Register at DIAglobal.org/Dissolution

OVERVIEW

Dissolution testing is an important tool from early development to life cycle management of a drug product. The implementation of Quality by Design (QbD) principles requires understanding of process parameters, product attributes and their impact on in-vitro dissolution and bioavailability.

In early development, biorelevant dissolution/release testing, i.e. the evaluation of luminal behaviour of drug products in gastrointestinal lumen with in vitro methodologies, is useful for predictions of formulation and food effects on plasma levels. It is also utilised to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.

Recent updates and case studies on these subjects will be discussed by scientists working in academia, industry and regulatory agencies from Europe, the US and Japan.

OBJECTIVES

• Assess the opportunities of biorelevant dissolution testing.
• Discuss Quality by Design (QbD) applications, Real Time Release Testing (RTRT) and physiologically based pharmacokinetic modelling.
• Examine case studies of biorelevant dissolution examinations used for assessing product performance attributes.
• Evaluate the efforts to improve and facilitate the in-vivo predictability of biorelevant tests.
• Address strategies for linking quality control dissolution methods with biorelevant in-vitro performance testing.

KEY SESSIONS AND TOPICS INCLUDE

Biorelevant Testing and Methodology Tools and Applications

• Definitions/background for biorelevant testing.
• Update of a current relevant EU initiative (orbito project).
• Preclinical and clinical applications.
• PBPK modelling.

Quality Control Applications

• Quality by Design (QbD) applications; Real Time Release Testing (RTRT).
• Discriminating methods and addressing process changes during life cycle of a drug product.

Regulatory Considerations

• EU, FDA and Japanese regulatory perspectives on the role of dissolution testing in product design and control.
• EDQM perspectives on the role of dissolution testing in product design and controlThere will be a discussion and a chance for attendees to ask questions at the end of each session.

WHO WILL ATTEND

The programme is designed to benefit scientists, academia, regulatory and graduate students who are interested or already working in oral dosage formulation development.

PROGRAMME COMMITTEE

In vitro Testing for Meeting Future Challenges for Veterinary Dosage Forms

The oral route of administration is one of the most used for veterinary products. When developing formulations that are going to be applied to different animal species it is important to consider the physiological differences among the these species. This workshop will discuss the biopharmaceutics aspects of veterinary dosage forms. The first day will be dedicated to discuss the challenges when working with different animal species and the physiological differences for dogs, cattle, pigs, horses, and poultry that may impact the oral administration of drug products. On the second day several cases studies on development of dissolution tests for unusual drug products, such as medicated feeds, chewable, and palatable dosage forms, will be presented.

Why Attend?

• Gain insight into the USP revision process and how to work with USP.
• Better understand how to access physiological differences in different animal species (dogs, cattle, cats, and pigs).
• Hear from key industry stakeholders on dissolution issues.
• Learn more about chewable and palatable dosage forms.

Registration and Additional Information

Group discounts are available for 3+ participants from the same company.

Visit: http://usp.org/in-vitro-vet, email: conferences@usp.org, or call: +1-301-816-8130.

Upcoming Events

View a complete list of USP meetings and events: www.usp.org/meetings.

Who Should Participate

• Analytical chemists
• QA/QC analysts
• R&D scientists and managers
• Manufacturing scientists and managers
• Regulatory affairs specialists
• Contract research organizations
• Contract manufacturing organizations

Planning Committee:

• James Demuth, Ph.D.—Chair, USP General Chapters- Dosage Forms Expert Committee
• Jennifer Johansson, JD—Generic Animal Drug Alliance (GADA)
• Craig Parks, MS, DVM—Animal Health Institute (AHI)
• Julie Lorenz, Ph.D.—Zoetis
• David Long, M.S., Ph.D.—Member, USP General Chapters-Dosage Forms Expert Committee
• Marilyn Martinez—Government Liaison, USP Solubility Criteria for Veterinary Drugs (FDA/Center for Veterinary Medicine)
• Eden Bermingham, M.S., DVM—FDA/Center for Veterinary Medicine
• Mai Huynh—Government Liaison, USP General Chapters- Dosage Forms Expert Committee (FDA/Center for Veterinary Medicine)
• Morgan Puderbaugh—USP Scientific Liaison, Chemical Medicines

Dissolution 1-on-1: Free In-Depth Training in a Self-Paced Environment Now available in Chinese!

The training and education of dissolution analysts is a vital part of every pharmaceutical company’s regulatory compliance program. Agilent has produced a standardized online training course that allows individuals to train at their own pace. The course is available free of charge via the internet. The objective of Dissolution 1-on-1 is to help companies easily and consistently train their employees to ensure everyone is capable of conducting accurate and reliable testing. Because this training is available online, not only can individuals access the material any time of day but it is also available worldwide. This allows firms to standardize on a training program and know everyone is receiving accurate, up-to-date training materials.

To access Dissolution 1-on-1, visit the Dissolution Exchange at http://dissolution.chem.agilent.com/.

This in-depth course provides six chapters of information as well as a reference section and a comprehensive glossary of terms. It incorporates many updates including the latest industry changes regarding dissolution apparatus qualification plus an introduction to dissolution testing. To access the course and assessment package in Chinese, simply select Chinese as your language of choice.

The training material is presented through the use of text, diagrams, and animated sequences. Select regions of the screen are highlighted to indicate more information is available. The course is ideal for someone new to dissolution and is an excellent reinforcement for those who already have dissolution experience.

INFORMATION ON ASSESSMENT AND CERTIFICATION

This globally accessible resource is highly interactive and is an easy-to-navigate learning experience. Simply register once and you’ll gain access to a wealth of information to support your dissolution testing training needs for a long time to come.

Agilent has also partnered with CoAcS, Ltd., to produce a comprehensive assessment package that you can purchase to test analysts on the course material. This testing package allows you to identify managers by site or department who can in turn identify those that need training and assessment. The training package offers up to three opportunities for successful completion, at which time the user and his/her manager receive confirmation of satisfactory completion. Training packages are managed and tracked online for your convenience.

Be sure to take a tour of the course to learn more. Or contact your Agilent Representative today for detailed information on our training resources.

9810 Variel Avenue Chatsworth, CA 91311, USA	Toll Free: 800.821.8165 Phone: 818.882.7266	Fax: 818.882.9470 www.hansonresearch.com

New Partnership: Shimadzu & Hanson Research Will Focus on Pharmaceutical Testing Improvements

Los Angeles, CA—October 20, 2015—Shimadzu and Hanson Research have formed a strategic alliance to bring analytical improvements to pharmaceutical dissolution testing laboratories. The partnership combines unique technologies and talents from the two companies to help improve analytical accuracy, regulatory compliance, and testing throughput.

Hanson Research, a privately held Southern California technology company that focuses primarily on developing high tech instruments for pharmaceutical dissolution and diffusion testing, and Shimadzu Scientific Instruments, a leading provider of analytical instrumentation headquartered in Columbia, MD , will integrate Hanson’s semi-automated Vision® dissolution platform with Shimadzu’s UV-1800 to create an automated on-line system. The combined package will address the growing demand for automation efficiencies, better reporting and data integrity, audit-proof security compliance, and simplification of complex processes.

For dissolution labs that require an HPLC analytical finish, Hanson will introduce a semi-automated integration of their Vision® AutoPlus™ dissolution autosampler to Shimadzu’s HPLC product. It is intended to save the analyst’s time and reduce human error.

Keith Hamman, President of Hanson Research, says that the companies’ combined know-how and commitment to customer support will bring a level of expertise to the pharmaceutical testing market that’s not easy to find these days. “There are many analytical instrument vendors out there that are highly skilled experts in very niche industries,” said Hamman. “There are also a few manufacturers that have broad knowledge of many industries. To be able to work with the brilliant folks at Shimadzu and merge our unique skill sets allows us to focus on the customer’s whole dissolution testing process rather than just separate segments. The partnership’s goal is customer success.”

Terry Adams, Vice President of Marketing for Shimadzu Scientific Instruments states, “Shimadzu is proud to work with Hanson Research, a company that shares our dedication to customer satisfaction. Their rugged, versatile dissolution system is an ideal complement to Shimadzu’s UV-vis and HPLC instrumentation, allowing us to meet customer demand for seamless, unified platforms for dissolution testing.”

The Shimadzu- and Hanson-integrated products will launch at the American Association of Pharmaceutical Scientists (AAPS) annual meeting and expo in Orlando, FL, October 25, 2015.

ABOUT HANSON RESEARCH

Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.

CONTACT

Sara Hanson Hanson Research Corp. pr@hansonresearch.com

9810 Variel Avenue Chatsworth, CA 91311, USA	Toll Free: 800.821.8165 Phone: 818.882.7266	Fax: 818.882.9470 www.hansonresearch.com

Newly Designed Dosage Wafer for Hanson Vertical Diffusion Cell Accommodates Strat-M® Membrane

New Design Minimizes Cell Leakage with Thicker Membranes

Los Angeles, CA—October 21, 2015—Hanson Research Corporation, an innovator in percutaneous diffusion cell testing, announced today its introduction of a special Vertical Diffusion Cell (VDC) accessory for use with the unique Merck Millipore Strat-M® membrane. This synthetic, non-animal-based model for transdermal diffusion testing is predictive of diffusion in human skin without lot-to-lot variability, safety, and storage limitations.

Diffusion through the Merck Millipore Strat-M® membrane is predictive of diffusion through human skin for a wide range of substances including active pharmaceutical ingredients (API), cosmetic actives, formulations, personal care products, pesticides, and chemicals.

“Hanson Research is excited to introduce a Vertical Diffusion Cell specifically designed to work with Merck Millipore’s Strat-M® membrane. The Strat-M® membrane is a breakthrough for researchers working with animal and human skin, considering all of the problems associated such as variability, storage, hydration, and the breakdown of skin. I believe our two companies provide scientists with an excellent solution for this critical area of diffusion testing,” stated Royal Hanson, CEO of Hanson Research.

The Hanson Vertical Diffusion Cell for use with the Merck Millipore Strat-M® membrane will be demonstrated at the American Association of Pharmaceutical Scientists (AAPS) annual meeting and expo in Orlando, FL, on October 25-29, 2015, and at the annual Controlled Release Society (CRS) meeting and exhibition in Seattle, Washington, July 17-20, 2016.

Merck Millipore and Strat-M are trademarks of Merck KGaA, Darmstadt, Germany.

ABOUT HANSON RESEARCH

Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.

CONTACT

Sara Hanson Hanson Research Corp. pr@hansonresearch.com

9810 Variel Avenue Chatsworth, CA 91311, USA	Toll Free: 800.821.8165 Phone: 818.882.7266	Fax: 818.882.9470 www.hansonresearch.com

California Tech Company to Use Swiss Dissolution Software for Turnkey On-Line UV Platform

Los Angeles, CA—October 20, 2015—Hanson Research, a privately held Southern California technology company which focuses primarily on developing high tech instruments for pharmaceutical dissolution and diffusion testing, has selected ARGUS/Dissolution as the PC software platform to control the upcoming Hanson/Shimadzu on-line UV system.

Hanson has already formed a strategic alliance with Shimadzu to offer dissolution users an on-line automated system which consists of Hanson Vision dissolution testers and autosamplers with the Shimadzu UV-1800. The instrument offering will be tied together with the ARGUS/Dissolution PC software which is said to be robust, scalable, user-friendly, and 21 CFR Part 11 compliant, the latter being a critical requirement of dissolution users today.

Solvias AG, a privately held analytical and chemical development company based in Switzerland, developed ARGUS/Dissolution as an all-in-one software solution covering the entire dissolution workflow from data acquisition to the release of the spectrophotometric results.

According to Hanson Research President, Keith Hamman, Hanson chose ARGUS software not only because of the software’s ability to utilize the advanced capabilities of the Vision tester and autosampler but because of its audit-proof compliance. “Dissolution analysts require system flexibility and ease of use,” said Hamman. “Some pharmaceutical products only require simple, straightforward testing while other products have quite complex methods. Our instruments are designed to accommodate both ends of the spectrum. The challenge was to provide a software product that takes advantage of our instrument’s great features and capabilities which users rely on. ARGUS/Dissolution hit that target perfectly. And because the software was developed by dissolution industry users, the security compliance is probably the best in the business.”

Says CEO of Solvias, Karen Huebscher, “We at Solvias are excited about the cooperation with Hanson Research, a company that is contributing high-quality equipment to the dissolution market for so many years.”

Hanson’s on-line UV system, with the Shimadzu UV-1800 and ARGUS/Dissolution software, will be launched at the American Association of Pharmaceutical Scientists (AAPS) annual meeting and expo in Orlando, FL, October 25, 2015.

ABOUT HANSON RESEARCH

Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.

CONTACT

Sara Hanson Hanson Research Corp. pr@hansonresearch.com

9810 Variel Avenue Chatsworth, CA 91311, USA	Toll Free: 800.821.8165 Phone: 818.882.7266	Fax: 818.882.9470 www.hansonresearch.com

Hanson Research to Offer On-Line UV to Pharmaceutical Dissolution Industry

Los Angeles, CA-October 19, 2015—Hanson Research, a privately held Southern California technology company which focuses primarily on developing high tech instruments for pharmaceutical dissolution and diffusion testing, will launch an on-line UV system at the American Association of Pharmaceutical Scientists (AAPS) annual meeting and expo in Orlando, FL, October 25, 2015.

Hanson Research currently sells a refined line of modular dissolution testers and autosamplers which provide users with a flexible, semi-automated approach for both immediate-release and extended-release dosage forms. The systems are semi-automated because the dissolution samples are collected into capped vials or test tubes but then have to be processed off-line by UV or HPLC by the user. With Hanson’s new system, the samples will be automatically pushed into flow cells where UV absorbance readings will take place before the samples are then collected into capped test tubes or returned back to the vessels.

Hanson Research chose Shimadzu and their renowned UV-1800 and Solvias’ ARGUS/Dissolution software to complete the package. Hanson reports that this trinity of expertise combines dissolution, spectrophotometry, and 21 CFR Part 11 PC software expertise under one umbrella for the benefit of the user.

The systems are scalable and configurable starting with one dissolution tester and a peri-pump (“Closed Loop with Peri-Pump”) all the way up to three-bath systems using precision autosampling (“Detect & Collect”). This modularity can accommodate simpler dissolution runs or extremely complex methods and high throughput. The foundation of the new system is the Hanson Vision line of dissolution testers and precision autosamplers.

Hanson’s instrument technology has had a modular design concept since the company commercialized the world’s first dissolution tester in the 1960s. That same approach is still a design requirement today as they continue to innovate. Says Royal Hanson, CEO of Hanson Research, about their new on-line UV system, “We wanted to work with a world class, high-quality UV and the best dissolution software package available. Therefore it was only natural that we chose Shimadzu and Solvias’ ARGUS/Dissolution. These folks are also great people and great partners. Although this is being marketed as a Hanson product, Shimadzu and Solvias are standing shoulder to shoulder with us as we ensure customer success. We’ve collaborated to bring the industry an on-line UV system that’s so flexible that nearly any dissolution method that requires a UV finish, whether in R&D or QC, will benefit.”

ABOUT HANSON RESEARCH

Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.

CONTACT

Sara Hanson Hanson Research Corp. pr@hansonresearch.com

9810 Variel Avenue Chatsworth, CA 91311, USA	Toll Free: 800.821.8165 Phone: 818.882.7266	Fax: 818.882.9470 www.hansonresearch.com

Media Replacement Now Available for Vision® Classic 6™ Dissolution Tester

New Accessory Provides Classic 6™ with 7th Position for Warmed Media

Los Angeles, CA—August 3, 2015—Hanson Research, the pioneer of dissolution and diffusion equipment, today introduced the new Media Replace Beaker system for the Vision G2 Classic 6, an award-winning 6-position dissolution tester. With the addition of the new Media Replace Beaker system, the Classic 6 can now simultaneously warm an additional 1 L of media while performing a six-sample dissolution test. The warmed media can then be replaced either manually into the dissolution vessels or automatically using the Vision® AutoPlus™ autosampler.

“Dissolution labs with a tight budget need a high-quality yet low-cost dissolution tester like the Classic 6,” stated Keith Hamman, President of Hanson Research. “With the new Media Replace Beaker system, labs still get the benefit of a low-cost, compact tester but with the added advantage of higher capability.”

The Media Replace Beaker system consists of a jacketed beaker that warms media to the intended test temperature. The two ports in the beaker’s jacket connect it to both the Classic 6 water bath and Vision Heater, which allows warmed water to continuously flow through the entire system, creating a stabilized temperature environment for media. The Media Replace Beaker system is an optional accessory available for your new or existing Classic 6 dissolution tester. For more information about this product, please contact your local Hanson representative or email us at sales@hansonresearch.com

ABOUT HANSON RESEARCH

Hanson Research is a global technology company that specializes in analytical test instruments for the pharmaceutical industry. Founded by the innovator of modern dissolution test technology, Hanson Research helps ensure the world’s pharmaceuticals are pure, safe, and effective by manufacturing equipment that sets the global standard for quality, innovation, and long-term value. Hanson instruments are used by scientists in over 75 countries worldwide and are supported by the industry’s top customer service team. For more information, please visit hansonresearch.com.

CONTACT

Sara Hanson Hanson Research Corp. pr@hansonresearch.com

Distek, Inc., Awarded Japanese Patent for Modularity Design and Position Software Control

North Brunswick, NJ—October 12, 2015—Distek, Inc., an industry leader in pharmaceutical laboratory testing instruments, accessories, and validation services, has been awarded Japanese Patent 5773914 for its modularity design and the individual position software control.

Distek’s patented, self-contained, modularity design is configurable for up to eight positions when in use on the symphony 7100 “Bathless” Dissolution Instrument and six positions when in use on the sensIR 3200 “Bathless” Disintegrator. This modularity design allows users unprecedented ease and scalability.

“Distek is excited to have been awarded this patent, which exemplifies our commitment to our global customers by providing intellectual property protection for our innovative product features, which offer valuable benefits to our customer base,” says Jeff Brinker, President, Distek, Inc. “This patent in particular allows our global customers a great deal of flexibility in the symphony 7100 and sensIR 3200 platforms in its modularity both mechanically as well as in the user-interface design.”

For additional information, contact Distek’s Corporate Office at +1 732 422 7585, by e-mail at info@distekinc.com, or visit www.distekinc.com.

ABOUT DISTEK, INC.

CONTACT

Sirius inForm Biorelevant Dissolution Platform to Be Used by Leading Research Group at Purdue University

September 16, 2015—Sirius Analytical announced today that Purdue University has acquired the Sirius inForm, a platform for biorelevant dissolution and solubility analyses. The system will be used in Purdue’s Department of Industrial and Physical Pharmacy under the ownership of Professor Lynne Taylor.

The Sirius inForm measures the kinetics of dissolution, absorption, controlled supersaturation, and precipitation and accommodates multiple dosage forms and sample types. Innovative methods such as biphasic dissolution and gradient pH adjustments show how a drug may behave under biorelevant conditions and in the presence of additives/excipients. Automation and precision engineering ensure that experiments are accurate and highly reproducible.

“My group’s overall goal is to enhance drug delivery by optimizing and understanding the physicochemical properties of drugs and excipients. Of particular interest are amorphous solid dispersions which are used to improve the oral delivery of poorly water-soluble drugs. We are also interested in the stability of pharmaceutical salts and the impact of excipients on product performance. The Sirius inForm will allow us to perform automated experiments with a wide range of customizable parameters to investigate pH-dependent dissolution, flux through real-time permeation studies, and precipitation kinetics under biorelevant conditions,” said Professor Taylor.

Karl Box, CSO of Sirius Analytical, explained why this collaboration is particularly valuable for Sirius: “Working closely with Purdue, particularly Professor Taylor, has been immensely important for Sirius over the last seven years. Through our work together we have developed a deep understanding of the relationship between solubility, precipitation kinetics, and the solid state of drugs, and we are thrilled that Professor Taylor will be using our latest automated instrument for her cutting-edge research. We are certain this collaboration will lead to new innovations and fundamentally progress understanding of dissolution, solubility, flux, and ultimately enhanced methods for drug delivery.”

ABOUT SIRIUS ANALYTICAL

Sirius Analytical Instruments Ltd. was established in 1989 and has offices in Forest Row, UK; Beverly, MA, USA; and Seoul, Korea. The company specializes in the provision of instruments and CRO services, primarily to the Pharmaceutical, Biotechnology, Academic, and Agrochemical sectors. Sirius’s products and services focus on measurement and understanding of physicochemical properties. Properties measured include pKa, log P, log D, solubility, dissolution, particle size and shape analysis, and the behavior of biological and small molecule formulations when they are injected into the human body. Sirius continues to innovate by both investing in its proprietary technologies and via scientific and commercial collaborations with strategic partners.

CONTACT

Contact Rebecca Heys
Telephone 00 44 (0)1342 820720
Email Rebecca.Heys@sirius-analytical.com
Website www.sirius-analytical.com

A Brand New Automated Suspension Drug Testing System SUS-4000 from Logan Instruments Corp.

Somerset, NJ—October 8, 2015—With a large array of products, Logan Instruments Corp. has developed a new product to test suspension drugs using a flow-through method. The principle of this system is as follows: A membrane is mounted between the suspension cell (donor) and the flow-through chamber (receptor). The Logan dry-heat, temperaturecontrolling system maintains a preset temperature, typically 37 °C, with the use of thermostatically controlled heater blocks surrounding the suspension cells. The drug is distributed to the membrane by homogenous agitating motion allowing the drug to penetrate the membrane and collected by the flow-through media. After mixing, the samples are collected into tubes for further analysis.

This new automated system tests the suspension samples in a “flow-through suspension cell” instead of the traditional USP Methods I and II, collecting up to 20 sample time points. The flowthrough suspension cell volume can be adjusted from 12 to 20 mL. The flow rate for the CFT pump can be adjusted from 1 to 32 mL. The flow-through pump module constantly withdraws pre-heated medium from the dry heat reservoir and passes it through the membrane. The medium mixes with the released suspension drug, then mixes again in a delivering loop. The sets of precise volume samples are then automatically delivered into HPLC vials or glass tubes simultaneously, where there is no built up pressure in the system and no leakage. The samples can run in a closed or open loop. A printer will also be available to document the system test.

CONTACT

For more information, please contact us at info@loganinstruments.com.
To learn more about Logan Instruments Corp.:
Jensen Lee
Logan Instruments Corp.
19 C Schoolhouse Rd.
Somerset, NJ 08873
Office: 732-302-9888
Fax: 732-302-9898
jensen@loganinstruments.com