Now there's an easy way to bring the power, accuracy and sheer speed of fiber optic technology to your dissolution research. The new Fiber Optics Dissolution System is a complete package that provides immediate data points from all specimens for dissolution rate analysis. Ideal for formulations labs and method development teams investigating immediate release products, this system includes the Hanson SR8–Plus™ Dissolution Test Station, C Technologies IO™ Fiber Optic Analysis System (featuring a Varian Cary™ 50 UV/VIS Spectrophotometer), and a complete System Validation Package.

Features:

• Complete fiber optic dissolution system providing everything you need for research, method development and quality control programs.
• Fiber optic technology eliminates the need to remove samples. The concentration of dissolved constituent is measured in situ, directly in the vessel.
• Immediate data points are provided from all specimens for comprehensive dissolution rate analysis.
• Ideal research tool for formulations teams investigating drug release characteristics and variances caused by formula modifications.
• System components include industry-proven Hanson SR8-Plus™ dissolution tester, C Technologies fiber optic system, and Varian Cary™ 50 detector.
• Hanson E-Probes™ automatically drop fiber optic probes to specified sampling position in vessels, then return back to media level after sample analysis.
• A single scanning UV/VIS spectrophotometer eliminates stray light problems as well as the need for cross-calibration and corrections common with other fiber optic systems.
• An extensive data acquisition and analysis software package is included with the fully-loaded PC workstation.
• A complete system validation package is available. Hanson and C Tech/Varian software is USP/FDA compliant, including 21CFR11.
• Qualified sales and service support worldwide.

Data Acquisition and Sample Analysis

A primary consideration in fiber optic dissolution is the problem of excipient particles present in the sample volume analyzed. The C Technologies IO™ system addresses this concern by employing an excipient correction algorithm using a baseline correction method. This method corrects the data collected from the spectral absorption band of the active by subtracting the measured absorbance value of a reference wavelength outside the drug’s absorption band. Since excipient spectra are typically linear and easily validated, subtracting this offset value from the measured in-band absorption therefore corrects that value for the effects of the particles.

Although this baseline correction should be verified on a product-to-product basis, this method has enjoyed real-world success in the pharmaceutical research lab. One such study involved a developmental immediate-release pharmaceutical drug (*Pfizer, Morris Plains , New Jersey ). This product comprised commonly used excipients and an active ingredient delivered in a capsule shell. The IO™ data presented illustrates the baseline uniformity of the excipient blend and capsule shell in relation to the UV/VIS spectra of the active ingredient. Also shown is the direct correlation of fiber optic dissolution results vis-à-vis traditional off-line results on the same product.

Method Validation

The tables below present method validation data for applying IO™ fiber optic dissolution monitoring to an immediate-release product (*Hoffman-La Roche, Basel , Switzerland ). The drug studied was a soft gelatin capsule containing 200mg of active substance dissolved in a mono- and diglyceride filling. Validation studies were performed in accordance with standard USP and ICH protocols. Although no excipient particles existed in this case, turbidity was still generated due to metal oxide pigments from the capsule shell. The tables presented from this study summarize the validation experiments conducted, the acceptance criteria for the results of these measurements, and the results of the validation experiments. It was concluded that these results meet all the acceptance criteria for linearity (coefficient of correlation and y-intercept), precision, and accuracy. In addition, no significant differences (p=95%) were observed in the fiber optic data when compared to the existing reference method based on manual sampling and filtration.