Pharmaceutical products, preparation using

Biotechnology products are pharmaceutical products prepared by industrial processes that involve the use of biological systems such as fermentation or tissue culture. For some industries, these processes involve the use of genetically engineered organisms. The preparation of products generally involves recombinant DNA, monoclonal antibody/hybridoma, continuous cell lines, and cellular therapy technology. 

Crude chlorophyll is prepared commercially from alfalfa meal or nettles by extraction with alcohol and partition into benzene. It is used as a colouring matter, particularly for foods and pharmaceutical products. 

Occurs in the high-boiling fraction of coal tar. Most conveniently prepared by Skraup s reaction by healing a mixture of aniline, glycerol, sulphuric acid and nitrobenzene. Used in the manufacture of dyestuffs, and pharmaceutical products. 

Therapeutics. Compounds containing the furan or tetrahydrofuran ring are biologically active and are present in a number of pharmaceutical products. Eurfurjdamine [617-89-0] is an intermediate in the diuretic, furosemide. Tetrahydrofurfurylamine [4795-29-3] may also have pharmaceutical applications. 5-(E)imethyiaininomethyi)furfuryi alcohol [15433-79-17 is an intermediate in the preparation of ranitidine, which is used for treating ulcers. 2-Acet5dfuran [1192-62-7] prepared from acetic anhydride and furan is an intermediate in the synthesis of cefuroxime, a penicillin derivative. 2-Euroic acid is prepared by the oxidation of furfural. Both furoic acid [88-14-2] and furoyl chloride [527-69-5] are used as pharmaceutical intermediates. 

Another group of natural flavoring ingredients comprises those obtained by extraction from certain plant products such as vanilla beans, Hcotice root, St. John s bread, orange and lemon peel, coffee, tea, kola nuts, catechu, cherry, elm bark, cocoa nibs, and gentian root. These products are used in the form of alcohohc infusions or tinctures, as concentrations in alcohol, or alcohol—water extractions termed fluid or soHd extracts. Official methods for their preparation and specifications for all products used in pharmaceuticals are described (54,55). There are many flavor extracts for food use for which no official standards exist the properties of these are solely based on suitabiUty for commercial appHcations (56). 

Human blood plasma contains over 700 different proteins (qv) (1). Some of these are used in the treatment of illness and injury and form a set of pharmaceutical products that have become essential to modem medicine (Table 1). Preparation of these products is commonly referred to as blood plasma fractionation, an activity often regarded as a branch of medical technology, but which is actually a process industry engaged in the manufacture of speciaUst biopharmaceutical products derived from a natural biological feedstock (see Pharmaceuticals). 

Other uses include use as a reaction and extraction solvent in pharmaceutical production as an intermediate for the preparation of catalysts, antioxidants (qv), and perfumes and as a feedstock in the production of methyl isopropenyl ketone, 2,3-butanedione, and methyl ethyl ketone peroxide. Concern has also arisen at the large volume of exported MEK which has been covertly diverted and used to process cocaine in Latin American countries... 

Nitrilotriacetonitrile [628-87-5], N(CH2CN)2, a precursor to nitrilotriacetic acid [139-13-9], N(CH2COOH)2, can be prepared from the reaction of formaldehyde cyanohydrin with ammonia (26). Formaldehyde cyanohydrin is also used as an intermediate in pharmaceutical production. Commercial formaldehyde cyanohydrin is available as a 70% aqueous solution stabiLhed by phosphoric acid. 

Polyisobutylene and isobutylene—isoprene copolymers are considered to have no chronic hazard associated with exposure under normal industrial use. Some grades can be used in chewing-gum base, and are regulated by the PDA in 21 CPR 172.615. Vulcanized products prepared from butyl mbber or halogenated butyl mbber contain small amounts of toxic materials as a result of the particular vulcanization chemistry. Although many vulcanizates are inert, eg, zinc oxide cured chlorobutyl is used extensively in pharmaceutical stoppers, specific recommendations should be sought from suppHers. 

Gelatin has long been used as a food ingredient (e.g., gelling and foaming agent), in the preparation of pharmaceutical products (e.g., soft and hard capsule, microspheres), in the... 

The use of computers in developing new pharmaceutical products is nowadays commonplace, and a number of tools and databases have been developed to improve their use. Although intellectual property rights have to date rarely been the subject of court cases, protection is available and the courts are prepared to enforce these rights, even in an international context. 

Fungi may be potential pathogens or occur as contaminants in pharmaceutical products. In performing tests on potential antiflin preparations the differing culture requirements of the fungi should be borne in mind, otherwise tests similar to those used for antibacterial... 

An alternative to extraction crystallization is used to obtain a desired enantiomer after asymmetric hydrolysis by Evonik Industries. In such a way, L-amino acids for infusion solutions or as intermediates for pharmaceuticals are prepared [35,36]. For example, non-proteinogenic amino acids like L-norvaline or L-norleucine are possible products. The racemic A-acteyl-amino acid is converted by acylase 1 from Aspergillus oryzae to yield the enantiopure L-amino acid, acetic acid and the unconverted substrate (Figure 4.7). The product recovery is achieved by crystallization, benefiting from the low solubility of the product. The product mixture is filtrated by an ultrafiltration membrane and the unconverted acetyl-amino acid is reracemized in a subsequent step. The product yield is 80% and the enantiomeric excess 99.5%. 

Some gum users now take gum in a pre-prepared form. Spray dried gum acacia has been used in pharmaceutical products for some time. The spray dried gum offers the pharmaceutical manufacturer a clean ready to use product. Instant forms of gum acacia have been offered by suppliers for some time. The instant products can be rapidly made into solution and used. Obviously the instant gum is more expensive. A manufacturer that uses gum as a minor ingredient may well find that the capital and labour cost of purifying raw gum is not cost effective. A company that uses gum acacia as a major ingredient might come to a different conclusion. Instantised gums pose different problems to the analytical chemist.. One approach that can be used is to have an optical rotation specification for the product. Even this approach is not entirely proof against a material that contains a blend of gums of different optical rotation. 

Its major disadvantage is its selectivity it only detects endotoxin-based pyrogens. In practice, however, endotoxin represents the pyrogen that is by far the most likely to be present in pharmaceutical products. The LAL method is used extensively within the industry. It is used not only to detect endotoxin in finished parenteral preparations, but also in WFI and in biological fluids, such as serum or cerebrospinal fluid. 

The reduction of aromatic nitro-compounds is of exceptionally great interest, not only scientifically, hut also technically. The conversion of the hydrocarbons of coal tar into useful products began with the discovery of the nitration process the conversion, on the technical scale, of the nitro-group of nitrobenzene into the amino-group gave aniline, the starting material for the preparation of innumerable dyes and pharmaceutical products to aniline were added the homologous toluidines, xylidines, naphthylamines, and so on. 

The synthesis of aldehydes via hydroformylation of alkenes is an important industrial process used to produce in the region of 6 million tonnes a year of aldehydes. These compounds are used as intermediates in the manufacture of plasticizers, soaps, detergents and pharmaceutical products [7], While the majority of aldehydes prepared from alkene hydroformylation are done so in organic solvents, some research in 1975 showed that rhodium complexes with sulfonated phosphine ligands immobilized in water were able to hydroformylate propene with virtually complete retention of rhodium in the aqueous phase [8], Since catalyst loss is a major problem in the production of bulk chemicals of this nature, the process was scaled up, culminating in the Ruhrchemie-Rhone-Poulenc process for hydroformylation of propene, initially on a 120000 tonne per year scale [9], The development of this biphasic process represents one of the major transitions since the discovery of the hydroformylation reaction. The key transitions in this field include [10] ... 

Although some types of pharmaceutical products, like ophthalmic and injectable preparations, are sterilized by physical methods, including autoclaving, dry heat, or by bacterial filtration during their manufacture, many of them additionally require the presence of an antimicrobial preservative to maintain their aseptic condition throughout the period of their storage and use. Other types of preparations that are not sterilized during their... 

Near infrared spectroscopy (NIRS), a technique based on absorption and reflectance of monochromatographic radiation by samples over a wavelength range of 400-2500 run, has been successfully applied for food composition analysis, for food quality assessment, and in pharmaceutical production control. NIRS can be used to differentiate various samples via pattern recognitions. The technique is fast and nondestructive method that does not require sample preparation and is very simple to use compared too many other analytical methods such as HPLC. The drawback of NIRS, however, is that the instrument has to be calibrated using a set of samples typically 20-50 with known analyte concentrations obtained by suitable reference methods such as FIPLC in order to be used for quantitative analyses. Simultaneous quantification of the... 

A large number of methods have been developed for analysis of water-soluble vitamins simultaneously in pharmaceutical products (like multivitamin tablet supplements). In fact, for these products no particular sample preparations are required and the high concentrations simplify the detection, enabling the use of UV [636]. The use of MS is also reported [637]. As well, Moreno and Salvado [638] reports also the use of a unique SPE cartridge (C18) for separating fat-soluble and water-soluble vitamins, which are, then analyzed using different chromatographic systems. 

The preparation used in many of the described interactions between St. John s wort and conventional pharmaceutical products is the product manufactured by Lichtwer Pharma GmbH (Berlin, Germany). This product is marketed under the trade name, Jarsin (LI 160) in Germany and marketed in the United States under the trade name Kira . St. John s wort may also be sold in combination products with vitamins and other botanical preparations (32). The drug interaction potential between these combination products and cytochrome P450 (CYP) 3A and P-glycoprotein... 

Additives are all formulation constituents other than the active ingredient. Although additives could be classified into excipients and vehicles (excipients for solid preparations and vehicles for liquid ones), there are several other agents used in pharmaceutical formulations with specific functions such as preservatives, sweeteners, coatings, colorants, antioxidants, surfactants, emulsifying agents, and flavors. Since they comprise a vast amount of products, this section will deal with additives for compounding pharmaceutical products for internal use only [17,18]. 

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