What Happens to Tablets and Capsules in the Stomach: Endoscopic Comparison of Disintegration and Dispersion Characteristics of Two Microencapsulated Potassium Formulations

Graham, David Y.; Smith, James O.; Bouvet, Agnes A.

doi:10.1002/jps.2600790512

Cited by 24 publications

(11 citation statements)

References 19 publications

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“…Moreover, there is a statistically significant difference between the two solid forms (MET and MEC) for all parameters, demonstrating the great improvement of gastric tolerance of MET. These conclusions are in accordance with those of Graham et al (26,27) who previously demonstrated by videoendoscopy, a better dispersion of KCI microencapsulated tablet against KCI microencapsulated gelatin capsule. A difference of adherence to the gastric mucosa between the two formulations (tablet or capsule) could explain the results of our study.…”

Section: Discussionsupporting

confidence: 82%

What is the better formulation of microencapsulated potassium chloride?

Simoneau

Bergmann

Pamphile

et al. 1994

Eur. J. Drug Metab. Pharmacokinet.

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A single blind cross-over study was performed comparing a new microencapsulated potassium chloride tablet (MET) with two reference formulations of oral potassium, namely potassium chloride solution (PS), and microencapsulated potassium chloride capsules (MEC), in 18 normal healthy volunteers. The potassium chloride induced change in gastric potential difference (PD) of the mucosa was the main criterion of comparison and was assessed by the area above curve (AAC), the total duration of the effect (TDE), the maximal variation of PD (delta MAX), and the aggression index (AI). The results showed that all three formulations induced a fall in PD; the delta MAX and AAC were significantly greater for PS indicating a higher aggressive effect of the solution; MET had significantly less aggressive effect than MEC when assessed by all parameters.

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Section: Discussionsupporting

confidence: 82%

What is the better formulation of microencapsulated potassium chloride?

Simoneau

Bergmann

Pamphile

et al. 1994

Eur. J. Drug Metab. Pharmacokinet.

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“…Attempts to remove debris and reduce the presence of dark matter in the distal small bowel have consisted of using PEG-containing solutions, typically in volumes similar to those administered for colonic cleansing [10][11][12]. Our study was based on a hypothesis derived from previous studies of gastric and intestinal motility and from barium radiographic studies [5,6,13,14]. We hypothesized that administration of the prep the day prior might have a beneficial effect in that it might empty the right colon, which would enhance small bowel transit but would be unlikely to enhance visualization by distending the bowel when the capsule was present or enhance gastric emptying [14].…”

Section: Discussionmentioning

confidence: 99%

“…We hypothesized that administration of the prep the day prior might have a beneficial effect in that it might empty the right colon, which would enhance small bowel transit but would be unlikely to enhance visualization by distending the bowel when the capsule was present or enhance gastric emptying [14]. Gastric emptying of large solids such as the capsule is enhanced when the stomach is in the fasting state [5,6,13,14]. During this time, housekeeper waves propel indigestible objects from the stomach and enhance their transit through the small bowel.…”

Section: Discussionmentioning

confidence: 99%

Visualization of the Small Intestine Using Capsule Endoscopy in Healthy Subjects

2007

Self Cite

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The actual extent of lumen visualized by capsule endoscopy has not been studied systematically. Volunteers were randomized to receive a bowel preparation (prep) consisting of an isotonic solution containing polyethylene glycol and simethicone. The prep (200 ml) was given 30 min before the capsule. The capsule was taken with 100 ml of prep and 100 ml of water; 100 ml of prep was given 45 and 75 min later. The control administration was 100 ml of water and no simethicone. Forty percent of all frames taken in the small bowel were examined and individually scored for circumference, bubbles, debris, and lighting. Nine volunteers were studied twice. Only 50% of the circumference is seen normally. The prep improved the circumference to 62.5% as well as decreasing luminal debris and bubbles and improving the lighting. We conclude that the prep solution improved small bowel visualization, however, improvements are still needed to optimize visualization.

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“…If the analogy with solid dosage forms of potassium is valid, mucosal damage could be reduced or prevented by reformulation as a micro‐encapsulated product 32 , . 33 Of interest, alendronate and pamidronate are both associated with erosive oesophagitis and both contain an amino side chain. It has been suggested that this structure predicts risk for development of erosive mucosal damage 3 , .…”

Section: Discussionmentioning

confidence: 99%

Alendronate gastric ulcers

Graham

Malaty

1999

Aliment Pharmacol Ther

102

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Background : It appears likely that drugs other than NSAIDs may cause ulcers and ulcer complications (e.g. potassium chloride). Alendronate (Fosamax) is used in the treatment and prevention of metabolic bone disease and has also been associated with severe oesophageal damage and stricture. We have previously shown that the dose of alendronate used for Paget's disease (40 mg) causes gastric damage similar to NSAIDs. The usual dose for the treatment of postmenopausal osteoporosis is 10 mg per day. Aim : To investigate whether the 10 mg dose of alendronate causes gastric ulcers. Methods : We performed an endoscopist‐blind, crossover, randomized, single‐centre comparison of 10 mg of alendronate/day and placebo in volunteers aged 40 years or more. Video‐endoscopy was used to evaluate the presence and degree of mucosal damage to the oesophagus, stomach, or duodenal bulb after 7 and 14 days of treatment. Results : Twenty‐four healthy volunteers participated, including 15 women and nine men, ranging in age from 41 to 52 years. Visible gastric mucosal damage was present in nine (38%) who received alendronate compared to three (13%) in the placebo group. There was a marked difference in the severity of mucosal damage; there were no ulcers or large erosions in those receiving placebo. In contrast, potentially clinically significant gastric mucosal injury was seen in six subjects receiving alendronate (two developed antral ulcers and four had large (4–8 mm) superficial antral erosions) compared to none in the placebo group (P = 0.0219). One subject developed oesophageal damage in the form of multiple linear superficial erosions in the mid and distal oesophagus. Duodenal injury was not seen. Conclusion : Alendronate causes gastric ulceration, suggesting that alendronate use may be associated with ulcer complications such as acute upper gastrointestinal bleeding. The results of this study suggest the need for post‐marketing surveillance to clarify the nature, frequency and magnitude of any potential gastrointestinal side‐effects associated with the use of this drug.

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What Happens to Tablets and Capsules in the Stomach: Endoscopic Comparison of Disintegration and Dispersion Characteristics of Two Microencapsulated Potassium Formulations

Cited by 24 publications

References 19 publications

What is the better formulation of microencapsulated potassium chloride?

What is the better formulation of microencapsulated potassium chloride?

Visualization of the Small Intestine Using Capsule Endoscopy in Healthy Subjects

Alendronate gastric ulcers

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