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Bioavailability Challenges in Drug Development – Bioanalytical Research
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container hfeed" id="page"> <div class="site-content" id="content"> <div class="content-area" id="primary"> <main class="site-main" id="main"> <article id="post-110" class="post-110 post type-post status-publish format-standard has-post-thumbnail hentry category-drug-development tag-bioavailability tag-drug-delivery-systems tag-drug-development tag-lipid-based-formulations tag-micronization tag-particle-size-reduction tag-pharmaceutical-technologies tag-prodrugs tag-solid-dispersions tag-solubility-enhancement" itemtype="https://schema.org/CreativeWork" itemscope> <div class="inside-article"> <div class="featured-image page-header-image-single "> <img width="1200" height="628" src="https://bioanalyticalresearch.com/archive/wp-content/uploads/2024/11/banner-1-min-scaled-e1732605608685.jpg" class="attachment-full size-full" alt="" itemprop="image" decoding="async" fetchpriority="high" /> </div> <header class="entry-header"> <h1 class="entry-title" itemprop="headline">Bioavailability Challenges in Drug Development</h1> <div class="entry-meta"> <span class="posted-on"><time class="entry-date published" datetime="2024-11-26T12:50:32+05:30" itemprop="datePublished">November 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://bioanalyticalresearch.com/archive/author/bioanalyticalresearch/" title="View all posts by bioanalyticalresearch" rel="author" itemprop="url"><span class="author-name" itemprop="name">bioanalyticalresearch</span></a></span></span> </div> </header> <div class="entry-content" itemprop="text"> <p><span style="font-weight: 400;">In the pharmaceutical sciences, bioavailability is one of the most critical factors that dictate whether a new therapeutic agent will be a success or a failure. Bioavailability is a vital parameter quantifying the extent and rate at which a drug reaches its site of action or is absorbed into circulation upon administration. It has proved that optimizing drug bioavailability is difficult. Poorly water-soluble drugs are a considerable proportion of new chemical entities in the pipelines of drug development.</span><span style="font-weight: 400;"><br /> </span></p> <p><span style="font-weight: 400;">Great bioavailability challenges exist in the design and development phase of drugs. These are mainly determined by the chemical properties of the drug, determining the solubility and permeability of the drug. This is because any dissolved drug is capable of passing through cell membranes. The pharmaceutical industry has made use of numerous creative ways to pass these hurdles, thereby enhancing the solubility and accordingly the bioavailability. </span></p> <h4><b>Solubility Enhancement Techniques</b></h4> <p><span style="font-weight: 400;">The most important strategies are the solubility enhancement techniques. These include solid dispersions, particle size reduction, and the use of surfactants and solubilizers such as cyclodextrins. The term solid dispersion refers to the process of incorporating one or more active ingredients dispersed in an inert carrier or matrix in a solid state, which can improve the dissolution rate and subsequently the bioavailability of the incorporated compound. Preparations of such dispersions are often carried out through techniques such as spray drying, freeze-drying, or melting methods.</span></p> <p><span style="font-weight: 400;">Another important approach includes size reduction of the particle, particularly for enhancing the dissolution rate in poorly water-soluble drugs. Techniques that have been applied include nanonization and micronization to reduce the particle size of the drug, thereby increasing the surface area and hence the dissolution rate.</span></p> <h4><b>New Drug Delivery Systems</b></h4> <p><span style="font-weight: 400;">Advances in drug delivery systems also continue to play their part in overcoming the challenges of bioavailability. For instance, lipid-based formulations, incorporating self-emulsifying drug delivery systems (SEDDS), have been particularly effective in enhancing the oral bioavailability of lipophilic drugs. The rationale is how such systems form fine oil-in-water emulsions upon contact with the GI fluids, making it an avenue for solubilizing the drug.</span><span style="font-weight: 400;"><br /> </span></p> <p><span style="font-weight: 400;">Moreover, polymeric micelles and liposomes as drug carriers have allowed the encapsulation of hydrophobic drugs in order to enhance their solubility and stability in the biological setting. The carrier protects the drug from enzymatic breakdown but assures better absorption and distribution into the body.</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://bioanalyticalresearch.com/publication-trends/index/drug development" target="_blank" title="drug development - yearwise publication trends">drug development</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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Prodrugs are chemically modified derivatives of drug molecules, which undergo enzymatic and/or chemical transformation in vivo for release of the active parent drug. This technique is applied to drugs that are inherently insoluble or unstable at physiological conditions. The formation of salts in the drug can also greatly increase solubility, especially for drugs with ionizable functional groups.</span></p> <h4><b>Physiological and Biological Factors</b></h4> <p><span style="font-weight: 400;">It has to be emphasized that principal challenges from a bioavailability aspect are not only physicochemical but also biological and physiological. Different pH values of the gastrointestinal tract, the presence of food, and the variability of intestinal microflora impact the dissolution and absorption of drugs. Moreover, the role of intestinal efflux and influx transporters within an epithelial layer can play a serious role in the bioavailability of administered drugs. </span></p> <h4><b>The Add-on Method of Solubility in Permeability Enhancement</b></h4> <p><span style="font-weight: 400;">Although penetration enhancement is as important as improvement in solubility, more bioavailability problems are still tackled under this approach. The human intestinal tract has taken the position of a selective barrier primarily by the epithelium that does not let the absorption of many drugs. This kind of barrier function is maintained both through a physical structure as well as through a number of biological factors that include efflux transport proteins.</span></p> <p><span style="font-weight: 400;">These proteins, such as P-glycoprotein (P-gp), actively transport drugs out of cells, thereby reducing their absorption and bioavailability. One approach to this problem is through permeability enhancers, where these agents alter the properties of the intestinal barrier temporarily in such a way that more drugs are able to cross the barrier. Thus substances such as fatty acids and chitosans can open up the tight junctions between epithelial cells, or detergents to inhibit efflux pumps, contributing to higher absorption levels of drugs.</span></p> <p><span style="font-weight: 400;">Applying advanced formulation techniques has also dominated the application in enhancing bioavailability. Techniques associated with the use of amorphous solid dispersions involve converting a poorly soluble drug from its crystalline form to an amorphous form that is of high energy. Such alteration increases the solubility and the rate of dissolution of the drug. Maintaining stability in amorphous forms is challenging because they are prone to recrystallization. Polymers and other stabilizers are often used to prevent this, maintaining the drug’s amorphous state and thus its solubility.</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://bioanalyticalresearch.com/recent-publications/index/drug development" target="_blank" rel="noopener" title="drug development - yearwise publication list">drug development</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> ${paper.publishedDate}</p> `; publicationBlock.innerHTML = publicationHTML; resultsContainer.appendChild(publicationBlock); }); } function displayKeywordPapers(keywords) { var resultsContainer = document.getElementById('keyword-papers'); resultsContainer.innerHTML = ''; if (!keywords || keywords.length === 0) { resultsContainer.innerHTML = '<p>No data found.</p>'; return; } var keywordHTML = ''; keywords.forEach((key, index) => { let key_replace = key.replace(/ /g, '-'); key_replace = key_replace.toLowerCase(); keywordHTML += `<a href="https://bioanalyticalresearch.com/recent-publications/index/${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": "Dihydromyricetin ameliorates diabetic renal fibrosis via regulating SphK1 to suppress the activation of NF-\u03baB pathway.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945289", "publishedDate": "2024" }, { "title": "GASP: A Pan-Specific Predictor of Family 1 Glycosyltransferase Acceptor Specificity Enabled by a Pipeline for Substrate Feature Generation and Large-Scale Experimental Screening.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38947828", "publishedDate": "2024" }, { "title": "In Vivo Ocular Pharmacokinetics and Toxicity of Siponimod in Albino Rabbits.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38856116", "publishedDate": "2024" }, { "title": "Anti-amyloid-\u03b2 Antibodies and Anti-tau Therapies for Alzheimer\\\\\\'s Disease: Recent Advances and Perspectives.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945936", "publishedDate": "2024" }, { "title": "Systematic DOE Approach for Dry Granulation Study at Early Clinical Stage of Novel Drugs: An Industrial Case.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945947", "publishedDate": "2024" }, { "title": "Metabolomics analyses reveal the crucial role of ERK in regulating metabolic pathways associated with the proliferation of human cutaneous T-cell lymphoma cells treated with Glabridin.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946222", "publishedDate": "2024" }, { "title": "Differences in the DNA Methylome of T cells in Adults With Asthma of Varying Severity.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946998", "publishedDate": "2024" }, { "title": "What enlightenment has the development of lung cancer bone metastasis brought in the last 22 years.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946828", "publishedDate": "2024" }, { "title": "Single-step 3D bioprinting of alginate-collagen I hydrogel fiber rings to promoter angiogenic network formation.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38946589", "publishedDate": "2024" }, { "title": "Trichilia catigua against Helicobacter pylori: An in vitro, molecular and in silico approach.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945495", "publishedDate": "2024" }, { "title": "Preparation of antimicrobial peptides and their combination with hydrogels for wound healing applications.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38944068", "publishedDate": "2024" }, { "title": "Sodium Tungstate (NaW) Decreases Inflammation and Renal Fibrosis in Diabetic Nephropathy.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38944202", "publishedDate": "2024" }, { "title": "Integrating network pharmacology and animal experimental validation to investigate the action mechanism of oleanolic acid in obesity.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38246999", "publishedDate": "2024" }, { "title": "Carbon chain length in a novel anticancer aryl-urea fatty acid modulates mitochondrial targeting, reactive oxygen species production and cell killing.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945837", "publishedDate": "2024" }, { "title": "Exosomes in Bone Cancer: Unveiling their Vital Role in Diagnosis, Prognosis, and Therapeutic Advancements.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38947401", "publishedDate": "2024" }, { "title": "PHGDH: a novel therapeutic target in cancer.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38945960", "publishedDate": "2024" }, { "title": "Organoids in gastrointestinal diseases: from bench to clinic.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38948115", "publishedDate": "2024" }, { "title": "Brincidofovir inhibits polyomavirus infection .", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953354", "publishedDate": "2024" }, { "title": "NF2 regulates IP3R-mediated Ca signal and apoptosis in meningiomas.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953724", "publishedDate": "2024" }, { "title": "Clinical characteristics and multimodal imaging can help diagnosing and treating mild malformation of cortical development with oligodendroglial hyperplasia and epilepsy.", "url": "https:\/\/pubmed.ncbi.nlm.nih.gov\/38953904", "publishedDate": "2024" } ]; var keywordsArray = ["Bioavailability","Drug Development","Solubility Enhancement","Drug Delivery Systems","Prodrugs","Pharmaceutical Technologies","Particle Size Reduction","Lipid-based Formulations","Solid Dispersions","Micronization"]; displayResults_recent(recent_papers); displayKeywordPapers(keywordsArray); // function stripslashes(str) { // if (typeof str === 'string') { // return str.replace(/\/g, ''); // } // } </script></p> <h4><b>Targeted Drug Delivery Systems</b></h4> <p><span style="font-weight: 400;">Targeted drug delivery systems are yet another advanced approach at making it possible to solve the problems of bioavailability. In this system, the drug is delivered in a controlled way to specific parts of the body, this is particularly useful with drugs that are poorly soluble or have significant side effects when distributed systemically.</span></p> <p><span style="font-weight: 400;">Such techniques under research include magnetic drug targeting, whereby drugs are attached to the magnetic particles and guided by an external magnetic field directly to the target site, and ligand-directed targeting, whereby drugs are conjugated with ligands that recognize specific receptors of target cells.</span></p> <h4><b>Future Outlook and Innovation</b></h4> <p><span style="font-weight: 400;">Excipients and drug carriers should be developed in the future with a view to the improvement of both solubility and permeability. Nanotechnology has emerged as highly promising. The design of particles that enhance the dissolution of poorly soluble drugs and assist their penetration across biological barriers, thereby facilitating absorption, is one such promising area. For example, nanoparticles have surfaces that could be engineered with targeting ligands to guide them to specific points in the body, thereby reducing off-target side effects and improving the efficacy of treatment.</span></p> <h4><b>Conclusion</b></h4> <p><span style="font-weight: 400;">Bioavailability challenges in the development of drugs may be overcome through a multi-paradigmatic approach that combines cutting-edge pharmaceutical technologies, innovative formulation techniques, and an understanding of biological interactions. As far as this field is advancing with research, the developmental better and safer drugs would ostensibly advance to improve people’s lives worldwide, hence changing medicine. In this holistic approach to addressing bioavailability, the therapeutic agents will better be delivered toward the greater goal of personalized medicine because drugs can be tailored to particular patients based on their biological characteristics. It makes available and promises better therapeutic outcomes while minimizing adverse effects, an important advancement in the field of health care.</span></p> <p></p> <h4><b>References</b></h4> <ol> <li>Bhalani, D.V., Nutan, B., Kumar, A. and Singh Chandel, A.K., 2022. <a href="https://www.mdpi.com/2227-9059/10/9/2055">Bioavailability enhancement techniques for poorly aqueous soluble drugs and therapeutics.</a> <i>Biomedicines</i>, <i>10</i>(9), p.2055.</li> <li>Nguyen, T.T.L., Kim, J.W., Choi, H.I., Maeng, H.J. and Koo, T.S., 2022. <a href="https://www.mdpi.com/1420-3049/27/6/1977">Development of an LC-MS/MS Method for ARV-110, a PROTAC Molecule, and Applications to Pharmacokinetic Studies.</a> <i>Molecules</i>, <i>27</i>(6), p.1977.</li> <li>Balla, A., Jeong, Y.S., Kim, H.J., Lee, Y.J., Chung, S.J., Chae, Y.J. and Maeng, H.J., 2021. <a href="https://www.mdpi.com/1999-4923/13/8/1133">Effects of 1α, 25-dihydroxyvitamin D3 on the pharmacokinetics of procainamide and its metabolite N-acetylprocainamide, organic cation transporter substrates, in rats with PBPK modeling approach</a>. <i>Pharmaceutics</i>, <i>13</i>(8), p.1133.</li> <li>Spooner, N., Anderson, K.D., Siple, J., Wickremsinhe, E.R., Xu, Y. and Lee, M., 2019. <a href="https://www.tandfonline.com/doi/abs/10.4155/bio-2019-0041">Microsampling: considerations for its use in pharmaceutical drug discovery and development. </a><i>Bioanalysis</i>, <i>11</i>(10), pp.1015-1038.</li> <li>Zhu, X., Ma, K., Zhou, K., Pan, X., Liu, J., Nürnberg, B., Alesutan, I., Völkl, J. and Lang, F., 2022. <a href="https://karger.com/kbr/article/47/6/399/824497">Requirement of Na+/H+ Exchanger NHE1 for Vasopressin-Induced Osteogenic Signaling and Calcification in Human Aortic Smooth Muscle Cells.</a> <i>Kidney and Blood Pressure Research</i>, <i>47</i>(6), pp.399-409.</li> <li>Denniff, P. and Spooner, N., 2014. <a href="https://pubs.acs.org/doi/abs/10.1021/ac5022562">Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis.</a> <i>Analytical chemistry</i>, <i>86</i>(16), pp.8489-8495.</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;">drug development</b>“</h2> </div> </div><div class="author-main"><div id="results_author"></div><div style="text-align: center;"><a class="register-button" href="https://bioanalyticalresearch.com/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; 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