Gastric acid binding chewing pastilles

Details Gastric acid binding chewing pastilles Gastric acid binding chewing pastilles

1997-05-16

2000-06-20

Kulkosky, Peter F.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

424440, A61K 4742, A61K 968

Patent

active

060775246

DESCRIPTION:

BRIEF SUMMARY
The invention relates to chewing pastilles based on certain natural and/or synthetic polymers comprising antacids as active ingredients.
By the term pastilles there is generally understood--see also W. Rahn, Pharmazeutische Zeitung, pp 2214-2218 (1982)--preparations which can be sucked or chewed in the mouth. Namely, it is differentiated essentially between tablets, hard candies and gum pastilles (also designated as gum candies).
The processes for producing such dosage forms are basically distinguished from each other.
Tablets are pressed on tablet machines. To this end, the tablet mass has to be prepared by mixing and granulating. Several authors already have dealt with granulating methods for active substances which are difficult to process.
Candies are prepared by mixing saccharose and glucose syrup, boiling the resulting mixture at about 130.degree. C., and removing most of the water from the mass in vacuo to a residual water content of from 0.5 to 2%. To the highly viscous candy mass cooled down to about 85.degree. C. are added the active substances and flavors and admixed by kneading. With continuous cooling, the candy mass is drawn into strands, shaped, and cut in tapered rollers and other candy machines. It is known that, due to the viscosity of the candy mass, the distribution of the active substance is rather non-uniform.
Gum pastilles are prepared by initially dissolving in an agitator vessel hydrocolloids, e.g., gum arabic, together with saccharose, glucose syrup, sorbitol, xylitol, and the like in water, and dissolving, emulsifying or suspending the active ingredients in this base mass. The casting composition thus obtained is cast into so-called powder trays. These are, for example, flat wooden boxes of about 80.times.40 cm filled with starch, especially corn starch. The desired shapes are pressed into the smoothed powder using a stamp board, and the warm casting solution is exactly metered and pumped into the thus obtained wells, wherein the cast mass is not bound to the powder. Tray by tray, 500 to 1000 pastilles each, is thus cast, stacked, and water is removed from the pastilles in drying chambers to about 10% of residual moisture within 3 to 4 days. The pastilles thus produced are "depowdered" and then subjected to a final treatment.
The subject matter of DE 41 40 116 A1 is pastilles based on natural and/or synthetic polymers or fat-like substances with sugar and/or sugar substitutes, comprising poly(dimethyl siloxane) (Dimeticon, Simeticone), and a process for the preparation thereof.
According to Rompp Chemie Lexikon, 9th edition, page 200, 1989, the term "antacids" is used to mean substances which are to counteract hyperacidity of the gastric juice. Suitable compounds include magnesium hydroxide, magnesium oxide, magnesium carbonate, magnesium silicate, aluminum hydroxides, aluminum phosphate, magnesium aluminum silicates, hydrotalcite and magaldrate. Although, according to Rompp, the use of the prior sodium hydrogen carbonate and calcium carbonate should be desisted from, numerous commercial products are available which contain these components at least in minor proportions.
The object of the present invention as compared to the prior art has been to provide a novel single dosable dosage form of antacids using a casting process per se known from confectionery manufacture, which dosage form is characterized by: finest distribution of the active ingredient within the pastille, very accurate single dosing of the active ingredient, very easy handling of the active ingredient, especially convenient intake of the medicament, and optimum sustaining of the active ingredient in the stomach by the pastilles being slowly chewed.
The aforementioned object is achieved by pastilles based on at least partially or completely water soluble natural and/or synthetic polymers, selected from gums, alginates, carrageens, starch, pectin, and gelatin which form gels or viscous solutions in aqueous systems, and further adjuvants and additives, the pastilles containing antacids as active ingredients.
It has b

REFERENCES:
patent: 3347682 (1967-10-01), Rosenstein
patent: 4010283 (1977-03-01), Canonne
patent: 4163777 (1979-08-01), Mitra
patent: 4971787 (1990-11-01), Cherukuri et al.
patent: 5591473 (1997-01-01), McArdle

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