Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1986-02-14
1987-08-04
Griffin, Ronald W.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
426 5, 427 3, 424 48, 424479, A61K 936, A23G 330
Patent
active
046845232
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to coated edible products, hereinafter called "dragees", comprising a core covered with a shell adhering to the core and in which at least the shell has a sorbitol base. Coated edible products of the kind cited above are typical of the sweet and pharmaceutical industry.
The use of sorbitol as a sweetening constituent agent in the shell and possibly in the core in dragees is known in the art, being particularly desirable for medico-dietetic reasons, and for its weak karyogenic activity.
The disadvantages arising from the high hygroscopicity of sorbitol are also well known, and generally render difficult the tumbling operation carried out in an enrober, which is the basic operation for producing the shell of the dragee. In fact, by carrying out the tumbling operation with aqueous sorbitol-based syrups it proved impossible to obtain a smooth and structurally homogeneous shell. In order to overcome these disadvantages it was proposed, as described in the Italian Patent Application No. 68801-A/79 in the name of the applicant, to use sorbitol including as an additive a small quantity of sucrose esters.
In cases in which the organoleptic characteristics of the dragee are particulary important, as in the case of the sweet industry, the use of sorbitol with small quantities of sucrose ester additives according to known methods, does not, however, prove wholly satisfactory. As is known, in fact, a considerable percentage of consumers do not perceive a very pleasant sensation upon contact of the sorbitol with the palate.
It has now been discovered, and this constitutes the basis of this invention, that this unpleasant sensation on the consumer's palate can be eliminated by adding to the sorbitol a quantity of the methyl ester of L-aspartyl-L-phenyl-alanine in a proportion not greater than 0.5% by weight, while at the same time obtaining a smooth and structurally homogeneous shell.
Therefore one object of the present invention is a dragee comprising a core covered with a shell adhering to the core and in which at least the shell has a sorbitol base characterised in that the shell comprises a plurality of layers consisting essentially of sorbitol and of the methyl ester of L-aspartyl-L-phenyl-alanine (aspartame), the latter being present in a proportion of no more than 0.5% by weight referred to the weight of anhydrous sorbitol.
The methyl ester of the L-aspartyl-L-phenyl-alanine, designated in what follows by the commonly known term aspartame, is a a commercially available synthetic sweetener. Nevertheless its use in the production of dragee has never been suggested up to now. The problems connected with the low solubility of aspartame in water are in fact known, as well as its instability as a sweetener, particularly in aqueous solution, rendering it hardly suitable for use as a constituent of enrobing syrups for tumbling processes.
It has now been discovered that by carrying out the tumbling operation using an aqueous syrup consisting of aspartame and sorbitol, within well-defined concentration limits, it is possible to make dragees with improved organoleptic characteristics and in which the aspartame in the shell retains its sweetening properties for a practically unlimited period.
A further object of this invention is a method for the preparation of a dragee comprising a core and a shell adhering to the core by a tumbling process in an enrober, the said method comprising a plurality of stages of spraying said cores with a sorbitol-based aqueous syrup, characterised in that the said syrup comprises per 100 parts by weight of anhydrous sorbitol, 20 to 60 parts of water and 0.02 to 0.5 parts of aspartame.
As is known the tumbling operation, which will be described in more details below, comprises a plurality of syrup-spraying stages, by means of which the shell is formed in successive layers. Preferably in the method according to the invention, the temperature of the syrup is maintained at 40.degree. to 45.degree. C. in each spraying stage.
It is important that the distribution of the as
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Ferrero S.p.A.
Griffin Ronald W.
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