Pharmaceutical process development

D. W. Guest, Evaluation of simulated moving bed cliromatography for pharmaceutical process development , J. Chromatogr. 760 159-162 (1997). 

Guest D. W. (1997) Evaluation of Simulated Moving Bed Chromatography for Pharmaceutical Process Development, J. Chromatogr. A 760 159-162. 

J.K. Liang, S. Byrn, A. Newman, J. Stults and V. Smolenskayay, On-line Raman spectroscopy in pharmaceutical process development Application and future prospects. Am. Pharm. Rev., 10, 45-51 (2007). 

Doherty, S. LaPack, M. David, P. etal., Integrated analytical technology Instrumental in achieving efficient pharmaceutical process development National ACS Meeting, October 2001, Chicago, IL. 

Anderson [2] presents a wide range of topics on pharmaceutical process development, including a number of different problems related to process scale-up, such as solvent and reagent selection, purification, and limitations to various operations. He notes that most reactors used for scale-up operations are selected for flexibility in running many different processes, especially for pilot plants and multiproduct manufacturing plants. 

N. Wu, J Dempsey, P. Yehl, A. Dovletoglou, D. Ellison, and J Wyvratt, Practical aspects of fast HPLC separations for pharmaceutical process development using monoUthic columns. Anal. Chim. Acta 523 (2004), 49-156. 

The ability of 2-MeTHF to act as a slot-in replacement has led to its uptake in pharmaceutical process development labs. Researchers at Eli Lilly have performed a Horner-Wadsworth-Emmons reaction using commercially available (5 )-propylene oxide and triethylphosphonoacetate (Figure 5.10). The yield was found to be strongly influenced by the solvent used, and 2-MeTHF was found to be the superior solvent. 

McKay B, Hoogenraad M, Damen EWP, and Smith AA. Advances in Multivariate Analysis in Pharmaceutical Process Development. CurrOpin Drug Disc Dev 200 6 966-977. 

Basu, P.K., Mack, R.A., Vinson, J.M. Consider a new approach to pharmaceutical process development. Chemical Engineering Progress 95, 82-90 (1999)... 

Figure 74 shows another example of evaluation in 254-nm UV light from the area of pharmaceutical process development. Here, starting materials, in-process control, mother Uquor, wash water and the end product are monitored by TLC. With in-process control, TLC gives rapid and reliable results with an accuracy that is quite adequate for the chemical production process. 

Statistical Considerations in Pharmaceutical Process Development and Validation... 

Pharmaceutical Process Development Current Chemical and Engineering... 

Pharmaceutical Process Development, Roche Carolina Inc., Florence, SC, USA... 

Merrimack Street Lawrence, MA 01843 Fax 978-794-9580 E-mail info phasex4scf.com Internet site www.phasex4scf com pharmaceutical process development with supercritical fluids... 

Petrides D P, Koulouris A, Lagonikos P T (2002). The role of process simulation in pharmaceutical processes development and product commercialization. Pharmaceut. Engin. 22 1-8. 

Abrahim A, Al-Sayah M, Skrdla P, Bereznitski Y, Chen Y, Wu N, Practical comparison of 2.7 p.m fused-core silica particles and porous sub-2 p.m particles for fast separations in pharmaceutical process development, J. Pharmaceut. Biomed.Anal. 2010 51(1) 131-137. 

For the pharmaceutical industry, scale-up activities often refer to the scale-up of processes in pilot plants. More important, pharmaceutical process development frequently involves fitting a process to available plant equipment rather than designing an optimal plant for the manufacture of every drug substance in the pipeline. Only for the manufacture of commercially successful drugs is a dedicated plant designed and built. 

Roberts, K. J. Docherty, R. Taylor, L. S., Materials Science Solid Form Design and Crystallisation Process Development. In Pharmaceutical Process Development Current Chemical and Engineering Challenges-, Blacker, J., Williams, M. T., Eds. Royal Society of Chemistry Cambridge, UK, 2011 pp. 286-316. 

Co-crystals represent a novel class of crystalline solids which possess scientific and regulatory advantages along with enormous intellectual property potential. In the earlier stages of pharmaceutical process development, an efficient cocrystal screening is essential in order to determine the different possible stoichiometries and the different polymorphic forms for each stoichiometry. When all the different phases are identified, the relative stability of the solid phases in solution has to be determined. This step requires the construction of the... 

Wu, N., JilUan, D., Dempsey, J., Yehl, P, Dovletogolous, A., Ellison, D. and Wyvratt, J. Practical aspect of fast HPLC separation for pharmaceutical process development using monolithic columns. Anal. Chim. Acta. 523 149-156, 2004. 

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