Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy

Med Oncol. 2016 Aug;33(8):91. doi: 10.1007/s12032-016-0795-z. Epub 2016 Jul 14.

Abstract

We previously reported that oral ingestion of polaprezinc, a zinc-L-carnosine, suspended in sodium alginate solution prevents oral mucositis in patients receiving radiotherapy or high-dose chemotherapy. In the present study, we developed a novel preparation of polaprezinc and evaluated clinical effect of the lozenge preparation in patients receiving high-dose chemotherapy for hematopoietic stem cell transplantation. The preparation contained 18.75 mg polaprezinc in a tablet and showed an excellent uniformity and stability up to 24 weeks after storage under room temperature. The incidence rate of grade ≥ 2 oral mucositis was 74 % in patients without premedication, whereas the rate was remarkably reduced in patients receiving the suspension (23 %) or lozenge (13 %) of polaprezinc (P < 0.01). The use of non-opioid analgesic drugs such as anti-inflammatory agents and local anesthetics for oral pain was also greatly reduced by polaprezinc suspension or its lozenge (16 % for suspension and 13 % for lozenge compared with 89 % with no premedication, P < 0.01). These findings suggest that polaprezinc lozenge is simple to apply and highly effective for prevention of oral mucositis associated with high-dose chemotherapy for hematopoietic stem cell transplantation.

Keywords: Analgesic; Hematopoietic stem cell transplantation; High-dose chemotherapy; Lozenge; Oral mucositis; Polaprezinc.

MeSH terms

  • Adult
  • Aged
  • Anti-Ulcer Agents / administration & dosage*
  • Antineoplastic Agents / adverse effects*
  • Carnosine / administration & dosage
  • Carnosine / analogs & derivatives*
  • Female
  • Hematologic Neoplasms / therapy
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Male
  • Middle Aged
  • Organometallic Compounds / administration & dosage*
  • Stomatitis / chemically induced
  • Stomatitis / prevention & control*
  • Tablets / chemical synthesis
  • Transplantation Conditioning / adverse effects*
  • Young Adult
  • Zinc Compounds / administration & dosage

Substances

  • Anti-Ulcer Agents
  • Antineoplastic Agents
  • Organometallic Compounds
  • Tablets
  • Zinc Compounds
  • polaprezinc
  • Carnosine