Medicinal preparation comprising fexofenadine hydrochloride and process for its preparation

摘要

In the present invention, there is disclosed a peroral medicinal preparation in the form of tablets, coated tablets or pellets comprising fexofenadine hydrochloride with a rapid onset of activity as oral therapeutic of allergic reactions. The preparation can be prepared by dry mixing followed either by direct tabletting or briquetting or by compacting, in the form of a tablet or coated tablet or capsule filling in which an active substance – fexofenadine hydrochloride is present in an amount ranging from about 100 mg to about 1000 mg, which is 15 to 50 percent by weight, based on the total weight of the preparation. The preparation further comprises at least one ancillary substance being selected from the group consisting of polyols and/or saccharides. Preferably, the polyol is one or more mannitols with particle size in the range of 100 to 520 microns, preferably 180 to 360 microns. The preparation process of the above-described pharmaceutical composition is characterized in that a mixture of the active substance and at least one ancillary substance being selected from the group consisting of polyols and/or saccharides is prepared by dry mixing followed by adjustment of particle size of the so formed mixture to the range of 100 to 2000 microns, preferably 800 microns and further followed by either direct tabletting or briquetting or by compacting with final treatment of so prepared tablet material, which can be used for molding cores and/or tablets, and/or microtablets or for the preparation of pellets and/or micropellets and/or powders and/or granules and/or as a filling into capsules.