abstract |
A solid orally disintegrable preparation that can be easily administered to the elderly or children, without water. The development of a solid preparation that disintegrates rapidly in the presence of saliva in the oral cavity, in a little water, or in the stomach with adequate resistance (hardness) has been sought so that it is not damaged in the production processes and in the distribution, and that also is not rough. A solid rapid disintegration preparation comprising (i) a pharmacologically active ingredient, (ii) a sugar and (iii) a low substituted hydroxypropyl cellulose having between 5% or more and less than 7% by weight of hydroxypropyl group. The solid preparation preferably disintegrates rapidly orally, which can take the form of a tablet. The sugar may be a sugar alcohol, which is preferably mannitol or erythritol. The sugar comprises between 5 and 97 parts by weight per 100 parts by weight of the preparation. The low substituted hydroxypropyl cellulose has between 5% or more and less than 7% by weight of hydroxypropyl group and is used in an amount ranging from 3 to 50 parts by weight per 100 parts by weight of said solid preparation. The pharmacologically active ingredient can be lansoprazole, voglibose, manidipine hydrochloride, pioglitazone hydrochloride, candesartan cilexetil. The preparation may comprise fine granules, as well as the pharmacologically active ingredient found in the fine granules. Use of a low substituted hydroxypropyl cellulose having between 5% or more and less than 7% by weight of hydroxypropyl group to be applied to the production of a solid fast disintegration preparation comprising a pharmacologically active ingredient and a sugar as described. A method for improving the rapid disintegration capacity of the solid preparation comprising a pharmacologically active ingredient and a sugar, said method involves including low substituted hydroxypropyl cellulose having between 5% or more and less than 7% by weight of hydroxypropyl group. |