Examples of Form and Formulation

1 Indinavir sulfate ethanolate - a case of a salt hydrate/solvate 

Given that reliable performance is a critical feature of an antiviral compound, a key issue in the development of Indinavir was managing the problem of consistent oral bioavailability [25]. Indinavir sulfate ethanolate is a crystalline compound, which was selected for the drug product over the crystalline free base monohydrate form of Indinavir on the basis of superior oral pharmacokinetics in animals including humans. The base form, a material with less than 0.02 mg ml solubility in water at 22 °C, is only 

Data from Yeh etal. [27]. Cmax refers to the maximum plasma concentration achieved, AUC is the calculated area under the plasma-time curve, and Irnax is the time at which Cmax occurs. The numbers in parentheses are the percentage variability on the means. The salt form has lower variability between subjects than the free base monohydrate. 

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