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Making GORD treatment easier to swallow

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Pantoprazole, a proton pump inhibitor (PPI) commonly used in the treatment of gastro-oesophageal reflux disease (GORD), is now available in Australia in the form of delayed-release granules.1 The release of pantoprazole granules provides another treatment option for patients who have difficulty swallowing tablets.2

Senior gastroenterologist and lecturer at Monash University Dr Sanjay Nandurkar said a proportion of patients with GORD may have difficulty with swallowing tablets due to dysphagia, strictures or dysmotility.

"The granule formulation will help this subset," Dr Nandurkar said. 

Pantoprazole is most commonly prescribed in the form of 20mg or 40mg enteric-coated tablets.1 However, the tablets must be swallowed whole so that their enteric coating protects the active ingredient (i.e. pantoprazole) from gastric acids, until it reaches the alkaline environment of the intestine.3 Because the tablets cannot be crushed or chewed, they are inappropriate for patients who are unable to swallow – for example, those who are tube feeding.2

"As this subset is likely to be elderly, this will help optimise the management of these patients and improve their quality of life," Dr Nandurkar added.

The new granule formulation, like tablets, can be administered orally, either in a mixture of apple juice or sauce, or via a naso-gastric or gastric tube.

As it does not need to be swallowed, the granule formulation is suitable for patients who have difficulty swallowing, or those who are receiving nil by mouth.4


Previously, the only pantoprazole treatment option for these patients was intravenous administration of the drug. Intravenous pantoprazole is indicated for patients with severe conditions (e.g. acute upper gastrointestinal bleeding, peptic ulcer disease with high risk of stigmata) as well as those receiving nil by mouth.4 It has been shown to be pharmocodynamically equivalent to the tablet form of the medication in preventing gastrointestinal bleeding in such cases.5

The granules have provided a great alternative to intravenous administration, according to senior specialist at the Department of Gastroenterology, Concord Hospital Professor Peter Katelaris.

"Obviously intravenous access is not a viable option for patients requiring chronic therapy. It is a short term in-hospital option we use for people bleeding and other complications," Professor Katelaris explained.

Intravenous pantoprazole has also been shown to have an equivalent effect to pantoprazole tablets in suppressing gastric acid production in less severe cases.5 But not all patients with excess gastric acid who have difficulty swallowing are in a condition that is serious enough to warrant intravenous drug administration, even in cases where patients are hospitalised. In cases where patients are not hospitalised, intravenous administration of the drug may not be practical.2

Pantropazole delayed-release granules, however, are simple for non-acute patients to administer at home; they simply need to be mixed with a little apple juice or sauce.1 The granules may also be more practical for nil by mouth hospitalised patients requiring PPI therapy, as the medication can be administered via their gastric tube, rather than intravenously.2

A clinical trial has shown that the tablet and granule forms of pantoprazole are pharmacodynamically equivalent in suppressing gastric acid production in patients with GORD and a history of erosive oesophagitis.2 Another study has demonstrated that the granules have an equivalent treatment effect regardless of administration route (i.e. administration with juice, sauce or via gastric tube).6

Pantoprazole delayed-release granules provide an alternative treatment method for patients who cannot swallow tablets.


Patients may be unable to swallow tablets for various reasons, but only a few who cannot swallow will be ill enough to need intravenous drug administration. Thus the granules enable easier and safer treatment of GORD and related gastro-oesophageal system diseases in this group of patients.2

Professor Katelaris says the pantoprazole delayed-release granules "fill this niche", especially in elderly patients.


References

  1. Product Information: Somac.  Nycomed Pty Ltd; 2009.
  2. Hogan D, Pratha V, Riff D, Ducker S, Schwartz H, Soffer E, et al. Oral pantoprazole in the form of granules or tablets are pharmacodynamically equivalent in suppressing acid output in patients with gastro-oesophageal reflux disease and a history of erosive oesophagitis. Aliment Pharmaco Ther. 2007; 26(2): 249-56.
  3. Pandey VP, Kamalakkannan V, Manavalan R, Mani LKP. Development of tablet formulation of enteric coated pantoprazole with domperidone. Indian Pharmacist. 2006; 5(54): 73-8.
  4. Kaplan GG, Bates D, McDonald D, Panaccione R, Romagnuolo J. Inappropriate use of pantoprazole: Extent of the problem and successful solutions. Clin Gastroenterol Hepatol. 2005; 3(12): 1207-14.
  5. Bajaj JS, Dua KS, Hanson K, Presberg K. Prospective, randomised trial comparing effect of oral versus intravenous pantoprazole on rebleeding after nonvariceal upper gastrointestinal bleeding: A pilot study. Dig Dis Sci. 2007; 52(9): 2190-4.
  6. Tammara BK, Weisel K, Katz A, Meng X. The pharmacokinetics of pantoprazole delayed-release granules administered by three different methods in healthy subjects. Am J Gastroenterol. 2006; 101(Suppl 2): S90.

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Dates

Posted On: 7 May, 2009
Modified On: 16 January, 2014

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