Abstract
When drugmakers design and test dosage formulations of new medications, they mix hundreds of kilograms of the active pharmaceutical ingredient (API) with excipients such as polymer binders and inorganic salt lubricants to produce tablets. At this point in the drug development pipeline, time is short and supply of the API, which can cost thousands of dollars per kilogram, can become tight. To avoid losing time and money by synthesizing more drug, a Bristol-Myers Squibb development team has engineered a process to recover kilograms of pristine APIs from unused or off-spec tablets generated during formulation testing (Org. Process Res. Dev. 2017, DOI: 10.1021/acs.oprd.7b00146).Daniel S. Hsieh and coworkers first crush tablets containing the API, cellulose-based binders, magnesium stearate and silicon dioxide lubricants, and PVA-PEGpolymeric tablet coatings. After dissolving the material in warm water, the researchers separate out polymer and other solids by centrifuge, remove soluble polymers by ultrafiltrat...
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