{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T18:00:36Z","timestamp":1781632836177,"version":"3.54.5"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T00:00:00Z","timestamp":1770422400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,10]],"date-time":"2026-03-10T00:00:00Z","timestamp":1773100800000},"content-version":"vor","delay-in-days":31,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["J Pharm Health Care Sci"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Mianserin suppositories are a hospital preparation usable for patients who cannot take oral medication. However, data on the stability of hospital preparations are limited. Therefore, this study investigated the stability of mianserin suppositories over time and the appropriate storage methods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      For the long-term chemical stability testing, five conditions were compared: RL; room temperature (15\u201330\u00b0C) under ambient light, RD; room temperature in the dark, CL; cool temperature (2\u20138\u00b0C) under ambient light, CD; cool temperature in the dark, and FD; frozen temperature (\u221220\u00b0C) in the dark. High-performance liquid chromatography (HPLC) was used to compare time-dependent component contents at 0, 2, 4, 8, 16, and 24\u2009weeks (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095). Microbial limit tests for total aerobic microorganisms and fungi were conducted using the agar plate dilution method immediately after preparation and after 24\u2009weeks in RL, and after 24\u2009weeks at FD (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20094).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A gradual decline was observed under all storage conditions. The residual content rate (mean\u2009\u00b1\u2009standard error (SE)) after 24\u2009weeks was as follows: RL, 96.2\u2009\u00b1\u20090.3%; RD, 96.2\u2009\u00b1\u20090.2%; CL, 97.0\u2009\u00b1\u20090.3%; CD, 97.3\u2009\u00b1\u20090.3%; and FD, 98.3\u2009\u00b1\u20090.2%. Under all conditions\u2014immediately after preparation, after 24\u2009weeks of RL, and after 24\u2009weeks of FD\u2014the total aerobic microbial count was \u22641000 colony-forming units (CFU)\/g, and the total fungal count was \u2264100 CFU\/g.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The results showed that the residual content remained satisfactory above 95% from immediately after preparation through 24\u2009weeks under all storage conditions, ranging from RL to FD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s40780-026-00543-9","type":"journal-article","created":{"date-parts":[[2026,2,7]],"date-time":"2026-02-07T04:24:57Z","timestamp":1770438297000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Storage stability of hospital-prepared mianserin suppositories: evaluation of residual active ingredient content and bacteriological contamination under different storage conditions"],"prefix":"10.1186","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7309-7374","authenticated-orcid":false,"given":"Rei","family":"Tanaka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-0873-4857","authenticated-orcid":false,"given":"Tomoe","family":"Ichikawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2478-0190","authenticated-orcid":false,"given":"Junya","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,2,7]]},"reference":[{"key":"543_CR1","unstructured":"Hanawa T. In-hospital preparations for the assistance of the medication evidence based quality management of the In-hospital formulations. J Pharm Sci Technol Jpn. 2012;72:9\u201314."},{"key":"543_CR2","doi-asserted-by":"crossref","unstructured":"Eslick GD, Talley NJ. Dysphagia: epidemiology, risk factors and impact on quality of life\u2015a population-based study. Aliment Pharmacol Ther. 2008;27:971\u201379.","DOI":"10.1111\/j.1365-2036.2008.03664.x"},{"key":"543_CR3","doi-asserted-by":"crossref","unstructured":"Frowen J, Hughes R, Skeat J. The prevalence of patient-reported dysphagia and oral complications in cancer patients. Support Care Cancer. 2020;28:1141\u201350.","DOI":"10.1007\/s00520-019-04921-y"},{"key":"543_CR4","doi-asserted-by":"crossref","unstructured":"Masman AD, van Dijk M, Tibboel D, Baar FP, Math\u00f4t RA. Medication use during end-of-life care in a palliative care centre. Int J Clin Pharm. 2015;37:767\u201375.","DOI":"10.1007\/s11096-015-0094-3"},{"key":"543_CR5","doi-asserted-by":"crossref","unstructured":"Coyle N, Adelhardt J, Foley KM, Portenoy RK. Character of terminal illness in the advanced cancer patient: pain and other symptoms during the last four weeks of life. J Pain Symptom Manage. 1990;5:83\u201393.","DOI":"10.1016\/S0885-3924(05)80021-1"},{"key":"543_CR6","doi-asserted-by":"crossref","unstructured":"Matsumoto K, Kimura S, Takahashi K, Yokoyama Y, Miyazawa M, Kushibiki S, et al. Pharmaceutical studies on and clinical application of olanzapine suppositories prepared as a hospital preparation. J Pharm Health Care Sci. 2016;2:20.","DOI":"10.1186\/s40780-016-0055-6"},{"key":"543_CR7","first-page":"47","volume":"16","author":"J Sato","year":"2023","unstructured":"Sato J, Fujimoto T, Umeda S, Tsukagoshi M, Tanaka R. Experience with preparation and use of hospital preparation of perospirone suppositories for patients with delirium. Jpn J Pharm Palliat Care Sci. 2023;16:47\u201351.","journal-title":"Jpn J Pharm Palliat Care Sci"},{"key":"543_CR8","first-page":"1024","volume":"13","author":"J Nakamura","year":"1995","unstructured":"Nakamura J, Uchimura N. Mianserin in treatment of delirium and its mechanism. J Clin Exp Med. 1995;13:1024\u201325.","journal-title":"J Clin Exp Med"},{"key":"543_CR9","doi-asserted-by":"publisher","first-page":"147","DOI":"10.1097\/00004850-199705000-00005","volume":"12","author":"J Nakamura","year":"1997","unstructured":"Nakamura J, Uchimura N, Yamada S, Nakazawa Y. Does plasma free-3-methoxy-4-hydroxyphenyl(ethylene)glycol increase in the delirious state? A comparison of the effects of mianserin and haloperidol on delirium. Int Clin Psychopharmacol. 1997;12:147\u201352.","journal-title":"Int Clin Psychopharmacol"},{"key":"543_CR10","volume-title":"Japanese association of supportive care in cancer. Clinical guidelines for delirium in adult cancer patients (2025 version)","author":"Japan Psycho-Oncology Society","year":"2025","unstructured":"Japan Psycho-Oncology Society. Japanese association of supportive care in cancer. Clinical guidelines for delirium in adult cancer patients (2025 version). Tokyo: Kanehara & Co., Ltd; 2025."},{"key":"543_CR11","doi-asserted-by":"publisher","first-page":"702","DOI":"10.5649\/jjphcs.38.702","volume":"38","author":"T Nakajima","year":"2012","unstructured":"Nakajima T, Iwata M, Nawata S, Saito H, Nakamura Y, Kobayashi Y, et al. Physicopharmaceutical approach for hospital preparation of mianserin hydrochloride suppositories. Jpn J Pharm Health Care Sci. 2012;38:702\u201307.","journal-title":"Jpn J Pharm Health Care Sci"},{"key":"543_CR12","doi-asserted-by":"publisher","first-page":"12","DOI":"10.1186\/s40780-016-0046-7","volume":"2","author":"S Nawata","year":"2016","unstructured":"Nawata S, Kohyama N, Uchida N, Numazawa S, Ohbayashi M, Kobayashi Y, et al. The pharmacokinetics of mianserin suppositories for rectal administration in dogs and healthy volunteers: a pilot study. J Pharm Health Care Sci. 2016;2:12.","journal-title":"J Pharm Health Care Sci"},{"key":"543_CR13","first-page":"1127","volume":"1","author":"R Tanaka","year":"2016","unstructured":"Tanaka R, Ishikawa H, Sato T, Shino M, Matsumoto T, Omae K, et al. Delirium improvement with mianserin suppositories in cancer patients. Clin Oncol (Belmont). 2016;1:1127.","journal-title":"Clin Oncol (Belmont)"},{"key":"543_CR14","unstructured":"The Japanese Society of Hospital Pharmacists. Guidelines for the making and use of hospital preparations. https:\/\/www.jshp.or.jp\/activity\/guideline\/20230206-2.pdf. revised in 2023 January. 2023. Accessed 22 Dec 2025."},{"key":"543_CR15","first-page":"18","volume":"20","author":"N Kase","year":"1996","unstructured":"Kase N, Yazaki H, Fukushima E. Determination of lidocaine in suppositories. Bull of The Public Health Lab of Chiba Prefecture. 1996;20:18\u201322.","journal-title":"Bull Of The Public Health Lab Of Chiba Prefecture"},{"key":"543_CR16","first-page":"173","volume":"58","author":"T Sakakibara","year":"2022","unstructured":"Sakakibara T, Kume T, Harada S, Ikeuchi S, Morimoto A, Shino M. Stability of mouthwash based on betamethasone sodium phosphate. J Jpn Soc Hosp Pharm. 2022;58:173\u201376.","journal-title":"J Jpn Soc Hosp Pharm"},{"key":"543_CR17","unstructured":"The Japanese ministry of Health, labour and welfare. The Jpn Pharmacopoeia, 18th Edition. 2021. https:\/\/www.pmda.go.jp\/rs-std-jp\/standards-development\/jp\/0192.html. Accessed 22 Dec 2025."},{"key":"543_CR18","unstructured":"Organon-Japan. Tetramide\u00ae tablets interview form. 17th ed. Revised in Feb 2024."},{"key":"543_CR19","doi-asserted-by":"publisher","first-page":"31","DOI":"10.1007\/s12393-021-09292-x","volume":"14","author":"M Peleg","year":"2022","unstructured":"Peleg M. A New look at models of the combined effect of temperature, pH, water activity, or other factors on microbial growth rate. Food Eng Rev. 2022;14:31\u201344.","journal-title":"Food Eng Rev"},{"key":"543_CR20","first-page":"20","volume":"72","author":"Y Yanagihara","year":"2012","unstructured":"Yanagihara Y. Role and task of Pharmaceutical manufacturing in clinical practice. J Pharm Sci Technol Jpn. 2012;72:20\u201325.","journal-title":"J Pharm Sci Technol Jpn"},{"key":"543_CR21","unstructured":"Nakamura J, Uchimura N, Yamada S, Nakazawa Y. Effects of mianserin hydrochloride on delirium: comparison with the effects of oxypertine and haloperidol. Jpn J Neuropsychopharmacol. 1994;14:269\u201377."},{"key":"543_CR22","unstructured":"Kishimoto K, Nagashima M, Shigeoka S, Minowa K, Kadoi H, Moriyasu T, et al. Quality control for hospital preparation of medicine - the stability test -. Ann Rep Tokyo Metr Inst Pub Health. 2006;57:93\u201399."},{"key":"543_CR23","doi-asserted-by":"crossref","unstructured":"Takeuchi K, Koh M, Tamura A, Amasaki M, Ueda H. Experience in using In-hospital formulation quetiapine suppositories for delirium in cancer patients. Palliat Care Res. 2017;12:717\u201322.","DOI":"10.2512\/jspm.12.717"}],"container-title":["Journal of Pharmaceutical Health Care and Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s40780-026-00543-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40780-026-00543-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s40780-026-00543-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T17:42:38Z","timestamp":1781631758000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s40780-026-00543-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2,7]]},"references-count":23,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["543"],"URL":"https:\/\/doi.org\/10.1186\/s40780-026-00543-9","relation":{"has-preprint":[{"id-type":"doi","id":"10.21203\/rs.3.rs-8418873\/v1","asserted-by":"object"}]},"ISSN":["2055-0294"],"issn-type":[{"value":"2055-0294","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2,7]]},"assertion":[{"value":"21 December 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 January 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 February 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human ethics and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"31"}}