Design and Development of a Topical Emulogel Formulation Containing Tenofovir Disoproxil by Factorial Design

Design and Development of a Topical Emulogel Formulation Containing Tenofovir Disoproxil by Factorial Design | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Design and Development of a Topical Emulogel Formulation Containing Tenofovir Disoproxil by Factorial Design TARAKARAMARAO CHALLA, RamyaDevi B This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7828983/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 21 Mar, 2026 Read the published version in Journal of Pharmaceutical Innovation → Version 1 posted You are reading this latest preprint version Abstract Background: Tenofovir disoproxil is a drug used to treat chronic hepatitis as well as HIV/AIDS prevention for skin or mucus membrane. Aim: The 2 3 factorial design was chosen because it necessitates the application of design, which exhibited 13 experimental runs constructed using design expert software. Materials and Methods: The independent variables include methocel k100 LV (X1), Koliphor p188 (X2), and Tween 80 (X3), with an experimental design. Using FTIR and DSC, the prepared emulgels were evaluated for their physical appearance, spreadability, pH, washability, in-vitro dissolution studies, ex-vivo diffusion studies, in-vitro intestinal permeability studies, polydispersity index, particle size, and zeta potential, drug release kinetics, and drug-excipient compatibility studies . Results and Conclusion: The product is easy to spread and wash, and no skin sensitivity has been noted. The order of drug dissolution in various formulations is illustrated below: E5<E7<E6<E10<E1=E3=E4=E8=E11=E12=E13<E9<E2. The formulation R 2 was greater when fitted to the first order equation, indicating that the formulations had a first order release in E2, E9, and E10. The high R 2 with Higuchi is exhibited in E1, E3, E4, E5, E6, E7, E8, E11, E12, and E13. The release exponent ('n' value) formulation E5 demonstrates fickian diffusion, while E1, E3, E8, E11, E12, and E13 demonstrate a non-fickian diffusion mechanism. E2, E4, E6, E7, E9, and E10 illustrate super case II transport. The E5 formulation follows Higuchi diffusion, and diffusion exponents less than 0.5 suggest Fickian diffusion. Ex vivo diffusion tests were performed to optimise formulation E5 using sheep skin, resulting in 100% drug release within 6.0 hours of diffusion. The drug release has zero order kinetics (r 2 =0.8741) and fickian diffusion (n=0.2597). In vitro intestinal permeability studies were conducted to optimise formulation E5 utilising sheep intestine (T100) for 100% drug release in 5.0 hours. The medication is released through Higuchi diffusion (r 2 =0.8831) and non-fickian diffusion (n=0.6923). The FTIR and DSC investigations revealed no interactions between tenofovir and the various excipients used. The particle size of the emulgel formulation (E5) was found to be 244.3nm, with a polydispersity index of 0.113. This revealed a relatively homogeneous dispersion, with formulation E5 having a zeta potential of -43.1mv. The ANOVA of the time required for 100% drug release (T100) was statistically significant (p<0.0078). Emulgel Tenofovir disoproxil Ex vivo diffusion In vitro zeta potential Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 21 Mar, 2026 Read the published version in Journal of Pharmaceutical Innovation → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7828983","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":554934526,"identity":"a1d86334-e8dd-4988-a68e-390198b32cb8","order_by":0,"name":"TARAKARAMARAO 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Design","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Emulgel, Tenofovir disoproxil, Ex vivo diffusion, In vitro, zeta potential","lastPublishedDoi":"10.21203/rs.3.rs-7828983/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7828983/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Tenofovir disoproxil is a drug used to treat chronic hepatitis as well as HIV/AIDS prevention for skin or mucus membrane. \u003cstrong\u003eAim:\u003c/strong\u003e The 2\u003csup\u003e3\u003c/sup\u003e factorial design was chosen because it necessitates the application of design, which exhibited 13 experimental runs constructed using design expert software.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods:\u003c/strong\u003e The independent variables include methocel k100 LV (X1), Koliphor p188 (X2), and Tween 80 (X3), with an experimental design. Using FTIR and DSC, the prepared emulgels were evaluated for their physical appearance, spreadability, pH, washability, in-vitro dissolution studies, ex-vivo diffusion studies, in-vitro intestinal permeability studies, polydispersity index, particle size, and zeta potential, drug release kinetics, and drug-excipient compatibility studies\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults and Conclusion:\u003c/strong\u003e The product is easy to spread and wash, and no skin sensitivity has been noted. \u0026nbsp;The order of drug dissolution in various formulations is illustrated below: E5\u0026lt;E7\u0026lt;E6\u0026lt;E10\u0026lt;E1=E3=E4=E8=E11=E12=E13\u0026lt;E9\u0026lt;E2. The formulation R\u003csup\u003e2\u003c/sup\u003e was greater when fitted to the first order equation, indicating that the formulations had a first order release in E2, E9, and E10. The high R\u003csup\u003e2\u003c/sup\u003e with Higuchi is exhibited in E1, E3, E4, E5, E6, E7, E8, E11, E12, and E13. The release exponent ('n' value) formulation E5 demonstrates fickian diffusion, while E1, E3, E8, E11, E12, and E13 demonstrate a non-fickian diffusion mechanism. E2, E4, E6, E7, E9, and E10 illustrate super case II transport. The E5 formulation follows Higuchi diffusion, and diffusion exponents less than 0.5 suggest Fickian diffusion. Ex vivo diffusion tests were performed to optimise formulation E5 using sheep skin, resulting in 100% drug release within 6.0 hours of diffusion. The drug release has zero order kinetics (r\u003csup\u003e2\u003c/sup\u003e=0.8741) and fickian diffusion (n=0.2597). In vitro intestinal permeability studies were conducted to optimise formulation E5 utilising sheep intestine (T100) for 100% drug release in 5.0 hours.\u0026nbsp; The medication is released through Higuchi diffusion (r\u003csup\u003e2\u003c/sup\u003e=0.8831) and non-fickian diffusion (n=0.6923). The FTIR and DSC investigations revealed no interactions between tenofovir and the various excipients used.\u0026nbsp; The particle size of the emulgel formulation (E5) was found to be 244.3nm, with a polydispersity index of 0.113. This revealed a relatively homogeneous dispersion, with formulation E5 having a zeta potential of -43.1mv. The ANOVA of the time required for 100% drug release (T100) was statistically significant (p\u0026lt;0.0078).\u003c/p\u003e","manuscriptTitle":"Design and Development of a Topical Emulogel Formulation Containing Tenofovir Disoproxil by Factorial Design","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-12-05 06:30:49","doi":"10.21203/rs.3.rs-7828983/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"efb94099-832d-4d93-98a5-e7dd1de361bb","owner":[],"postedDate":"December 5th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-03-23T16:05:21+00:00","versionOfRecord":{"articleIdentity":"rs-7828983","link":"https://doi.org/10.1007/s12247-026-10543-9","journal":{"identity":"journal-of-pharmaceutical-innovation","isVorOnly":false,"title":"Journal of Pharmaceutical Innovation"},"publishedOn":"2026-03-21 15:58:31","publishedOnDateReadable":"March 21st, 2026"},"versionCreatedAt":"2025-12-05 06:30:49","video":"","vorDoi":"10.1007/s12247-026-10543-9","vorDoiUrl":"https://doi.org/10.1007/s12247-026-10543-9","workflowStages":[]},"version":"v1","identity":"rs-7828983","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7828983","identity":"rs-7828983","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}