Introduction to Automation

The acceptance criteria quoted in the USP Chapters on Dissolution and Drug Release mean that a minimum of 6 and possibly up to 24 individual tests may be required per batch of formulation in order to meet pharmacopoeial requirements. Furthermore, the increasing use of extended and delayed-release preparations means that such tests may extend over 12, 24 hour or longer periods.

These demands together with the rise in multi-point testing brought about by the need for in vitro – in vivo correlation means that the dissolution or drug release test has now become one of the most common analyses employed in the pharmaceutical industry.

Manual dissolution testing is time consuming and labour intensive. As a result, an increasing number of laboratories are turning to automated tablet dissolution systems as a means of improving efficiency and reproducibility.

The advantages of automated systems are well documented i.e. improved methodology, accuracy, reproducibility and throughput although one should balance against these advantages the costs involved in setting up, programming, validating, operating and most importantly maintaining the automated system concerned, for example, in the event of breakdown.

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