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<article article-type="research-article" dtd-version="1.2" xml:lang="ru" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink"><front><journal-meta><journal-id journal-id-type="issn">2658-6533</journal-id><journal-title-group><journal-title>Research Results in Biomedicine</journal-title></journal-title-group><issn pub-type="epub">2658-6533</issn></journal-meta><article-meta><article-id pub-id-type="doi">10.18413/2658-6533-2026-12-2-0-5</article-id><article-id pub-id-type="publisher-id">4155</article-id><article-categories><subj-group subj-group-type="heading"><subject>Pharmacology</subject></subj-group></article-categories><title-group><article-title>&lt;strong&gt;Optimization of Naltrexone and Nicotine Co-Delivery via PVP/PVA Microneedle Systems: A Translational Approach&lt;/strong&gt;&lt;br /&gt;
&amp;nbsp;</article-title><trans-title-group xml:lang="en"><trans-title>&lt;strong&gt;Optimization of Naltrexone and Nicotine Co-Delivery via PVP/PVA Microneedle Systems: A Translational Approach&lt;/strong&gt;&lt;br /&gt;
&amp;nbsp;</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><name-alternatives><name xml:lang="ru"><surname>Raikar</surname><given-names>Amisha S.</given-names></name><name xml:lang="en"><surname>Raikar</surname><given-names>Amisha S.</given-names></name></name-alternatives><email>amisharaikarofficial@gmail.com</email></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="ru"><surname>Bhilegaonkar</surname><given-names>Shilpa P.</given-names></name><name xml:lang="en"><surname>Bhilegaonkar</surname><given-names>Shilpa P.</given-names></name></name-alternatives><email>shilpabhilegaonkar@gmail.com</email></contrib></contrib-group><pub-date pub-type="epub"><year>2026</year></pub-date><volume>12</volume><issue>2</issue><fpage>0</fpage><lpage>0</lpage><self-uri content-type="pdf" xlink:href="/media/medicine/2026/2/Биомедисследования-100-113.pdf" /><abstract xml:lang="ru"><p>Background: Addiction to alcohol and nicotine remains a global health challenge, with current treatment options often hindered by issues of frequent dosing and low patient adherence. Transdermal drug delivery systems, such as microneedle patches, offer a promising solution to overcome these limitations by enabling controlled and sustained drug release. The aim of the study: To optimize and characterize microneedle patches for the transdermal delivery of Naltrexone HCl and Nicotine USP to support alcohol and smoking cessation. The goal is to enhance treatment efficacy and patient adherence through advanced drug delivery systems. Materials and methods: The research began with preformulation analyses to assess the solubility, thermal behaviour, and structural integrity of the drugs, ensuring their suitability for incorporation into microneedle patches. Various formulations were developed, varying the concentrations of Polyvinylpyrrolidone (PVP) and incorporating 3% Tween 80 as a permeation enhancer. In vitro studies were conducted to evaluate drug release profiles and permeation capabilities. Results: Microneedle patches demonstrated significant cumulative drug permeation, highlighting their potential for effective transdermal delivery. Formulations with reduced PVP ratios exhibited slower drug release rates. However, the addition of 3% Tween 80 successfully enhanced drug release, achieving complete drug permeation over time. These findings underscore the patches&amp;#39; ability to provide controlled release while maintaining structural integrity. Conclusion: The optimized microneedle patches present a novel approach to managing alcohol and nicotine addiction by addressing challenges related to frequent dosing and adherence. By improving drug delivery efficiency and patient compliance, these systems hold significant potential to enhance the success of addiction treatment strategies</p></abstract><trans-abstract xml:lang="en"><p>Background: Addiction to alcohol and nicotine remains a global health challenge, with current treatment options often hindered by issues of frequent dosing and low patient adherence. Transdermal drug delivery systems, such as microneedle patches, offer a promising solution to overcome these limitations by enabling controlled and sustained drug release. The aim of the study: To optimize and characterize microneedle patches for the transdermal delivery of Naltrexone HCl and Nicotine USP to support alcohol and smoking cessation. The goal is to enhance treatment efficacy and patient adherence through advanced drug delivery systems. Materials and methods: The research began with preformulation analyses to assess the solubility, thermal behaviour, and structural integrity of the drugs, ensuring their suitability for incorporation into microneedle patches. Various formulations were developed, varying the concentrations of Polyvinylpyrrolidone (PVP) and incorporating 3% Tween 80 as a permeation enhancer. In vitro studies were conducted to evaluate drug release profiles and permeation capabilities. Results: Microneedle patches demonstrated significant cumulative drug permeation, highlighting their potential for effective transdermal delivery. Formulations with reduced PVP ratios exhibited slower drug release rates. However, the addition of 3% Tween 80 successfully enhanced drug release, achieving complete drug permeation over time. These findings underscore the patches&amp;#39; ability to provide controlled release while maintaining structural integrity. Conclusion: The optimized microneedle patches present a novel approach to managing alcohol and nicotine addiction by addressing challenges related to frequent dosing and adherence. By improving drug delivery efficiency and patient compliance, these systems hold significant potential to enhance the success of addiction treatment strategies</p></trans-abstract><kwd-group xml:lang="ru"><kwd>Microneedle Patches</kwd><kwd>Transdermal Drug Delivery</kwd><kwd>Naltrexone Hydrochloride</kwd><kwd>Nicotine</kwd><kwd>Addiction Treatment</kwd></kwd-group><kwd-group xml:lang="en"><kwd>Microneedle Patches</kwd><kwd>Transdermal Drug Delivery</kwd><kwd>Naltrexone Hydrochloride</kwd><kwd>Nicotine</kwd><kwd>Addiction Treatment</kwd></kwd-group></article-meta></front><back><ack><p>The authors wish to express their gratitude to Mihir Virji (Nico Orgo) for generously providing a sample of nicotine for this research</p></ack><ref-list><title>Список литературы</title><ref id="B1"><mixed-citation>Robinson LE, Didier N, Thomas R, et al. Combination Treatment with Varenicline and Nicotine Patch on Smoking Cessation Outcomes in Heavy Drinkers at 26-Week Follow-up. Journal of Clinical Psychopharmacology. 2022;44(4):362-368. DOI: 10.1097/JCP.0000000000001864</mixed-citation></ref><ref id="B2"><mixed-citation>Dodd S, Harper J, Berk M. Current Pharmacotherapies for Smoking Cessation and Promising Emerging Drugs. Current Reviews in Clinical and Experimental Pharmacology. 2024;19(3):259-268. DOI: https://doi.org/10.2174/0127724328274939231121114142</mixed-citation></ref><ref id="B3"><mixed-citation>Nunez C, Hoots JK, Schepers ST, et al. Pharmacological investigations of effort-based decision-making in humans: Naltrexone and nicotine. PLoS ONE. 2022;17(10):e0275027. DOI: https://doi.org/10.1371/journal.pone.0275027</mixed-citation></ref><ref id="B4"><mixed-citation>Gude S. Exploring innovative drug delivery systems for the targeted treatment and rehabilitation of individuals affected by narcotics and psychotropic substances: a multidisciplinary approach in pharmaceutics. Translational and Regulatory Sciences. 2024;6(3):72-83. DOI: https://doi.org/10.33611/trs.2024-003</mixed-citation></ref><ref id="B5"><mixed-citation>Shang X, Guo K, E F, et al. Pharmacological interventions on smoking cessation: a systematic review and network meta-analysis. Frontiers in Pharmacology. 2022;13:1012433. DOI: https://doi.org/10.3389/fphar.2022.1012433</mixed-citation></ref><ref id="B6"><mixed-citation>Wang AL, Shi Z, Elman I, et al. Reduced cigarette smoking during injectable extended-release naltrexone treatment for opioid use disorder. American Journal of Drug and Alcohol Abuse. 2020;46(4):472-477. DOI: https://doi.org/10.1080/00952990.2020.1741001</mixed-citation></ref><ref id="B7"><mixed-citation>Ward HB, Beermann A, Nawaz U, et al. Evidence for schizophrenia-specific pathophysiology of nicotine dependence. Frontiers in Psychiatry. 2022;13:804055. DOI: https://doi.org/10.3389/fpsyt.2022.804055</mixed-citation></ref><ref id="B8"><mixed-citation>Lin C, Gaiha SM, Halpern-Felsher B. Nicotine dependence from different e-cigarette devices and combustible cigarettes among US adolescent and young adult users. International Journal of Environmental Research and Public Health. 2022;19(10):5846. DOI: https://doi.org/10.3390/ijerph19105846</mixed-citation></ref><ref id="B9"><mixed-citation>Liu Y, Han F, Xia Z, et al. The effects of bupropion alone and combined with naltrexone on weight loss: a systematic review and meta-regression analysis of randomized controlled trials. Diabetology &amp;amp; Metabolic Syndrome. 2024;16(1):93. DOI: https://doi.org/10.1186/s13098-024-01319-7</mixed-citation></ref><ref id="B10"><mixed-citation>El Hayek SA, Shatila MA, Adnan JA, et al. Is there a therapeutic potential in combining bupropion and naltrexone in schizophrenia? Expert Review of Neurotherapeutics. 2022;22(9):737-749. DOI: https://doi.org/10.1080/14737175.2022.2124369</mixed-citation></ref><ref id="B11"><mixed-citation>Avery J. Naltrexone and alcohol use. American Journal of Psychiatry. 2022;179(12):886-887. DOI: https://doi.org/10.1176/appi.ajp.20220821</mixed-citation></ref><ref id="B12"><mixed-citation>Ayyala D, Bottyan T, Tien C, et al. Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease. Hepatology Communications. 2022;6(12):3433-3442. DOI: https://doi.org/10.1002/hep4.2080</mixed-citation></ref><ref id="B13"><mixed-citation>Santos GM, Ikeda J, Coffin P, et al. Targeted oral naltrexone for mild to moderate alcohol use disorder among sexual and gender minority men: a randomized trial. American Journal of Psychiatry. 2022;179(12):915-926. DOI: https://doi.org/10.1176/appi.ajp.20220335</mixed-citation></ref><ref id="B14"><mixed-citation>Kedia SK, Ahuja N, Dillon PJ, et al. Efficacy of Extended-Release Injectable Naltrexone on Alcohol Use Disorder Treatment: A Systematic Review. Journal of Psychoactive Drugs. 2023;55(2):233-245. DOI: https://doi.org/10.1080/02791072.2022.2073300</mixed-citation></ref><ref id="B15"><mixed-citation>Leung JG, Narayanan PP, Markota M, et al. Assessing naltrexone prescribing and barriers to initiation for alcohol use disorder: a multidisciplinary, multisite survey. Frontiers in Psychiatry. 2022;13:856938. DOI: https://doi.org/10.3389/fpsyt.2022.856938</mixed-citation></ref><ref id="B16"><mixed-citation>Malhotra A, Drexler K, Hsu M, et al. Medication treatment for alcohol use disorder in special populations. American Journal on Addictions. 2023;32(5):433-441. DOI: https://doi.org/10.1111/ajad.13455</mixed-citation></ref><ref id="B17"><mixed-citation>Simpson TL, Achtmeyer C, Batten L, et al. Naltrexone augmented with prazosin for alcohol use disorder: results from a randomized controlled proof-of-concept trial. Alcohol and Alcoholism. 2024;59(5):agae062. DOI: https://doi.org/10.1093/alcalc/agae062</mixed-citation></ref><ref id="B18"><mixed-citation>Waddell JT, Corbin WR, MacKinnon DP, et al. Within‐and between‐person effects of naltrexone on the subjective response to alcohol and craving: A daily diary investigation. Alcoholism: Clinical and Experimental Research. 2022;46(3):477-491. DOI: https://doi.org/10.1111/acer.14780</mixed-citation></ref><ref id="B19"><mixed-citation>Tobin KV, Brogden NK. Thermosensitive biomaterial gels with chemical permeation enhancers for enhanced microneedle delivery of naltrexone for managing opioid and alcohol dependency. Biomaterials Science. 2023;11(17):5846-5858. DOI: https://doi.org/10.1039/D3BM00972F</mixed-citation></ref><ref id="B20"><mixed-citation>Alvarez JD, Leon E. Do opioid antagonists (naltrexone) lead to better tobacco cessation compared with placebo? Evidence-Based Practice. 2024;27(8):17-18. DOI: https://doi.org/10.1097/EBP.0000000000002077</mixed-citation></ref><ref id="B21"><mixed-citation>Anderson ES, Chamberlin M, Zuluaga M, et al. Implementation of oral and extended-release naltrexone for the treatment of emergency department patients with moderate to severe alcohol use disorder: feasibility and initial outcomes. Annals of Emergency Medicine. 2021;78(6):752-758. DOI: https://doi.org/10.1016/j.annemergmed.2021.05.013</mixed-citation></ref><ref id="B22"><mixed-citation>Waeiss RA, Knight CP, Hauser SR, et al. Lack of Successful Treatment for Concurrent Ethanol and Nicotine Consumption: Naltrexone and Varenicline Fail to Alter Concurrent Ethanol and Nicotine Consumption by female Alcohol-Preferring (P) rats. Psychopharmacology. 2019;236(6):1887-1900. DOI: https://doi.org/10.1007/s00213-019-5174-y</mixed-citation></ref><ref id="B23"><mixed-citation>McPheeters M, O&amp;rsquo;Connor EA, Riley S, et al. Pharmacotherapy for alcohol use disorder: a systematic review and meta-analysis. JAMA. 2023;330(17):1653-1665. DOI: https://doi.org/10.1001/jama.2023.19761</mixed-citation></ref><ref id="B24"><mixed-citation>Fornaro M, Carvalho AF, De Prisco M, et al. The prevalence, odds, predictors, and management of tobacco use disorder or nicotine dependence among people with severe mental illness: Systematic review and meta-analysis. Neuroscience and Biobehavioral Reviews. 2022;132:289-303. DOI: https://doi.org/10.1016/j.neubiorev.2021.11.039</mixed-citation></ref></ref-list></back></article>