Drug Substance Development
Aptuit's solid state chemistry group uses a variety of screening methods to discover new solid forms, including techniques developed and patented by our own scientists and only utilized in our solid form screens. The new forms identified, including salts, cocrystals, or amorphous forms, often lead to enhanced properties, especially those related to increased solubility and stability. We can maximize your success in drug substance development by providing methods to control and consistently manufacture API. This in-depth understanding of the API solid-form, its control in manufacturing, and consistent production is critical for upstream development and clinical trials.
The properties of a solid are important to its efficacy since efficacy is highly dependent on the solid form. To secure FDA approval of an NDA, it is critical to select the optimum solid form for manufacture. Our experienced scientists use a tiered approach to rationally select the optimal form of your specific drug for your specific application. This approach includes salt selection, polymorph screening and cocrystal screening, and comparative property determinations. We also include thermodynamic experiments to provide you with the most stable form. Investigations to determine optimal solid form should be carried out as early in the life of a new drug candidate . Aptuit’s scientists can work with you to plan a research protocol aimed at selection of the best form of your compound for development and manufacture. Additionally, our scientists can help determine changes in your drug product using a production screen that relies on the techniques used above as well as proprietary software to understand changes occurring which could be due to a change in the solid form of your API, or to your excipients present.