Pharmaceutical products, role

With reference to two products of your choice discuss the role catalysts have played in the development of a more economic and environmentally friendly bulk chemical industry. Why has catalysis had less impact on the development of fine and pharmaceutical products ... 

The pivotal role of natural a-amino acids among a myriad of biologically active molecules is widely appreciated, and is of particular importance in the pharmaceutical industry. Unnatural a-amino acids also have a prominent position in the development of new pharmaceutical products. It has been shown that substitution of natural a-amino acids for unnatural amino acids can often impart significant improvements in physical, chemical and biological properties such as resistance to proteolytic breakdown, stability, bioavailability, and efficacy. One of the many synthetic methods available for the production of enantiomerically enriched a-amino acids is the metal-catalyzed enantioselective reduction of a-de-hydroamino acid derivatives [90]. 

Solutions to practical problems rarely depend upon a single technique or a single approach. The following example of an impurity identification in a pharmaceutical product illustrates the key role that LC-MS can play in such an investigation, but also illustrates the limitations of the technique. The identification of this impurity has been published elsewhere in complete detail [75]. The problem and solution is summarized here. The impurity, designated as H3, was observed at 0.15% in a bulk lot of the drug substance in the structure below. The impurity required identification before the bulk lot could be released for use in further studies. 

Over the past 40 years, capillary electrophoresis (CE) has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrumental-based method for micro-scale separation, but also emerged as an indispensable tool in the biotech and pharmaceutical industries. CE has become a method of choice in research and development (R D) for molecular characterization, and in quality control (QC) for the release of the therapeutic biomolecules.In the biopharmaceutical industry, more and more CE methods have been validated to meet International Conference on Harmonization (ICH) requirements. In this chapter, we present real industrial examples to demonstrate the role of CE in R D of pharmaceutical products. The focus in this chapter is on method development analytical control for manufacturing and release of therapeutic proteins and antibodies. 

The market for pharmaceutical products clearly deviates from these preconditions in important respects. Product heterogeneity is the least critical of these preconditions since competitive markets would require only that consumers be able to assess differences in value (or quality) between goods with different products. Inadequacy of information, however, is a major problem, not only for consumers of prescription drugs, but for physicians in their roles as prescribers as well. Furthermore, whatever its merits may be, the patent system precludes free entry. 

The purpose of this chapter has been to provide a broad, general overview of the role of the pharmaceutical industry in the economy and in the health sector, and to explore a number of problems arising from the industry s cost structure and from the traditional imbalance in the global markets for pharmaceutical products. 

To decide on the allocation of public and private resources, some form of cost-effectiveness analysis is used in many countries, large and small (Drummond, Chapter 11). The single most common type of medical care to which this method is applied is the use of pharmaceutical products. Sometimes the decision involves new uses for existing products developed and produced in the country making the decision, and sometimes it involves products imported from abroad. Sometimes as well the decision involves the potential allocation of resources to a new product if brought to market, and often public funds play a role in such innovation. 

The demographic shifts in life expectancy gains further complicate any analysis of the sources of longer life. To identify the specific role of pharmaceuticals in this remarkable trend, we focus on empirical research based on data from the last 20-30 years. The role of pharmaceutical products is not obvious, however, because of simultaneously increased average income, decreased poverty, greater and faster access to medical facilities, and improved training for health professionals, all of which combine with access to new and improved pharmaceutical products to yield longer life. 

Residual solvents are organic volatile chemicals that remain in active substances, excipients, and other pharmaceutical products after processing. In spite of their toxic properties, solvents play an important role in the production of pharmaceuticals, during the synthesis, separation, or purification, and their use cannot be avoided. Solvents in this category do not include those used as excipients. 

With the generally increasing concerns about the environment, chemical pollution, and green issues, GSK and other pharmaceutical and chemical companies have made significant efforts to incorporate sustainable business prachces and procedures in the manufacture of Ac live Pharmaceutical Ingredients (API) used in pharmaceutical products. This has placed greater emphasis on the role of the process chemist as they seek to discover commercially viable and environmentally sustainable processes for the manufacture of the new medicines. 

Baertschi SW. The Role of Stress Testing in Pharmaceutical Product Development, presented at the American Association of Pharmaceutical Scientists Midwest Regional Meeting, Chicago, IL, May 20, 1996. 

How have pharmacists roles in delivering pharmaceutical products and services evolved over the past... 

Hydrogen reactions play an important role in the production of fine chemicals, vitamins and pharmaceutical products. In recent years continuous reactors rather than the traditional batch reactors are becoming more interesting. 

The physical and chemical characterization of any pharmaceutical product is only as reliable as the quality of the analytical methodologies utilized to assess it. Without question, the role of analytical services to the overall drug product development process is invaluable. Good analytical testing with proper controls could mean the difference between a marketable product and one that is eliminated from development. Analytical methodologies intended for characterization and/or assessment of marketed pharmaceutical products must be relevant, validatable, and transferable to manufacturing/quality assurance laboratories. 

The packaging of a pharmaceutical product fulfils a variety of roles, such as product presentation, identification, convenience, and protection until administration or use. Selection of packaging requires a basic knowledge of packaging materials, the environmental conditions to which the product will be exposed, and the characteristics of the formulation. Several types of packaging are used to contain and protect the pharmaceutical preparations, such as the primary packaging around the product and secondary packaging such as a carton and subsequent transit cases [1],... 

Another example of how catalysis plays a key role in enabling our lives is in the synthesis of pharmaceuticals. Knowles s development, at Monsanto in the early 1970s, of the enantioselective hydrogenation of the enamide precursor to L-DOPA (used to treat Parkinson s disease), using a Rh-chiral phosphine catalyst (Section 3.5), led to a share in the Nobel prize. His colaureates, Noyori and Sharpless, have done much to inspire new methods in chiral synthesis based on metal catalysis. Indeed, the dramatic rise in the demand for chiral pharmaceutical products also fuelled an intense interest in alternative methodologies, which led to a new one-pot, enzymatic route to L-DOPA, using a tyrosine phenol lyase, that has been commercialized by Ajinomoto. 

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