Drug – bio-affecting and body treating compositions – In vivo diagnosis or in vivo testing – Ultrasound contrast agent
Patent
1997-06-13
1999-03-09
Dees, Jose G.
Drug, bio-affecting and body treating compositions
In vivo diagnosis or in vivo testing
Ultrasound contrast agent
5147723, A61K 4904, A61K 4730
Patent
active
058796622
DESCRIPTION:
BRIEF SUMMARY
The invention relates to an oral echo contrast medium for ultrasonic diagnosis for displaying the entire gastrointestinal tract. An echo contrast medium must meet the following requirements:
It must not be toxic, it must not influence the intestinal peristalsis, it must not be resorbed, and it must not cause any sonic shadows that would make diagnosis more difficult. In addition, the echo contrast medium must dilate the intestine and fill the intestine homogeneously.
In the past, water, fruit juices, and milk have been used primarily as aids in oral echo contrast media for ultrasonic diagnosis. The results of ultrasonic examinations performed with them are unsatisfactory, however. In addition, patients must drink between one and two liters of fluid.
Recently, attempts have also been made to use cellulose fibers or other hollow bodies containing air, or laminated silicates as echo contrast media, but they have proven to be disadvantageous because sonic shadows occur which make a diagnosis impossible, especially in deeper layers.
The goal of the invention is to propose an oral echo contrast medium for ultrasonic diagnosis in human medicine to investigate the gastrointestinal tract, said medium permitting a detailed representation of the investigated area and suppressing the development of interfering sonic shadows.
Surprisingly, it has been found that an oral contrast medium containing the following components in a liter of water: polyvinylpolypyrrolidone (PVPP); one thickening agent and a cross-linked insoluble polyvinylpolypyrrolidone, also referred to as, that produces an increase in contrast that leads to the desired successful diagnosis.
In particular, a sharp demarcation of the intestinal mucosa is obtained with the oral echo contrast medium according to the invention, thus providing a very good opportunity of investigating other organs through the sonic window produced in this manner.
All of the components used in the oral echo contrast medium according to the invention must be investigated to ensure that they are not toxic, do not influence intestinal peristalsis, are not resorbed, and do not produce any sonic shadows but dilate the intestine and fill it homogeneously.
In particular organic natural thickening agents and/or organically converted natural substances and/or completely synthetic organic substances are particularly useful as thickening agents.
Preferred organic natural thickening agents include agar-agar, gum tragacanth, carrageenan, alginates, gum arabic, pectins, polyoses, guar powder, starch, xanthene, dextrins, gelatins, and/or casein. Thickening agents based on organically converted natural substances include in particular carboxymethylcellulose and/or cellulose ether.
Organic natural thickening agents and thickening agents based on organically converted natural substances are overwhelmingly readily soluble in water.
Fully synthetic organic thickening agents can also include medium and high molecular weight polyvinylpyrrolidones, also known as povidones, that are very readily soluble in water.
In order to be able to wet the intestinal mucosa better, it is proposed according to the invention to add to the echo contrast medium a suitable pharmaceutically approved surfactant or one approved by legislation governing food, preferably a non-ionic surfactant. A poloxamer that acts as a non-ionic surfactant can be used, for example. It is also possible to use so-called sugar surfactants. Other surfactants approved by legislation governing food can also be used for the desired purpose.
In addition, mannite can be added to the echo contrast medium according to the invention since this substance, in addition to having a sweetening effect, also has a mildly laxative action. In addition, the poloxamer, when added as a surfactant for wetting the intestinal mucosa better, has a mildly laxative action.
Such a laxative effect however is likewise desirable for the comfort of the patients treated with the echo contrast medium according to the invention.
In addition, taste corrigents, especially aromatic
REFERENCES:
patent: 5370901 (1994-12-01), Tournier et al.
patent: 5420176 (1995-05-01), Unger et al.
Takayama et al. "Dissolution Behavior of Flufenamic Acid Dispersed in Crosslinked Insoluble Polyvinylpyrrolidone," Chem. Pharm. Bull., vol. 30, No. 10, pp. 3701-3710, 1982.
Dees Jos,e G.
Hartley Michael G.
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