Pharmaceutical industry characteristics

As will be shown in the following sections 6.2.1, 6.2.2, and 6.2.3 all the main types of processes and techniques of size enlargement by agglomeration (Chapter 5) are being used in the pharmaceutical industry. Characteristic design features are based on what has been discussed above. The equipment is typically small, built from stainless steel, and can be cleaned easily inside and out to avoid cross-contamination. In addition, more and more installations are executed with a physical separation between the (dirty) drives and other mechanical parts that require technical maintenance and the containments that process the charge. Sophisticated control and recording devices are a common part of all systems, in part to satisfy the requirements of process validation. 

Comprehensive physicochemical characterization of any raw material is a crucial and multi-phased requirement for the selection and validation of that matter as a constituent of a product or part of the product development process (Morris et al., 1998). Such demand is especially important in the pharmaceutical industry because of the presence of several compounds assembled in a formulation, such as active substances and excipients, which highlights the importance of compatibility among them. Besides, variations in raw materials due to different sources, periods of extraction and various environmental factors may lead to failures in production and/or in the dosage form performance (Morris et al., 1998). Additionally, economic issues are also related to the need for investigating the physicochemical characteristics of raw materials since those features may determine the most adequate and low-cost material for specific procedures and dosage forms. 

A number of H EX reactors are presented in the literature, some of which have been designed for a specific chemistry. It is necessary to remember the necessary flexibihty and polyvalence which are required in fine chemicals or pharmaceutical industries. Nevertheless, owing to the low holdup and the rapidity of putting HEX reactors in operation, one can imagine types of H EX reactors devoted to a portfoho of reactions linked to the exothermicity, product characteristics (such as corrosion) or to the nature of the phases (hquid-hquid, gas-liquid, solid, etc.). 

One of the characteristics of the pharmaceutical industry is large quantities of paperwork, particularly in areas where GMP/GLP are strictly enforced. The slogan documentation, documentation, and documentation. .. is always in the mind of laboratory scientists. 

Then there are other proposals that, despite having been developed in other environments, display characteristics that make them relevant in part to the pharmaceutical industry one such case is Rogerson s 25 His analysis... 

Three submarkets of the pharmaceutical market can be distinguished innovative patented products sold by prescription, products whose patent has expired and are sold by prescription, and products sold without a prescription. The public regulation of prices in the first of these submarkets, and often also in the second, is a fact that can be observed in most Western countries, with certain notable exceptions such as the USA. Concern about the particular characteristics of the pharmaceutical market (for example, the existence of patents and the pharmaceutical industry s rate of return), together with the desire to provide the majority of the population with access to medicines, regardless of their ability to pay (in many countries the public sector is the main buyer in this market), has led to the fairly widespread adoption of more or less strict price intervention and control policies for pharmaceuticals. 

A brief synthesis of the characteristics of the pharmaceutical industry both worldwide and in Spain in particular was published by Craz-Roche and Duran1 in 1987 on the occasion of a meeting held in Madrid by the United Nations Industrial Development Organization. Benefit is still to be derived from reading it today, and moreover it stands as evidence of the development of thought on industrial policy. 

In a manner similar to that just described for differential thermal analysis, DSC can be used to obtain useful and characteristic thermal and melting point data for crystal polymorphs or solvate species. This information is of great importance to the pharmaceutical industry since many compounds can crystallize in more than one structural modification, and the FDA is vitally concerned with this possibility. Although the primary means of polymorph or solvate characterization s centered around x-ray diffraction methodology, in suitable situations thermal analysis can be used to advantage. 

Research (on medicines). Numerous definitions of research are used both in the literature and among scientists. In the broadest sense, research in the pharmaceutical industry includes all processes of medicine discovery, preclinical and clinical evaluation, and technical development. In a more restricted sense, research concentrates on the preclinical discovery phase, where the basic characteristics of a new medicine are determined. Once a decision is reached to study the medicine in humans to evaluate its therapeutic potential, the compound passes from the research to the development phase. 

With capillary electrophoresis (CE), another modern primarily analytically oriented separation methodology has recently found its way into routine and research laboratories of the pharmaceutical industries. As the most beneficial characteristics over HPLC separations the extremely high efficiency leading to enhanced peak capacities and often better detectability of minor impurities, complementary selectivity profiles to HPLC due to a different separation mechanism as well as the capability to perform separations faster than by HPLC are frequently encountered as the most prominent advantages. On the negative side, there have to be mentioned detection sensitivity limitations due to the short path length of on-capillary UV detection, less robust methods, and occasionally problems with run-to-run repeatability. Nevertheless, CE assays have now been adopted by industrial labs as well and this holds in particular for enantiomer separations of chiral pharmaceuticals. While native cyclodextrins and their derivatives, respectively, are commonly employed as chiral additives to the BGEs to create mobility differences for the distinct enantiomers in the electric field, it could be demonstrated that cinchona alkaloids [128-130] and in particular their derivatives are applicable selectors for CE enantiomer separation of chiral acids [19,66,119,131-136]. 

A further characteristic of this principle is that, if the activity of phosphodiesterase is decreased, the concentration of cyclic GMP will increase to an extent dependent upon the extent of the decrease in activity. This characteristic has been made use of by the pharmaceutical industry. Cyclic GMP has a vasodilatory effect and this is the case for the arterioles that supply blood to the corpus cavemosum in the penis, which controls the erection of the penis. Drugs were developed (e.g. sildenafil) that inhibits cyclic GMP phosphodiesterase and hence increases the cyclic GMP level which resnlts in vasodilation of the arterioles and an increase in the snpply of blood to the spongy tissue of the corpus cavemosum, which expands resulting in erection. This dmg has been found to be effective in some patients snffering from erectile dysfunction. This can be a particular problem in diabetic patients and more elderly men (Chapter 19). 

Our Investigation on durability and membrane characteristics changes under adverse conditions have much contributed to development of RO applications. Among these applications are those for ultra-pure water in electronic and pharmaceutical industries. Even under the circumstance of pH 7 and with 2 to 4 times per year of sterilization by H2O2 of as high as 1 %, the cellulose acetate membrane proved to show membrane life of more than 3 years. 

Table 9 Characteristics of Pharmaceutical Industry Wastewater Producing Allopathic Medicines [16] ...

Table 14 Characteristics of Wastewater from a Typical Pharmaceutical Industry [47]...

Table 17 Characteristics of a Concentrated Waste Stream of Synthesized Organic Chemicals—Type Pharmaceutical Industry [10]...

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