Varian, Inc. (NASDAQ:VARI), Palo Alto, Calif, has unveiled a new
dissolution system designed to simplify the testing of drug formulations
with extremely low quantities of active ingredients. The 400-DS, which
meets the compendial requirements of a USP Apparatus 7, supports the
testing of combinatorial products in which small amounts of drug are
combined as part of a medical device such as a stent or implant. Varian,
Inc. is a leading provider of automated and semi-automated dissolution
testing systems. These systems have been developed to meet regulatory
requirements and are capable of release rate testing in R&D studies
as well as pharmaceutical quality control laboratories.
Scientists use dissolution apparatus to determine bioavailability,
or the rate at which active ingredients in pharmaceutical dosage forms
become available for absorption within the body. This testing is
required throughout the pharmaceutical manufacturing process to ensure
product quality and long term stability.
Because dissolution tests are routinely run at 37 degrees C and can
be conducted over several days, the instrument was designed to minimize
evaporation, resulting in greater accuracy of test results (less than
0.2% volume loss per 24 hours, even when used with aqueous-organic
solutions). The closed-cell design of the 400-DS features a
patent-pending magnetic reciprocation mechanism for mixing. Media
replacement and sampling capabilities are built into the instrument as
well as the ability to switch between up to four different media types.
The Varian 400-DS can run up to 13 samples at one time and is
available in both 5 and 10 mL versions, significantly smaller media
volumes than is common with traditional dissolution apparatus. The
400-DS is controlled by a PC using Varian software that provides
compliance with 21 CFR Part 11 requirements for pharmaceutical
laboratories. The software simplifies method management, system
configuration, data security, record retention and audit features. A
single PC can independently control up to four 400-DS units.
"With the introduction of the 400-DS as the first compendial
small-volume dissolution apparatus, Varian is now able to assist
customers with challenging drug delivery scenarios, such as implants,
stents and intra-ocular devices," said Martin O'Donoghue,
senior vice president, Scientific Instruments, Varian, Inc. "The
addition of this system to our existing dissolution product range allows
our customers to test new combinatorial products with very slow release
rates and minimal amounts of active pharmaceutical ingredients."
Varian, Inc. is a leading worldwide supplier of scientific
instruments and vacuum technologies for life science and industrial
applications. The company provides complete solutions, including
instruments, vacuum components, laboratory consumable supplies,
software, training and support through its global distribution and
support systems. Varian, Inc. employs approximately 3,700 people and
operates manufacturing facilities in 13 locations in North America,
Europe and Asia Pacific. Varian, Inc. had fiscal year 2006 sales of $835
million, and its common stock is traded on the NASDAQ Global Select
Market under the symbol, "VARI".
For more information, visit http://www.varianinc.com or call
650/424-3845.
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