Pharmaceutical materials

Since the dryer is a batch-operating unit, it is commonly used in the pharmaceutical industiy to maintain batch identification. In addition to pharmaceutical materials, the conical mixer diyer is used to dry polymers, additives, inorganic salts, and many other specialty chemicals. 

SIMS is one of the most powerful surface and microanalytical techniques for materials characterization. It is primarily used in the analysis of semiconductors, as well as for metallurgical, and geological materials. The advent of a growing number of standards for SIMS has gready enhanced the quantitative accuracy and reliability of the technique in these areas. Future development is expected in the area of small spot analysis, implementation of post-sputtering ionization to SIMS (see the articles on SALI and SNMS), and newer areas of application, such as ceramics, polymers, and biological and pharmaceutical materials. 

P York, DJW Grant. Entropy of processing A new quantity for comparing solid state disorder of pharmaceutical materials. Int J Pharm 30(2-3) 161-180, 1986. 

Scanning electron microscopy is commonly used to study the particle morphology of pharmaceutical materials. Its use is somewhat limited because the information obtained is visual and descriptive, but usually not quantitative. When the scanning electron microscope is used in conjunction with other techniques, however, it becomes a powerful characterization tool for pharmaceutical materials. 

Sample preparation for more specialized work can require more intensive procedures and accessories [49]. Stages have been made for the SEM to accommodate a variety of experiments [50]. Heating, cooling, and mechanical manipulation would be useful for most pharmaceutical materials, but other... 

Compression of pharmaceutical materials has also been investigated with scanning electron microscopy. Simple powder mixtures have been used to illustrate the processes that occur during compression [68], The excipients chosen... 

Table 3 Surface Areas Reported for Selected Pharmaceutical Materials...

In an effort to put powder flow studies and hopper design on a more fundamental basis, Jenike [45] developed a powder shear tester and methodology that permits an assessment of powder flow properties as a function of consolidation load and time as well as powder-hopper material interactions. The methodology has been used extensively in the study of pharmaceutical materials [39,58-61]. From the yield loci obtained using this method, several parameters can be determined that influence powder flow, and discussions of these points are well documented in the literature [49,62,63]. 

Elamin, A., Effect of Milling and Spray-Drying on Water Interactions and Physicochemical Properties of Pharmaceutical Materials, PhD thesis, Uppsala University, 1994. 

It is indeed humbling to compose this introductory chapter as there is already a vast array of introductory literature on process analysis. " It is worthwhile, however, to expand upon these works as the field continues to advance. This chapter is written from a PA experience base spanning three disparate sectors (chemical, pharmaceutical and surveillance) and various real-time analytical problems. The experience includes disparate products (fine chemical, polymer, pharmaceutical materials during product manufacture, etc.) and material physical states as well as PA solutions. 

In some facilities, there is a need for refrigerated storage of one or more flammable or combustible raw materials, catalysts, intermediate products, or finished goods. These materials may be in solid or liquid form in containers, boxes, drums, or small portable tanks. Depending on quantity of materials to be stored and required temperature, these facilities can range from cold storage warehouses for storage of food products to walk-in freezer rooms for pharmaceutical materials. 

Figure 3.10 exemplifies the application of packed-column SFC for the rapid determination of the enantiomeric purity of pharmaceutical materials. The method employed a CHIRALCEL OD CSP with a carbon dioxide/methanol/ isopropylamine mobile phase under isocratic conditions. A flow rate of 4 mFmin was used to generate a high linear velocity whilst maintaining an outlet pressure of 200 bar by use of a back-pressure regulator to ensure reproducible chromatography. Baseline resolution of the enantiomers of propanolol was achieved in approximately 3 min with an overall cycle time of 4 min. Detection was by UV... 

Keywords Solid-state grinding Cocrystal formation Crystal engineering Pharmaceutical materials Polymorphism... 

Acknowledgements The authors gratefully acknowledge funding from the Pfizer Institute for Pharmaceutical Materials Science at the University of Cambridge. AVT additionally wishes to thank the Sidney Sussex North American Foundation for funding. 

However, recent progress in both radiation and polymer researches indicates a dramatic change in the circumstance of this research field, and the trend has been rapidly expanding, especially in the last decade. Polymers will be used not only as structural materials but also as electronic, optical, medical, and pharmaceutical materials, and radiation will be a powerful candidate to manipulate the structure and property of polymers. In this section, the... 

PharmEco (Johnson Matthey Pharmaceutical Materials), and Tripos, in the USA Alphora, Canada Clausen-Kaas, Denmark Evotec AG, Germany Meridiano Medical Sciences and Serichim, Italy CarboGen and Solvias, Switzerland ChemShop, The Netherlands Onyx, UK NARD Institute, Japan and Novotech, Australia. 

The Raman effect has also been broadly applied to online and bench-top quantitative applications, such as determination of pharmaceutical materials and process monitoring [4-6], in vivo clinical measurements [7], biological materials [8, 9], to name only a few. Because the absolute Raman response is difficult to measure accurately (sample presentation and delivered laser power can vary), these measurements are almost always calculated as a percentage with respect to the response from an internal standard. This standard is typically part of the sample matrix in a drug product, the standard may be an excipient in a biological sample, it is commonly water. 

In recent years there has been increasingly more interest in determining the amorphous content of pharmaceutical materials. This is due to... 

Clarke, F. C., Hammond, S. V., Jee, R. D. and Moffat, A. C. (2002) Determination of the information depth and sample size for the analysis of pharmaceutical materials using reflectance near-infrared microscopy. Appl. Spectrosc. 56, 1475-83. 

It defines anew term, OOS or out-of-specification result, which refers to a result obtained for the pharmaceutical material or drug product that does not comply with the regulatory specification for the particular test performed. Previously, FDA inspectors would prematurely term OOS laboratory results as product failures, which clearly was not established without proper laboratory and possibly more extensive investigational activities outside the laboratory environment. 

Pharmaceutical materials, in general, are becoming more potent. Effects that are therapeutically desirable in a patient may present a health hazard to workers handling these materials on a routine basis. Care must be taken to address worker safety when... 

Loi, D.T. and Thu, N.V. (1 970) Medicinal Trees and Pharmaceutical Material and Herbs in Vietnam. Pharmacy College Publisher, Hanoi, pp. 209-211. 

Gohel, M. C., and Sumitra, M. (2002), Modulation of active pharmaceutical material release from a novel tablet in capsule system containing an effervescent blend, J. Controlled Release, 79,157-164. 

Shlieout, G., Wiese, M., and Zessin, G. (1999), A new method to evaluate the consolidation behavior of pharmaceutical materials by using the Fraser-Suzuki function, Drug Dev. Ind. Pharm., 25, 29-36. 

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