Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1998-03-24
2000-11-14
Williamson, Michael A.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424439, 424441, 424464, 424474, A61K 920
Patent
active
061466611
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to chewable tablets as a gastrointestinal drug. More particularly, the invention concerns chewable tablets which have solved the problem of poor intrabuccal sensations by incorporating a sugar alcohol in a certain amount or more.
BACKGROUND ART
Chewable tablets are taken slowly by chewing or sucking in the mouth, and enable a pharmaceutical contained therein to be orally administered without water. Chewable tablets now on the market, however, may cause discomfort (e.g. roughness or dustiness) during or after ingestion, posing the problem of poor intrabuccal sensations. Particularly when a metal salt such as a calcium, magnesium or aluminum salt is incorporated, a marked discomfort arises. This is a serious problem for chewable tablets which remain in the mouth for a long time as compared with other preparations. By contrast, success in improving the sensations during or after ingestion were achieved by adjusting the particle sizes of the ingredients incorporated (Japanese Laid-Open Patent Publication No. 203332/89). This measure is not highly preferred for manufacture, because it increases the number of manufacturing steps. Poor intrabuccal sensations due to a calcium salt were also relieved by containing low viscosity hydroxyalkyl cellulose and high viscosity hydroxyalkyl cellulose (Japanese Laid-Open Patent Publication No. 306229/93). However, the effect obtained is not entirely satisfactory. Attempts have been made to improve the intrabuccal sensations by combining various additives such as sweeteners, acidic ingredients, taste correctives, polymeric compounds and essential oils of crude drugs. In such cases, the additive is needed in an amount of not less than 1.5 to 2 times the amount of the gastrointestinally active ingredient, thus making the size of the chewable table itself large. Such large tablets are difficult to take. In addition, a special machine for producing large tablets is required, posing an economic problem.
As described above, gastrointestinal chewable tablets thus far known have been unsatisfactory in intrabuccal sensations, and there has been a demand for correcting such a drawback.
DISCLOSURE OF THE INVENTION
We, the inventors, have conducted in-depth studies to improve the intrabuccal sensations characteristic of chewable tablets as a gastrointestinal drug. These studies have found that this objective can be attained by incorporating not less than a specific amount of a sugar alcohol into the gastrointestinally active ingredient; such a finding led us to accomplish the present invention.
That is, this invention concerns chewable tablets containing a sugar alcohol with a dissolution endotherm of 20 calories or more per gram of a gastrointestinally active ingredient.
The gastrointestinally active ingredient used in the invention may be any pharmaceutically active ingredient for a gastrointestinal drug, such as a mucous membrane repairing agent or an antacid. The particle size of the starting material for the gastrointestinal drug should desirably be small, but any commercially available grade poses no problem. The gastrointestinally active ingredient may be a single ingredient or a mixture of two or more ingredients.
Examples of the mucous membrane repairing agent are sucralfate, sodium azulene sulfonate, aldioxa, glycyrrhizic acid and its salts, L-glutamine, copper chlorophyllin potassium, histidine hydrochloride, porcine gastric wall pepsin decomposition product, and methylmethionine sulfonium chloride.
The antacid includes not only a common antacid generally recognized as being effective in neutralizing gastric acid, but also an H.sub.2 receptor blocking antisecretory effective in healing the gastrointestinal tract. Examples of the antacid are sucralfate, dried aluminum hydroxide gel, magnesium aluminosilicate, magnesium silicate, synthetic aluminum silicate, synthetic hydrotalcite, magnesium oxide, magnesia alumina hydrate, aluminum hydroxide gel, magnesium hydroxide, sodium bicarbonate, magnesium carbonate, precipitated calci
REFERENCES:
patent: 5013557 (1991-05-01), Tai
Chugai Seiyaku Kabushiki Kaisha
Williamson Michael A.
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