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Rapidly Dissolving Tablet Formulation

IP.com Disclosure Number: IPCOM000027954D
Publication Date: 2004-Apr-14
Document File: 1 page(s) / 40K

Publishing Venue

The IP.com Prior Art Database

Abstract

A tablet formulation has been found for medications containing se-rotonine 5-HT2/dopamine D2 antagonists, 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 tradi-tional packaging and handling methods can be used.

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Rapidly Dissolving Tablet Formulation

A tablet formulation has been found for medications containing se-
rotonine 5-HT2/dopamine D2 antagonists, 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 tradi-
tional 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)

Sodium hydrogen carbonate (buffer)

Citric acid (buffer)

Aspartam (sweetener)

Colloidal silica (glidant)

Magnesium stearate (lubricant)

Lemon taste (flavor)

Alternatively, orange or tangerine flavors may be used. In order
to keep the disintegration time below one minute, the tablet hard-
ness should be kept at about 30 N.