Pharmaceuticals collection systems

M. Kim, H. Chung, Y. Woo and M. Kemper, New rehable Raman collection system using the wide area illumination (WAI) scheme combined with the synchronous intensity correction standard for the analysis of pharmaceutical... 

Based on IT-Guru s in-depth analysis, the pharmaceutical manufacturing system network engineering analyst can collect object, scenariowide, and global statistics as follows ... 

Pharmaceutical products have been manufactured into compressed tablets for many years. During the 1950s, much research was devoted to the physics of compression.f Since that time, the pharmaceutical industry has attained a much greater understanding of the compression process, which resulted in the development of more robust pharmaceutical formula-tions. This has been achieved by the use of instrumented tablet presses and sophisticated data collection systems combined with the development of mathematical models. 

These responsibdities are further elaborated on in QIO by stating that Senior management has the ultimate responsibility to achieve the quality objectives. Management should participate in the design, implementation, monitoring and maintenance of an effective pharmaceutical quality system, define individual and collective roles, responsibilities, authorities and inter-relationships of all organisational units related to the pharmaceutical quality system. 

The cl mg discovery process can be envisioned as four interconnected phases (see Figure 8.1). Generally, these are the acquisition of chemicals to be tested for biological activity, the determination of the activity of those chemicals on biological systems (pharmacodynamics), the formulation of the most active of these for therapeutic testing in humans (pharmaceutics), and the determination of adequate delivery of the active drug to diseased tissues (pharmacokinetics). Each of these collections of processes is interconnected with the others and failure in any one of them can halt the development process. It is worth considering each process separately, as well as the relationships between them. 

Usually a separate CRF is used to capture serious adverse events, as those must be reported to the FDA within 24 hours. That often means that the serious adverse events CRF data and the regular trial CRF adverse events are collected in different data tables, if not entirely different software systems. Pharmaceutical companies often want to reconcile the two databases to ensure that all serious adverse events appear in the regular-trial CRF adverse events database and that any event in the serious adverse events database is flagged properly as serious in the regular CRF adverse events database. 

The simplest technique is the use of the 96-well collection plate format (analogous to the format used in SPE) in conjunction with a liquid handling robotic system it follows the same principle as bulk scale LLE. However, immobilization of the aqueous plasma sample on an inert solid support medium packed in a cartridge or in the individual wells of a 96-well plate and percolating a water-immiscible organic solvent to extract the analyte from this medium evoked significant enthusiasm from the pharmaceutical industry. 

A different issue is one that is quite common in the Pharmaceutical industry. A relatively frequent situation that arises is the need to identify a 0.1% impurity from a reaction mixture or metabolism sample. These samples are often quite convoluted in terms of the amount of compounds present as well as the general complexity of the separation, akin to a natural products extract, as can be seen in Fig. 19.19. However, to simplify this scenario to just a two-component mixture is appropriate for this section. Under common LC-NMR systems, it is typically required to have at least 50 pg of material for a complete structure elucidation (to enable the collection of long-range heteronu-clear correlation data, HMBC). Therefore, one must be able to load 50 mg of the mixture on the column. Keep in mind, that if a ID 1H spectrum is all that is needed (in the case of a regiochemical issue in an aromatic system) this task becomes more amenable. The point trying to be made is that LC-NMR is a fantastic technique, but it must be used in... 

Fully automated workstations can automatically fill vessels with dissolution medium, drop the tablets or capsules, collect multiple samples, and clean vessels. Zymark MultiDose Automated Dissolution Workstation (Zymark Corporation, Hopkinton, MA), Sotax AT70 Smart (Sotax Corporation, Horsham, PA), and AUTO DISS systems (Pharma Test GmbH, Hainburg, Germany) are several popular automated systems used within the pharmaceutical industry. 

For smaller samples, Raman spectra can be collected through a microscope. Process microspectroscopy systems, such as might be used for semiconductor chip manufacturing or pharmaceutical high throughput... 

Figure 7.4 Collection of commercial Raman probes designed for different installations (a) laboratory scale probe with interchangeable immersion or noncontact optics, shown with immersion option (b) probe shown in (a) installed in laboratory fermentation reactor (c) production scale immersion probe (d) probe shown in (c) installed in a glass reactor (e) gas phase probe with flow through cell (f) probe shown in (e) installed in process piping (g) wide area illumination (WAI) noncontact probe after completion of a pharmaceutical tablet coating operation. Adapted, with permission. Copyright 2004 Kaiser Optical Systems, Inc.

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