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Modulation of gastric pH by a buffered soluble effervescent formulation : a possible means of improving gastric tolerability of alendronate

Hodges, Lee Ann and Connolly, S.M. and Winter, John and Schmidt, Thomas. J. and Stevens, Howard and Hayward, Marshall and Wilson, Clive (2012) Modulation of gastric pH by a buffered soluble effervescent formulation : a possible means of improving gastric tolerability of alendronate. International Journal of Pharmaceutics, 432. pp. 57-62. ISSN 0378-5173

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Abstract

Gastrointestinal side-effects of alendronate (ALN) are believed to be associated with oesophageal lodging of tablets and perhaps reflux of gastric contents with alendronate under strongly acidic pH conditions. This leads to unfavourable posture restrictions when dosing. This clinical study evaluated gastric emptying and gastric pH after administration of Fosamax® tablets and a novel effervescent ALN formulation with a high buffering capacity. This novel formulation, EX101, was developed to potentially improve gastric tolerance. Gastric pH was monitored by nasogastric probes. Gastric emptying was determined simultaneously by scintigraphic imaging of 99mTc-DTPA labelled formulations. Both formulations tested rapidly cleared the oesophagus and there were no statistically significant or physiologically relevant differences in gastric emptying times. Mean pH at time to 50% gastric emptying of the radiolabel was significantly higher in EX101-treated subjects compared to those treated with Fosamax®. At time to 90% gastric emptying of the radiolabel, mean pH values were comparable. Mucosal exposure to ALN at pH less than 3 is irritating to gastro-oesophageal tissue. Ingestion of Fosamax® resulted in ALN being present in the stomach at a pH below 3 within minutes. EX101 minimised the possibility of exposing the oesophagus (in case of reflux) to acidified ALN

Item type: Article
ID code: 41048
Keywords: alendronate, gastric transit, pH, gamma scintigraphy, gastric tolerability, buffering, binosto, steovess, soluble effervescent formulation , gastric pH , improvement, Pharmacy and materia medica, Pharmaceutical Science
Subjects: Medicine > Pharmacy and materia medica
Department: Faculty of Science > Strathclyde Institute of Pharmacy and Biomedical Sciences
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Depositing user: Pure Administrator
Date Deposited: 07 Sep 2012 16:18
Last modified: 27 Mar 2014 10:29
URI: http://strathprints.strath.ac.uk/id/eprint/41048

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