Gastric emptying of large single unit dosage forms

Davis, S.S.; Norring-Christensen, F; Khosla, R.; Feely, Liam C.

doi:10.1111/j.2042-7158.1988.tb05220.x

Cited by 58 publications

(19 citation statements)

References 9 publications

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“…This observation generally agrees with the phenomenon that nondisintegrating monolithic dosage forms are treated by the stomach as indigestible solids and usually leave the stomach under the influence of phase III contractions ('housekeeper' waves) of the migrating myoelectric complex (MMC). 6,7 In the present study, two tablets were administered concurrently in each individual, and on most occasions the two tablets emptied from the stomach at or about the same time. However, for some subjects this was not the case, which may be explained by tablets residing in different positions in the stomach.…”

Section: Resultsmentioning

confidence: 99%

An Investigation into the In Vivo Performance Variability of pH Responsive Polymers for Ileo-Colonic Drug Delivery Using Gamma Scintigraphy in Humans

Ibekwe

Liu

Fadda

et al. 2006

Journal of Pharmaceutical Sciences

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Section: Resultsmentioning

confidence: 99%

An Investigation into the In Vivo Performance Variability of pH Responsive Polymers for Ileo-Colonic Drug Delivery Using Gamma Scintigraphy in Humans

Ibekwe

Liu

Fadda

et al. 2006

Journal of Pharmaceutical Sciences

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“…One factor, that might contribute to variable gastrointestinal-transit times, is concurrent food and drug intake [12], which, together with tablet size, is known to affect gastric emptying. Tablets of 10 mm diameter or less empty from the fed stomach in a linear fashion [5], whereas an increase in tablet size and concomitant food intake lead to increased variability in gastric emptying.…”

Section: Discussionmentioning

confidence: 99%

“…Venous blood samples (10 mL) were collected from an arm vein at predose on days 2, 4, 6 and 7, and at the following time points after the last dose on the 7th treatment day: 0 (predose), 2,3,4,5,6,7,8,10,12,16,20,24,30,36 and 48 h. Plasma samples, obtained by centrifugation were stored at ≤ − 20 ° C until analysis.…”

Section: Multiple-dose Pharmacokinetic Studymentioning

confidence: 99%

Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation

Brunner

Ziegler

Stefano

et al. 2005

Brit J Clinical Pharma

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AimsThe aims of the study were to: (1) evaluate the gastrointestinal transit, release and absorption of budesonide from tablets with a new multimatrix formulation (M MX®) designed to release the drug throughout the whole colon, and (2) assess the influence of food on budesonide bioavailability. MethodsTwo phase I studies, each comprising 12 healthy males, were performed. Gastrointestinal transit of 153 Sm-labelled tablets containing 9 mg budesonide was evaluated by means of pharmaco-scintigraphy. The effect of food was tested by comparing plasma pharmacokinetics after intake of a high fat and high calorie breakfast with fasting controls. Results153 Sm-labelled tablets reached the ascending colon after a mean ± SD 9.8 ± 6.9 h. Initial tablet disintegration was observed in the ileum in 42% and the ascending and transverse colon in 33% of subjects. Ninety-six per cent of the dose was absorbed into the systemic circulation during passage through the whole colon including the sigmoid. Food significantly decreased C max values from 1429 ± 1014 to 1040 ± 601 pg mL − 1 ( P = 0.028) and AUC values from 14 814 ± 11 254 to 13 486 ± 9369 pg h − 1 mL − 1 ( P = 0.008). Mean residence time and t max increased by 12-29%. There was no drug accumulation after 1 week of once daily oral administration of budesomide. ConclusionsMMX®-budesonide tablets appear suitable for targeted colonic drug delivery. Transit parameters and low systemic bioavailability warrant further studies with the new formulation.

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“…The position of the Oros system was determined by three independent observers by reference to external anatomical markers. These markers took the form of technetium-99m labelled adhesive patches attached to the subjects (Davis et al, 1988).…”

Section: Labelling Of Oros Systems and Gamma Scintigraphymentioning

confidence: 99%

Relationship between the rate of appearance of oxprenolol in the systemic circulation and the location of an oxprenolol Oros 16/260 drug delivery system within the gastrointestinal tract as determined by scintigraphy.

Davis

Washington

et al. 1988

Brit J Clinical Pharma

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1. The position in the gastrointestinal tract of an orally administered oxprenolol Oros drug delivery system labelled with technetium‐99m DTPA was followed by gamma scintigraphy, and the corresponding plasma drug concentration‐time profiles after oral and i.v. administration were used to relate pharmacokinetic and transit data. 2. Gastric emptying time (0.8 +/‐ 0.4 h, mean +/‐ s.d.), and the time to arrival in the colon (3.8 +/‐ 0.7 h) were reasonably consistent after administration of the Oros system to fasted subjects, as were the calculated small intestine transit times (3.0 +/‐ 0.7 h). As expected there were wide individual variations in colonic transit, so that recorded values for total transit ranged from 6 to 32 h (median, 24.7 h). 3. Absorption of oxprenolol occurred throughout the GI tract including the colon. Plasma drug concentration‐time profiles and input functions (calculated by deconvolution) could be related to transit behaviour and in vitro release. Inflexions in the calculated rate of drug input when the Oros system was located in the colon corresponded with periods of stagnation at the hepatic and splenic flexures in two subjects and the ileocaecal junction in two others. The mechanism of these changes is unclear.

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Gastric emptying of large single unit dosage forms

Cited by 58 publications

References 9 publications

An Investigation into the In Vivo Performance Variability of pH Responsive Polymers for Ileo-Colonic Drug Delivery Using Gamma Scintigraphy in Humans

An Investigation into the In Vivo Performance Variability of pH Responsive Polymers for Ileo-Colonic Drug Delivery Using Gamma Scintigraphy in Humans

Gastrointestinal transit, release and plasma pharmacokinetics of a new oral budesonide formulation

Relationship between the rate of appearance of oxprenolol in the systemic circulation and the location of an oxprenolol Oros 16/260 drug delivery system within the gastrointestinal tract as determined by scintigraphy.

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