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Details
Inventors: Myers, Garry L.; Battist, Gerald E.; Fuisz, Richard C.;
Assignee: Fuisz Technologies Ltd. (Chantilly, VA)
Primary Examiner: Hulina; Amy
Assistant Examiner:
Attorney, Agent or Firm: Nolan; Sandra M., Schmidt; Richard D.

The present invention is a method and a dosage unit for delivery of a controlled-release system. The dosage unit is a quick dissolve unit which can be prepared by mixing uncured shearform matrix and a controlled-release system, either molding or compacting a unit dosage form and curing the shearform matrix. The controlled-release systems used in the present invention include instantaneous release components, delayed release components, sustained release components, and combinations thereof.

DETAILED DESCRIPTION OF THE INVENTION The present invention is a method of making comestible units which disintegrate quickly in the mouth of the consumer.
The units produced in accordance with the present invention disintegrate nearly instantaneously.
However, these units or tablets are capable of being manufactured so that they can be handled for packaging and distribution without deterioration of the integrity of the comestible units.
In the past, comestible units such as tablets have been made primarily by compressing feedstock under extremely high-pressure in order to provide the necessary hardness for handling required during packaging and distribution.
Consequently, prior art tablets so produced are limited in that their high density reduces the capability of making them quickly disintegratable in the mouth.
High density packing resulting from the high compression hinders the disintegration and wetting of the interior portion of the tablet.
This aspect of the prior art has been improved by the technology disclosed in parent U.
S.
application Ser.
No.
194,682, filed on Feb.
10, 1994 now U.
S.
Pat.
No.
5,654,003.
As a result of the present invention, however, a significant step forward has been made in the art of preparing comestible units which disintegrate very quickly in the mouth and which can deliver a controlled-release system.
In fact, tablets produced by the present invention disintegrate within seconds.
The product is prepared by a unique combination of processing steps.
The present invention also includes products which are produced by the new process.
The first step of the procedure of the first embodiment is to mix an uncured shearform matrix and a controlled-release system which includes an active ingredient, to prepare for molding a unit dosage.
"Shearform matrix" in the present invention means a matrix produced by subjecting a feedstock which contains a carrier material to flash flow processing.
Flash flow processing can be accomplished several ways.
Flash-heat and flash-shear are two processes which can be used



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