ポリスチレンスルホン酸カルシウムを含有するゼリー状製剤に関する検討

抄録

To reduce the gritty feeling of orally administered calcium polystyrene sulfonate powder (PS-Ca), we have developed a jelly dosage form containing PS-Ca. The jelly form (PS-Ca jelly), containing gelatin, carrageenan, and pectin, was confirmed to show a less gritty feeling when it was evaluated by the human volunteer's sensory test. Moreover, these additives seemed to regulate its adhesiveness and cohesiveness. In vitro potassium exchange profiles of PS-Ca jelly obtained by the press-through method and the paddle bead method showed no difference between PS-Ca jelly and PS-Ca powder (Kalimate^®), which was selected as a reference dosage form. A bioequivalence test of these forms was also performed with measuring serum potassium concentration changes, using nephrectomized rats. No statistically significant difference was found. The physical appearance of PS-Ca jelly stored at 60°C for 28 days remained unchanged, and the loss of water was within 2%. We have concluded that the newly formulated PS-Ca jelly will be able to contribute to the improvement of a patient's QOL.