Simulations Plus, Inc. (AMEX: SLP), the leading provider of simulation software for oral drug absorption and neural net structure-to-property prediction of ADMET properties for pharmaceutical discovery and development, announced today that it has released version 1.0 of DDDPlus™, a simulation of in vitro dissolution experiments for formulation scientists in the pharmaceutical industry.
Walt Woltosz, chairman and chief executive officer of Simulations Plus, said: “DDDPlus stands for Dose Disintegration and Dissolution, and Plus is our branding for Simulations Plus. DDDPlus is a new tool for formulation scientists that will enable them to predict how changes in formulation or changes in experimental setup are likely to affect dissolution rate. Dissolution rate is a critical parameter in the development of new dosage forms, in making generic versions of existing drugs, and in quality control for production.”
“In the past,” Woltosz continued, “formulation scientists worked by the ‘cut and try’ method. An initial formulation was developed based on instinct and experience. If it did not meet requirements, another was made and tested, making for a time-consuming and expensive process. Time to market is money in the pharmaceutical industry, and we perceived that simulation could be a useful tool in this area as it has been for gastrointestinal absorption with our flagship GastroPlus™ software. We believe this simulation is the first to detail all of the interactions that affect dissolution rate in an in vitro experiment. These interactions include particle size distribution, type of experimental apparatus, pH in the fluid, volume of fluid, speed of agitation, buffer composition, and effects of excipients such as surfactants and solubilizers. DDDPlus is the result of a two-year development effort and the result is truly exciting.”
Ron Creeley, vice president of marketing and sales of Simulations Plus, said: “We’ve been demonstrating beta versions of DDDPlus for several months, and the level of enthusiasm has exceeded even our expectations. Numerous companies have requested evaluation copies, and one company ordered prior to release. We believe this new core product will have a very positive impact on revenues and earnings in fiscal year 2005.”