Excipient distribution

Mutchler Pharmaceutical Ingredients, Inc., Harrington Park, New Jersey, U.S.A. 

In the pharmaceutical industry, distributors fall under intense scrutiny, as critical players in the supply chain. From the early development of many drug products to production and commercialization, distributors are integral parts of the entire process— supplying equipment, active pharmaceutical ingredients (APIs), and excipients—the focus of this chapter. 

Traceability of excipients is a major focus of concern during the development and production of drug products. Knowing with certainty exactly where the excipients were manufactured and how many times they change hands and are repacked, 

THE EVOLUTION AND SPECIALIZED ROLE OF THE PHARMACEUTICAL DISTRIBUTOR IN THE PHARMACEUTICAL INDUSTRY 

Chemical distribution has had a long presence throughout the economic development of the United States, the origins of which developed from the goal of increasing the efficiency by which a manufacturer marketed their goods and services (4). From 

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Although microscopy and imaging are used in a number of the above disciplines, a separate chapter is devoted to the use of optical and electron imaging techniques and image analysis, which play an increasingly important role in contaminant analysis and dmg-excipient distribution. 

Raman chemical images and spectra obtained from an over-the-counter pharmaceutical tablet were shown earlier in this chapter. The two active-ingredient particles are visualized in Fig. 23A, a chemical surface map of aspirin derived from the two-dimensional image of Fig 6C, The compositional texture of the tablet becomes more obvious when seen as a surface map. Figure 23B shows the chemical surface map for excipient distribution. As anticipated, where the active ingredient is localized, the excipient is absent. 

Currently, both FT-Raman and dispersive Raman spectrometers are being used within the pharmaceutical industry. Dispersive Raman spectroscopy in the form of Raman microprobes are heavily employed in the research area to map active-excipient distribution using the diffraction limited spatial resolution attainable with the microprobe. In this subsection, it is inappropriate to describe the varied applications of Raman microscopy to the study of pharmaceuticals thus, the reader is referred to the literature [108,109] and Chapter 14. Dispersive Raman analyzers are also being used for reaction analysis, pilot-plant batch analysis, and process monitoring. FT-Raman spectrometers have been adopted for formulated product analysis and for incoming goods testing. 

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