Evaluation of the Stability of Indomethacin Oral Spray in Two Different Formulation Conditions
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- Tazawa Yuki
- Department of Pharmacy, Hokkaido University Hospital
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- Kagami Keisuke
- Department of Pharmacy, Hokkaido University Hospital
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- Watanabe Yuko
- Department of Pharmacy, Hokkaido University Hospital
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- Kubota Kosei
- Department of Pharmacy, Hokkaido University Hospital
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- Harada Sachiko
- Department of Pharmacy, Hokkaido University Hospital
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- Kobayashi Masaki
- Department of Pharmacy, Hokkaido University Hospital
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- Yamada Takehiro
- Department of Pharmacy, Hokkaido University Hospital
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- Iseki Ken
- Department of Pharmacy, Hokkaido University Hospital Laboratory of Clinical Pharmaceutics and Therapeutics, Division of Pharmasciences, Faculty of Pharmaceutical Sciences, Hokkaido University
Bibliographic Information
- Other Title
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- 製剤組成が異なる2種類のインドメタシン口腔スプレーの安定性評価
- セイザイ ソセイ ガ コトナル 2シュルイ ノ インドメタシン コウコウ スプレー ノ アンテイセイ ヒョウカ
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Abstract
Indomethacin (IM) oral spray is a hospital preparation that is used to reduce pain from oral mucositis induced by radiotherapy and chemotherapy. IM oral spray consists of IM (0.25%) dissolved in KH2PO4-NaOH buffer (Formulation A) or Formulation A containing xylitol (Xyl) and glycerin (Gly) (Formulation B). To clarify the stability of IM oral spray in two different formulation conditions, we evaluated the residual rates of IM in these formulations to determine the optimal storage temperature and shelf-life. IM oral spray was stored at freezer temperature (−20°C), refrigerator temperature (4°C) and room temperature (25°C) for up to 16 weeks after preparation. The residual rate of IM was determined by using HPLC. The residual rates of IM in Formulation A and Formulation B after storage for 16 weeks at freezer temperature were ≥95%. When stored at refrigerator temperature, the residual rate of IM in Formulation A was 96.1% after 12 weeks, and the residual rates of IM in Formulation B were 95.8% after 2 weeks, 90.1% after 4 weeks and 72.7% after 12 weeks. These results suggested that Formulation A is stable for at least 12 weeks when stored at 4°C. However, degradation of IM seemed to be accelerated in the formulation containing Xyl and Gly, suggesting that the expiration date should be shortened to 2 weeks at 4°C. In addition, both formulations were stable for at least 16 weeks in a freezer, indicating that long-term preservation is possible.<br>
Journal
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- YAKUGAKU ZASSHI
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YAKUGAKU ZASSHI 138 (4), 565-570, 2018-04-01
The Pharmaceutical Society of Japan
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Details 詳細情報について
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- CRID
- 1390282681192835968
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- NII Article ID
- 130006601898
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- NII Book ID
- AN00284903
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- ISSN
- 13475231
- 00316903
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- NDL BIB ID
- 028963468
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- PubMed
- 29608007
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- Text Lang
- ja
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- Data Source
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- JaLC
- NDL
- Crossref
- PubMed
- CiNii Articles
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- Abstract License Flag
- Disallowed