Why carry out this study?

Most prescription-based constipation medications, including lubiprostone, are available in oral formulations. Given that constipation affects a wide variety of patients, including patients at both ends of the age spectrum (pediatric and elderly) and patients with a range of comorbidities, optimizing the acceptability and ease of ingestion of oral medications may be important to optimizing adherence in certain populations.

Two randomized studies were conducted to evaluate whether sprinkled lubiprostone formulation, designed as an alternative to swallowing capsules, showed biological equivalence to the currently available capsules.

What was learned from the study?

In the pharmacokinetic study, evaluation of concentrations of the drug metabolite showed greater systemic exposure with the sprinkle formulation than with the capsule formulation.

Although the sprinkled lubiprostone formulation caused improvement in bowel function, it did not appear to be truly biologically equivalent.