| 摘要 |
The invention relates to a film-coated tablet for therapeutic use, namely as antiviral medicament, and to the process for preparing the same. According to the invention, the film-coated tablet for theraputic use comprises at least 50% by weight of 2-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-ethyl-L-valinate or a salt thereof, a cellulosic excipient, a binder, a lubricant and, optionally, a disintegration agent, in an amount of 0.5...20% by weight, it also comprises 0.05...3% by weight of colloidal silicon dioxide, where the 2-(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]-ethyl-L-valinate or the salt thereof are present in the granules of the tablet and (a) the lubricant, the silicon dioxide and at least one part of the cellulosic excipient are present extragranularly and the friability of the tablet does not exceed 1%, the hardness of the tablet is of at least 9kP and the ejection force does not exceed 1,000 Newtons; or (b) the tablet contains 3...30% by weight of cellulosic excipient and the lubricant, the silicon dioxide and the cellulosic excipient are present extragranularly. The claimed process for preparing the tablet consists in mixing at least about 50% from the tablet weight of 9-(2-hydroxyethoxy)methyl]guanine or a salt thereof, optionally a binder or a part thereof and, optionally, a portion of a cellulosic excipient, granulating a granulation solution in order to form the granules or dissolving the binder or a part thereof into the granulation solution before said solution having been added to 9-(2-hydroxyethoxy)methyl]guanine or to a salt thereof, redrying the granules, mixing them with the lubricant, the colloidal silicon dioxide and at least one portion of the cellulosic excipient and then in compressing the mixture for forming a tablet.
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