Pharmaceuticals, defined

The ICH S6 expert working group drafting the guideline for the preclinical safety evaluation of biotechnology-derived pharmaceuticals defined such products as follows products derived from characterised cells through the use of a variety of expression... 

Fine chemicals are generally considered chemicals that are manufactured to high and weU-defined standards of purity, as opposed to heavy chemicals made in large amounts to technical levels of purity. Fine chemicals usually are thought of as being produced on a small scale and the production of some fine chemicals is in tens or hundreds of kilograms per year. The production of others, especially fine chemicals used as dmgs or food additives (qv), is, however, in thousands of metric tons (see Pharmaceuticals). For example, the 1990 U.S. production of aspirin [50-78-2] and acetaminophen [103-90-2] was on the order of 20,500 t and 15,000 t, respectively. 

The US. Pharmacopeia (USP XXII) or National Formula (NFXVII) (20) also provide a similar description however, the peroxide value is not defined (Table 9). These specifications are also given in the Handbook of Pharmaceutical Excipients (HPE), pubhshed jointiy by the American Pharmaceutical Association and The Pharmaceutical Society of Great Britain (21), which defines lecithins both from plants and eggs. The Merck Index (22) specifies a slightiy lower acid value. The Japanese Monograph (ISCI-II) (23) specifies a slightiy lower acetone-insoluble matter and a lower heavy-metal content. 

Bioavailability, Bioequivalence, and Pharmacokinetics. Bioavailabihty can be defined as the amount and rate of absorption of a dmg into the body from an adrninistered dmg product. It is affected by the excipient ingredients in the product, the manufacturing technologies employed, and physical and chemical properties of the dmg itself, eg, particle size and polymorphic form. Two dmg products of the same type, eg, compressed tablets, that contain the same amount of the same dmg are pharmaceutical equivalents, but may have different degrees of bioavailabihty. These are chemical equivalents but are not necessarily bioequivalents. For two pharmaceutically equivalent dmg products to be bioequivalent, they must achieve the same plasma concentration in the same amount of time, ie, have equivalent bioavadabihties. 

Tableting, pressing, mol ding, and extrusion operations are commonly used to produce agglomerates of well-defined shape, dimensions, and uniformity in which the properties of each item are important and output is measured in pieces per hour (see Ceramics, ceramics processing Pharmaceuticals Metallurgy, powderp tallurgy Plastics processing).

Provision of a defined quantity for dispensing and metering, as in agricultural chemical granules or pharmaceutical tablets. 

Other fractional lives could similarly be defined. For example, the life-time t is the time required for the concentration to decay to lie its initial value then we find T = l/k. The lifetime is the average time elapsed before a molecule reacts. In pharmaceutics, a shelf-life tgo is defined to be the time required for Ca to reach the value 0.90 Ca, giving tgo = O.lOSlkf)... 

Pharmacopoeia publications provide a final important source of information for the pharmaceutical industry, regulatory authorities, and the healthcare professions. These are concerned with establishing quality standards. These publications include monographs that define specifications for the purity and identity of established pharmaceutical ingredients, both active and non-active, together with recognised analytical methods that may be used to evaluate them. The most relevant are the United States Pharmacopoeia (USP) and the European Pharmacopoeia (Ph.Eur). 

As illustrated above there exist a large variety of techniques for preparing liposomes. From a pharmaceutical point of view, optimum liposome preparation techniques would avoid the use of organic solvent and detergents (which are difficult to remove), would exhibit a high trapping efficiency, would yield well-defined vesicles which can be produced in a reproducible way, and would be rapid and amenable to scale-up procedures (see Sec. VIII). 

Pharmaceutical microbiology may be defined as that part of microbiology which has a special bearing on pharmacy in all its aspects. This will range fiom the manufacture and quality control of pharmaceutical products to an understanding of the mode of action of antibiotics. The full extent of microbiology on the pharmaceutical area may be judged fiom the chapter contents. 

The existence and possible presence of bacterial spores determines the parameters, i.e. time and temperature relationships, of thermal sterilization processes which are used extensively by the food and pharmaceutical industry. These are defined below (see also Chapters 20 and 23). 

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