Composition and method for investigating alimentary functions

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United States of America Patent

PATENT NO 4657755
SERIAL NO

06568184

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ATTORNEY / AGENT: (SPONSORED)

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Abstract

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Enterically administrable diagnostic compositions for investigating alimentary functions comprising multiple units of a size of at the most 5 mm, preferably between 0.5 and 1.3 mm, in particular between 0.7 and 1.0 mm, each unit comprising a tracer substance binding agent (such as an ion exchange resin) with which a radioactive tracer substance with a half-life of at the most 5 days, in particular .sup.99m Tc, .sup.113m ln, .sup.111 ln and .sup.129 Cs, is associated. The tracer substance binding agent is being formulated with pharmaceutically acceptable excipients, in particular granulating excipients, in such a way that the exposure of the gastrointestinal mucosa to the tracer substance 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 substance binding agent is granulated with one or more excipients and which are optionally coated. Preferred units comprise cross-sectionally substantially homogeneous multi-component cores made by granulating the tracer-binding agent surface properties. Tracer substances are normally present in an amount from about 2 to about 20% by weight, preferably from about 5 to about 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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Patent Owner(s)

Patent OwnerAddress
BENZON PHARMA A DANISH LIMITED COMPANYHELSEHOLMEN 1 DK-2650 HVIDOVRE

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Inventor(s)

Inventor Name Address # of filed Patents Total Citations
Bechgaard, Helle Hellerup, DK 3 281
Christensen, Finn N Copenhagen, DK 2 142
Jensen, Jens R Stenlose, DK 3 227

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