Pharmacological, pharmaceutical and clinical profiles of sucroferric oxyhydroxide (P-TOL<sup>®</sup> Chewable Tab. 250 mg, 500 mg), a therapeutic agent for hyperphosphatemia

DOI Web Site Web Site PubMed 29 References
  • Tatemichi Satoshi
    Pharmacology Research Group, Pharmacology and Pharmacokinetics Research Laboratory, Kissei Pharmaceutical Co., Ltd.
  • Nakagaki Fumiaki
    Biologics CMC Research and Technology Group, Pharmaceutical Research Laboratory, CMC Research Department, Kissei Pharmaceutical Co., Ltd.
  • Yoshioka Shoichi
    Clinical Development, Clinical Projects Management Section for Biologics Products and LCM Strategy, Clinical Development, Clinical Projects Management Department, Kissei Pharmaceutical Co., Ltd.
  • Shichiri Natsuko
    Clinical Administration, Clinical Research Department, Kissei Pharmaceutical Co., Ltd.

Bibliographic Information

Other Title
  • 新規高リン血症治療剤スクロオキシ水酸化鉄（ピートル<sup>®</sup>チュアブル錠250 mg，500 mg）の薬理学的特性，製剤学的特性および臨床試験成績
  • 新薬紹介総説 新規高リン血症治療剤スクロオキシ水酸化鉄(ピートルチュアブル錠250mg, 500mg)の薬理学的特性,製剤学的特性および臨床試験成績
  • シンヤク ショウカイ ソウセツ シンキ コウリン ケッショウ チリョウザイ スクロオキシ スイサンカテツ(ピートルチュアブルジョウ 250mg, 500mg)ノ ヤクリガクテキ トクセイ,セイザイガクテキ トクセイ オヨビ リンショウ シケン セイセキ

Search this article

Description

<p>Sucroferric oxyhydroxide (P-TOL® chewable tablets, 250 and 500 mg) is a phosphate binder for oral use; it is composed of polynuclear iron (III)-oxyhydroxide, sucrose, and starches, and is currently indicated for alleviating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The results of non-clinical pharmacological studies have suggested that P-TOL consistently decreases serum phosphorus levels in the aqueous environment at pH levels similar to those in the gastrointestinal tract, thereby suppressing the progression of secondary hyperparathyroidism, aberrant calcification, and abnormal bone metabolism associated with hyperphosphatemia. Since the diameter of the P-TOL tablet exceeds 15 mm, it is manufactured with a doughnut-shape to minimize choking hazards. From the results of pharmaceutical studies, it was indicated that the P-TOL tablets promptly disintegrated in the gastrointestinal tract and excessive iron uptake from this product is unlikely to occur. In clinical studies, P-TOL (one tablet/dose, t.i.d.) decreased serum phosphorus levels during treatment Week 1 and allowed stable, long-term control of serum phosphorus levels. Furthermore, P-TOL was expected to reduce the tablet burden on patients and to improve medication adherence. The most common adverse reaction was diarrhea. However, in most cases, the symptoms were mild and oral administration of P-TOL could be continued. Although iron-related parameters tended to increase, iron uptake from this product was low, and the risk of iron overload was considered to be low. These findings confirm the efficacy and safety of P-TOL in CKD patients with hyperphosphatemia. Therefore, sucroferric oxyhydroxide therapy is a potentially useful treatment option for hyperphosphatemia.</p>

Journal

References(29)*help

See more

Keywords

Details 詳細情報について

Report a problem

Back to top