Amorphous Pharmaceutical Product Development Using Containerless Methods

Amorphous Pharmaceutical Product Development Using Containerless Methods Project Summary The overall objective of this research is to advance drug discovery through precise “engineering” of the structure and properties of API-bearing phases. Many emerging drugs cannot be used in their naturally insoluble crystalline forms or they require crystallization in a preferred polymorph in order to be active. In some cases amorphous forms made using conventional methods contain residual crystal nuclei and consequently have short shelf lives. Control of crystalline phase selection can be difficult to achieve and a detailed understanding of mechanisms is needed to optimize product yield and quality. The new research will result in an advanced “platform technology” for drug discovery, synthesis and characterization. The research will optimize performance of the technology and characterize and document its performance through benchmarking experiments on a variety of pharmaceutical compounds. Materials to be investigated will be selected by the research team and provided by collaborating drug companies and scientific collaborators. The technical objectives are to: (i) Optimize a new method for rapid drug synthesis and screening, (ii) Identify critical pathways to form amorphous or select crystalline polymorphs through processing, (iii) Test process parameters in systematic experiments that control nucleation, crystallization and phase selection in drug and drug- polymer compositions. Commercialization is being realized through sales of instruments and sales of drug screening services. Throughout the project the research team is working with several drug companies and a pre-competitive consortium to develop markets.Amorphous Pharmaceutical Product Development Using Containerless Methods Project Narrative The proposed technology can revolutionize drug delivery to patients. The overall objective of this work is to advance drug discovery through precise “engineering” of the structure and properties of API-bearing phases. The research will result in an advanced processing platform technology for drug discovery, synthesis and characterization. The resulting technology and methods developed will be offered as processing and screening services and marketed to pharmaceutical laboratories as a research instrument. The most important goal of medical care is to optimize patient outcomes through the effective administration of treatments. Many emerging drugs cannot be used in their naturally insoluble crystalline forms or they must be crystallized in appropriate forms that are active in the body. The new, patented containerless processing method that will be commercially developed as a result of the proposed research is a high value and enabling tool for next generation drug development. The approach will enables the production of high solubility amorphous drug forms and optimize phase selection in crystalline drug and drug-polymer products. As a result of the new process, advanced drug formulations can become available to treat a variety of diseases more effectively.