Process pharmaceutical

Pharmaceutical Processes. The pharmaceutical industry is a principal user of extraction because many pharmaceutical intermediates and products ate heat-sensitive and cannot be processed by methods such as distillation. A usehil broad review can be found in the Hterature (241). 

Miscellaneous Pharmaceutical Processes. Solvent extraction is used for the preparation of many products that ate either isolated from naturally occurring materials or purified during synthesis. Among these are sulfa dmgs, methaqualone [72-44-6] phenobarbital [50-06-6] antihistamines, cortisone [53-06-5] estrogens and other hormones (qv), and reserpine [50-55-5] and alkaloids (qv). Common solvents for these appHcations are chloroform, isoamyl alcohol, diethyl ether, and methylene chloride. Distribution coefficient data for dmg species are important for the design of solvent extraction procedures. These can be determined with a laboratory continuous extraction system (AKUEVE) (244). 

The excellent corrosion resistance means that tantalum is often the metal of choice for processes carried out in oxidising environments or when freedom from reactor contamination of the product or side reactions are necessary, as in food and pharmaceutical processing. Frequently, the initial investment is relatively high, but this is offset by low replacement costs owing to the durabiUty of the metal. 

Basic types of extruders include axial end plate, radial screen, rotary cyhnder or gear, and ram or piston. For a review, see Newton [Powder Technology Pharmaceutical Processes, Chuha et al. (eds.), Elsevier, 391 (1994).]... 

Figure 9.7 The cold composite stream for the pharmaceutical process.

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. 

Today it is estimated that some 90% of the chemicals used have, at some stage in their manufacture, come into contact with a catalyst. The range is truly broad from bulk chemicals such as acetic acid and ammonia to consumer products such as detergents and vitamins. Virtually all major bulk chemical and refining processes employ catalysts. The number of fine, speciality and pharmaceutical processes currently using catalysts is still relatively small by comparison, but a combination of economic and environmental factors is focusing much research on this area. The great... 

Many failures in pharmaceutical processing have arisen because of the inability of those responsible for its design to be aware of the distribution and survival potential of microorganisms in the environment and in the raw materials and equipment used in a pharmaceutical factory. 

Butters, M., Catterick, D., Craig, A. et al. (2006) Critical Assessment of Pharmaceutical Processes - A Rationale for Changing the Synthetic Route. Chemical Reviews, 106(7), 3002-3027. 

Shifflet, M. J. and Shapiro, M., Validation of a cation-exchange method to test for residual amounts of a cleaning and sanitizing solution on pharmaceutical process equipment, BioPharm, 51, Jan. 2000. 

A variety of approaches exist for stabilizing proteins, for example, chemical modification, immobilization, and site-directed mutagenesis [95,96], but these techniques are not within the scope of this chapter. The focus here will be on stabilization of proteins via formulation development. The principal formulation strategy is to stabilize the protein using clinically acceptable additives (excipients) or through the use of suitable pharmaceutical-processing technologies. 

Sterilization. In some processes, such as food and beverage and pharmaceutical processes, water might need to be sterilized before it is reused or recycled. Chemical oxidation (e.g. ozonation) can be used. Ultraviolet light is an alternative for lightly contaminated water. Alternatively, a combination of chemical oxidation and UV light can be... 

Biotechnology of Industrial Antibiotics, Erick J. Vandamme Pharmaceutical Process Validation, edited by Bernard T. Loftus and Robert A. Nash... 

Automation and Validation of Information in Pharmaceutical Processing, edited by Joseph F. deSpautz... 

Pharmaceutical Process Engineering, Anthony J. Hickey and David Ganderton... 

Pharmaceutical Process Scale-Up, edited by Michael Levin... 

Pharmaceutical Process Validation An International Third Edition, Revised and Expanded, edited by Robert A. Nash and Alfred H. Wachter... 

Woodley, J.M. (2008) New opportunities for biocatalysis making pharmaceutical processes greener. Trends in Biotechnology, 26 (6), 321-327. 

Infrared microscopy is well suited for in situ analysis of contaminants fount in pharmaceutical processes. Due to the nondestructive nature of the analysis further experiments such as energy dispersive x-ray analysis may be performer on the same sample once IR investigations are complete. To illustrate the potentia of IR microspectroscopy, one application from the Bristol-Myers Squibl laboratories is presented. 

Density is defined as the ratio of the mass of an object to its volume. It is dependent on the type of atoms in the molecule, as well as the arrangement of the atoms in the molecule and the arrangement of molecules in the sample. In a solid, the arrangement of the molecules, and therefore the density, is related to the crystalline nature of the compound. The density of a powder or granulation can affect a number of pharmaceutical processes, including flow, mixing, and tableting. 

It is the objective of this chapter to discuss the various mechanisms whereby water can interact with solid substances, present methodologies that can be used to obtain the necessary data, and then discuss moisture uptake for nonhydrating and hydrating crystalline solids below and above their critical relative humidities, for amorphous solids and for pharmaceutically processed substances. Finally, transfer of moisture from one substance to another will be discussed. 

Carpenter, J. F., Kreilgaard, L., Jones, L. S., Webb, S., Randolph, T. W. Mechanisms of protein stabilization by nonionic surfactants. Freeze-Drying of Pharmaceuticals and Biologicals, presented by National Science Foundation, Industry/University Cooperative Research Center for Pharmaceutical Processing, CPPR, Brownsville, Vermont USA, 1998... 

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