{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T09:24:17Z","timestamp":1782984257600,"version":"3.54.5"},"reference-count":48,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2019,7,14]],"date-time":"2019-07-14T00:00:00Z","timestamp":1563062400000},"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>Preterm birth (PTB) is a major cause of infant mortality in the United States and around the globe. Makena\u00ae\u2014once-a-week intramuscular injection of 17-\u03b1 Hydroxyprogesterone caproate (17P)\u2014is the only FDA approved treatment for the prevention of PTB. Invasive delivery of 17P requires hospitalization and expert personnel for injection. Vaginal delivery of 17P would be preferable, because of high patient compliance, reduced systemic exposure, fewer side effects, and no need for hospitalization. The objective of the present study was to prepare and evaluate a self-nanoemulsifying vaginal tablet of 17P. A solid self-nanoemulsifying preconcentrate (S-SNEDDS) of 17P and dimethylacetamide (DMA) was developed using medium chain triglycerides, a non- immunogenic surfactant, and co-processed excipient (PVA-F100). The tablet prepared was characterized for emulsification time, particle size, solid state properties, and drug release. The formulation showed &gt;50% inhibition of TNF-\u03b1 release from LPS-stimulated RAW 264.7 cells. Importantly, there were significant differences in rates of PTB and average time to delivery between control and vaginal 17P-treated groups in LPS-stimulated timed pregnant E15.5 mice. Considering the lacuna of therapeutic approaches in this area, vaginal delivery of 17P for the prevention of preterm birth has significant clinical relevance.<\/jats:p>","DOI":"10.3390\/pharmaceutics11070335","type":"journal-article","created":{"date-parts":[[2019,7,15]],"date-time":"2019-07-15T04:55:27Z","timestamp":1563166527000},"page":"335","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["17-\u03b1 Hydroxyprogesterone Nanoemulsifying Preconcentrate-Loaded Vaginal Tablet: A Novel Non-Invasive Approach for the Prevention of Preterm Birth"],"prefix":"10.3390","volume":"11","author":[{"given":"Manali","family":"Patki","sequence":"first","affiliation":[{"name":"Pharmaceutical Sciences, St. John\u2019s University, Queens, NY 11439, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiersten","family":"Giusto","sequence":"additional","affiliation":[{"name":"Pharmaceutical Sciences, St. John\u2019s University, Queens, NY 11439, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samir","family":"Gorasiya","sequence":"additional","affiliation":[{"name":"Pharmaceutical Sciences, St. John\u2019s University, Queens, NY 11439, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra E.","family":"Reznik","sequence":"additional","affiliation":[{"name":"Pharmaceutical Sciences, St. John\u2019s University, Queens, NY 11439, USA"},{"name":"Pathology and Obstetrics and Gynecology and Women\u2019s Health, Montefiore Medical Center\/Albert Einstein College of Medicine, Bronx, NY 10461, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8252-0234","authenticated-orcid":false,"given":"Ketan","family":"Patel","sequence":"additional","affiliation":[{"name":"Pharmaceutical Sciences, St. John\u2019s University, Queens, NY 11439, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2019,7,14]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"31","DOI":"10.2471\/BLT.08.062554","article-title":"The worldwide incidence of preterm birth: A systematic review of maternal mortality and morbidity","volume":"88","author":"Beck","year":"2010","journal-title":"Bull. 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