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

 

 

Click to expand

 

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

 

 

FLOVITRO™ Technology

 

Description

 

The Equipment

 

Schematic Diagram

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FloVitro™ Dissolution Testing

A unique approach in characterizing in vitro dissolution of drug products

 

 

 
Related Information

 

Exploring Suitability and Feasibility of a Novel In Vitro Dissolution System.

Presented by Arzu Selen, Ph.D., U.S. Food and Drug Administration at the 2008 AAPS Annual Meeting and Exposition.

Register to download a copy of the poster.

 

FloVitro™ Technology leaflet

(pdf file: 1 Mo)

 

FloVitro™ Technology presentation (240 kb) - Update of a presentation given by Dr. Lyn Hughes at the "Dissolution - Moving beyond Quality Control Conference in Jan 2006 together with a paper "Evaluation of Novel In Vitro Dissolution Testing Technology" (150 kb) given by Bristol Myers Squibb

 

Rohm and Haas creates new in vivo-like dissolution testing

(available on Labtechnologist.com)