Bioequivalence among three methods of administering pantoprazole granules in healthy subjects

Abstract

Three methods of administering pantoprazole delayed-release granules for oral suspension-with apple juice orally, with applesauce orally, and with apple juice through a nasogastric tube--were bioequivalent in healthy subjects.

Effect of Food and Dosing Regimen on Safety and Efficacy of Proton Pump Inhibitors Therapy—A Literature Review

“…While pantoprazole tablets need to be ingested whole, granules can be opened; this provides a convenient alternative for children or patients with dysphagia [56]. In a randomized, open-label study of 25 healthy adults, Tammara et al [62] compared two methods of intake of 40 mg pantoprazole granules: with 5 mL (one teaspoon) of applesauce or with 5 mL of apple juice. Both administration methods resulted in comparable AUC and C max values and hence can be considered bioequivalent.…”

“…We are convinced that knowledge on this subject is vital to professionally educate patients with the aim to improve their compliance and increase the effectiveness of PPI therapy. -should be taken 60 min before a meal [40] -should be placed on the tongue to disintegrate and swallowed, with or without water [40] DR capsules ↓ AUC (by 35-38%) [34], ↓ C max (by 24-40% and 58-63%, depending on the study) [36,38], ↑ t max (by 2 h) [36] -should be taken 60 min before a meal [33] -should be swallowed whole or with content mixed with 15 mL of applesauce [33] DR granules for oral suspension no studies found -should be taken 60 min before a meal [33] -should be mixed with 5-15 mL of water [33] DR tablets no significant changes in AUC and C max , ↑ t max (by 1.3 h) [41] -can be taken with or without food [41] -should be swallowed whole with water [41] -can be taken with or without food [56,59] -should be swallowed whole with water [56,59] -preferably should be administered in the morning [61] DR granules for oral suspension ↓ AUC (by 29%), ↓ C max (by 51%), ↑ t max (by 2 h) [56] -should be taken 30 min before a meal [56] -content should be sprinkled into 5 mL of applesauce/apple juice [56,62] -do not mix with water or other liquids or food [56] Rabeprazole DR capsules ↓ AUC (by 27%), ↓ C max (by 55%), ↑ t max (by 2 h) [65] -should be taken 30 min before a meal [63] -content should be sprinkled onto a small amount of applesauce/apple juice/yoghurt/fruit or vegetable-based baby food/infant formula/pediatric electrolyte solution [63,65] -can be administered both in the morning or in the evening [67] -evening intake can be beneficial for patients with nocturnal acid breakthrough or nocturnal reflux [66] DR tablets no significant changes in AUC and C max , ↑ t max (by 2.5 h) [42] no significant changes in median intragastric pH [23,24] -can be taken with or with...…”

Pharmacokinetics of rabeprazole granules versus tablets, and the effect of food on the pharmacokinetics of rabeprazole granules in healthy adults—cross‐study comparison

“…granule formulation has been developed, to facilitate ease of administration. Similar enteric-coated granules for pantoprazole, [8][9][10] lansoprazole, [11][12][13][14][15] omeprazole, 16,17 and esomeprazole [18][19][20] are available in some countries. Enteric-coated granules have several advantages over enteric-coated tablets, including rapid emptying in the small intestine; faster drug dissolution and absorption; and quicker onset of action.…”