Dissolution Testing

As part of the Research & Development programme in support of Advance Release Technologies, Rohm and Haas has developed improved methodology in the area of dissolution testing.  These methodologies are in the area of Buccal and GI dissolution.  Both methods give excellent correlation with in-vivo data.

BUCCAL DISSOLUTION:

In this reference, a novel dissolution testing system that is capable of characterizing buccal dissolution is described. It has been demonstrated to correlate with human taste perception in examples tested to date. The method is rapid, repeatable, and can be applied to all the common liquid and dissolve-in-the-mouth solid dosage forms.
See "A new method of characterizing the buccal dissolution of drugs"
pdf file size: 410 kb.

GI DISSOLUTION:

Reported here is a new approach to dissolution testing that incorporates disintegration, solids transfer, dissolution, changing pH/composition of fluids, absorption, and clearance. It is capable of giving excellent Level A IVIVC and appears to be predictive across different dosage forms of the same drug. No mathematical model is needed. The data from the equipment is directly comparable to blood plasma concentration-time profiles.  A patent (US 6,799,123) has been granted for this technology.
See "A new wave in dissolution testing" - pdf file size: 425 kb.

Two papers linked to this technology were presented at the "Dissolution - Moving Beyond Quality Control" Conference held in Philadelphia in January 2006. The paper, "New GI Dissolution Testing Technology" (240 kb) given by Dr. Lyn Hughes is an update on the general technology together with a paper "Evaluation of Novel In-Vitro Dissolution Testing Technology" (150 kb) given by Bristol Myers Squibb.

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.