FLOVITRO DISSOLUTION TEST METHODOLOGY

FloVitro™ Dissolution testing is a new, patented, in vitro dissolution testing technology developed at Rohm and Haas Company. It has the unique ability to generate dissolution curves that match plasma profiles directly without the need for mathematical modeling. The technique has been shown to be extremely useful in comparing different dosage forms of the same drug because, unlike traditional dissolution tests (eg USP), the test method conditions are specific to the API and not to the dosage form. This allows the use of the method as a predictive tool when developing different dosage forms, for example when developing an extended release dosage when only immediate release data is available. It also holds great promise for demonstrating bioequivalence because the test method conditions are independent of the dosage form, so that different dosage forms can be compared on a constant test basis.

A webcast presentation on this technology is available at the American Association of Pharmaceutical Scientists (AAPS) website as part of their 'Distance Learning' program. To access this program click on this link:

http://www.aapspharmaceutica.com/meetings/distance/webcasts/

and select:
Session 6: BCS Extensions and Method Development Challenges
New GI Dissolution Testing Technology
Lyn Hughes, Ph.D., Rohm and Haas Research Laboratories.

FloVitro™ Technology is available from Rohm and Haas either as an analytical service or for use under license. Contact a Rohm and Haas representative for further details.

Related link: Buccal Dissolution Testing

NEW FLOVITRO™ TECHNOLOGY: THE EQUIPMENT

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The equipment is entirely in vitro, utilizing three stirred flow-through cells connected in series. The first cell represents gastric conditions, the second represents intestinal conditions, and the third represents the circulatory system. The technology is compatible with all the common dosage forms, including tablets, capsules, suspensions, liquids, powders, disintegrating and non-disintegrating.

NEW FLOVITRO™ TECHNOLOGY: SCHEMATIC DIAGRAM

• Provides a direct correlation to in vivo behavior

• Predicts the dissolution profiles of different formulations of the same drug

• Includes drug equilibrium, absorption and clearance effects

• Incorporates bio-relevant solids transfer in the GI tract

• Enables the use of multiple fluids and pH-time profiles

• Reduces the amount of in vivo data needed in development

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