Gelled compositions

Details Gelled compositions Gelled compositions

2000-03-06

2003-02-18

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Matrices

C424S440000, C424S434000, C424S078100

Reexamination Certificate

active

06521257

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a gelled composition for internal use. It comprises a carrier for adsorption as an effective ingredient, and belongs to the fields of medicine and food.
BACKGROUND ART
Most conventional medicines comprising a carrier for adsorption as an effective ingredient generally require large dosages and are orally administered after being suspended in water or the like medium. However, the compliance from patients has been extremely low for several reasons. First, it is necessary to suspend the carrier for adsorption in water prior to administration, and this procedure is tedious. Second, the carrier for adsorption leaves a strong taste in the mouth. Third, the patient may sense a foreign substance in the mouth due to the remaining carrier. Fourth, it has been very difficult to take an effective dosage for treatment because of the relatively large dosage of the carrier for adsorption as compared with other preparations. Finally, the unpleasant feeling of a foreign substance in the mouth while taking such a composition often caused side effects such as nausea or vomiturition. There has thus been a problem in medical treatment since the desired treatment effect of the medicine cannot be fully obtained even though its high usefulness has been clinically established.
DISCLOSURE OF THE INVENTION
An objective of this invention is to provide an easily taken composition comprising a carrier for adsorption as an effective ingredient.
Conventional pharmaceutical preparations that include a carrier for adsorption as an effective ingredient must be suspended in water or the like medium before being taken. Furthermore, the carrier for adsorption often has a strong taste and requires a large dosage. Together, these caused a significant reduction in patients' compliance with taking the preparation. Conventional pharmaceutical preparations also pose a serious problem in that simply decreasing the amount of solvent used for the carrier for adsorption increased the unpleasant taste of that carrier, resulting in further reduction of patients' compliance (no improvement of patients' compliance at all). The present inventors focused their attention on these issues.
The present inventors considered that the unpleasant taste was caused by the difference in the taste between the carrier for adsorption and the medium such as water. We therefore sought a dosage composition that would taste less like the carrier for adsorption. Subsequently, we succeeded in not only significantly decreasing the dosage but also reducing the taste of the carrier for adsorption by adding a gelling component to a composition comprising the carrier for absorption, thus providing a gelled composition. Furthermore, the present inventors found it possible to apply the gelled composition thus prepared not only to medicines but also to foods such as health foods.
The present invention thus relates to a composition that has less of the taste of the carrier for adsorption that is comprised as an effective ingredient. The present invention also relates to its application for medicine and food. More specifically, the present invention relates to:
(1) a gelled composition for internal use comprising a carrier for adsorption as an effective ingredient,
(2) the gelled composition according to (1), wherein said carrier for adsorption is an ion exchange resin,
(3) the gelled composition according to (2), wherein said carrier for adsorption is selected from the group consisting of cholestyramine, calcium polystyrene sulfonate, or sodium polystyrene sulfonate,
(4) the gelled composition according to (1) wherein the composition comprises pectin as a gelling agent,
(5) the gelled composition according to (1) wherein the composition comprises pectin and agar as the gelling agent,
(6) a pharmaceutical preparation comprising the gelled composition for the internal use according to any one of (1) to (5), and
(7) a food comprising the gelled composition for internal use according to any one of (1) to (5).
Herein, “gelled” refers to highly viscous liquid, semiliquid, semisolid or solid states.
A gelled composition of this invention comprises a carrier for adsorption and a gelling agent as the effective ingredients. There is no particular limitation on the type of carriers for adsorption as long as they are water-insoluble. For example, anion-exchange resin, cation-exchange resin, or activated carbon granules for adsorption can be used.
An anion-exchange resin such as cholestyramine and a cation-exchange resin such as calcium polystyrene sulfonate or sodium polystyrene sulfonate can be employed in the present invention as the specific agent in the carrier for adsorption. Furthermore, the type of gelling agent is not particularly limited. For example, pectin, agar, arabic gum, xanthum gum, tragacanth gum, karaya gum, ghatti gum, guar gum, gellan gum, locust bean gum, alginic acid or its salt (e.g., sodiumalginate), carrageenan, gelatin, dextrin, starches (corn starch, rice starch, wheat starch, potato starch, pueraria starch, tapioca starch, carboxymethyl starch, hydroxypropyl starch, hydroxyethyl starch, chemically cross-linked starch, &agr;-starch, and so on), celluloses (hydroxypropylmethyl cellulose, carboxymethyl cellulose, methyl cellulose, methylethyl cellulose, hydroxypropyl cellulose, crystalline cellulose and so on), polyvinyl alcohol, polyvinylpyrrolidone, polyethylene glycol (macrogol), or mannans can be used singly or in an appropriate combination. Of these, a complex gel comprising pectin and agar is especially preferable because this complex gel is able to significantly reduce the peculiar taste of a carrier for adsorption.
The content of a carrier for adsorption in the gelled composition according to this invention varies depending on the amount of effective ingredient of the pharmaceutical preparation, or the swelling rate (water absorption rate) of the carrier for adsorption. However, it usually ranges from 0.1% to 50.0% (w/w %, same hereafter) relative to the total amount of the pharmaceutical preparation, and preferably from 5.0% to 20.0% for cholestyramine, and 10.0% to 30.0% for calcium polystyrene sulfonate or sodium polystyrenesulfonate. The gelling agent content usually ranges from 0.01% to 10.0%, and preferably 0.5% to 2.5% for pectin, 0.1% to 0.5% for agar, and 0.5% to 2.0% for gelatin.
A gelled composition of this invention may further contain, as needed, a stabilizer, surfactant, solubilizer, buffer, sweetener, seasoning, suspending agent, coating, flavor/spice (aromatic), colorant, pH adjuster, viscosity increasing agent, Ca-supplier, dispersant, antiseptic (preservative), solvent (dissolving agent) and the like. For example, sodium alginate, various gums, glycerin, etc. can be used as a stabilizer; sodium lauryl sulfate, polysorbate 80, or the like can be used as a surfactant; ethanol or the like can be used as a solubilizer; phosphate, carbonate, and so on can be used as a buffer; purified sucrose, aspartame, fructose, sorbitol, xylitol, glucose, mannitol, maltose, trehalose, palatinose, powdered-reduced maltose millet jelly, oligosaccharide, erythritol, stevioside, glycyrrhizin, etc. can be used as a sweetener; menthol, edible fruit juice, caramel, or glucono-(-lactone, etc. can be used as a seasoning; sodium alginate, arabic gum, lactose, or the like can be used as a suspending agent; purified shellac, hydroxypropylmethyl cellulose phthalate, or the like can be used as a coating; fruit flavor, prune, mint oil, and so on can be used as a flavor/spice (aromatic); orange essence, edible dye, caramel, or the like can be used as a colorant; citric acid or its salt, tartaric acid or its salt, succinic acid, lactic acid, calcium lactate, phosphate, glucono-&dgr;-lactone, etc. can be used as a pH adjuster; dextrin, xanthum gum, soybean lecithin, polyethylene glycol, etc. can be used as a viscosity increasing agent; calcium lactate, calcium hydrogenphosphate, calcium carbonate, calcium chloride, calcium citrate, calcium sulfate, etc. can be used as a Ca-supplier; arabic g

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