Key result
Dexlansoprazole 60 mg capsule granules administered via nasogastric tube or orally via syringe demonstrated bioequivalence to the intact capsule for maximum plasma concentration and AUC.
Why the study?
Does administration of dexlansoprazole 60 mg granules via nasogastric tube or oral syringe provide equivalent bioavailability to intact capsules?
Does administration of dexlansoprazole 60 mg granules via nasogastric tube or oral syringe provide equivalent bioavailability to intact capsules?
Dexlansoprazole 60 mg capsule granules can be administered via nasogastric tube or oral syringe without altering systemic exposure compared to intact capsules.
Answers are grounded in this paper and cite their sources.
Supports NG tube/syringe dexlansoprazole use in dysphagic patients; extends bioequivalence data but leaves open clinical outcome confirmation.
OBJECTIVE: To assess the effect of route of administration on the bioavailability of dexlansoprazole 60 mg delayed-release capsule granules. METHODS: (dexlansoprazole) after dexlansoprazole capsule granules were mixed with water and administered via 16 French nasogastric tube or orally via syringe was compared to administration of the intact capsule in the fasted state, swallowed with water. Blood samples were collected before and after dosing to determine dexlansoprazole pharmacokinetic parameter estimates and plasma concentrations. RESULTS: Similar values for area under the plasma concentration-time curve and observed maximum plasma concentration were achieved when the dexlansoprazole 60 mg capsule was administered as the intact capsule or when the granules were mixed with water and administered via nasogastric tube or orally via syringe. The primary endpoints of maximum plasma concentration and area under the plasma concentration-time curve demonstrated bioequivalence when assessing these alternative routes of administration. Most adverse events were rated as mild and were comparable irrespective of administration route. CONCLUSION: Systemic exposure to dexlansoprazole was equivalent regardless of administration route. The dexlansoprazole capsule was well tolerated.
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Kukulka et al. (2018) studied this question. Dexlansoprazole capsule granules via nasogastric tube or orally via syringe vs. Intact capsule swallowed with water was evaluated on Maximum plasma concentration and area under the plasma concentration-time curve. Dexlansoprazole 60 mg capsule granules administered via nasogastric tube or orally via syringe demonstrated bioequivalence to the intact capsule for maximum plasma concentration and AUC.
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