SOTAX Group acquires Dr. Schleuniger® Pharmatron, further expanding its global leadership position as a provider of pharmaceutical testing solutions

June 2013—The SOTAX Group, a global leader in the development and manufacturing of dissolution testing, automated sample preparation, and physical testing equipment for the pharmaceutical industry, has acquired Dr. Schleuniger® Pharmatron.

Dr. Schleuniger® Pharmatron, with headquarters in Thun, Switzerland and a U.S. subsidiary in Manchester, NH, is a company engaged in the engineering and manufacturing of equipment for the physical testing of pharmaceutical dosage forms, such as tablets, capsules, ampules, and other solid dosage forms.

With this acquisition, the SOTAX Group strengthens its global leadership position as a solution provider for the pharmaceutical industry and becomes the world's largest manufacturer of equipment for testing the physical properties of pharmaceutical dosage forms.

"The acquisition and integration of Dr. Schleuniger® Pharmatron is a further step towards ensuring sustainable growth by strengthening our innovation leadership. The Dr. Schleuniger® Pharmatron brand stands for a long history of high quality and innovative technology. This will complement our existing product lines in an ideal way," explains Thomas Pfammatter, CEO of the SOTAX Group.

"Being part of a leading global company with the worldwide sales and service capabilities of the SOTAX Group will open up new opportunities for us. It puts us in a position to serve our customers and partners even better," says Martin Strehl, Chairman of the Board & CEO of Dr. Schleuniger® Pharmatron.

Dr. Schleuniger® Pharmatron's Manchester, NH, operations will be integrated into the Westborough, MA, Americas organization of SOTAX Group. The Thun, Switzerland, site of Dr. Schleuniger® Pharmatron will remain as a separate entity and become the hub of the physical testing business of the SOTAX Group.

Leveraged by the extensive worldwide sales and service network of SOTAX, product and application specialists from Dr. Schleuniger® Pharmatron and SOTAX will continue to deliver best-in-class service and support to our customers.

Press contacts:

SOTAX AG
Binningerstrasse 106
4123 Allschwil 3600 Thun
Switzerland
Contact: Ms Petra Silbereisen
Phone: +41 61 487 54 54
E-mail: info@sotax.com
Web: www.sotax.com PHARMATRON AG
Uttigenstrasse 28
Switzerland
Mr Martin Strehl
+41 33 27 50 00
info@pharmatron.ch
www.pharmatron.com

Agilent Technologies Enhances Dissolution Workstation Software for Greater Instrument Control and Improved Monitoring of Pharmaceutical Ingredients

Santa Clara, CA—August 1, 2013—Agilent Technologies Inc. (NYSE: A) today introduced an enhanced version of its Dissolution Workstation Software, providing better data integration, method change control, and instrument monitoring for controlling multiple dissolution systems. Dissolution is a technique used in the pharmaceutical industry to determine the rate at which pure active pharmaceutical ingredients dissolve.

The software supports laboratory capabilities to build, edit, search, retrieve, execute, and archive all dissolution methods and test reports from a single interface. To improve efficiency, the new features allow users to:

• Consolidate and maintain electronic data in one location, with options for exporting information into a laboratory information management system or into business tools such as SAP Crystal Reports or Microsoft Excel.
• Monitor the dissolution apparatus for vibration, environmental impacts, and failure investigation assistance when using the optional Instrument Module.
• Comply with the latest enhanced mechanical qualification guidelines, including verifying accessories prior to each test.
• Add an automated system-cleaning cycle to the end of each method, extending the life of dissolution equipment.

"One of the greatest enhancements is the addition of vibration monitoring to the Dissolution Workstation Software," said Allan Little, marketing director for Agilent's Dissolution Systems business. "Though there is no standard guidance on vibration measurements, it is important that laboratories understand the impact vibration can have on their dissolution testing. With baseline values for vibration on the x-, y- andz-axes, dissolution systems as well as their environments may be consistently monitored. This added benefit may be used during early research to develop internal tolerances for specific methods or as part of a quality control initiative for well-established methods."

Dissolution Workstation Software organizes, executes, and manages methods and information for all Agilent dissolution equipment, including the Agilent 708-DS, 709-DS, BIO-DIS, Apparatus 7, and dissolution sampling systems. Continuous audit trails provide reliable traceability of methods and system operation, and reduce the time required to document information manually.

For more information about the Dissolution Workstation Software, visit www.agilent.com/lifesciences/ dissolutionsoftware.

Distek, Inc. Awarded U.S. Patent for Its Silicone Dissolution Vessel Covers

North Brunswick, NJ—June 28, 2012—Distek, Inc., an industry leader in dissolution testing products, accessories, and validation services, is pleased to announce the official patent for its Silicone Vessel Covers (US 8,434,378 B2).

Distek's patented flexible vessel cover is chemically resistant and physically more durable than the rigid covers currently on the market. The dual-sided universal vessel cover fits all vessels that are dimensionally compliant to the current specifications as well as vessels with smaller ID openings. The universal flexible vessel cover is also designed and labeled for use with Distek sampling probes.

The covers are available in two configurations, a small center hole for paddle-only applications and a larger hole with a removable center cap for basket applications.

"The release of this innovative vessel cover offers Distek and non-Distek customers alike a superior option to current choices of vessel covers," says Jeff Seely, Vice President of Sales & Business Development. "The chemically resistant and durable design will not only provide extended life of the cover but will also reduce the overall consumable cost."

For additional information on this or any of Distek's industry leading products and services, contact Distek's Corporate Office at +1 732 422 7585, by email at info@distekinc.com, or visit www.distekinc.com.

Sean Gilmore
Distek, Inc.
121 North Center Drive
North Brunswick, NJ 08902
T: 732 422 7585
F: 732 422 7310
E: info@distekinc.com

Distek, Inc. Releases the ezTab Line of Tablet Hardness Testers

North Brunswick, NJ—July 1, 2012—Distek, Inc., an industry leader in dissolution testing products, accessories, and validation services, is pleased to release its multiparameter ezTab Tablet Hardness Testers.

The Distek ezTab Tablet Hardness Tester is USP<1217> and EP<2.9.8> compliant and offers outstanding flexibility and configurability while maintaining a user-friendly experience customers around the world have come to expect from Distek instruments.

The ezTab is available in two models, ezTab 300 and ezTab 400. The 4-in-one design of the ezTab 400 not only measures tablet hardness but also thickness, diameter, and weight via an externally connected balance. The ezTab 300 3-in-one configuration measures hardness, thickness, and diameter.

Jeff Seely, Vice President of Sales and Business Development, says, "The release of the ezTab hardness tester line gives our customers an easy-to-use and cost-effective option for determining tablet hardness and other critical parameters in the lab or on the production floor in a small, easy-to-use package."

For additional information on this or any of Distek's industry leading products and services, contact Distek's Corporate Office at +1 732 422 7585, by email at info@distekinc.com, or visit www.distekinc.com.

Sean Gilmore
Distek, Inc.
121 North Center Drive
North Brunswick, NJ 08902
T: 732 422 7585
F: 732 422 7310
E: info@distekinc.com

ERWEKA Launches MediPrep 820! A New Dissolution Media Preparation Unit

June 2013—The preparation of media is a time-consuming and labor-intensive step in dissolution testing with several critical parameters like temperature and degassing power. ERWEKA, a world leader in high quality test equipment for the pharmaceutical and life science industry, launches the all new MediPrep 820 series media preparation system.

Media are prepared in a validated approach according to the requirements of USPGeneral Chapter <711>. The MediPrep 820 series offers quick and easy preparation of up to 8 L of dissolution media in less than 15 minutes. In a single pass, the media for dissolution tests can be precisely mixed, heated, and degassed. The delivered volume (controlled volumetrically), the temperature within each vessel, and the degassing will be automatically documented according GLP/GMP.

Due to a special approach and optimized hardware, foaming media like 1% SDS (sodium dodecyl sulfate) can also be used. The results of the degassing are typically less than 4.0 mg/L dissolved oxygen and therefore in compliance with the USPspecifications. To prevent cross-contamination, an automated cleaning procedure is integrated.

Utilizing the HMI color interface, the MediPrep 820 is easy to handle for daily use as well for adjustment and calibration of all instrument parameters like temperature, pressure, and delivery volume. Options include the use of concentrate, a remote filling hand for direct filling into tester vessels, as well as media tanks.

Simulations Plus

Integrating Science and Software

Simulations Plus Software Used in Regulatory Submittals

US FDA, UK MHRA, and European EMA Accept Simulation Results in Applications

Lancaster, CA—May 14, 2013—Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that results of simulations using its GastroPlus™ software have been submitted to major regulatory agencies as part of applications by its customers.

John DiBella, vice president of marketing and sales for Simulations Plus, noted, "The first submittal to a regulatory agency was reported by Pfizer in 2008, which resulted in Pfizer being allowed to forego a human trial after GastroPlus simulations showed that it would not be necessary. In the past 12 months, four additional customers have submitted simulation results to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the British Medical Health Regulatory Agency (MHRA). Each of these involved a consulting contract with Simulations Plus to assist the sponsor with the GastroPlus simulations and model development. Simulations Plus also provided assistance in preparation of the submittals to the regulatory agencies. The acceptance of simulation results by these agencies is an indication of the growing importance of simulation and modeling technology in pharmaceutical research and development."

Walt Woltosz, chairman and chief executive officer of Simulations Plus, added, "The four submittals John describes resulted in:

1. Eliminating a clinical trial to demonstrate that fasted and fed states would not produce significantly different results for the absorption of the drug candidate.
2. Identifying the particle size specification for a re-engineered product to ensure bioequivalence to an existing product.
3. Explaining the variations observed in different formulations.
4. Scaling complex processes involving metabolism and carriermediated transport from adult to pediatric/neonate populations.

These four submissions signal a developing trend for the use of simulation and modeling results to reduce the cost and time to bring new drug products to market. Note that these four involved Simulations Plus consulting services. A number of other submittals have been made by sponsors on their own. Regulatory agencies in the U.S., Europe, China, and Japan all have GastroPlus for their internal use, so sponsors can submit GastroPlus input files to these agencies to make evaluation of results fast and convenient. In time, we believe other sponsors will increasingly utilize powerful simulation software to help streamline the regulatory process and provide regulators with accurate data for evaluation purposes."

About Simulations Plus, Inc.
Simulations Plus, Inc., is a premier developer of ground-breaking drug discovery and development simulation and modeling software, which is licensed to and used in the conduct of drug research by major pharmaceutical, biotechnology, agrochemical, and food industry companies worldwide. We also provide a productivity tool called Abbreviate! for PCs. Simulations Plus, Inc., is headquartered in Southern California and trades on the NASDAQ Capital Market under the symbol "SLP." For more information, visit our Web site at www.simulations-plus.com.

Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995—With the exception of historical information, the matters discussed in this press release are forward-lookinwg statements that involve a number of risks and uncertainties. Words like "believe," "expect," and "anticipate" mean that these are our best estimates as of this writing, but that there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, our ability to identify and close acquisitions on terms favorable to the Company, and a sustainable market. Further information on our risk factors is contained in our quarterly and annual reports as filed with the Securities and Exchange Commission.

For Further Information:
Simulations Plus, Inc.
42505 10th
Street West
Lancaster, CA 93534-7059

Contact: Simulations Plus Investor Relations Ms. Renée Bouché 661-723-7723 renee@simulations-plus.com Hayden IR Mr. Cameron Donahue 651-653-1854 cameron@haydenir.com

Dissolution Accessories Introduces High Precision Vessels for Most Dissolution Testers and Models in the Market

Oosterhout, The Netherlands—August 2013—Dissolution Accessorieshas launched Ultra Precision vessels to fit the most common dissolution testers in the market without the use of an extra adapter ring. The High Precision vessel fits directly into the dissolution tester and eliminates the need to purchase these extra rings.

Do you want a sophisticated glass vessel with uniform bottom curvature and inner surface regularity that can help you solve prednisone qualification issues?

Dissolution Accessories provides a solution here. A novel integrated glass fabrication technology first brought the finest and the most elaborate glass vessels to the world.

• Inside bottom extremely close to true hemisphere.
• Extremely low tolerance of radius of inside bottom. Inside cylindrical body extremely close to true circle.
• Agreement of both centers of cylindrical body and bottom.
• Inside cylindrical body extremely close to true cylinder.
• Vessel center is nearly perfectly vertical and guaranteed by the concentricity.
• Extremely low tolerance of inside diameters of cylindrical body.
• Extremely low vessel-to-vessel variation.

Each High Precision vessel is supplied with an individual certificate and is tested and manufactured in an ISO-9001/ISO-14001 environment, using a three-dimensional coordinate-measuring machine (Brown & Sharpe, PMM-C700P) for vessel certification.

For more information, please contact
Adrie Alders, +31 162 471485,
info@dissolutionaccessories.com, or go to www.dissolutionaccessories.com

About Dissolution Accessories
Dissolution Accessories is a supplier of accessories used in the field of dissolution testing. Besides many standard products, Dissolution Accessories also develops customer specific products. We serve customers in more than 100 countries, either directly or through distribution channels.

Message for the Nutraceuticals and Natural Products Chemistry and In Vitro Release & Dissolution Testing Focus Groups

August 2, 2013

Greetings Everyone,

Many of you may recall the roundtable discussion at the 2012 AAPS Annual Meeting in Chicago, "Dissolution and Disintegration Methods for Gelatin Capsules, Including Dietary Supplements." Much was discussed in the context of a planned USP workshop, announced below:

USP is working on a revision of the General Chapter <711> Dissolution, in the paragraph that allows the use of enzymes in the dissolution testing of capsules in the presence of crosslinking.

This revision in is going to affect all pharmaceutical and dietary supplement companies, and we would like to have as many interested parties coming to our workshop as possible. The preliminary agenda is at http://www.usp.org/meetings-courses/workshops/dissolution-testing-capsules.

Margareth R.C. Marques, M.Sc., Ph.D.
Sr. Scientific Liaison
Department of Standards Development
United States Pharmacopeia
e-mail: MRM@usp.org

Thank you for your attention and best regards,

Bob Chapman, Chair
AAPS Nutraceuticals & Natural Products Chemistry Focus Group

Greg Martin, Chair
AAPS In Vitro Release and Dissolution Testing Focus Group