Robustness of a Fiber Optic Dissolution Method for a Controlled Release Dosage Form
Dale M. Roberts, Saji K. Thomas, Philip A. Goliber, and Philip J. Palermo

This poster describes an easy to use procedure to collect and analyze data to meet the requirements of ruggedness and robustness as required for validation by USP 24 and tripartite ICH texts on validation of analytical procedure.
 

Analytical Performance of a Fiber Optic Probe System
Kevin Bynum, Kurt Roinestad, Abe Kassis, John Pocreva, Lane Gehrlein, Frank Cheng, Philip Palermo

This paper compares the use of an in-situ fiber optic dissolution system to conventional HPLC or UV-sipper systems in terms of accuracy, speed and ease-of-use.

Rapid release solid dosage formulations present conventional dissolution analysis with a serious challenge. Sublingual 500 mg Vitamin B12 solid dosage formulations were evaluated by ultraviolet spectroscopy via the highly sensitive in situ fiber optic dissolution technology of the Rainbow Dynamic Dissolution Monitor®.

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The Rainbow Dynamic Dissolution Monitor® (Delphian Technology Inc., Woburn, USA) is a simple and convenient UV absorbance technique for acquiring precise, accurate, reproducible and robust dissolution profiles of drug formulations containing a single active ingredient...

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Dissolution testing is a time-consuming and labor-intensive test procedure. The technique requires a sample of dissolution medium be removed from each of the test vessels at a specified time point(s)...

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In the Question and Answer section of Dissolution Technologies (November 1999) the final question raised the issue of hollow shaft sampling with fiber optics...

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With the increased testing demand in the laboratories of pharmaceutical companies, governmental institutions and contract service companies, automation becomes an important issue.  Automated procedures can guarantee a higher throughput of samples with increased accuracy and a decreased variation due to human interference...

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Manual dissolution testing entails time-consuming sample preparation.  Samples withdrawn from the dissolution vessels require filtration, then the clear solutions have to be transferred into cells for quantification by UV/VIS spectroscopy via an absorption reading.  This article describes the validation of a new method that enables the extent of dissolution to be determined without any sample preparation because the active substance concentration is measured directly in the dissolution vessels with a fiber optic probe...

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A fiber-optic (FO) probe-based dissolution test system has been developed for the USP dissolution and extended-release tests for solid dosage forms...

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