United States Patent:  6,048,541

Assignee:  Fuisz Technologies Ltd. (Chantilly, VA)

Filed:  August 12, 1998

The invention relates to compositions useful for making tablets which can be formed using conventional tableting machines and which disintegrate rapidly in the mouth with optional chewing. The compositions typically include shearform matrices which have been recrystallized using crystallization promoters.

SUMMARY OF THE INVENTION

The invention provides compositions and dosage units having improved properties and methods of making them.

Co-owned U.S. patent application Ser. No. 08/915,068, filed Aug. 20, 1997, describes tablet formulations derived from saccharide-based carriers in which the use of a unique combination of feedstock ingredients yields self-binding, flowable matrices and tablet compositions. This combination--which employs a blend of sugar alcohols, i.e., sorbitol and xylitol--is superior to glycerine in providing cohesive properties and flowability.

Applicants have discovered that tablet compositions derived from hygroscopic matrices containing these sugar alcohols are useful--in the presence of tableting aids and crystallization promoters--in both high- and low-pressure tableting processes. Tablets therefrom rapidly dissolve when placed in the mouth, generally in less than 30 seconds, especially when chewed.

The tablet compositions of the invention are based on matrices which comprise at least one sugar alcohol, which matrices fall into one of the following groups:

One group--called "single floss" or "unifloss" systems--is exemplified by a shearform matrix, or floss, containing a carrier and two or more sugar alcohols, one of which is xylitol.

A second group--termed "dual floss"--is exemplified by (I) a first shearform carrier matrix (the "base floss") comprising a carrier and at least one sugar alcohol, generally sorbitol; and (II) a second shearform binder matrix (the "binder floss") comprising a carrier and xylitol.

Actives and other conventional tablet ingredients can be added, in suitable amounts, to the compositions of the present invention during the production of the matrices and/or after the matrices are collected and chopped, but before tableting.

Claim 1 of 15 Claims

1. A flowable composition for making comestible units comprising:

a) partially crystallized shearform particles treated with at least one of ethanol and lactose, and

b) particles containing at least one bio-affecting agent.

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