| 摘要 |
Pharmaceutical particulate formulations of the S-(+)- enantiomer of ibuprofen comprising i) 40-70 % w/w of S-(+)-ibuprofen, ii) a water-soluble pharmaceutically acceptable binder, iii) optionally, silica in an amount not exceeding 2 % w/w, with the proviso that the formulation does not contain water-soluble polyvinylpyrrolidone. The formulations have a relatively high load of S-(+)- ibuprofen and, accordingly, a relatively low content of excipients. The formulations exhibit good flowability, good compactability and possesses excellent tabletting properties. Thus, the formulations allow the preparation of, e.g., tablets which display minimal or greatly diminished adherence (sticking) to tablet punches and/or dies during compression, and which have excellent disintegration and dissolution properties and reduced tendency towards time-dependent reduction of dissolution rate. The water-soluble binder may be hydrophilic substances like, e.g., gelatin, starch or acacia. When silica is present in a formulation, colloidal silicas such as Aerosil<R> 200, Aerosil<R> 380, Cab-O-Sil<R> M5, Cab-O-Sil<R> EH5 or Syloid<R> have proved to be well suited. Furthermore, the invention relates to a process for the preparation of a formulation as mentioned above and to solid drug dosage forms comprising such a formulation. |
