costly and sophisticated instrumentation and complex statistical methods. In this study, a new and simple qualitative blend confirmatory test is introduced based on a well known acoustic phenomenon. Several over the counter (OTC) product powder blends are analysed and it is shown that each product has a unique and highly reproducible acoustic signature. The acoustic frequency responses generated during the dissolution of the product are measured and recorded in real time. It is shown that intra-batch and inter-batch variation for each product is either insignificant or non-existent when measured in triplicate. This study demonstrates that Broadband Acoustic Resonance Dissolution Spectroscopy or BARDS can be used successfully to determine inter-batch variability, stability and uniformity of powder blends. This is just one application of a wide range of BARDS applications which are more cost effective and time efficient than current methods.

journal_name

Int J Pharm

authors

Fitzpatrick D,Scanlon E,Krüse J,Vos B,Evans-Hurson R,Fitzpatrick E,McSweeney S

doi

10.1016/j.ijpharm.2012.07.073

subject

Has Abstract

pub_date

2012-11-15 00:00:00

pages

134-9

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(12)00794-6

journal_volume

438

pub_type

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