Spoilage-Chemical and Physicochemical Deterioration of Pharmaceuticals

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Chapter: Pharmaceutical Microbiology : Microbial Spoilage, Infection Risk And Contamination Control

Microorganisms form a major part of the natural recycling processes for biological matter in the environment. As such, they possess a wide variety of degradative capabilities, which they are able to exert under relatively mild physicochemical conditions.


SPOILAGE—CHEMICAL AND PHYSICOCHEMICAL DETERIORATION OF PHARMACEUTICALS

 

Microorganisms form a major part of the natural recycling processes for biological matter in the environment. As such, they possess a wide variety of degradative capabilities, which they are able to exert under relatively mild physicochemical conditions. Mixed natural communities are often far more effective cooperative bio-deteriogens than the individual species alone, and sequences of attack of complex substrates occur where initial attack by one group of microorganisms renders them susceptible to further deterioration by secondary, and subsequent, microorganisms. Under suitable environmental selection pressures, novel degradative pathways may emerge with the capability to attack newly introduced synthetic chemicals (xenobiotics). However, the rates of degradation of materials released into the environment can vary greatly, from half-lives of hours (phenol) to months (‘hard’ detergents) to years (halogenated pesticides).

 

The overall rate of deterioration of a chemical depends on its molecular structure; the physicochemical properties of a particular environment; the type and quantity of microbes present; and whether the metabolites produced can serve as sources of usable energy and precursors for the biosynthesis of cellular components, and hence the creation of more microorganisms.

 

Pharmaceutical formulations may be considered as specialized microenvironments and their susceptibility to microbial attack can be assessed using conventional ecological criteria. Some naturally occurring ingredients are particularly sensitive to attack, and a number of synthetic components, such as modern surfactants, have been deliberately constructed to be readily degraded after disposal into the environment. Crude vegetable and animal drug extracts often contain a wide assortment of microbial nutrients besides the therapeutic agents. This, combined with frequently conducive and unstable physicochemical characteristics, leaves many formulations with a high potential for microbial attack unless steps are taken to minimize it.

 

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