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Challenges in the Development of Generic Drugs and Comparison of Dissolution Profiles – Pharma
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itemtype="https://schema.org/CreativeWork" itemscope> <div class="inside-article"> <div class="featured-image page-header-image-single "> <img width="800" height="419" src="https://thepharma.net/archive/wp-content/uploads/2024/10/banner-18-01-1.jpg" class="attachment-full size-full" alt="" itemprop="image" decoding="async" fetchpriority="high" srcset="https://thepharma.net/archive/wp-content/uploads/2024/10/banner-18-01-1.jpg 800w, https://thepharma.net/archive/wp-content/uploads/2024/10/banner-18-01-1-300x157.jpg 300w, https://thepharma.net/archive/wp-content/uploads/2024/10/banner-18-01-1-768x402.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /> </div> <header class="entry-header"> <h1 class="entry-title" itemprop="headline">Challenges in the Development of Generic Drugs and Comparison of Dissolution Profiles</h1> <div class="entry-meta"> <span class="posted-on"><time class="entry-date published" datetime="2024-10-26T15:22:47+05:30" itemprop="datePublished">October 26, 2024</time></span> <span class="byline">by <span class="author vcard" itemprop="author" itemtype="https://schema.org/Person" itemscope><a class="url fn n" href="https://thepharma.net/archive/author/thepharma/" title="View all posts by thepharma" rel="author" itemprop="url"><span class="author-name" itemprop="name">thepharma</span></a></span></span> </div> </header> <div class="entry-content" itemprop="text"> <p><span style="font-weight: 400;">Generic drug development has been one of the pillars of the pharmaceutical industry, providing less expensive versions of branded medications, thereby making access to many vital therapies easier. However, despite these economic and public health benefits, the process of generic drug development is not problem-free. One of the most critical elements in this process is that these generic drugs must be therapeutically equivalent to their counterpart brand-name drugs. Much of this is determined by dissolution profile comparisons, a test showing how a drug is released from its dosage form and made available for absorption in the body. This test is, therefore, a critical quality control measure and a requirement for regulatory agencies in the process of approving generic drugs. However, due to the complexity of dissolution profiles and the differences in methods used in testing across different regulatory environments, this very process poses a gigantic challenge to the developers of generic drugs. This paper gives insight into the complex process of dissolution profile comparison, regulatory challenges, and scientific breakthroughs that are redesigning the future of generic drug development.</span></p> <h3><b> Dissolution Profile Comparison: Demystified</b></h3> <p><span style="font-weight: 400;">The comparison of dissolution profiles is one of the most prominent exercises in generic drug development. In simple terms, this involves a comparison of the dissolution behavior of a generic drug against the original branded drug. The dissolution profile shows the rate and efficiency with which a drug releases its active pharmaceutical ingredient into the administration medium, thereby making its way into the body. This becomes very critical because the extent and rate of dissolution have direct implications for drug bioavailability, hence its therapeutic efficacy.</span></p> <p><span style="font-weight: 400;">The primary objective of a generic drug, therefore, will be to have a dissolution profile similar to that of the reference product to prove bioequivalence. Bioequivalence means that a generic drug can deliver an equivalent amount of active ingredients into the bloodstream within the same period as the branded drug and elicit an equivalent therapeutic response. The regulatory agencies, like the U.S. More to the point, agencies like the FDA, EMA, and others all require rigorous dissolution testing to ensure generics meet these standards.</span></p> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Yearwise Publication Trend on <b>“<a href="https://thepharma.net/publication-trends/index/generic drugs" target="_blank" title="generic drugs - yearwise publication trends">generic drugs</a>”</b></h2> </div> </div><div class="results-container"><div class="chart-block" style="padding:15px;"> <div class="left"> <div id="results" class="results"></div> </div> <div class="right"> <div class="chart-container"><canvas id="publicationChart"></canvas></div> </div> <div class="keywordsdiv"> <div style="text-align:center;"><b>Find publication trends on relevant topics</b> </div> <span class="gp-icon icon-tags"><svg viewBox="0 0 512 512" aria-hidden="true" xmlns="http://www.w3.org/2000/svg" width="1em" height="1em"><path d="M20 39.5c-8.836 0-16 7.163-16 16v176c0 4.243 1.686 8.313 4.687 11.314l224 224c6.248 6.248 16.378 6.248 22.626 0l176-176c6.244-6.244 6.25-16.364.013-22.615l-223.5-224A15.999 15.999 0 00196.5 39.5H20zm56 96c0-13.255 10.745-24 24-24s24 10.745 24 24-10.745 24-24 24-24-10.745-24-24z"></path><path d="M259.515 43.015c4.686-4.687 12.284-4.687 16.97 0l228 228c4.686 4.686 4.686 12.284 0 16.97l-180 180c-4.686 4.687-12.284 4.687-16.97 0-4.686-4.686-4.686-12.284 0-16.97L479.029 279.5 259.515 59.985c-4.686-4.686-4.686-12.284 0-16.97z"></path></svg></span> <span id="keyword-stats"></span> </div> </div></div></div><div class="inside-article"><style> table { margin: 0 0 1.5em; 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if (!statistics || Object.keys(statistics).length === 0) { resultsContainer.innerHTML = '<p>No data found.</p>'; return; } var tableHTML = `<div class='pub-scroll'> <table class='tablediv' border='1' cellspacing='0' cellpadding='0'> <tr> <th>Year</th> <th>Publication Count</th> </tr>`; Object.entries(statistics).sort(([yearA], [yearB]) => yearB - yearA).forEach(([year, count]) => { const displayCount = count === 0 ? 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All of these factors may affect the dissolution profile and, therefore, have significant impacts on the assessment of bioequivalence. The final important complication of dissolution testing concerns the physical and chemical properties of the drug itself, like its solubility, particle size, and formulation.</span></p> <p><span style="font-weight: 400;">One of the most commonly applied methods for dissolution profile comparison is the similarity factor (f2), which is a mathematical expression quantifying the closeness of two curves obtained from in vitro dissolution testing. The limitations in the applicability of the f2 method are: it requires at least three time points, the dissolution profiles should have low variability, and very fast or very slow dissolution of drug products may not be applicable by the f2 method, which may result in possible misinterpretations of bioequivalence.</span></p> <p><span style="font-weight: 400;">In view of all these limitations, some alternative approaches have been explored by regulatory agencies and researchers and can thus be classified as model-independent or model-dependent methods. On the other hand, model-independent methods such as mean dissolution time and area under the curve make available the possibility of a more flexible approach to comparing dissolution profiles. Model-dependent methods consist of fitting the dissolution data to any mathematical model, like Weibull or zero-order models, which describe the kinetics of drug release. These techniques can provide more insight into the dissolution process but are very resource-intensive with respect to model selection and result interpretation.</span></p> <h3><b>Regulatory Challenges in Dissolution Testing</b></h3> <p><span style="font-weight: 400;">The landscape of dissolution testing regulations varies across regions. While the FDA, EMA, and other controlling authorities have set guidelines on dissolution testing and bioequivalence, these standards are not globally harmonized. This lack of standardization has strained the developers of generic drugs, who must comply with diverse regulatory requirements in each market they seek to enter.</span></p> <p><span style="font-weight: 400;">For instance, although the FDA requires in vitro dissolution testing to assist in supporting even minor or moderate changes in manufacturing, the European Medicines Agency and Health Canada can have different parameters for evaluating these changes. Furthermore, alternative methods to the f2 calculation, such as model-independent and model-dependent approaches, could be adopted by various regulatory agencies, thereby making the approval process all the more cumbersome.</span></p> <p><span style="font-weight: 400;">Another such challenge in regulation is the setting of clinically relevant dissolution specifications. CRDS are dissolution specifications directly related to the clinical performance of the drug. In-depth knowledge of the pharmacokinetics and pharmacodynamics of the drug and the generation of extensive in vivo and in vitro data are needed to develop a CRDS. Therefore, there may be some difficulty in establishing a CRDS for generic drugs, as full, detailed clinical data from the reference product is not available.</span></p> <h3><b>Scientific and Technological Advancements</b></h3> <p><span style="font-weight: 400;">Notwithstanding the problems, some of the obstacles in dissolution profile comparison are being surmounted by scientific and technological advancements. One such powerfully developing tool in this regard is physiologically-based pharmacokinetic modeling. PBPK models simulate the drug’s ADME process in the human body and, therefore, can possibly make more appropriate predictions of bioequivalence.</span></p> <p><span style="font-weight: 400;">In vitro dissolution data from the PBPK model can thus be combined with in vivo pharmacokinetic data to predict the effect of changes in the dissolution profile on the bioavailability of the drug. This approach will not only help in understanding the dissolution process but will also provide the establishment of clinically relevant dissolution specifications. This PBPK modeling could also be utilized for a change in dissolution specification during the drug’s life cycle, which thus generally avoids huge and time-consuming clinical studies.</span></p> <p><span style="font-weight: 400;">Another exciting development in this area is the application of biorelevant dissolution media. Standard dissolution testing is usually conducted with simplistic aqueous solutions that poorly simulate the conditions in the human gastrointestinal tract. On the other hand, biorelevant media are designed to feature the composition and other properties of GI tract fluids from different parts, making the assessment more realistic of the drug’s in vivo dissolution and absorption. Application of biorelevant media in dissolution testing would better predict in vivo drug performance and facilitate the development of more robust generic formulations.</span></p> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Recent Publications on <b>“<a href="https://thepharma.net/recent-publications/index/generic drugs" target="_blank" rel="noopener" title="generic drugs - yearwise publication list">generic drugs</a>”</b></h2> </div> </div> <div class="pb-main"><div class="article-scroll"><div id="results_recent" class="results"></div></div><div class="keywordsdiv" style="margin: 0px 15px;margin-top:20px;"> <div style="text-align:center;"><b>Find publications on relevant topics</b> </div> <span class="gp-icon icon-tags"><svg viewBox="0 0 512 512" aria-hidden="true" xmlns="http://www.w3.org/2000/svg" width="1em" height="1em"><path d="M20 39.5c-8.836 0-16 7.163-16 16v176c0 4.243 1.686 8.313 4.687 11.314l224 224c6.248 6.248 16.378 6.248 22.626 0l176-176c6.244-6.244 6.25-16.364.013-22.615l-223.5-224A15.999 15.999 0 00196.5 39.5H20zm56 96c0-13.255 10.745-24 24-24s24 10.745 24 24-10.745 24-24 24-24-10.745-24-24z"></path><path d="M259.515 43.015c4.686-4.687 12.284-4.687 16.97 0l228 228c4.686 4.686 4.686 12.284 0 16.97l-180 180c-4.686 4.687-12.284 4.687-16.97 0-4.686-4.686-4.686-12.284 0-16.97L479.029 279.5 259.515 59.985c-4.686-4.686-4.686-12.284 0-16.97z"></path></svg></span> <span id="keyword-papers"></span> </div></div></div><div class="inside-article"> <style> .pb-main{ border: solid 1px #ccc; border-top: none; margin-bottom: 20px; padding-bottom: 25px; background:#fff; } .author-main { border: solid 1px #ccc; border-top: none; margin-bottom: 20px; padding-bottom: 25px; background:#fff; } .publication-block { padding: 10px; margin-bottom: 10px; background-color: #f9f9f9; text-align: left; background: #FFF; border-bottom: solid 1px #ccc; margin-left: 15px; margin-right: 15px; } .publication-block h3 { margin: 0 0 10px; color: #000!important; } .publication-block a { font-size: 16px !important; line-height: 1em; font-weight: 600; text-transform: none; color: #000; padding: 0px; } .publication-block a:hover{ color: #227cdc; text-decoration:underline; } .article-scroll { max-height: 445px; overflow-y: auto; overflow-x: hidden; } ::-webkit-scrollbar-track { -webkit-box-shadow: inset 0 0 6px rgba(0,0,0,0.3); background-color: #efefef; border-radius:30px; } ::-webkit-scrollbar { width: 6px; background-color: #efefef; border-radius:30px; } ::-webkit-scrollbar-thumb { background-color: #ababab; border-radius:30px; } .publication-block p { margin-bottom: .5em; font-size: 15px; color: #000; } h3 { font-size: 18px !important; margin-bottom: 20px; line-height: 1.2em; font-weight: 600; text-transform: none; } a { padding: 5px; color: #a71c49; } #keyword-papers{ margin-top: 20px; text-align: center; } </style> <script> function decodeString(str) { str = str.replace(/\\'/g, "'"); str = str.replace(/\\'/g, "'"); str = str.replace(/\\'/g, "'"); return str; } function displayResults_recent(papers) { var resultsContainer = document.getElementById('results_recent'); if (!papers || papers.length === 0) { resultsContainer.innerHTML = '<p>No recent publications found.</p>'; return; } papers.forEach(paper => { var publicationBlock = document.createElement('div'); publicationBlock.className = 'publication-block'; var title_de = decodeString(paper.title); var publicationHTML = ` <div style="margin-bottom: 10px;line-height: 24px;"><a href="${paper.url}" target="_blank" title="${title_de}">${title_de}</a></div> <p><strong>Issue Release:</strong> ${paper.publishedDate}</p> `; publicationBlock.innerHTML = publicationHTML; resultsContainer.appendChild(publicationBlock); }); } function displayKeywordPapers(keywords) { var resultsContainer = document.getElementById('keyword-papers'); resultsContainer.innerHTML = ''; if (!keywords || keywords.length === 0) { resultsContainer.innerHTML = '<p>No data found.</p>'; return; } var keywordHTML = ''; keywords.forEach((key, index) => { let key_replace = key.replace(/ /g, '-'); key_replace = key_replace.toLowerCase(); keywordHTML += `<a href="https://thepharma.net/recent-publications/index/${key_replace}" target="_blank" title="${key} - publication list">${key}</a>`; if (index < keywords.length - 1) { keywordHTML += ', '; } }); resultsContainer.innerHTML = keywordHTML; } // Call the function with the PHP data var recent_papers = [ { "title": "PERI-operative biologic DMARD management: Stoppage or COntinuation during orthoPaEdic operations (the PERISCOPE trial) - a study protocol for a pragmatic, UK multicentre, superiority randomised controlled trial with an internal pilot, economic evaluation and nested qualitative study.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38910007", "publishedDate": "2024" }, { "title": "A conceptual framework to build effective medicine pricing policies for low and middle-income countries (LMICs).", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38908991", "publishedDate": "2024" }, { "title": "Prediction and Interpretation Microglia Cytotoxicity by Machine Learning.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38949724", "publishedDate": "2024" }, { "title": "Intellectual property licensing of therapeutics during the COVID-19 crisis: lessons learnt for pandemic preparedness and response.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38956614", "publishedDate": "2024" }, { "title": "Patient-Level Savings on Generic Drugs Through the Mark Cuban Cost Plus Drug Company.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38874962", "publishedDate": "2024" }, { "title": "International Prescription Drug Price Comparisons: Estimates Using 2022 Data.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38855386", "publishedDate": "2024" }, { "title": "Cutaneous Pharmacokinetics-Based Bioequivalence: A Clinical Dermal Open Flow Microperfusion Verification Study Using Lidocaine and Prilocaine Combination Topical Products.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38857708", "publishedDate": "2024" }, { "title": "Tailoring drug release from long-acting contraceptive levonorgestrel intrauterine systems.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38648956", "publishedDate": "2024" }, { "title": "Prescription-based cost analysis of medicines for cardiovascular risk factors at Indian Council of Medical Research-Rational Use of Medicine Centre Hospitals of India.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38687313", "publishedDate": "2024" }, { "title": "Revitalizing Cancer Treatment: Exploring the Role of Drug Repurposing.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38672545", "publishedDate": "2024" }, { "title": "Comparative Bleeding Risk of Brand Vs Generic Rivaroxaban in Elderly Inpatients with Atrial Fibrillation.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38765878", "publishedDate": "2024" }, { "title": "Spending on nucleos(t)ide analogues for hepatitis B in medicaid beneficiaries: 2012-2021.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38710472", "publishedDate": "2024" }, { "title": "Comparative evaluation of dissolution profiles of the generic drug lamivudine 150 mg tablet marketed in Peru vs. the innovative Epivir.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38808847", "publishedDate": "2024" }, { "title": "Physiologically based absorption modeling to predict the bioequivalence of two apixaban formulations.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38747478", "publishedDate": "2024" }, { "title": "Impact of Incorporating Future Mandatory Price Reductions with Generic Drug Entry on the Cost-Effectiveness of New Drugs: A Policy Simulation Study of Dupilumab in Atopic Dermatitis Treatment.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38727495", "publishedDate": "2024" }, { "title": "Bioequivalence Study of Two Formulations of Simvastatin 20 mg Tablet in Healthy Filipino Participants under Fasting Conditions: A Randomized, Open-label, Two-way Crossover Study.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38846170", "publishedDate": "2024" }, { "title": "Influencing Factors of Generic Prescribing Behavior of Physicians: A Structural Equation Model Based on the Theory of Planned Behavior.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38813068", "publishedDate": "2024" }, { "title": "The politics and governance of drug production in public-private partnerships: Brazils response to hepatitis C.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38771862", "publishedDate": "2024" }, { "title": "Assessment of disease pattern and drug utilization among neurology intensive care unit patients in a developing country: an observational analysis.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38781014", "publishedDate": "2024" }, { "title": "Generic cancer drugs are still in short supply: The ongoing shortage has forced hospitals to continue rationing drugs and prompted new calls for federal investment and long-term solutions.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38163921", "publishedDate": "2024" } ]; var keywordsArray = ["Generic drug development","dissolution profile comparison","bioequivalence","PBPK modeling","biorelevant dissolution media","global harmonization"]; displayResults_recent(recent_papers); displayKeywordPapers(keywordsArray); // function stripslashes(str) { // if (typeof str === 'string') { // return str.replace(/\/g, ''); // } // } </script></p> <h3><b>The Way Forward: Global Harmonization and Innovation</b></h3> <p><span style="font-weight: 400;">There is an increasing call for and need for global harmonization of regulatory standards related to generic drug development and dissolution profile comparison. That will reduce the burden on a generic drug developer for having only one dissolution test requirement to conduct dissolution tests for working on approvals of high-quality generics in any region. Such efforts are underway by international organizations like the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).</span></p> <p><span style="font-weight: 400;">Further, more innovation in dissolution test methods is required. Indeed, developing new models, technologies, and approaches will bring an evident improvement in the in vivo prediction of drug performance, hence providing high-quality and reliable generic drugs. Therefore, regulatory agencies, industry, and academic collaboration would act as the driving force behind such innovations, ensuring that generic drugs continue to remain one of the ways to provide safe, effective, and affordable treatments to patients worldwide.</span></p> <h3><b>Conclusion</b></h3> <p><span style="font-weight: 400;">Generic drug development is a rather complex and difficult process, especially with regard to establishing bioequivalence using dissolution profile comparison. Variables in the methods of dissolution testing, limitations of classic approaches like the f2 similarity factor, and diverse regional regulatory requirements all conflate to present challenges for a generic drug developer. However, improvements in areas such as PBPK modeling, biorelevant dissolution media, and global harmonization efforts do bring with them some promising solutions to these challenges. It is by embracing these innovations, coupled with working toward more consistent regulatory standards, that the pharmaceutical industry can go on to continue its high-quality generic drug delivery for patient needs around the world.</span></p> <p></p> <h3><b>References</b></h3> <ol> <li>Abend, A.M., Zhang, L., Fredro-Kumbaradzi, E., Hoffelder, T., Cohen, M.J., Anand, O., Delvadia, P., Mandula, H., Zhang, Z., Kotzagiorgis, E. and Lum, S., 2022. <a href="https://link.springer.com/article/10.1208/s12248-022-00691-4">Current approaches for dissolution similarity assessment, requirements, and global expectations.</a> <i>The AAPS Journal</i>, <i>24</i>(3), p.50.</li> <li>Aburub, A., Chen, Y., Chung, J., Gao, P., Good, D., Hansmann, S., Hawley, M., Heimbach, T., Hingle, M., Kesisoglou, F. and Li, R., 2022. <a href="https://link.springer.com/article/10.1208/s12248-022-00699-w">An IQ consortium perspective on connecting dissolution methods to in vivo performance: analysis of an industrial database and case studies to propose a workflow. </a> <i>The AAPS Journal</i>, <i>24</i>(3), p.49.</li> <li>Bego, M., Patel, N., Cristofoletti, R. and Rostami-Hodjegan, A., 2022. <a href="https://link.springer.com/article/10.1208/s12248-021-00672-z">Proof of concept in assignment of within-subject variability during virtual bioequivalence studies: propagation of intra-subject variation in gastrointestinal physiology using physiologically based pharmacokinetic modeling. </a><i>The AAPS Journal</i>, <i>24</i>(1), p.21.</li> <li>Chirumamilla, S.K., Banala, V.T., Jamei, M. and Turner, D.B., 2021. <a href="https://www.mdpi.com/1999-4923/13/8/1169">Mechanistic PBPK modelling to predict the advantage of the salt form of a drug when dosed with acid reducing agents</a>. <i>Pharmaceutics</i>, <i>13</i>(8), p.1169.</li> <li>Li, M., Zhang, X., Wu, D., Anand, O., Chen, H., Raines, K. and Yu, L., 2021. <a href="https://link.springer.com/article/10.1208/s12248-021-00639-0">Understanding in vivo dissolution of immediate release (IR) solid Oral drug products containing weak acid BCS class 2 (BCS class 2a) drugs.</a> <i>The AAPS Journal</i>, <i>23</i>, pp.1-13.</li> <li>Macwan, J.S., Fraczkiewicz, G., Bertolino, M., Krüger, P. and Peters, S.A., 2021. <a href="https://ascpt.onlinelibrary.wiley.com/doi/full/10.1002/psp4.12634">Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: the case of bisoprolol. </a><i>CPT: Pharmacometrics & Systems Pharmacology</i>, <i>10</i>(6), pp.622-632.</li> </ol> <p></div></div> <div style="background: #f7f7f7;border: 1px solid rgba(0, 0, 0, 0.07);"> <div style="padding: 30px;"><div class="Adblock-main"> <div class="Adblock-head"> <h2>Top Experts on “<b style="color:#000;font-size:22px;">generic drugs</b>“</h2> </div> </div><div class="author-main"><div id="results_author"></div><div style="text-align: center;"><a class="register-button" href="https://thepharma.net/expert-search" target="_blank" rel="noopener">Find experts on any field</a></div></div><div class="inside-article" style="background: none;border: none;box-shadow: none;margin-top: -70px;"> <style> .author-block { padding: 15px; margin-bottom: 10px; text-align: left; font-size: 15px; line-height: 1.2; background: #FFF; border-bottom: solid 1px #ccc; margin-left: 15px; margin-right: 15px; } .author-block h3 { margin: 0 0 10px; color: #227cdc; } .author-block p { margin: 5px 0; } .author-b { display: flex; justify-content: space-between; flex-wrap: wrap; margin-bottom:10px; } .author-b .ainfo { flex: 1 1 30%; box-sizing: border-box; text-align: left; background: #dcdcdc; padding: 7px 14px; border-radius: 5px; margin-top: 3px; margin-right: 10px; } @media (max-width: 768px) { .author-b .ainfo { flex: 1 1 100%; margin: 10px 0; } } </style> <script> function displayResults_author(authors) { var resultsContainer = document.getElementById('results_author'); resultsContainer.innerHTML = ''; if (!authors || Object.keys(authors).length === 0) { resultsContainer.innerHTML = '<p>No authors found.</p>'; return; } Object.values(authors).slice(0, 10).forEach(author => { if (author.affiliation.length > 400) { return; } var authorBlock = document.createElement('div'); 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