Lactulose pastilles

Details Lactulose pastilles Lactulose pastilles

1995-12-01

1997-11-18

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Food or edible as carrier for pharmaceutical

424440, 424441, 424464, 424435, 514774, 514778, 514779, 514782, A61K 920

Patent

active

056885210

DESCRIPTION:

BRIEF SUMMARY
This application is a 371 of PCT/EP94/01344 filed Apr. 28, 1994 published as WO94/25002, Nov. 10, 1994.
The invention relates to sucking pastilles on the basis of certain natural or synthetic polymers comprising 4-O-.beta.-D-galactopyranosyl-D-fructose (lactulose) as an active substance.
By the term pastilles there are 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 these forms of administration are basically distinguished from each other.
Tablets are pressed in 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 difficult to process.
Candies are prepared by mixing saccharose and glucose syrup, cooking 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. Due to the viscosity of the candy mass, the distribution of the active substance is known to be 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 others in water and solving, emulsifying or suspending the active substances in this base mass. The casting composition obtained this way is cast into so called powder trays. These are, for example, flat wooden boxes having a size of 80 cm.times.40 cm being 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, whereby the cast mass is not bound with the powder. Tray by tray, 500 to 1000 pastilles in each case, is cast this way, stacked, and water is removed from the pastilles in drying chambers to about 10% residual moisture within 3 or 4 days. The pastilles produced this way are "depowdered" and then transferred to a final treatment.
Lactulose is a synthetic disaccharide from D-galactose and D-fructose obtained by alkaline lactose epimerization which has been marketed for a long time by various offerers as liver therapeutic and intestinal regulator in various forms of administration. For example, lactulose is commercially available in the form of syrup or granulate. However, pharmaceutical single-dose applications are lacking.
From Chemical Abstracts, 1990, Vol. 113, Ref. 130924s, it is known a chewing gum containing lactulose. A serious drawback of this form of administration consists in only a portion of the preparation being taken up by the human body, while the base material of the chewing gum has to be disposed of after usage.
EP-0 189 722 B1 describes a laxative composition on the basis of lactulose which is essentially obtained by adding a water soluble calcium or magnesium salt to an aqueous lactulose syrup, adjusting the pH from 2.5 to 5, and subsequently adding a pectin. Following this, the whole is agitated for at least 5 minutes and cooled down to a temperature at which the product gels. The gel obtained this way may be taken then by means of a spoon. Therefore, an exact single-dosing of the active substance is not possible.
In EP-0 189 722 B1, U.S. Pat. No. 3,860,708 and U.S. Pat. No. 3,867,534 are referred to and it is specified that in these two patent specifications in the same way it is specified in form of a common meaningless phrase that lactulose may be present not only in the preferred form of a syrup but as well in further galenic forms, which applies to gel candies. However, within the qu

REFERENCES:
patent: 3860708 (1975-01-01), Prout
patent: 3867524 (1975-02-01), Ebner
Patent Abstracts of Japan, vol. 14, No. 403 (C-0753) Aug. 31, 1990 & JP,A,02 150 240 (Tsutomu) Jun. 8, 1990.
Chemical Abstracts, No. 18093, vol. 121 (Mamoru, et al) & JP A6 040 922, (Morinaga Milk Industry Co. Ltd.) Feb. 15, 1994.
Walter Rahn, "Pharmaceutical Forms of Sucking", (translated from Pharmazeutische Zeitung, pp. 2214, 1982) pp. 1-14, dated Oct. 14, 1982.
Chemcial Abstracts, vol. 113, 130924s, 1990.

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