Dissolution device makes ‘dosage dumping’ a thing of the past, says Agilent

18-Nov-2010 - Last updated on 18-Jul-2013 at 10:53 GMT

Agilent Technologies has launched its 708-DS Dissolution Apparatus, a quality control instrument that can be set up for manual or automated applications to measure the release rate of an API over time.

The dissolution test measures the rate at which active pharmaceutical ingredients (API) dissolve and is a key indicator of the quality of the manufacturing process, says Agilent.

The company claims its device enables scientists to assess batch-to-batch performance, bioequivalency and other characteristics of compounds, maintaining consistent samples throughout the process and allowing global manufacturers to compare batches produced worldwide.

Allan Little, dissolution project manager at Agilent Technologies, told in-PharmaTechnologist the apparatus minimises variability and improves results, He said: “Many external variables could influence the outcome of the dissolution test. Precise centring of each individual dissolution vessel is just one way we have eliminated potential problems.

“The test should reveal information based on the dosage form, not the tester in which it was tested,” he added.

According to Little, dissolution is one of the required tests for each batch of a wide range of pharmaceutical products, with the exception of injectables and aerosols.

He said: “It is critical that a sufficient quantity of the API becomes bioavailable at the appropriate time to ensure the proper therapeutic outcome.” Similarly, it is also “important that dosage dumping does not occur,” he added.

Manual and automated models

The 708-DS Dissolution Apparatus is available as a basic manual model and with several automated configurations for high-throughput online sampling and online UV analysis.

Agilent says the platform, which conforms to international pharmacopeia specifications, boasts a range of optional capabilities including dosage dropping, – to automatically start a test – a motorised manifold for sample removal which promises no hydrodynamic disturbances, and temperature monitoring throughout a dissolution run.

As the firm says dissolution is a key test in the quality control (QC) and method development markets within the global pharma industry, it claims the number of tests performed is continuously rising in both market segments.

“The flexibility of the system will allow global companies to standardise on one platform,” said Little, adding “Agilent looks forward to continuing to drive innovation and discovery in the dissolution market.”