SOLID ORAL PHARMACEUTICAL PRODUCT WITH INCREASED EFFICACY AND PREDETERMINED STEADY STATE OF SOLUBILITY

摘要

The present invention relates to a solid oral pharmaceutical preparation with protracted release of the active ingredient consisting of discrete solid granules containing the active ingredient soluble in the stomach and auxiliary agents and of an equally solid external phase surrounding the said granules, whereby the granules forming the internal phase consist of granules prepared from a powder mixture which contains as active ingredient, or in addition to it a pharmaceutically acceptable basic bismuth salt, particularly bismuth subnitrate /basic bismuth nitrate/ or bismuth subcarbonate and auxiliary materials prepared with an aqueous emulsion containing a hydrophobic component and hydrophylic emulsifiers, and the external phase contains a solid, dry, amphoteric gel forming substance preferably tragacanth in an amount of 1-50 per cent w/w related to the total weight of the preparation in admixture with auxiliary agents. The preparation is produced by the wetting of the powder mixture containing the basic bismuth salt, auxiliary material and in given case additional active ingredient with the aqueous emulsion of the hydrophobic component prepared by applying the hydrophylic emulsifiers then by granulation and admixing the dried granules with the amphoteric gel forming substance, and pressing it into tablets, or filling into capsules.