Press Release Summary:
Designed to enable testing of drug formulations with extremely low quantities of active ingredients, Model 400-DS meets compendial requirements of USP Apparatus 7. It supports testing of combinatorial products in which small amounts of drug are combined as part of medical device such as stent or implant. Available in 5 and 10 mL versions, Model 400-DS can run up to 13 samples at one time and switch between up to 4 different media types.
Original Press Release:
New Dissolution Apparatus from Varian, Inc. Enables Testing of Combinatorial Drug-Device Products
PALO ALTO, Calif., April 24 /-- Varian, Inc. (NASDAQ:VARI) today announced the availability of 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."
For additional information about Varian's 400-DS line of products please visit: www.varianinc.com/cgi-bin/nav?products/dissolution/index&cid=PPPJOOHFIH
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". Further information is available on the company's Web site: www.varianinc.com.
CONTACT: Public Relations of Varian, Inc., +1-650-424-3845, or email@example.com
Web site: www.varianinc.com/