Which dosage form is MOST likely to present problems with bioequivalence?

The aerosol for inhalation dosage form is most likely to present problems with bioequivalence due to several factors inherent to its formulation and delivery method. Bioequivalence refers to the comparison of two drug products in terms of the availability of the active ingredient in the systemic circulation, at an appropriate concentration and rate, which is essential for therapeutic equivalence.

Aerosol formulations often involve complex and highly variable factors including particle size distribution, plume geometry, and the specific inhalation technique used by the patient. These factors can significantly influence how much of the drug reaches the lungs and enters systemic circulation. Inhalation aerosols need to ensure that the drug is delivered in a very specific size range, as particles that are too large or too small may not have the desired therapeutic effect. Moreover, variations in the device used for inhalation—such as differences in inhaler construction or design—can also impact the deposition of the drug in the respiratory tract.

In contrast, solid dosage forms like tablets and capsules tend to be more straightforward in their formulation and delivery, typically involving less variability in how the drug is absorbed in the gastrointestinal tract. Liquid dosage forms also permit some degree of standardization in terms of absorption, though they can be subject to issues such as stability and