Title:  Process for forming chewable quickly dispersing comestible unit and product therefrom

United States Patent:  5,935,600

Inventors:  Cherukuri; Subraman R. (Vienna, VA); Fuisz; Richard C. (McLean, VA); Sanghvi; Pradeepkumar P. (Herndon, VA); Misra; Tushar K. (Leesburg, VA); Sisak; John R. (Fairfax, VA)

Appl. No.:  097999

The present invention deals with compositions and methods for preparing comestible units which disperse quickly in the mouth, especially when chewed. The present invention also includes the product made therefrom. The method includes initiating crystallization of shearform matrix with crystallization/bindig promoter and combining it 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 most preferred forms of the invention, the active ingredient is an antacid and the crystallization/binding promoter is ethanol.

It has also been found that when calcium is included as an active ingredient, the release characteristics of the dosage unit are very favorable. As a matter of fact, the unit can actually be used as a calcium supplement because of its high calcium release characteristics.

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 antacids, e.g., calcium carbonate, can be made which have no chalky taste or mouthfeel. In addition, they can be made chewable, while retaining the friability of tablets.

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

These and other advantages and objects of the present invention will be appreciated from the following description. The description and the examples are not intended to limit the scope of the invention.

Claim 1 of 16 Claims

1. A method of preparing quick dissolve comestible units comprising:

a) initiating crystallization of shearform matrix;

b) before or after initiating crystallization combining a crystallization/binding promoter and an additive with said shearform matrix to form flowable, compactible micro-particulates; and

c) compacting the combination resulting from step "b", which includes at least partially crystallized shearform matrix, to form said comestible units

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