i- Center for Drug Evaluation and Research (CDER) researchers recently conducted a study titled, The effect of food vehicles in vitro performance of pantoprazole sodium delayed release sprinkle formulation, to better understand the oral drug effectiveness when sprinkled onto or into certain foods. “Sprinkling” a drug into food vehicles is a common alternative for patients who have difficulty swallowing solid foods or medications. Previous research has shown that mixing incompatible foods and drugs may impact the drug’s rate of dissolution in the gastrointestinal tract, potency, and may even lead to undesired side effects.
- Researchers focused on pantoprazole sodium (antacid), which patients are currently advised to mix with applesauce or apple juice, as supported by in vivo data described in the labeling.
- The study evaluated several food vehicles and their effect on the in vitro performance (i.e., the process of dissolving in the body) of the drug. Researchers chose apple juice and applesauce, as well as pudding, yogurt, and milk. The foods differed in their viscosity (thickness), pH level (or how acidic/basic an item is), and water content.
- In the study, the researchers sprinkled the pantoprazole sodium granules on the food vehicles for different amounts of contact time (30, 60, or 120 minutes). Then they placed the mixture into a dissolution apparatus for in vitro dissolution testing and took samples after various time periods.
- Researchers found that the food’s pH and the length of time it was mixed with the drug affected drug performance. When researchers mixed the drug into low pH food vehicles, such as applesauce or apple juice, the drug performed similarly to the control group. Conversely, high pH food vehicles, such as milk, with a long contact time (e.g., 120 minutes) caused premature drug release, drug degradation, and loss of performance. In conclusion, researchers confirmed that an in vitro assessment can detect the effect of the food vehicle on drug performance, which has implications for evaluating drug safety and efficacy.
Lab Study Shows Oral Antacid Drug Performs Differently When Mixed with Various Food Vehicles
Thursday, July 20, 2023
