{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T06:05:15Z","timestamp":1778133915732,"version":"3.51.4"},"reference-count":45,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2025,1,1]],"date-time":"2025-01-01T00:00:00Z","timestamp":1735689600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T00:00:00Z","timestamp":1733097600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Controlled Release"],"published-print":{"date-parts":[[2025,1]]},"DOI":"10.1016\/j.jconrel.2024.11.062","type":"journal-article","created":{"date-parts":[[2024,12,6]],"date-time":"2024-12-06T22:50:17Z","timestamp":1733525417000},"page":"842-854","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":4,"special_numbering":"C","title":["Formulation development of dual-compartment topical inserts combining tenofovir alafenamide and elvitegravir for flexible on-demand HIV prevention"],"prefix":"10.1016","volume":"377","author":[{"given":"Vivek","family":"Agrahari","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"M. Melissa","family":"Peet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neelima","family":"Chandra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Prakash","family":"Ramalingam","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pardeep K.","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sriramakamal","family":"Jonnalagadda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Onkar N.","family":"Singh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Timothy J.","family":"McCormick","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gustavo F.","family":"Doncel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Meredith R.","family":"Clark","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"78","reference":[{"key":"10.1016\/j.jconrel.2024.11.062_bb0005","series-title":"Global HIV & AIDS statistics - fact sheet","author":"UNAIDS","year":"2024"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0010","unstructured":"Pre-Exposure Prophylaxis (PrEP), in, Centers for Disease Control and Prevention 2019."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0015","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.3004006","article-title":"Emtricitabine-tenofovir concentrations and pre-exposure prophylaxis efficacy in men who have sex with men","volume":"4","author":"Anderson","year":"2012","journal-title":"Sci. Transl. Med."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0020","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1016\/S0140-6736(20)31065-5","article-title":"Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial","volume":"396","author":"Mayer","year":"2020","journal-title":"Lancet"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0025","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pmed.1003670","article-title":"PrEP uptake, persistence, adherence, and effect of retrospective drug level feedback on PrEP adherence among young women in southern Africa: results from HPTN 082, a randomized controlled trial","volume":"18","author":"Celum","year":"2021","journal-title":"PLoS Med."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0030","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0258542","article-title":"Adolescent girls and young women\u2019s PrEP-user journey during an implementation science study in South Africa and Kenya","volume":"16","author":"Rousseau","year":"2021","journal-title":"PloS One"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0035","doi-asserted-by":"crossref","first-page":"2154","DOI":"10.1007\/s10461-020-03145-0","article-title":"The PrEP journey: understanding how internal drivers and external circumstances impact the PrEP trajectory of adolescent girls and young women in Cape Town, South Africa","volume":"25","author":"O\u2019Rourke","year":"2021","journal-title":"AIDS Behav."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0040","doi-asserted-by":"crossref","first-page":"1361","DOI":"10.1007\/s10461-016-1458-y","article-title":"Experiences with HPTN 067\/ADAPT study-provided open-label PrEP among women in Cape Town: facilitators and barriers within a mutuality framework","volume":"21","author":"Amico","year":"2017","journal-title":"AIDS Behav."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0045","first-page":"29","volume":"64","year":"2022","journal-title":"Med Lett Drugs Ther"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0050","first-page":"239","article-title":"Formulation and pharmacology of long-acting cabotegravir, Curr Opin HIV","volume":"10","author":"Trezza","year":"2015","journal-title":"AIDS"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0055","first-page":"15","article-title":"Lenacapavir: a first-in-class HIV-1 capsid inhibitor, Curr Opin HIV","volume":"17","author":"Dvory-Sobol","year":"2022","journal-title":"AIDS"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0060","doi-asserted-by":"crossref","first-page":"1774","DOI":"10.1093\/ajhp\/zxad223","article-title":"Lenacapavir: a first-in-class capsid inhibitor for the treatment of highly treatment-resistant HIV","volume":"80","author":"Prather","year":"2023","journal-title":"Am. J. Health-Syst. Pharm."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0065","doi-asserted-by":"crossref","first-page":"2121","DOI":"10.1056\/NEJMoa1506110","article-title":"Use of a vaginal ring containing Dapivirine for HIV-1 prevention in women","volume":"375","author":"Baeten","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0070","doi-asserted-by":"crossref","first-page":"2133","DOI":"10.1056\/NEJMoa1602046","article-title":"Safety and efficacy of a Dapivirine vaginal ring for HIV prevention in women","volume":"375","author":"Nel","year":"2016","journal-title":"N. Engl. J. Med."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0075","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0147743","article-title":"Safety, acceptability and adherence of Dapivirine vaginal ring in a microbicide clinical trial conducted in multiple countries in sub-Saharan Africa","volume":"11","author":"Nel","year":"2016","journal-title":"PloS One"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0080","doi-asserted-by":"crossref","first-page":"e77","DOI":"10.1016\/S2352-3018(20)30300-3","article-title":"Safety, adherence, and HIV-1 seroconversion among women using the dapivirine vaginal ring (DREAM): an open-label, extension study","volume":"8","author":"Nel","year":"2021","journal-title":"Lancet HIV"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0085","doi-asserted-by":"crossref","first-page":"1517","DOI":"10.1097\/QAD.0000000000001868","article-title":"Reasons for nonadherence to the dapivirine vaginal ring: narrative explanations of objective drug-level results","volume":"32","author":"Montgomery","year":"2018","journal-title":"Aids"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0090","doi-asserted-by":"crossref","DOI":"10.1016\/j.ebiom.2022.104361","article-title":"Single dose topical inserts containing tenofovir alafenamide fumarate and elvitegravir provide pre- and post-exposure protection against vaginal SHIV infection in macaques","volume":"86","author":"Dobard","year":"2022","journal-title":"EBioMedicine"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0095","doi-asserted-by":"crossref","DOI":"10.1016\/j.ebiom.2022.104338","article-title":"Pharmacokinetics and efficacy of topical inserts containing tenofovir alafenamide fumarate and elvitegravir administered rectally in macaques","volume":"86","author":"Makarova","year":"2022","journal-title":"EBioMedicine"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0100","doi-asserted-by":"crossref","first-page":"348","DOI":"10.3390\/pharmaceutics16030348","article-title":"Preclinical and early clinical development of Tenofovir Alafenamide\/Elvitegravir topical inserts for effective on-demand vaginal and rectal HIV prevention","volume":"16","author":"Peet","year":"2024","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0105","doi-asserted-by":"crossref","first-page":"374","DOI":"10.3390\/pharmaceutics11080374","article-title":"Topical inserts: a versatile delivery form for HIV prevention","volume":"11","author":"Peet","year":"2019","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0110","doi-asserted-by":"crossref","first-page":"91","DOI":"10.1016\/S0010-7824(99)00010-4","article-title":"A vaginal fluid simulant","volume":"59","author":"Owen","year":"1999","journal-title":"Contraception"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0115","doi-asserted-by":"crossref","first-page":"146","DOI":"10.1016\/j.jpba.2016.08.022","article-title":"Stability behaviour of antiretroviral drugs and their combinations. 4: characterization of degradation products of tenofovir alafenamide fumarate and comparison of its degradation and stability behaviour with tenofovir disoproxil fumarate","volume":"131","author":"Golla","year":"2016","journal-title":"J. Pharm. Biomed. Anal."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0120","doi-asserted-by":"crossref","first-page":"1057","DOI":"10.3390\/pharmaceutics12111057","article-title":"Performance and stability of Tenofovir Alafenamide formulations within subcutaneous biodegradable implants for HIV pre-exposure prophylaxis (PrEP)","volume":"12","author":"Li","year":"2020","journal-title":"Pharmaceutics"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0125","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijpharm.2020.119623","article-title":"Trans-urocanic acid enhances tenofovir alafenamide stability for long-acting HIV applications","volume":"587","author":"Sizovs","year":"2020","journal-title":"Int. J. Pharm."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0130","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1038\/sj.ijir.3900986","article-title":"Histological and functional aspects of different regions of the rabbit vagina","volume":"15","author":"Oh","year":"2003","journal-title":"Int J Impot Res"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0135","doi-asserted-by":"crossref","first-page":"110","DOI":"10.1159\/000070184","article-title":"Surface area of the human vagina as measured from vinyl polysiloxane casts","volume":"55","author":"Pendergrass","year":"2003","journal-title":"Gynecol. Obstet. Invest."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0140","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1530\/jrf.0.0200085","article-title":"Comparison of vaginal tolerance tests of spermicidal preparations in rabbits and monkeys","volume":"20","author":"Eckstein","year":"1969","journal-title":"J. Reprod. Fertil."},{"issue":"Suppl. 3","key":"10.1016\/j.jconrel.2024.11.062_bb0145","first-page":"S174","article-title":"Preclinical assessment of the proinflammatory potential of microbicide candidates","volume":"37","author":"Doncel","year":"2004","journal-title":"J. Acquir. Immune Defic. Syndr."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0150","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1016\/j.immuni.2007.01.007","article-title":"Initial events in establishing vaginal entry and infection by human immunodeficiency virus type-1","volume":"26","author":"Hladik","year":"2007","journal-title":"Immunity"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0155","doi-asserted-by":"crossref","first-page":"529","DOI":"10.1016\/j.chom.2016.03.005","article-title":"Th17 cells are preferentially infected very early after vaginal transmission of SIV in macaques","volume":"19","author":"Stieh","year":"2016","journal-title":"Cell Host Microbe"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0160","doi-asserted-by":"crossref","first-page":"1130101","DOI":"10.3389\/fcimb.2023.1130101","article-title":"A phase I study to assess safety, pharmacokinetics, and pharmacodynamics of a vaginal insert containing tenofovir alafenamide and elvitegravir","volume":"13","author":"Thurman","year":"2023","journal-title":"Front. Cell. Infect. Microbiol."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0165","doi-asserted-by":"crossref","first-page":"696","DOI":"10.1093\/infdis\/jiae211","article-title":"A phase 1 clinical trial to assess the safety and pharmacokinetics of a tenofovir alafenamide\/elvitegravir insert administered rectally for HIV prevention","volume":"230","author":"Riddler","year":"2024","journal-title":"The Journal of Infectious Diseases"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0170","doi-asserted-by":"crossref","unstructured":"G.K. Bolhuis, N.A. Armstrong, Excipients for direct compaction--an update, Pharm. Dev. Technol., 11 (2006) 111\u2013124.","DOI":"10.1080\/10837450500464255"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0175","doi-asserted-by":"crossref","first-page":"58","DOI":"10.1016\/S1461-5347(99)00237-0","article-title":"An overview of the different excipients useful for the direct compression of tablets","volume":"3","author":"Jivraj","year":"2000","journal-title":"Pharm. Sci. Technol. Today"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0180","doi-asserted-by":"crossref","first-page":"257","DOI":"10.3109\/10837450.2013.775154","article-title":"Why is mannitol becoming more and more popular as a pharmaceutical excipient in solid dosage forms?","volume":"19","author":"Ohrem","year":"2014","journal-title":"Pharm. Dev. Technol."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0185","doi-asserted-by":"crossref","first-page":"1551","DOI":"10.1002\/jps.2600661112","article-title":"Polyethylene glycol as a binder for tablets","volume":"66","author":"Shah","year":"1977","journal-title":"J. Pharm. Sci."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0190","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1208\/s12249-013-0007-5","article-title":"The effect of lubricants on powder flowability for pharmaceutical application","volume":"14","author":"Morin","year":"2013","journal-title":"AAPS PharmSciTech"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0195","article-title":"Pharmaceutical assessment of polyvinylpyrrolidone (PVP): as excipient from conventional to controlled delivery systems with a spotlight on COVID-19 inhibition","volume":"60","author":"Kurakula","year":"2020","journal-title":"J Drug Deliv Sci Technol"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0200","series-title":"Dosage Forms, IntechOpen, Rijeka","first-page":"3","article-title":"Multifunctional roles of PVP as a versatile biomaterial in solid state","author":"Marouene","year":"2021"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0205","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1016\/j.antiviral.2015.06.010","article-title":"The rational design and development of a dual chamber vaginal\/rectal microbicide gel formulation for HIV prevention","volume":"120","author":"Ham","year":"2015","journal-title":"Antiviral Res."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0210","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1016\/j.toxrep.2017.12.011","article-title":"Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a three-dimensional vaginal epithelium model","volume":"5","author":"Ayehunie","year":"2018","journal-title":"Toxicol. Rep."},{"key":"10.1016\/j.jconrel.2024.11.062_bb0215","article-title":"Use and procurement of additional lubricants for male and female condoms: WHO\/UNFPA\/FHI360: Advisory Note","year":"2012","journal-title":"World Health Organization (WHO)"},{"key":"10.1016\/j.jconrel.2024.11.062_bb0220","doi-asserted-by":"crossref","first-page":"890","DOI":"10.1007\/s11095-017-2129-z","article-title":"A review of disintegration mechanisms and measurement techniques","volume":"34","author":"Markl","year":"2017","journal-title":"Pharm. Res."},{"key":"10.1016\/j.jconrel.2024.11.062_bib221","doi-asserted-by":"crossref","first-page":"552","DOI":"10.1073\/pnas.90.2.552","article-title":"Erosion kinetics of hydrolytically degradable polymers","volume":"90","author":"Tamada","year":"1993","journal-title":"Proc. Natl. Acad. Sci. U. S. A."}],"container-title":["Journal of Controlled Release"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0168365924008216?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0168365924008216?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,12,19]],"date-time":"2024-12-19T21:29:38Z","timestamp":1734643778000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0168365924008216"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1]]},"references-count":45,"alternative-id":["S0168365924008216"],"URL":"https:\/\/doi.org\/10.1016\/j.jconrel.2024.11.062","relation":{},"ISSN":["0168-3659"],"issn-type":[{"value":"0168-3659","type":"print"}],"subject":[],"published":{"date-parts":[[2025,1]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Formulation development of dual-compartment topical inserts combining tenofovir alafenamide and elvitegravir for flexible on-demand HIV prevention","name":"articletitle","label":"Article Title"},{"value":"Journal of Controlled Release","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jconrel.2024.11.062","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2024 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}]}}