Processing amorphous pharmaceutical compounds

Period of Performance: 05/01/2016 - 11/30/2016


Phase 1 SBIR

Recipient Firm

13213 Locksley Ln Array
Silver Spring, MD 20904
Principal Investigator


? DESCRIPTION (provided by applicant): The objective of the proposed project is to advance the development a tool for research on amorphous pharmaceutical screening/production towards a commercial product. Commercialization will be through sales of research instruments and potentially drug screening services to pharmaceutical companies. Many emerging drugs cannot be used in their naturally insoluble crystalline forms. In some cases amorphous forms made using conventional methods contain residual crystal nuclei and consequently have short shelf lives before they crystallize. The novel use of the proposed containerless method avoids nucleation allowing completely amorphous materials to be synthesized is sufficient quantities for research. This capability is important for benchmarking products, understanding drug/biner phase relationships, and in the optimization of large scale production methods such as spray drying. In addition to benchmarking and synthesis of small quantities of drugs, the proposed device is useful for characterizing the behavior of drug solutions of the type that are used in spray drying. The principal goals of the proposed R&D are to: (i) demonstrate key performance benchmarks by comparing data on test drugs representative of commercial pharmaceutical compounds made using MDI's instrument and standard rotovap synthesis, and (ii) optimize the capability to meet commercial drug research requirements. The long term objective is to provide a new laboratory- scale process platform and a tool that can be used to optimize drug production using conventional manufacturing methods such as spray drying. The proposed research has five main technical objectives that are targeted to achieving the project goals and that will lead to development of a commercially-viable non-contact pharmaceutical research and screening technology. The work will include instrumentation research, measurements on selected drug and drug-polymer materials, and analysis/benchmarking of the performance of the method. The project will be performed by an experienced team of scientists and engineers who are expert in the areas of the proposed research. During the Phase I, MDI will be working with Merck, SSCI and a process engineer/scientist as documented in the letters of support included with the proposal.