Pharmaceutical industry toxicity concerns

In addition to solvents, inorganic and drug-related impurities, the pharmaceutical industry must pay close attention to the presence of compounds whose biological effects are known or likely to be seriously detrimental to the health of the patient. These are highly toxic impurities, and of particular concern are genetic toxins. These compounds are implicated in one way or another in increasing the risk of cancer. 

Toxic Decomposition Products In situations where the content of the API in a drug product is well above 90% as indicated above, the formation of toxic degradation products within the shelf life (which may cause untoward effects to the patients) may warrant the reassignment of a different expiration date or recall of the drug product in question. Consequently, the pharmaceutical industry is often concerned with both the amount as well as the nature of the degradation products. The formation of toxic products is particularly problematic with protein drugs which may maintain therapeutic activity after deliberate modification or pertubation of molecular structure in a domain removed from that associated with therapeutic activity... 

Critical temperatures of substances vary over a wide range, allowing for SCF selection for specific applications. Supercritical CO2 is especially useful in the food and pharmaceutical industries where toxicity of the extraction medium, solvent entrapment, and thermal stability of materials are concerns. Specifically, SCFs required for processing thermally labile compounds such as proteins and peptides should have a critical temperature that is close to ambient conditions (e.g., CO2 and ethylene with critical temperatures of 31.1°C and 9.3°C, respectively). 

This classic in the field of pharmacology provides detailed information on anatomy and functions of the autonomic nervous system. Although primarily concerned with drugs and how they act upon the body, there are also excellent sections on the toxicity of gases and vapors and heavy metals. Goodman and Gilman thoroughly evaluate many of the more widely used compounds utilized by the pharmaceutical industry. 

Dryer emissions in the pharmaceutical industry are similar to those in many chemical process dryers in that both gaseous and particulate emissions can be significant. However, of greatest concern are VOCs. Many of these compounds are photochemically reactive and contribute to tropospheric ozone formation. An added concern is that some of these compounds are toxic both short-term and long-term exposure to them are undesirable and can lead to adverse health effects. 

There is also concern over occupational exposure to fentanyl. Fentanyl contamination and urinary excretion has been noted in pharmaceutical industry employees although no sings of toxicity were reported." Exposure and toxicity may occur in health care workers. "" There is also concern over exposure to fentanyl in operating rooms, and the phenomenon of second-hand exposures to fentanyl, with ensuing addiction in health care workers, and especially physicians, anaesthetists and surgeons where there is a recognised problem of drug abuse." " ... 

Polymers are commonly used as gelators. However, only a handful of polymers are biodegradable in vivo, and concerns of toxicity from the degradation of polymers have limited the use of gels as drug delivery systems in pharmaceutical industries. 

The increase in environmental awareness and the acute effects of some toxic compounds have raised questions over the safety of using many chemicals invented for agricultural and industrial applications. A great deal of current research addresses the management and remediation of old contaminated sites. Recent concerns regard the safety of consumer chemicals, especially nanomaterials the effect of pharmaceuticals on ecosystems and the combined effect that chemical cocktails have on human and ecosystem health. 

The irradiation of polymers is widespread in many industries. For example, microlithography is an essential process in the fabrication of integrated circuits that involves the modification of the solubility or volatility of thin polymer resist films by radiation. The sterilization by radiation of medical and pharmaceutical items, many of which are manufactured from polymeric materials, is increasing. This trend arises from both the convenience of the process and the concern about the toxicity of chemical sterilants. Information about the radiolysis products of natural and synthetic polymers used in the medical industry is required for the evaluation of the safety of the process. 

Mercury is mined predominantly as HgS in cinnabar ore and is then converted commercially to a variety of chemical forms. Key industrial and commercial applications of mercury are found in the electrolytic production of chlorine and caustic soda the manufacture of electrical equipment, thermometers, and other instruments fluorescent lamps dental amalgam and artisanal gold production. Use in pharmaceuticals and in biocides has declined substantially in recent years, but occasional use in antiseptics and folk medicines is still encountered. Thimerosal, an organomercurial preservative that is metabolized in part to ethylmercury, has been removed from almost all the vaccines in which it was formerly present. Environmental exposure to mercury from the burning of fossil fuels, or the bioaccumulation of methylmercury in fish, remains a concern in some regions of the world. Low-level exposure to mercury released from dental amalgam fillings occurs, but systemic toxicity from this source has not been established. 

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