Solid-State Screening and Development of Ranolazine Polymorph under different conditions

Solid-State Screening and Development of Ranolazine Polymorph under different conditions | 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 Article Solid-State Screening and Development of Ranolazine Polymorph under different conditions Sunita N. Vaidya, Surendra Agrawal, Pranita Jirvankar, Nikita Chambhare, and 1 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5910579/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Purpose The goal of the research was to see if a polymorph of RNZ may improve the medicine's permeability and water solubility. Methods For determination of solvents effect, pure drug (RNZ) was recrystallized from various solvents and crystals obtained were studied for IR. The effect of temperature and humidity was determined by keeping the RNZ crystals at 0 o C, 40 o C and 70 o C for humidity at 75% RH and crystals were studied for IR for any change of RNZ polymorph were created with the solvent evaporation technique. The improved polymorph was physically and chemically characterized by using FT-IR, DSC, XRD and POM. The solubility study of crystalline forms in water and the impact of crystallization on temperature and humidity on crystalline phases was carried out. Results The DSC thermograms of a pure drug (RNZ) and polymorph are studied for a pure drug (RNZ), lone endothermic peak was It has been seen and is situated at 122 o C. This spectrum neither showed the presence of water of crystallization nor any indication of glass transition. DSC thermogram of polymorph which was recrystallized from ethanol, exhibited a single endothermic peak at 137 o C. According to the XRD study, the diffraction lines of a pure drug (RNZ) were matching with the polymorph. The solvents used for the purification of RNZ exhibited differences in the crystal lattice as supported by FT-IR. Conclusion The solvents used for the purification of RNZ exhibited differences in the crystal lattice. It was interesting to investigate the factors affecting RNZ polymorphic transformation. The transformation was noted at RH = 75% (± 5) for form II while both the formed showed stability at different temperatures. Biological sciences/Biochemistry/Biocatalysis Biological sciences/Biochemistry/Structural biology polymorph X-ray diffraction Differential scanning calorimeter Furious transfer Infra-Red Spectroscopy Polarized optical microscopy solubility Full Text Additional Declarations Competing interest reported. All authors have not conflict of interest for publication. Cite Share Download PDF Status: Posted 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-5910579","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":411615325,"identity":"a0c617b4-7471-4d0e-9c56-a477becb302e","order_by":0,"name":"Sunita N. 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All authors have not conflict of interest for publication.","formattedTitle":"Solid-State Screening and Development of Ranolazine Polymorph under different conditions","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"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":"polymorph, X-ray diffraction, Differential scanning calorimeter, Furious transfer Infra-Red Spectroscopy, Polarized optical microscopy, solubility","lastPublishedDoi":"10.21203/rs.3.rs-5910579/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5910579/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003ePurpose\u003c/h2\u003e \u003cp\u003eThe goal of the research was to see if a polymorph of RNZ may improve the medicine's permeability and water solubility.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eFor determination of solvents effect, pure drug (RNZ) was recrystallized from various solvents and crystals obtained were studied for IR. The effect of temperature and humidity was determined by keeping the RNZ crystals at 0\u003csup\u003eo\u003c/sup\u003eC, 40\u003csup\u003eo\u003c/sup\u003eC and 70\u003csup\u003eo\u003c/sup\u003eC for humidity at 75% RH and crystals were studied for IR for any change of RNZ polymorph were created with the solvent evaporation technique. The improved polymorph was physically and chemically characterized by using FT-IR, DSC, XRD and POM. The solubility study of crystalline forms in water and the impact of crystallization on temperature and humidity on crystalline phases was carried out.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe DSC thermograms of a pure drug (RNZ) and polymorph are studied for a pure drug (RNZ), lone endothermic peak was It has been seen and is situated at 122\u003csup\u003eo\u003c/sup\u003eC. This spectrum neither showed the presence of water of crystallization nor any indication of glass transition. DSC thermogram of polymorph which was recrystallized from ethanol, exhibited a single endothermic peak at 137\u003csup\u003eo\u003c/sup\u003eC. According to the XRD study, the diffraction lines of a pure drug (RNZ) were matching with the polymorph. The solvents used for the purification of RNZ exhibited differences in the crystal lattice as supported by FT-IR.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eThe solvents used for the purification of RNZ exhibited differences in the crystal lattice. It was interesting to investigate the factors affecting RNZ polymorphic transformation. The transformation was noted at RH\u0026thinsp;=\u0026thinsp;75% (\u0026plusmn;\u0026thinsp;5) for form II while both the formed showed stability at different temperatures.\u003c/p\u003e","manuscriptTitle":"Solid-State Screening and Development of Ranolazine Polymorph under different conditions","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-06 10:29:18","doi":"10.21203/rs.3.rs-5910579/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":"978c40a9-02f2-43fc-bc43-e700c7f77231","owner":[],"postedDate":"February 6th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":43890695,"name":"Biological sciences/Biochemistry/Biocatalysis"},{"id":43890696,"name":"Biological sciences/Biochemistry/Structural biology"}],"tags":[],"updatedAt":"2025-02-10T06:08:47+00:00","versionOfRecord":[],"versionCreatedAt":"2025-02-06 10:29:18","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5910579","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5910579","identity":"rs-5910579","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}