Stability of esomeprazole capsule contents after in vitro suspension in common soft foods and beverages.
OBJECTIVE
To determine the in vitro stability of esomeprazole pellets from an opened capsule after suspension in various common soft foods and beverages.


METHODS
In vitro study.


METHODS
Pharmaceutical company research laboratory.


RESULTS
Pellets from opened esomeprazole 20-mg capsules were suspended in 100 ml of tap water, milk (1.5% fat), orange juice, apple juice, yogurt, or cultured milk for 30 minutes, then added to 500 ml of hydrochloric acid to simulate gastric acid exposure. After a 2-hour incubation, the mixture was filtered through a sieve, and the collected pellets were dissolved in an alkaline solution. Esomeprazole concentrations were measured using reverse-phase liquid chromatography The stability of the esomeprazole pellets exceeded 98% in all beverages and soft foods except milk.


CONCLUSIONS
Administration of the pellets from an opened esomeprazole capsule shortly after suspending them in tap water, yogurt, cultured milk, orange juice, or apple juice may be a practical alternative for patients who cannot swallow an intact capsule. Bioavailability studies comparing esomeprazole administered as an intact capsule to that of the pellets from an opened capsule suspended in these beverages or soft foods are recommended to confirm these findings.
Johnson
David A
DA
Division of Gastroenterology, Eastern Virginia School of Medicine, Norfolk, Virginia 23505, USA. dajevms@aol.com
Roach
Albert C
AC
Carlsson
Anders S
AS
Karlsson
Anders A S
AA
Behr
Dan E
DE
D000818:Animals; D000897:Anti-Ulcer Agents / Q000737:chemistry*; D001628:Beverages; D002214:Capsules; D032084:Citrus sinensis; D003611:Dairy Products; D004355:Drug Stability; D064098:Esomeprazole / Q000737:chemistry*; D018565:Food-Drug Interactions; D005744:Gastric Acid / Q000737:chemistry; D006851:Hydrochloric Acid / Q000737:chemistry; D027845:Malus; D008892:Milk; D015014:Yogurt
D000897:Anti-Ulcer Agents; D002214:Capsules; D064098:Esomeprazole; D006851:Hydrochloric Acid