Chapter 2, Problem 2.19P

During the early part of the 20th century, sulfanilamide (an antibacterial drug) was only administered by injection or in a solid pill. In 1937, a pharmaceutical company decided to market a liquid formulation of the drug. Since sulfanilamide was known to be highly insoluble in water and other common pharmaceutical solvents, a number of alternative solvents were tested and the drug was found to be soluble in diethylene glycol (DEG). After satisfactory results were obtained in tests of flavor, appearance, and fragrance, 240 gallons of sulfanilamide in DEG were manufactured and marketed as Elixir Sulfanilamide. After a number of deaths were determined to have been caused by the formulation, the Food and Drug Administration (FDA) mounted a campaign to recall the drug and recovered about 232 gallons. By this time, 107 people had died. The incident led to passage of the 1938 Federal Food, Drug, and Cosmetic Act that significantly tightened FDA safety requirements.

Not all of the quantities needed in solving the following problems can be found in the text. Give sources of such information and list all assumptions.

1. The dosage instructions for the elixir were to “take 2 to 3 teaspoons in water every four hours.” Assume each teaspoon was pure DEG, and estimate the volume (mL) of DEG a patient would have consumed in a day.
2. The lethal oral dose of diethylcne glycol has been estimated to be 1.4mLDEG/kg body mass. Determine the maximum patient mass (lb_1T1) for which the daily dose estimated in Part (a) would be
fatal. If you need values of quantities you cannot find in this text, use the Internet. Suggest three reasons w hy that dose could be dangerous to a patient whose mass is well above the calculated value.

Estimate how many people would have been poisoned if the total production of the drug had been consumed.

List steps the company should have taken that would have prevented this tragedy.