Pharmaceuticals, and Pharmacological Applications

In 1957 Carol published a short review on the application of infrared methods to pharmaceutical analysis. Among the substances for which infrared methods had been developed at that time he mentioned atropine, nitroglycerine, sodium A-lauroyl sarcosinate, phenobarbital, testosterone, and progesterone. Other substances for which analytical methods were given were penicillin G in the presence of penicillin F, K, or dihydro-F ethinyl testosterone aspirin, phenacetin, and caffeine and estrogenic substances, e.g., estrone, equilin, and estradiol-17-/J (cis). 

Infrared spectra are now widely used in the examination of pharmaceuticals. The sixteenth revision of The Pharmacopoeia of the United States (U.S.P.) and the eleventh edition of the National Formulary (N.F.) have presented identification tests which used infrared spectroscopy, whereas no infrared tests were used in U.S.P. XV or N.F. X. Infrared spectra have attained acceptance in legal considerations and are now given in patent applications as characteristics of antibiotics of unknown structure. In the pharmaceutical industry there are many applications for quantitative infrared analyses in research and development work, pharmacy research, and in various phases of pharmaceutical production. For example, infrared data are used to characterize reaction conditions and yields, to assay the purity of intermediate products, to examine such problems as the stability of a drug in the material in which it is suspended, and to maintain quality control in the chemical production of bulk drugs. A recent review (Papendick et al, 1969) has given many references to fractionation and isolation methods for pharmaceutical analysis, such as the various types of chromatography, electrophoresis, countercurrent distribution, and extraction. The authors presented many references to infrared analyses for a wide variety of compounds (Table 16.1). 

The techniques of sample preparation of pharmaceuticals are essentially those discussed more generally earlier in this book, such as the preparation of films, mulls, pellets, and solutions, and the use of ATR. Carol (1957) referred to most of these methods for the preparation of pharmaceutical compounds. Warren et al. (1967) have discussed pharmaceutical applications of the internal refiection technique. They have given examples of the suitability of the method for the analyses of less 

Nitrogenous organic bases Sympathomimetic amines Amino acids Amino ethers Barbiturates Imidazoles 

It should be noted that many polar substances with poor solubilities in the usual solvents can be dissolved in water or in D2O. Examples of the potential use of aqueous solutions in pharmaceutical research are to be found in the discussions of aqueous solutions (thap. 3), enzymology (Chap. 15), hydrogen-deuterium exchange (Chap. 11), nucleic acids (Chap. 12), carbohydrates (Chap. 6), amino acids (Chap. 9), amines (Chap. 8), clinical chemistry (Chap. 18), and inorganic ions (Chap. 19). 

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In this chapter, the use of derivatization with CDAs will be reviewed, with emphasis on pharmaceutical and pharmacological applications. The intent here is not the exhaustive listing of publications in this field but rather the Ulustration of principles and applications, including discussion of recent and interesting examples. 

Drugs. Pharmaceuticals, and Pharmacological Applications Table 16.9 (continued) 411... 

The chapter on Drugs, Pharmaceuticals, and Pharmacological Applications (Chap. 16) refers to many collections of infrared and other types of spectra. Among these collections are spectra for a very wide variety of biochemical and other compounds, not only drugs and pharmaceuticals. 

In particular, three-dimensional tissue constructs with human cells have opened a new avenue for tissue engineering for pharmaceutical and pathophysiological applications (8). These technologies have a great potential to estimate the dynamic pharmacological effects of drug candidates, metastasis processes of cancer cells, and toxicity expression of nanomaterials. 

CNTs are of importance as useful bio-nanomaterials for pharmaceutical applications and biomedical engineering. However, despite the contribution of CNTs to bio-nanomaterials for pharmaceutical applications, the potential risks of CNTs about the exposure to human health have not been adequately assessed. Toxicology issues associated with CNT inhalation, dermal toxicity, pulmonary, biodistribution, biocompatibility, blood compatibility, and elimination need to be addressed prior to their pharmacological application in humans. 

A Sponsor submits a clinical trial application to the Competent Authority in each member state where the trials are to be conducted. The Competent Authority has 60 days to review and approve or reject the application. Application is in prescribed forms and covers the proposed clinical trial protocol, manufacturing, and quality controls on the drug, and supporting data, such as (1) chemical, pharmaceutical, and biological data, (2) nonclinical pharmacological and toxicological data, and (3) clinical data and previous human experience. The supporting data are submitted in the Common Technical Document (CTD) format (see Section 7.11). 

Delaney, F.J. (2007) An impact analysis of the application of the threshold of toxicological concern concept to pharmaceuticals. Regulatory Toxicology and Pharmacology, 49, 107-124. 

With growing attention to hair analysis for drugs of abuse and pharmaceutical drugs, a number of pharmacological, analytical, and technical problems became of interest, which have been focused in a Consensus Report and revised at the SOFT Conference 1992 in Cromwell, Hartford, CT. Main problems arose with the questions of external contamination, the routes of incorporation of drugs into hair, possible dose-response relationships, interpretation of results, and their application to forensic, clinical, and occupational cases. 

APPLICATIONS IN PHARMACY, PHARMACEUTICAL CHEMISTRY AND PHARMACOLOGY Possible applications and recent developments Polarographic activity of pharmaceuticals... 

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