A higher proportion of new drug candidates are exhibiting very low solubility in water leading to poor dissolution rates and correspondingly low oral bioavailability. Additionally, some new API materials have undesirable properties including hygroscopicity or instability, either chemical or physical. Solid state chemistry may be used to counter these problems and plays an important role in ensuring your drug has the desired properties when delivered to market. At Aptuit, our detailed analysis techniques can often result in manufacturing efficiencies, reduced waste, less cost and improved timelines.
The Solid State Chemisty services, comprising of SSCI and the solid state group located in Verona, Italy provide services for which we have an outstanding reputation. We provide specialized services in the areas of polymorphism, crystalization, problem solving and stability. Our focus is to understand, improve and protect your active pharmaceutical ingredient (API drug substance), formulated product and intellectual property. Solid State Chemistry plays an important role throughout the development of drug candidates and we can assist every step of the way.
At the early stages of development, API is often in short supply, so to counter this challenge our experienced scientists have been optimizing screening techniques for the past decade. These internal research and development efforts have enabled us to become more proficient in our screening efforts, potentially using less API material in the process. Additionally, an extensive research program has been conducted on cocrystals, amorphous materials and amorphous dispersions to support our clients’ growing needs for new forms to help overcome physical property constraints and to obtain intellectual property. Our analytical chemists have also been working extensively on developing solid state analytical methods for the quantification of solid forms in drug substance or drug product.
Our solid state chemistry group brings widespread experience of polymorphism, crystallization and API development and the ability to solve virtually any problems/issues presented to them. This enables us to support our clients in developing API while building sound intellectual property. Our areas of expertise include: