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Rapidly Dissolving Tablet Formulation

IP.com Disclosure Number: IPCOM000030402D
Publication Date: 2004-Aug-11
Document File: 1 page(s) / 38K

Publishing Venue

The IP.com Prior Art Database

Abstract

A tablet formulation has been found for medications containing antipsychotics like risperidone, which rapidly disintegrates in the mouth providing a pleasant mouth feel and adequate taste-masking of bitter tasting pharmaceutical ingredients.

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Rapidly Dissolving Tablet Formulation

A tablet formulation has been found for medications containing an-
tipsychotics like risperidone, which rapidly disintegrates in the
mouth providing a pleasant mouth feel and adequate taste-masking
of bitter tasting pharmaceutical ingredients. Furthermore, the
hardness of the tablet has to be high enough so that traditional
packaging and handling methods can be used.

Such formulations were described for example in patents US
6,368,625, US 6,024,981, and US 6,221,392 of Cima Labs, USA, ei-
ther claiming an in-mouth viscosity enhancing material or a matrix
containing a nondirect compression filler and a lubricant.

We found a formulation comprising a direct-compression tablet com-
plying with above requirements. The formulation contains

Active pharmaceutical ingredient

Lactose (filler)

Microcrystalline cellulose (filler and disintegrant)

Crospovidone (disintegrant)

Hydroxypropylcellulose (water-swellable polymer)

Aspartam (sweetener)

Magnesium stearate (lubricant)

Iron oxide (dye)

Peppermint flavor

Mask-it Powder (flavor, taste masking)

Citric acid can be added as additional taste masking agent.

In order to keep the disintegration time below one minute, the
tablet hardness should be kept at about 30 N.