Dissolution Highlights of the AAPS Annual Meeting

Vivian A. Gray

At the AAPS Annual Meeting in San Diego, November 10–15, 2007, there was quite a bit of programming devoted to dissolution. A brief summary of the sessions follows below. The annual meeting presentation slides can be found on the AAPS website under past meetings using the following link http://www.aapspharmaceutica.com/meetings/pastmeetings/index.asp There are no presentation slides available for the two Open Forums.

Symposium
In Vitro Release Testing of Dosage Forms Based on Novel Technologies: Developments and Challenges

The moderators were Susan S. D'Souza of Sepracor and Sunil Iyer of Virginia Commonwealth University. Sunil started the session with the talk, "A New ‘Biorelevant' Approach to Accelerated Release Testing and IVIVC of a Long-acting Biodegradable Implant." Susan followed with her talk on "Accelerated Methods to Characterize In Vitro Drug Release from Biodegradable Microspheres." The next speaker was Balaji Narasimhan from Iowa State University discussing "Combinatorial Design of Biomaterials and Drug Delivery: Challenges and Opportunities." Micheline Markey from Conor Medsystems presented "Drug Eluting Stents: Characterization of Release Kinetics." The session ended with a talk on "Dissolution of Low Solubility Products: Case Studies" given by Pradeep Sathe of the FDA.

Symposium
Determination of In Vivo–In Vitro Correlations (IVIVC) for Sustained Release (SR) Parenterals (Depo Formulations)

The moderators were Kenneth J. Norris and Jaymin C. Shah from Pfizer. The session started with Patrick Marroum from FDA speaking on "In Vitro/In Vivo Correlations for Parenterals Sustained Release Formulations." The other speaker, Colm Farrell of ICON Development Solutions, spoke on "Difficulty in Determination of IVIVC for SR Parenterals." There was much audience participation, and the bottom line was to talk to FDA regarding the dissolution methodology early in development.

Sunrise Session
Dissolution Method Validation and Method Transfer

The moderator of this session was Vivian A. Gray of V. A. Gray Consulting. Margareth Marques of USP elaborated on method validation. Vivian followed up with a discussion of method transfer, including sources of problems.

Open Forum
Understanding the Impact of QbD on Establishment of Specifications for Dissolution and Impurities

Sponsored by PDD
Qingxi Wang of Merck and Arzu Selen of FDA spoke directly to the utility of dissolution testing and the patient benefit of applying QbD principles to developing appropriate dissolution tests, with attention paid to the early stages of product development. Sanjay Sehgal of Wyeth emphasized the importance of IVIVC in setting clinically relevant specifications. He also reiterated the importance of understanding the impact of critical variables (e.g., raw materials). Mansoor Khan of the FDA brought up the issue of dose dumping with clinical consequences; this included a discussion of the influence of alcohol on absorption and side effects

Open Forum
Analytical Instrument Qualification: An Update and Current Trends

Sponsored by APQ
Alger Salt from GSK gave a talk titled "Performance Verification of Dissolution Testing." He discussed the various documents that instruct on mechanical calibration of the dissolution equipment. He presented an unbiased comparison of only mechanical calibration versus chemical qualification. The discussion that followed was a hot debate on the new FDA draft guidance for mechanical calibration.

AAPS In Vitro Release and Dissolution Testing Focus Group Business Meeting

The business meeting was lead by Chair-elect Steve Mayock; Qingxi Wang was unable to attend. The annual meeting had quite a bit of dissolution programming (see above descriptions). The activities of the past year were reviewed. There are two papers in the works, a review paper on the utility of the dissolution test and a paper on added value of the dissolution test according to phase of development. The face-to-face meeting was held on April 24, 2007, and a summary of this meeting is in the August issue of Dissolution Technologies. A workshop, co-sponsored by FDA, is planned for April 28–30, 2008, titled "Role of Dissolution in QbD and Drug Product Life Cycle." It will be held in Crystal City, Virginia. The program agenda should soon be available on the AAPS website.

If you are interested in being involved in the focus group and are a member of AAPS, let the organizers know. For the organizers' e-mail information, contact the Research Editor, vgray@dissolutiontech.com

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