Rapidly disintegrating pharmaceutical dosage form and process for preparation thereof

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The compressed pharmaceutical dosage forms of the present invention rapidly disintegrates when contacted by water, saliva and aqueous solutions, and are particularly useful in the oral delivery of drugs.
As used in the present invention "disintegrate" includes both the dissolution and dispersion of the dosage form when contacted with the aforementioned fluids.
These dosage forms generally disintegrate in the mouth within about 30 seconds, and preferably within about 20 seconds or less.
The dosage forms contain coated particles comprising at least one pharmaceutical coated with a taste-masking coating, a water-disintegratable, compressible carbohydrate, and a binder.
These ingredients are dry blended and then compressed into a mass, preferably a wafer, having a hardness sufficient to cause the carbohydrate to disintegrate after oral administration.
Upon disintegration, the coated pharmaceutical particles are released from the dosage form with no objectionable taste and swallowed by the user.
Conventional tableting machines can be used to compress the ingredients into the final dosage form.
Since the ingredients are dry blended, water-soluble, as well as water-insoluble, coated pharmaceuticals can be used in the dosage form.
Further, in view of the use of a taste-masking coating, pharmaceuticals having an objectional taste may also be used in the present invention.
The water-disintegratable, compressible carbohydrate used in the present invention includes carbohydrate materials conventionally used in tablets.
The carbohydrates facilitate the breakup of the dosage form after oral administration, and are described in Liberman et al.
, Pharmaceutical Dosage Forms, Marrel Dekker, Inc.
, New York, 2 Ed.
Vol.
1, pp.
205-209 (1990), which is hereby incorporated by reference.
Preferred water-disintegratable, compressible carbohydrates include mannitol, sorbitol, dextrose, sucrose, xylitol, lactose, and mixtures thereof.
The binder in the present invention is used to add cohesiveness to the formulation, thereby providing the necessary bonding to form a cohesive mass or compact upon compression