Drug product aging problems

If the components are not miscible in the solid and the liquid states, their DSC peaks remain unchanged. This allows to identify components of the drug product, to follow aging problems with polymorphism and in favourable cases to quantify the drug substance and the excipients.f ° ... 

Amygdalin, a compound isolated from the pits of apricots, peaches, and wild cherries, is commonly known as laetrile. Although it has no known therapeutic value, amygdalin has been used as an unsanctioned anticancer drug both within and outside of the United States. One hydrolysis product formed from amygdalin is mandelic acid, used in treating common skin problems caused by photo-aging and acne. 

Although considerable progress has been made in the metabolic profile approach, a number of problems remain to be overcome. Many of these centre around the fluctuations in component composition, not from metabolic disorders, but brought about by other influences. These are principally due to diet and the metabolic variations in individuals in relation to activity. Drugs can also affect the excretion levels of compounds, in addition to the production of their own metabolites. These factors all make quantitative data difficult to obtain and evaluate. Careful statistical analysis of the results are necessary and a population of 500 subjects, grouped in age and sex, has been studied with a view to obtaining a suitable data base for urinary organic acids [370]. 

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