Effect on bioavailability of admixing the contents of lansoprazole capsules with selected soft foods

Objective: This study was designed to compare the bioavailability of lansop razole when administered as an intact capsule and when the contents are adm ired with various soft foods. Background. Patients sometimes cannot swallow or have difficulty swallowing intact capsules such as lansoprazole. To enable them to ingest the drug, t he contents of the capsule can be admired with small amounts of soft foods. Methods: Twenty-four healthy adult volunteers participated in this single-d ose, 4-period crossover study by ingesting the contents of a 30-mg lansopra zole capsule that had been emptied into either a tablespoon of yogurt (regi men A), Ensure(R) pudding (regimen B), or cottage cheese (regimen C), or gi ven as an intact capsule (regimen D) during the first study period. The reg imen assignments were rotated at weekly intervals so that each subject rece ived each regimen. Blood samples were obtained over the 12-hour period afte r administration of each regimen, and pharmacokinetic parameters were deter mined. Results: Of the 23 subjects who completed all 4 periods of the study, 18 we re male and 5 were female. Their mean (+/- SD) age was 33.3 +/- 11.6 years, and their ages ranged from 19 to 52 years. No statistically significant di fferences between regimens were detected in mean maximum concentration, are a under the curve (AUC) from time zero to the last measurable concentration , and AUC from time zero to infinity (AUC(0-infinity)) using analysis of va riance. A statistically significant difference was detected in the time to maximum concentration between regimens C and D at 2.1 and 1.5 hours, respec tively (P less than or equal to 0.05). Bioavailability was assessed by the two 1-sided tests procedure using a 90% CI for the AUC(0-infinity) ratio of test to-reference regimens. The 90% CIs were all within an acceptable equi valence range of 0.80 to 1.25. Conclusion: These results indicate similar bioavailabilities between the re gimen in which the lansoprazole capsule was emptied and administration of t he intact capsule. However, they may have limitations in predicting the res ults in ill, elderly, or very young patients.