(638f) API Recovery From Pharmaceutical Waste Streams By High Performance Countercurrent Chromatography and Intermittent Countercurrent Extraction

When new projects are scaled up from the research and development stage into manufacturing, recovery or disposal of waste streams becomes more and more important to minimise cost and reduce both environmental and safety impact. Modern telescopic synthesis techniques and their follow-on purification processes are not always efficient enough to prevent loss of active pharmaceutical ingredients (API) in the waste stream. There are technologies available by which components of such streams can be recovered, treated or disposed of. However, most of them are based on selective filtration and aim to recover catalysts or reduce toxicity of pharmaceutical waste streams before they are released into the general water supply or burnt.

For any waste stream purification, the following stages of process optimization should be considered: prevention and minimising of environmental impact through process design; reuse of materials with no additional processing; recycling materials after such processing if required; disposal with energy recovery and finally benign disposal.

The drive towards greener processes, process economics, technology availability, and legislation, all play a part in the selection of the best available technology for waste stream processing.  One such technology is High Performance Counter Current Chromatography (HPCCC) which is being evaluated as new cost effective continuous platform technology as part of a 3 year Technology Strategy Board High Value Manufacturing initiative entitled “Scalable Technology for the Extraction of Pharmaceuticals” [1-2]. This is an industry led collaborative project involving end-users, GSK and Pfizer, a technology supply company, Dynamic Extractions, and Brunel University all actively working together to improve process efficiency and reduce both cost and waste.

HPCCC method development for waste steam purification is done at the analytical scale with subsequent scale up to the preparative 1L instrument. This demonstrates the potential of the technology for the recovery of active pharmaceutical ingredients from complex waste streams in both batch and continuous processing modes. The scalability of the HPCCC process enables optimization work at the laboratory scale to be transferred directly to the 18L pilot scale HPCCC. Different scenarios of throughput/purity/yield will be presented demonstrating the flexibility of the technology to purify the target compound at the required trial grade and avoiding expensive clean up processes. This process is therefore capable of reducing the environmental impact of pharmaceutical waste streams.

References

 1. Technology Strategy Board (TSB) High Value Manufacturing Award (Grant No. TP14/HVM/6/I/BD506K) “Scalable Technology for the Extraction of Pharmaceuticals (STEP) September 2009 to August 2012

2. Sutherland, I.A., Thickitt, C., Douillet, N., Freebairn, K., Johns, D., Mountain, C., Wood, P., Edwards, N.,  Rooke, D., Harris, G., Keay, D.,  Mathews, B., Brown, R., Garrard, I., Hewitson, P., Ignatova, S. Scalable Technology for the Extraction of Pharmaceutics: Outcomes from a 3 year collaborative industry/academia research programme, Journal of  Chromatography A 2013, 1282, 84-94