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Stability assessment and content determination test of oral liquid forms of beclomethasone dipropionate prepared in hospital pharmacy
  1. Yuki Saeki1,
  2. Miho Sakamoto1,
  3. Yuri Saito1,
  4. Kiyoko Kishimoto1,
  5. Sotaro Goto2,
  6. Jin Suzuki1,
  7. Toshinari Suzuki1,
  8. Takako Moriyasu1,3,
  9. Akiko Inomata1
  1. 1Tokyo Metropolitan Institute for Public Health, Hyakunincho, Shinjuku-ku, Tokyo, Japan
  2. 2Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Honkomagome, Bunkyo-ku, Tokyo, Japan
  3. 3Tokyo Food Sanitation Association Food Research Laboratory, Tokumaru, Itabashi-ku, Tokyo, Japan
  1. Correspondence to Yuki Saeki, Tokyo Metropolitan Institute for Public Health, Hyakunincho, Shinjuku-ku, Tokyo 169-0073, Japan; Yuuki_Saeki{at}


Objectives Oral beclomethasone dipropionate (BDP) is known for its use as a therapeutic medicine for gastrointestinal graft-versus-host disease (GI-GVHD). Despite growing demand for oral BDP formulation, no commercial forms have yet been marketed. Therefore, at the Tokyo Metropolitan Cancer and Infectious Disease Centre Komagome Hospital, pharmacists prepare oral liquid forms of BDP for patients with upper GI-GVHD. This study aims to develop a new high performance liquid chromatography (HPLC) method for measuring BDP in the prepared formulations and assessing its quality.

Methods We developed a new HPLC method for measuring BDP in prepared formulations validated according to international guidelines. Three types of formulations were prepared and analysed using the validated HPLC method. One contains 1 mg of BDP per 30 mL aqueous solution, and the others using ethanol for preparation contain 1 mg of BDP per 15 mL aqueous solution. For stability assessment, the BDP contents were assayed while formulations were stored in plastic bottles for 8 weeks under two different conditions of 25°C in bright light and 4°C in darkness. A content determination test was also conducted to assess the individual contents of BDP and lot-to-lot variation in dosage units.

Results A stability test demonstrated that the remaining BDP content after the storage period was greater than 90% of the initial content in almost all samples regardless of storage conditions. A content determination test showed thattwo new ethanol-containing formulations contained about 0.1 mg more BDP than the original ethanol-free formulation and it was close to the target BDP content of 1 mg. Furthermore, new formulations had less lot-to-lot BDP variation in dosage units than the original formulation.

Conclusions A new HPLC method for measuring BDP in prepared formulations was developed and validated. The results of the stability test and content determination test indicated that the newly designed formulations were superior to the conventional formulation.

  • clinical medicine
  • pharmaceutical preparations
  • analytic sample preparation methods
  • quality assurance, health care
  • chemistry, pharmaceutical

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