SOTAX Corporation	Phone (508) 417-1112
68A Elm Street	1 888 302-9925
Hopkinton, MA 01748-1668	Fax (508) 435-4691
USA	www.sotax.com

SOTAX Announces the Introduction of the Soft Gelatin Capsule Flow Cell into USP <2040> Disintegration and Dissolution of Dietary Supplements

Hopkinton, MA—August 2011—The SOTAX Group, the market leader and pioneer in USP Apparatus 4 Flow- variables associated with traditional manual dosage introduction." For further information on this or any of Distek's industry leading dissolution products and validation services, contact your local representative, Distek Headquarters at T:+1 732 422 7585, E: info@distekinc.com, or visit www.distekinc.com. ABOUT DISTEK, INC. Distek, Inc. (www.distekinc.com), headquartered in North Brunswick, New Jersey, is a leading manufacturer of pharmaceutical laboratory test equipment, specializing in dissolution products and services. Distek also provides solutions for UV fiber optics, media preparation, physical testing, disintegration, and validation services. Andrew Infante Distek, Inc. 121 North Center Drive North Brunswick, NJ 08902 T: 732 422 7585 F: 732 422 7310 E: info@distekinc.comThrough Dissolution, announces the introduction of the lipidic cell for soft gelatin capsule testing into the latest release of USP <2040> Disintegration and Dissolution of Dietary Supplements. This flow cell, which was first introduced in Eur. Ph. Chapter 2.9.42, has been official since 2006.

Designed specifically for use with lipidic products such as fat-based suppositories and oil-filled soft gelatin capsules, this flow cell solves the problems of floating and the formation of a lipidic layer on the surface of the dissolution medium seen in USP Apparatus 2 methods. The cell consists of three compartments. The lower part (1) is made up of two adjacent chambers connected to an overflow device. As the dissolution medium passes through chamber A, it is subjected to an upward flow. The flow in chamber B is directed downward to an exit that then leads upward to a filtering assembly. The middle part (2) of the cell has a cavity designed to collect lipophilic excipients that float on the dissolution medium. A metal mesh is used as a rough filter. The upper part (3) holds the filter in place. The sample is then collected and analyzed for drug release content.

For more information about the Soft Gelatin Capsule Flow-Through Cell and USP Apparatus 4, please contact us at sotaxusa@sotax.com or visit us at www.sotax.com

Distek, Inc., Releases New Dosage Delivery System (DDS)

North Brunswick, NJ—October 6, 2011—Distek, Inc., an industry leader in dissolution testing products and validation services, is pleased to introduce the new Dosage Delivery System (DDS). The Dosage Delivery System (DDS) allows for the unattended introduction of dosage forms at the start of a dissolution test.

The Dosage Delivery System (DDS) by Distek can introduce dosage forms at a defined temperature or specified date and time either simultaneously or at staggered times. Unattended dosage delivery saves analysts valuable time and ensures dosage introduction consistency between analysts.

Control of the electromagnetically actuated delivery system is integrated through the user interface of Distek's Symphony 7100, Model 2500, and Evolution 6100/6300. If preferred, the system can also be manually triggered and is compatible with older Distek models as well as non-Distek dissolution systems.

"Precise dosage introduction is an essential component of any successful dissolution test," says Jeff Seely, Global Manager - Sales, Marketing & Technical Service, Distek, Inc. "The Dosage Delivery System by Distek eliminates all variables associated with traditional manual dosage introduction."

For further information on this or any of Distek's industry leading dissolution products and validation services, contact your local representative, Distek Headquarters at T:+1 732 422 7585, E: info@distekinc.com, or visit www.distekinc.com.

ABOUT DISTEK, INC.

Distek, Inc. (www.distekinc.com), headquartered in North Brunswick, New Jersey, is a leading manufacturer of pharmaceutical laboratory test equipment, specializing in dissolution products and services. Distek also provides solutions for UV fiber optics, media preparation, physical testing, disintegration, and validation services.

Distek, Inc., Releases Model 2500 Water Bath Dissolution Unit

North Brunswick, NJ—August 31, 2011—Distek, Inc., an industry leader in dissolution testing products and validation services, is pleased to introduce its latest dissolution instrument, the Model 2500. A descendent of the trusted 2100 Series, the Model 2500 offers a robust collection of system and user-interface upgrades.

The Model 2500 Dissolution Test System offers ultimate flexibility and configurability while maintaining the reliability and ease of use that laboratories around the world have come to expect from the preceding four generations.

New features include a self-priming thermocirculator, wake-up and sleep modes, integrated control of the optional Dosage Delivery System (DDS), USB printing, electronic qualification tracking and alerts, and an extensive list of user-interface advancements intuitively accessed through the color touch-screen display.

Distek has coupled these innovations with the core features of RPM and bath temperature monitoring, a seamless molded water bath, manual and automated methods, a smooth non-motorized drive head lift, and test volume flexibility (100 mL to 4 L).

"The Model 2500 is the culmination of combining technological innovation with tradition," says Jeff Seely, Global Manager � Sales, Marketing & Technical Service, Distek, Inc. "The hundreds of pharmaceutical companies and universities around the world that have purchased a 2100 Series over the past three decades can upgrade to the Model 2500 with the confidence of a trusted brand."

For further information on this or any of Distek's industry leading dissolution products and validation services, contact your local representative, Distek Headquarters at T:+1 732 422 7585, E: info@distekinc.com, or visit www.distekinc.com.

ABOUT DISTEK, INC.

Distek, Inc. (www.distekinc.com), headquartered in North Brunswick, New Jersey, is a leading manufacturer of pharmaceutical laboratory test equipment, specializing in dissolution products and services. Distek also provides solutions for UV fiber optics, media preparation, physical testing, disintegration, and validation services.

SOTAX Corporation	Phone (508) 417-1112
68A Elm Street	1 888 302-9925
Hopkinton, MA 01748-1668	Fax (508) 435-4691
USA	www.sotax.com

SOTAX Introduces The Usp Apparatus 4 Dialysis Adapter For Drug Release Testing From Liposome And Nanoparticle Formulations

Hopkinton, MA—August 2011—The SOTAX Group, the market leader and pioneer in USP Apparatus 4 Flow-Through Dissolution, announces the release of a new Dialysis Adapter for use with the SOTAX CE7smart Flow-Through Dissolution System.

The patented A4D was designed and tested in collabora- tion with Professor Diane Burgess of the School of Pharmacy at The University of Connecticut. The adapter was designed to fulfill a growing application requirement for drug release testing from controlled-release parenteral products such as liposomes and nanoparticle formulations. ¹ Dr. Burgess's work on in vitro drug release testing using USP Apparatus 4 began several years ago with the study of microsphere formulations. ²

The challenges with monitoring drug release from these formulations are sample containment, filtration, and method standardization. Traditional small-scale drug-release testing on liposomes began with non-compendial samples and separate dialysis sac and diffusion-cell techniques. In order to incorpo- rate this into the USP 4 method, an adapter was designed which uses dialysis tubing fit over a compartment within the standard 22.6-mm flow cell. This new adapter allows researchers to discriminate different liposome formulations accurately and defines a standardized approach to dialysis testing.

SOTAX is a proud sponsor of The School of Pharmacy at the University of Connecticut. In late 2009, the University of Connecticut honored SOTAX with the dedication of the "SOTAX Dissolution and Drug Release Testing Laboratory" at UCONN.

For more information about the A4D Dialysis Insert and USP Apparatus 4, please contact us at sotaxusa@sotax.com or visit us at www.sotax.com.

¹ Bhardwaj, U.; Burgess, D. J. A novel USP apparatus 4 based release testing method for dispersed systems. Int. J. Pharm. 2010, 388 (1�2), 287�294.
² Rawat, A.; Stippler, E.; Shah, V. P.; Burgess, D. J. Validation of USP apparatus 4 method for microsphere in vitro release testing using Risperdal(®) Consta(®). Int. J. Pharm. 2011, 420 (2), 198�205.