Stability assessment and content determination test of oral liquid forms of beclomethasone dipropionate prepared in hospital pharmacy

Yuki Saeki; Miho Sakamoto; Yuri Saito; Kiyoko Kishimoto; Sotaro Goto; Jin Suzuki; Toshinari Suzuki; Takako Moriyasu; Akiko Inomata

doi:10.1136/ejhpharm-2023-003742

Stability assessment and content determination test of oral liquid forms of beclomethasone dipropionate prepared in hospital pharmacy

Eur J Hosp Pharm. 2023 Aug 14:ejhpharm-2023-003742. doi: 10.1136/ejhpharm-2023-003742. Online ahead of print.

Authors

Yuki Saeki¹, Miho Sakamoto², Yuri Saito², Kiyoko Kishimoto², Sotaro Goto³, Jin Suzuki², Toshinari Suzuki², Takako Moriyasu^{2

4}, Akiko Inomata²

Affiliations

¹ Tokyo Metropolitan Institute for Public Health, Hyakunincho, Shinjuku-ku, Tokyo, Japan Yuuki_Saeki@member.metro.tokyo.jp.
² Tokyo Metropolitan Institute for Public Health, Hyakunincho, Shinjuku-ku, Tokyo, Japan.
³ Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Honkomagome, Bunkyo-ku, Tokyo, Japan.
⁴ Tokyo Food Sanitation Association Food Research Laboratory, Tokumaru, Itabashi-ku, Tokyo, Japan.

PMID: 37580117
DOI: 10.1136/ejhpharm-2023-003742

Abstract

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.

Keywords: analytic sample preparation methods; chemistry, pharmaceutical; clinical medicine; pharmaceutical preparations; quality assurance, health care.