Simulations Plus and Northeastern University to Collaborate on Solubility Measurements

Company to Fund Landmark Study for Measuring Solubilities in Biorelevant Fluids LANCASTER, Calif.–Simulations Plus, Inc. (NASDAQ: SLP – News), a leading provider of simulation and modeling software for pharmaceutical discovery and development, announced that it has signed an agreement with Northeastern University to fund a research project that will measure solubilities in biorelevant fluids. Dr. John Crison, director of life sciences for Simulations Plus, said: “The solubility of new drug molecules is usually measured in laboratory experiments either in pure water or in buffer solutions. These are not the same as the fluids in the gastrointestinal tracts of humans or other animals, and it’s important for scientists to know what level of solubility to expect when drugs are dosed in animals and humans. In fact, one of the critical inputs to our GastroPlus™ software is the solubility of the drug at different values of pH. For ionizable compounds, the solubility can change by many orders of magnitude as pH changes. GastroPlus accounts for this by calculating the change in solubility as pH changes in different parts of the gastrointestinal tract.” Dr. Crison continued: “But pH is only one factor affecting solubility. Fluids in the human gastrointestinal tract contain a number of substances that can also affect solubility in complex ways. This study will measure the solubility of approximately 200 different drugs in simulated gastric fluid (SGF), fasted state simulated intestinal fluid (FaSSIF), and fed state simulated intestinal fluid (FeSSIF). These simulated biorelevant fluids include representative amounts of other substances that influence in vivo solubility.” Walt Woltosz, chairman and chief executive officer of Simulations Plus, added: “Solubility is a major concern in the development of many new drugs, so we’re very pleased to begin this collaboration with Dr. Rebecca Carrier and her lab at Northeastern University. Dr. Carrier was formerly at Pfizer and while there she developed considerable expertise in the study of solubility and dissolution. We believe that with the data that will be generated from this study, we will be in a better position to estimate the solubility and dissolution of new drug molecules in various parts of the gastrointestinal tract. We also expect to build a model to adjust solubilities measured in typical lab experiments to those that would be experienced in vivo, and to include that model as another valuable prediction in our ADMET Predictor software. This is the first such investment we’ve made. We’re looking for other such investment opportunities to further the science in our field while enhancing our products and services.” Ron Creeley, vice president of marketing and sales for Simulations Plus added: “In addition to the value provided to our own software and services, the unique database that will be developed under this collaboration will be a product in its own right. We believe many companies will be interested in licensing the database in order to better understand how in vivo solubility differs from that in buffer solutions. Especially for the many smaller companies who would not want to invest the entire amount needed to complete such a study, licensing the results for a much lower price will make economic sense.” About Simulations Plus, Inc. Simulations Plus, Inc., is a premier developer of groundbreaking drug discovery and development simulation and modeling software, which is licensed to and used in the conduct of drug research by major pharmaceutical and biotechnology companies worldwide. The Company has two other businesses, Words+, Inc. and FutureLab™, which are based on its proprietary software technologies. Simulations Plus, Inc., is headquartered in Southern California. For more information, visit our Web site at

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