United States Patent:   5,965,162

Assignee:  Fuisz Technologies Ltd. (Chantilly, VA)

Filed:  June 19, 1998

A composition and method for preparing multi-vitamin comestible units which disperse quickly in the mouth, especially when chewed, includes initiating crystallization of shearform matrix with crystallization/binding promoter and combining with an additive to form flowable, compactible micro-particulates. The combination is then shaped to form a comestible unit having high structural integrity, good appearance, and excellent release characteristics.

SUMMARY OF THE INVENTION

The present invention deals with compositions and methods for preparing comestible units which quickly disperse in the mouth of the consumer, especially when chewed, and the units themselves. The method includes initiating crystallization of shearform matrix before combining the shearform matrix with an additive to form flowable, compactible micro-particulates. The combination, which includes at least partially crystallized shearform matrix, is then compacted to form the comestible unit.

In one preferred form of the invention, the active ingredient is a multi-vitamin preparation and the crystallization/ binding promoter is ethanol. Other preferred actives can include edible calcium salts for antacid and mineral supplements.

One manifestation of the present invention is a method of administering an active ingredient to a human host. The method includes ingesting a quick dissolve comestible unit prepared by the method of the present invention. The next step requires the host to retain the quick dissolve unit in the oral cavity for a time sufficient to contact the unit with saliva while in the oral cavity. Finally, the human host can introduce water to the oral cavity, while the unit is retained therein, to enhance dissolution of the dosage unit.

Other embodiments of the invention involve chewable comestible units. These units, which are preferably tablets, are specially formulated and processed so that they are easily chewable and readily soluble when chewed. Water can be used to enhance dispersion/dissolution after ingestion.

Moreover, the dispersability of the unit is perceived as nearly instantaneous when chewed. Consequently, the consumer does not sense the effects of unpleasant ingredients lingering in the oral cavity.

Tablets containing multivitamins can be made which are pleasant tasting, have no gritty taste or mouthfeel, and dissolve quickly. In addition, they can be made chewable, while retaining the friability of tablets. Formulating a particularly palatable multi-vitamin chewable preparation is unusually challenging because of the mix of many water-soluble and insoluble active vitamin preparations included in one tablet.

It is, therefore, an object of the invention to provide another method for preparing a chewable dosage unit which quickly disintegrates in the mouth.

Claim 1 of 19 Claims

1. A method of preparing a quick dissolve comestible unit comprising:

a) initiating crystallization of shearform matrix particles comprising at least one member selected from the group consisting of monosaccharides, disaccharides, trisaccharides, polysaccharides, malto-oligosaccharides and sugar alcohols;

b) before or after initiating crystallization combining an additive with said shearform matrix to form flowable, compactible micro-particulates, said additive being at least one member selected from the group consisting of vitamins, mineral supplements and nutraceuticals; and

c) compacting said micro-particulates resulting from step "b", which includes at least partially crystallized shearform matrix, to form said comestible unit.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.