Europe pharmaceuticals

Heino Lennartz, Pres., Europe, Pharmaceutical Packaging Systems Donald E. Morel, Jr., Chmn. 

Sinackevich, N. V. 1997. Making the Most of Clinical Research in Russia Opportunity Knocks. Europe. Pharmaceutical Contractor pp. 64-68. 

The development of a new drug is both a time-consuming and a cost-intensive process. It takes 12 to 15 years and costs up to 800 million to bring a new drug to the market. As measured by the market capitalization, the pharmaceutical companies play a pivotal role in the global economy. In February 2003 Pfizer was ranked at position five worldwide, with a market capitalization of 163 billion. Ranking third as far as the market capitalization in Europe is concerned was GlaxoSmithKline, with a current value of 101 billion. Novartis was number five in Europe with 82 billion. 

Heico Chemicals is the only producer of acetamide in the United States. Small amounts are imported from Europe and Asia. It is shipped in 32-L (35-gal) dmms weighing about 80 kg. Acetamide appears to have a wide spectmm of appHcations. It suppresses acid buildup in printing inks, lacquers, explosives, and perfumes. It is a mild moisturi2er and is used as a softener for leather, textiles, paper, and certain plastics. It finds some appHcations in the synthesis of pharmaceuticals, pesticides, and antioxidants for plastics. 

Acetyl chlotide is manufactured commercially in Europe and the Fat East. Some acetyl chlotide is produced in the United States for captive appHcations such as acetylation of pharmaceuticals. 

Data-Star. This is Europe s leading on-line database service (39) and covers worldwide business news, financial information, market research, trade statistics, business analysis, healthcare / pharmaceuticals, chemicals / petrochemicals, chemical industry, biomedicine /life science, biotechnology, and technology, with an emphasis on Europe. It was originally formed as a joint venture among BRS, Predicasts, and Radio Suisse (the Swiss telecommunications company) (37). Data-Star offers access to about 300 bibliographic, abstract, directory, and fuU-text on-line databases, of which approximately 150 are also available on Dialog (40). 

Applications. These materials are stiU in developmental infancy. Current production is limited to one commercial process in Europe and a demonstration-scale process in North America. The lignins produced in these processes have potential appHcation in wood adhesives, as flame retardants (qv), as slow-release agents for agricultural and pharmaceutical products, as surfactants (qv), as antioxidants (qv), as asphalt extenders, and as a raw material source for lignin-derived chemicals. 

Uses of oxalic acid ia each region are summarized in Table 5 (58). The demand for agrochemical/pharmaceutical production and for separation/recovery of rare-earth elements in each region has been increasing. The use for marble polishing in western Europe is unique to the region. 

Estimates of world demand iu 1979 were as high as 1300 x 10 lU of vitamin D. This was divided iuto thirds for Europe, the United States, and the rest of the world, respectively. Of this demand, 90% was estimated for animal-feed fortification and 10% for food and pharmaceutical uses. It is estimated that the demand will be 1500—1600 x 10 IU iu 1997 for animal usage and 100 x 10 IU for human use. The United States will require approximately 500 TU (1 trillion units = 25 kg i j -vitamin D or 17 t of resiu) for animal use and 30 TU (approximately 1 t of crystalline (7j -vitamin D ) for human use. This represents approximately 50 t of vitamin D resiu/yr for animal use worldwide and about 2.5 t of crystalline vitamin D for human use. A substantial proportion of the vitamin D is imported, and with all uses iucluded, it is estimated that 80—90% of the sales are of vitamin D. ... 

Monochlorobenzene. The largest use of monochlorobenzene in the United States is in the production of nitrochlorobenzenes, both ortho and para, which are separated and used as intermediates for mbber chemicals, antioxidants (qv), dye and pigment intermediates, agriculture products, and pharmaceuticals (Table 5). Since the mid-1980s, there have been substantial exports of both o-nitrochlorobenzene, estimated at 7.7 million kg to Europe and -nitrochlorobenzene, estimated at 9.5 million kg to the Far East. Solvent use of monochlorobenzene accounted for about 28% of the U.S. consumption. This appHcation involves solvents for herbicide production and the solvent for diphenylmethane diisocyanate manufacture and other chemical intermediates. 

Coutor (U.S. Patent 2,036,924, 1936). See also Eisenlohr [Ind. Chem., 27, 271 (1951) Chem. Jng. Tech., 23, 12 (1951) Phorm. Ind., 17, 207 (1955) Trans. Indian Inst. Chem. Eng., 3, 7 (1949-1950)] and Husain et al. [Chim. Ind. ( 4ilan), 82, 435 (1959)]. This centrifuge revolves about a vertical axis and contains three actual stages. It operates at 3800 r/min and handles approximately 4.92 mVh (1300 gaPh) total liquid flow at 12-kW power requirement. Provision is made in the machine for the accumulation of solids separated from the hquids, for periodic removal. It is used, more extensively in Europe than in the United States, for the extraction of acetic acid, pharmaceuticals, and similar produces. 

SAN is also used for pharmaceutical and cosmetic packaging. Usage breakdown for Western Europe in the early 1990s has been estimated at 28% for household products, 21% for domestic electrical applications, 8% for battery casings, 12% for pharmaceutical/cosmetic packaging and a large figure of 31% for other applications. 

To get around this problem, pharmaceutical companies attempt to devise methods of enantioselective synthesis, which allow them to prepare only a single enantiomer rather than a racemic mixture. Viable methods have already been developed for the preparation of (5)-ibuprofen, which is now being marketed in Europe. We ll look further into enantioselective synthesis in the Chapter 19 Focus On. 

Figure 11.2 Regulator strategy for pharmaceutical manufacture in Europe.

The regulations also address the need to ensure that drug information provided by pharmaceutical firms is truthful, balanced, and accurately communicated. As such, it must be consistent with the indications for use and the established performance and limitations. In Europe, the directives do not impose a specific requirement to review advertising or promotional material before it is released. Acceptable standards may be achieved via voluntary codes of practice and self-regulation. However, national authorities must monitor such material and should have the power to act where the need arises. In the U S, the F DA must vet advertising and promotional material before it is released. 

The prominent position of quantum mechanics led a coterie of academic theoreticians to think that their approach could solve research problems facing the pharmaceutical industry. These theoreticians, who met annually in Europe and on Sanibel Island in Florida, invented the new subfields of quantum biology [45] and quantum pharmacology [46]. These names may seem curious to the uninitiated. They were not meant to imply that some observable aspect of biology or pharmacology stems from the wave-particle... 

Ruffolo R. Re-engineering discovery and development impact on the pharmaceutical industry of tomorrow. In Drug Discovery Technology Europe 2005, IBC Life Sciences. 

As mentioned above, significant changes in dmg regulation in Australia, Cypms and the Netherlands, were made as a result of the thalidomide disaster that occurred in Europe in 1961. This is a classic example of a crisis-led change. The disaster increased public concerns about pharmaceutical safety governments responded by imposing more stringent controls on the pharmaceutical sector, and with less resistance from the industry than would normally have been the case. 

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