Chiral CE for Non Peptide Somatostatin Drugs

DESCRIPTION (provided by applicant): Research Plan: Somatocor will optimize the preparation of a new class of chirally pure non-peptide somatostatin receptor agonists that have therapeutic advantages over the current generation of marketed somatostatin peptide analog drugs. An enantiospecific synthesis will be developed that enables the manufacture of a clinical drug candidate that meets FDA standards of quality and chiral purity. Establishment of efficient chiral analytical methods for the determination of the enantiomeric purity of synthetic intermediates and final drug product will be central to the development of a commercially viable enantiospecific manufacturing process. To this end, high resolution chiral capillary electrophoresis (CCE) methods will be developed for on line analysis of all reactions and chiral intermediates from the point that chirality is introduced in the overall synthetic process. The first line of CCE analytical method development will rely on UV detection. To complete the Phase I plan, proof of concept experiments will be performed for the development of CCE methods implementing mass spectrometry (MS) and MS-MS detection. These CCE-MS methods will be essential for performing bioanalytical studies including pharmacokinetic and drug metabolism analyses in Phase II.