Composition and method for investigating alimentary functions

A - Human Necessities – 61 – K

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167/47

A61K 51/12 (2006.01)

Patent

CA 1222947

ABSTRACT Enterally administrable diagnostic compositions for investigating alimentary functions comprise multiple units of a size of at the most 5mm, preferably between 0.5 and 1.3mm, in particular between 0.7 and 1.0 mm, each unit comprising a tracer-binding agent such as an ion exchange resin to which a radioactive tracer substance with a half-life of at the most 5 days, in particular 99mTc, 113mIn 111In and 129Cs, is associated, the tracer-binding agent being formulated with pharmaceutically acceptable excipients, in particular granulating excipients in such a way that the exposure of the gastrointestinal mucosa to the tracer-binding agent is reduced and that the units do not disintegrate during the passage through the gastrointestinal tract. Preferred units comprise cross-sectionally substantially homogeneous multi-component cores in which the tracer-binding agent is granulated with one or more excipients and which are optionally coated with a diffusion coating permitting the labelling of the units to be performed at the site of use by immersing the units in a solution of tracer substance. Tracer-binding agents are normally present in an amount of about 2-20% by weight, preferably about 5-10% by weight, calculated on the units. Due to low leaching and the non-disintegrating properties, the composition can be used to investigate gastric emptying also of the last 20% of a food bolus, cf. Fig. 2 which illustrates the average gastric emptying pattern for 7 healthy volunteers (A) compared to the emptying from a person with the "Giesskannen" phenomenon (B).

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