This five year anniversary issue marks the
perfect occasion to discuss the principles upon which Dissolution
Technologies was founded. In essence, the publication was
started because of my personal role in a dissolution laboratory.
My day-to-day experiences in the dissolution laboratory convinced
me that there was a definite need for a targeted publication on
the complexities of dissolution testing and its applications.
Hence, this publication was founded in 1994 with the overall objective
of keeping the dissolution user informed of new developments in
the field of dissolution testing while conveying useful information
on the day-to-day issues related to dissolution applications.
The publication was designed to be a discussion forum for scientific,
regulatory and practical applications related to dissolution testing.
Has Dissolution Technologies achieved
its lofty objectives? In retrospect, I feel that the publication
has made great strides towards accomplishing the objectives that
were set forth. Over the past five years, the regulatory role
of dissolution testing has increased significantly resulting in
close scrutiny of dissolution test equipment, media selection,
method parameters, methodology, applications, and specifications.
In response, Dissolution Technologies has featured articles on
pertinent dissolution developments in regard to:
· new regulatory and industry testing guidances,
· refinements in instrumentation and techniques,
· instrumentation calibration procedures, and
· method development, validation and specifications for
various dosage designs.
To strengthen and focus its editorial
content, Dissolution Technologies established an Editorial
Advisory Board in 1998. The editorial board members represent
the spectrum of scientific disciplines with dissolution experts
from regulatory agencies, academia, and various aspects of the
pharmaceutical industry. The scientific content of the publication
has been heightened by the implementation of the "peer review"
process of submitted articles which is currently facilitated by
the editorial advisory board. Another notable achievement for
Dissolution Technologies is the increased dissemination
of its scientific content via citation references on scientific
databases such as Chemical Abstract Services and International
Pharmaceutical Abstracts. In addition, the launching of the Dissolution
Technologies' website (www.dissolutiontech.com) has greatly enhanced
the global presence, recognition and distribution of the publication.
Even though the accomplishments for
Dissolution Technologies over the past five years have
been significant, I feel that the publication still has a definite
potential for future growth. Of course, the future growth of Dissolution
Technologies depends on the current as well as future applications
of dissolution testing. So, what are the current and future roles
for dissolution testing? This question is addressed by biopharmaceutical
and dissolution experts from regulatory, industry and academia
in the article "Role of Dissolution Testing: Regulatory,
Industry and Academic Perspectives" featured in this issue
of Dissolution Technologies. Each of the editorial perspectives
confirmed that dissolution testing has evolved into a very valuable
in vitro test for characterizing drug product performance but
several key issues still remain regarding the methodology and
its applications. These key issues will need to be addressed to
maintain the scientific value of dissolution testing and to allow
for the necessary growth in regard to dissolution applications.
An essential element to effectively addressing the dissolution
issues is communication between all of the various types of dissolution
users and regulators. Therefore, Dissolution Technologies
will continue to provide a global forum for regulatory, industry
and academic scientists to openly discuss and exchange information
on dissolution related topics.
The increased regulatory interest
and demands on dissolution testing promise to create several future
challenges for dissolution scientists. In response, Dissolution
Technologies will focus on providing information that will
help scientists address the future challenges. Of course, input
from our readers is necessary to insure that we adequately address
the issues that are pertinent.
I am looking forward to receiving
your comments and suggestions.
Thank you for these successful and exciting first five years!
Cynthia K. Brown
Managing Editor
Dissolution Technologies, Inc.