Enteric coating granules

Pancreatin is a pancreatic extract usually obtained from the pancrease of slaughterhouse animals. It contains a mixture of enzymes, principally amylase, protease and lipase, and, thus, exhibits a broad digestive capability. It is administered orally mainly for the treatment of pancreatic insufficiency caused by cystic fibrosis or pancreatitis. As it is sensitive to stomach acid, it must be administered in high doses or, more usually, as enteric-coated granules or capsules that may be taken directly or sprinkled upon the food prior to its ingestion. Individual digestive activities, such as papain, pepsin or bromelains (proteases), or a-amylase are sometimes used in place of pancreatin. 

Q86 Patients receiving Losec capsules should be advised to swallow the capsule whole. Losec capsules consist of enteric-coated granules, as omeprazole is acid-labile. 

Losec consists of omeprazole, a proton pump inhibitor. Proton pump inhibitors are acid-labile. Losec consists of enteric-coated granules that are encapsulated. Patients are advised to swallow the capsule whole. 

Absorption/Distribution - Most of these oral agents contain enteric-coated granules. Absorption of these agents is rapid and begins only after the granules leave the stomach. 

Because of its pH-dependent structure, orally administered omeprazole would be prematurely converted by gastric acid and poorly absorbed, and it is therefore formulated in enteric-coated granules, and is absorbed where the pH is above 6. 

Oral 15, 30 mg delayed-release capsules 15, 30 mg enteric-coated granules for oral suspension Pantoprazole (Protonix)... 

Lansoprazole, administered to healthy volunteers as encapsulated enteric-coated granules, disappeared from the blood with a half-life ranging between 1 and 2 hours [95]. 

Aabakken L, Bjornbeth BA, Hofstad B, Olaussen B, Larsen S, Osnes M. Comparison of the gastrointestinal side effects of naproxen formulated as plain tablets, enteric-coated tablets, or enteric-coated granules in capsules. Scand J Gastroenterol Suppl 1989 163 65-73. 

A paste formulation of omeprazole is approved for use in horses. The bioavailability of the omeprazole is lower from the paste formulation an from the enteric-coated granules. More omeprazole in the paste was absorbed when administered to horses that had feed withheld than when given to horses that were fed (Daurio et al 1999). In humans, approximately 80% of omeprazole and pantoprazole are excreted in urine, with the remainder excreted in feces. Lansoprazole is primarily excreted in feces (up to 70%), indicating substantial hepatic metabolism and biliary excretion. 

Dosage form Delayed-rcicasc capsules containing 20 mg of omeprazole in enteric-coated granules... 

Erosive esophagitis . 10 mg Zollinger-Ellison syndrome fiO mg NSAID-induced gastric ulcers treatment and prevention Dosage form Delayed-relea.se capsules containing 15 and. 10 mg of lansoprazole in enteric-coated granules... 

Many oral solutions are intended for pediatric administration, of which oral solution formulations are a subset of a larger choice of formulation type such as suspension, syrup, powder or microcapsules for constitution to a suspension, powder for reconstitution to a solution or suspension, solid particles (powder, coated particles, extended release, enteric-coated granules, beads) in packets or capsules to be sprinkled on food, oral powders, and chewable tablets. The broader topic of pediatric formulation development is beyond the scope of this chapter, but this chapter will cover selected oral solutions for pediatric administration. 

D X V 1 1 PO. Acid labile capsule contains enteric-coated granules, short half-life (<1hr). Inhibits cytochrome P450. Reported interactions with warfarin, phenytoin, diazepam, but not propranoiol or theophyiiine. May be approved for treatment of duodenal ulcers. 

Tuynman HARE, Festem HPM, Rohss K, Meuwissen SGML Lack of effect of antacids on plasma concentrations of omeprazole given as enteric-coated granules. BrJ Clin Pharmacol (1987) 24, 83S-5. 

Andersson T, Andren K, Cederberg C, Heggelund A, Lundborg P, Rohss K (1990) Bioavailability of omeprazole as enteric coated granules in conjunction with food on the first and seventh days of treatment. Drug Invest 2 184-188... 

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