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news.Aspen Technology, a provider of software and services to the process industries, said that its patented technology, which is part of aspenONE Process Development for Pharmaceuticals software, is being used by GlaxoSmithKline, AstraZeneca and other pharmaceutical companies to reduce their R&D time and costs.
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Aspen’s solubility modeling technology, which was developed in collaboration with pharmaceutical companies, is said to provide Quality by Design (QbD) capabilities that help manufacturers comply with the latest industry regulatory initiatives.
Aspen claimed that by making use of its aspenONE software, GSK is able to throroughly understand the solubility properties of new chemical entities (NCE) to assess risks and improve confidence during the development of new pharmaceuticals. Drug companies can also ensure a highly repeatable manufacturing process using this technology.
Aspen said that its simulation modeling technology optimises crystallisation design workflow by allowing pharmaceutical companies to save time and money, conduct clinical trials earlier, reduce cost of goods and supply disruptions and enable informed design of the final active pharmaceutical ingredient (API) manufacturing processes so they are optimised to produce less waste and higher yield.
Additionally, AspenTech has received a patent for creating a nonrandom two-liquid segment activity coefficient (NRTL-SAC) model that provides a simple yet scientific basis to predict drug solubility.
Stephen Carino, investigator at solid form sciences group of GlaxoSmithKline, said: “Screening for crystalline forms is an essential component in pharmaceutical drug development.
“In our high-throughput screening workflow, we have utilised NRTL-SAC in Aspen Properties to predict the equilibrium solubility of the drug in single- and multi-component solvent systems.
“The predicted solubility values are used in selecting an appropriate set of solvent systems that are unique for each of the crystallisation modes.
“This rational solvent selection coupled with the systematic screening approach has allowed us to assess risk around solid forms and improve our confidence in the API processes.”
Jamie Hintlian, vice president of pharmaceuticals at Aspen Technology, said: “Solubility is essential in evaluating drug candidacy and manufacturability. Without predictive tools, many organisations are forced to fly blind when it comes to this information.
“Solubility modeling and prediction adds value by enabling greater efficiencies, better decision making, faster process development, and better process performance.”