{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T06:11:53Z","timestamp":1790748713503,"version":"4.1.0"},"reference-count":39,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2023,3,10]],"date-time":"2023-03-10T00:00:00Z","timestamp":1678406400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>In the context of essential drug shortages, this article reports a proof of concept for the hospital preparation of a 2% propofol injectable nanoemulsion. Two processes for propofol were assessed: mixing propofol with the commercial Intralipid\u00ae 20% emulsion and a \u201cde novo\u201d process performed using separate raw materials (i.e., oil, water, and surfactant) and optimized for droplet size reduction with a high-pressure homogenizer. A propofol HPLC-UV stability-indicating method was developed for process validation and short-term stability. In addition, free propofol in the aqueous phase was quantified by dialysis. To envision routine production, sterility and endotoxin tests were validated. Only the \u201cde novo\u201d process using high-pressure homogenization gave satisfactory physical results similar to commercialized Diprivan\u00ae 2%. Both terminal heat sterilization processes (121 \u00b0C, 15 min and 0.22 \u00b5m filtration) were validated, but an additional pH adjustment was required prior to heat sterilization. The propofol nanoemulsion was monodisperse with a 160 nm mean droplet size, and no droplets were larger than 5\u00b5m. We confirmed that free propofol in the aqueous phase of the emulsion was similar to Diprivan 2%, and the chemical stability of propofol was validated. In conclusion, the proof of concept for the in-house 2% propofol nanoemulsion preparation was successfully demonstrated, opening the field for the possible production of the nanoemulsion in hospital pharmacies.<\/jats:p>","DOI":"10.3390\/pharmaceutics15030905","type":"journal-article","created":{"date-parts":[[2023,3,13]],"date-time":"2023-03-13T06:52:13Z","timestamp":1678690333000},"page":"905","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Hospital Production of Sterile 2% Propofol Nanoemulsion: Proof of Concept"],"prefix":"10.3390","volume":"15","author":[{"given":"Am\u00e9lie","family":"C\u00e8be","sequence":"first","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9rang\u00e8re","family":"Dessane","sequence":"additional","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4258-9204","authenticated-orcid":false,"given":"Pauline","family":"Gohier","sequence":"additional","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Marc","family":"Bernadou","sequence":"additional","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arnaud","family":"Venet","sequence":"additional","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2240-196X","authenticated-orcid":false,"given":"Fabien","family":"Xuereb","sequence":"additional","affiliation":[{"name":"Pharmaceutical Technology Department, Bordeaux University Hospital, F-33600 Pessac, France"},{"name":"INSERM, Biologie des Maladies Cardiovasculaires, University Bordeaux, U1034, F-33600 Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sylvie","family":"Crauste-Manciet","sequence":"additional","affiliation":[{"name":"Univ Angers, CHU Angers, INSERM, CNRS, MINT, SFR ICAT, UMR INSERM, F-49000 Angers, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,3,10]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"250","DOI":"10.1016\/j.ajem.2020.06.023","article-title":"Propofol and sedation in patients with coronavirus disease","volume":"42","author":"Sohn","year":"2021","journal-title":"Am. 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