Recent advances in drug delivery and formulation最新文献

{"title":"Global and Indian Regulatory Frameworks for Pharmaceutical Excipients, APIs, and Formulations: Challenges and Harmonization Strategies.","authors":"P Dhinesh Pandian, Rajaganapathy Kaliyaperumal","doi":"10.2174/0126673878362406250607104550","DOIUrl":"https://doi.org/10.2174/0126673878362406250607104550","url":null,"abstract":"<p><p>Pharmaceutical excipients play a critical role in drug formulation, ensuring stability, bioavailability, manufacturability, and patient safety. While India has made progress in aligning with international excipient regulations, significant regulatory gaps persist, including inconsistent enforcement, lack of mandatory GMP compliance, and inadequate impurity testing standards. These challenges create quality inconsistencies and potential safety risks, particularly for high-risk excipients. Indian excipient manufacturers face difficulties meeting international regulatory expectations, such as FDA, EMA, and PMDA requirements, due to differences in documentation, quality control, and risk assessment standards. Case studies highlight successful compliance strategies, including supplier qualification, in-house impurity testing, and risk-based categorization. To strengthen excipient regulation, mandatory GMP certification, a risk-based excipient categorization system, and alignment with IPEC-PQG, WHO, and ICH Q7 guidelines are recommended. Additionally, CDSCO must enhance oversight through advanced impurity testing and improved traceability requirements. Ensuring regulatory harmonization with global standards will enhance India's competitiveness in the excipient supply chain, facilitate international market access, and improve overall drug safety and efficacy. This review underscores the urgent need for structured regulatory reforms to streamline compliance, ensure excipient quality, and strengthen India's position in the global pharmaceutical industry.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144328307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gallic Acid: A Potent Antioxidant and Anti-inflammatory Agent in Modern Cosmeceuticals.","authors":"Urvashi Saini, Anjali Sharma, Vishnu Mittal","doi":"10.2174/0126673878341990250516063126","DOIUrl":"https://doi.org/10.2174/0126673878341990250516063126","url":null,"abstract":"<p><p>The cosmetics business is a valuable and stable multibillion-dollar business that keeps growing yearly with new, specialized goods. Natural goods contain a wealth of medicinally active chemicals used to treat a wide range of skin problems, including infections, inflammation, and damage caused by UV light and pollution. Cosmeceuticals are a mix of cosmetic and medical chemicals. Based on their main ingredients, they can be used for both beauty and health purposes. Many people think that natural goods are a great way to obtain cosmeceuticals. It has strong antiinflammatory, antibacterial, anti-cancer, and protective properties. The benefit for the skin has been said to be the most interesting. GA and its products have been used a lot as an adjuvant in many therapeutic formulations, as an alternative to hydro-cortisone in children with atopic dermatitis and other skin diseases, and as an ingredient in cosmetics because they are good for humans. GA is GRAS (generally recognized as safe) by the US Food and Drug Administration. Oxidative stress, which happens when too many free radicals build up, is the main cause of many skin diseases that get worse over time, like aging. Polyphenols, including gallic acid, represent a significant category of naturally occurring antioxidants. They have emerged as potent antioxidants suitable for incorporation into active makeup products. Recent advancements include patent filings related to novel applications and formulations of Gallic acid in cosmetic science that highlight innovative delivery systems, such as nano-formulations enhancing stability and efficacy, as well as its synergistic combinations with other active ingredients to address targeted skin concerns like pigmentation, aging, and sensitivity which meets the demands of modern consumers.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144182899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug Delivery Strategies for the Management of Attention-deficit/Hyperactivity Disorder (ADHD): A Case of Differentiated Product Development of Methylphenidate.","authors":"Shubham Kamble, Ganesh Deshmukh, Paras Jain, Abhishek Jha, Sanjeevani S Deshkar","doi":"10.2174/0126673878346123250515065256","DOIUrl":"https://doi.org/10.2174/0126673878346123250515065256","url":null,"abstract":"<p><p>ADHD is a common condition that affects many kids in the United States, about 2 to 18 percent of children between 6 and 17 years old. ADHD manifests as hyperactivity, impulsivity, and inattention, impacting various aspects of life. Effective management involves a combination of psychostimulant medication, such as methylphenidate, and behavioral therapy. Modified-release formulations, including chewable tablets, transdermal patches, and osmotic-controlled release tablets, offer improved treatment adherence and overall quality of life. Understanding the pathophysiology involves neuroimaging studies that reveal alterations in brain regions rich in dopamine receptors. Methylphenidate, a common ADHD medication, works by inhibiting dopamine reuptake, thereby increasing extracellular dopamine levels. Different drug delivery systems, such as extended-release chewable tablets, transdermal patches, and OROS formulations, provide diverse options for individual needs. The advent of innovative formulations like methylphenidate hydrochloride extendedrelease oral suspension (Quillivant ER) and methylphenidate hydrochloride multilayer extendedrelease capsules (Aptensio XR) addresses challenges in pediatric medication administration. Recent additions like the orally disintegrating tablet (Cotempla X-ODT) offer convenience and flexibility. Understanding the pharmacokinetics, pharmacodynamics, and benefits of these formulations enhances the ability to tailor ADHD treatment to individual patient needs.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recent Expansions and Future Outlook in the Delivery of Poorly Soluble Phytoconstituents through Solid Dispersion Technique.","authors":"Bhavesh Sahu, Kalyani Sakure, Ajazuddin, Hemant Badwaik","doi":"10.2174/0126673878341183250514112919","DOIUrl":"https://doi.org/10.2174/0126673878341183250514112919","url":null,"abstract":"<p><p>Phytoconstituents, derived from plants, possess significant therapeutic potential but often face challenges such as poor solubility and low bioavailability, limiting their efficacy. Solid dispersion (SD) is a promising approach to improve the solubility and bioavailability of these poorly water- soluble phytoconstituents. By dispersing the active drug in a hydrophilic carrier, solid dispersion enhances the surface area of the drug, improving its dissolution rate and enhancing absorption. This review provides an overview of the various generations of solid dispersions, highlighting the evolution from crystalline carriers in first-generation solid dispersions to the more advanced amorphous solid solutions in second and third-generation formulations, which offer enhanced solubility and bioavailability. The article also discusses various techniques for preparing solid dispersions, including solvent evaporation, melting, and spray-drying methods, and emphasizes the importance of selecting appropriate carriers, such as hydrophilic polymers, to optimize the dissolution rate of phytoconstituents. The study highlighted the recent case studies on several phytochemicals, like alkaloids, glycosides, Polyphenols, etc., demonstrating the effectiveness of solid dispersion in improving their solubility and therapeutic performance. Additionally, the review addresses the challenges related to the solubility of phytoconstituents and their impact on drug absorption, as well as the role of solid dispersion in overcoming these challenges. Overall, solid dispersion technology emerges as a versatile and effective tool for enhancing the oral bioavailability of phytoconstituents, paving the way for more efficient herbal therapies in modern medicine.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing Drug Stability Using Non-Aqueous Gels: Properties, Applications, and Emerging Challenges.","authors":"Jabin Ahmed, Aians H Kalita, Ghanshyam Das Gupta, Shubham Thakur","doi":"10.2174/0126673878371228250519073422","DOIUrl":"https://doi.org/10.2174/0126673878371228250519073422","url":null,"abstract":"<p><p>This study explores the emerging potential of non-aqueous gels for topical therapy, examining their unique properties, diverse applications, and the challenges involved in their formulation and clinical use. By highlighting these aspects, the article aims to shed light on the future of localized drug delivery and inspire further research and innovation in this promising field. Additionally, the article addresses the critical need for regulatory considerations, stability testing, and patient acceptability. It also emphasizes the role of non-aqueous gels in revolutionizing dermatological and transdermal therapies, particularly by enhancing the stability of drugs that are hydrolyzed in the presence of water.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144145393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancement in Nanotablet Research: An Overview.","authors":"Aparna Gupta, Gaurav Thakur, Peeyush Kaushik, Sandhya Jaiswal, Jyoti Singh, Saurabh Sharma, Sunny Dhiman, Supriya Agnihotri","doi":"10.2174/0126673878330529250324042529","DOIUrl":"https://doi.org/10.2174/0126673878330529250324042529","url":null,"abstract":"<p><p>Modern technologies such as nanotechnology are being applied in almost every sector to deliver affordable, environmentally friendly products. The integration of nanotechnology in medicine has revolutionized drug delivery systems, with nanotechnology emerging as a promising frontier. This review explores the synthesis and characterization of nanotablet drug formulations designed to enhance their potential across various applications. By employing characterization techniques such as X-ray diffraction, electron microscopy, and physisorption analysis, researchers have developed innovative drug delivery systems like Sophora Alopecuroides nanotablets to treat deadly diseases such as cancer. Evaluation of pre- and post-compression results indicated that nanotablets exhibited good hardness and flow properties, making these formulations potential drug delivery systems for enhanced bioavailability and sustained release properties. Specifically, sublingual sufentanil nanotablets, such as Zalviso®, have demonstrated efficacy in managing moderate to severe pain in healthcare settings when used in conjunction with a PCA device. However, recent regulatory updates indicate changes in the marketing authorization status of Zalviso®. In conclusion, this novel approach for synthesizing nanotablets presents a promising avenue for diverse applications, and based on the results, it is worth considering for future work.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144083132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Identifying Optimized Parameters to Enhance the Productivity of Gas Generating Pellets Using a Dome Type Extruder.","authors":"Ronak R Patel, Dharmik M Mehta","doi":"10.2174/0126673878351312250502072134","DOIUrl":"https://doi.org/10.2174/0126673878351312250502072134","url":null,"abstract":"<p><strong>Background: </strong>The extrusion-spheronization process continues to be utilized in pharmaceutical manufacturing, as evidenced by several recent patents and articles. The primary challenge in Pelletization via extrusion spheronization has been to optimize the production process to achieve high yields of spherical pellets ensuring they meet specific quality standards while keeping the production costs low.</p><p><strong>Objective: </strong>Therefore, this study aimed to identify the ideal parameters for maximizing production rates using a dome extruder while maintaining the desired physical characteristics of the pellets.</p><p><strong>Methods: </strong>By employing Design of Experiments (DoE) techniques and analyzing critical processing parameters, the research sought to delineate the optimal design space. The pellet formulation comprised Apixaban, microcrystalline cellulose, hypromellose, and sodium bicarbonate, intended to generate gas within the pellets. The study employed a Response Surface Methodology, specifically the Central Composite Face-Centered design, to systematically assess the impact of various process variables on both pellet properties and production rate. Key independent factors included Extruder speed (X1), Spheronization speed (X2), and Spheronization time (X3), which were determined based on the preliminary analyses. Characterization of pellets from each experiment encompassed measurements of sphericity via Aspect ratio (R1), Friability (R2), Bulk density (R3), and Percentage yield within a specific size range (R4).</p><p><strong>Results: </strong>From the results, it was discerned that extrusion and spheronization speed emerged as critical process parameters within defined spheronization time for maximizing production rates while concurrently maintaining satisfactory pellet properties. Based on the design space analysis, extrusion speed spans from 23 to 27 rpm, while spheronization speed extends from 700 to 900 rpm at 5 min to 7 min of spheronization time, yielding more than 90% of the desired fraction of spherical pellets with good physical properties.</p><p><strong>Conclusion: </strong>This study successfully optimized process parameters for pellet production using a dome-type extruder, employing a Quality by Design (QbD) approach. Key factors influencing pellet yield and quality-extrusion speed, spheronization speed, and spheronization time-were identified and systematically optimized. These optimized pellets may potentially undergo further coating with polymers to facilitate gastro-retentive or floating drug delivery systems, expanding their applicability in pharmaceutical formulations.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Lipid Microspheres for Topical Delivery of Norfloxacin: Development and Evaluation.","authors":"Aruna Murugan, Niserga Sawant, Vasanti Suvarna, Namita D Desai","doi":"10.2174/0126673878348440250422045340","DOIUrl":"https://doi.org/10.2174/0126673878348440250422045340","url":null,"abstract":"<p><strong>Objective: </strong>The objective of the present study is the development and evaluation of Norfloxacin lipid microspheres as topical gels for adjunct therapy to overcome complex clinical challenges presented by moist, thermally coagulated burn wounds.</p><p><strong>Methods: </strong>Norfloxacin-loaded lipid microspheres were prepared using the melt diffusion technique with Compritol ATO HD5, stearic acid, Tween 20, Span 80, and Transcutol P, and were incorporated into topical gels formulated with Carbopol 971P NF.</p><p><strong>Results: </strong>Lipid microspheres exhibited an average size of 65.22+23.39 μm and a drug entrapment efficiency of 81.58 ± 0.81%. Scanning electron microscopy confirmed spherical particle morphology, while differential scanning calorimetry indicated the amorphous nature of norfloxacin within the microspheres. In vitro studies demonstrated extended release of norfloxacin, with 72.33 ± 1.46% released from microspheres and 63.18 ± 1.24% from topical gels after 8 hours. Ex vivo studies revealed 28.16 ± 0.63% of norfloxacin permeating through second-degree burnt porcine skin and 21.12 ± 1.38% through intact porcine skin after 8 hours from topical gels. In vitro antibacterial studies indicated a lower MIC₉₀ of lipid microspheres compared to the pure drug.</p><p><strong>Conclusions: </strong>The approach shows promise in enhancing drug availability for managing burn wound complexities through improved solubility, extended release, and localized delivery. However, preclinical, clinical, and regulatory evaluations are required to establish the utility of the proposed approach. Further investigation into its application for other types of chronic or infected wounds could broaden its therapeutic potential.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144056905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancements and Challenges in Gastroretentive Drug Delivery Systems: A Comprehensive Review of Research Innovation, Technologies, and Clinical Applications.","authors":"Ayush Dubey, Mohammad Ovais, Amol Chhatrapati Bisen, A Rajendiran","doi":"10.2174/0126673878342430250414114531","DOIUrl":"https://doi.org/10.2174/0126673878342430250414114531","url":null,"abstract":"<p><p>Gastroretentive drug delivery systems (GRDDS) have emerged as a focal point of research and development, attracting substantial attention due to their potential to revolutionize oral drug administration. Their ability to enhance the bioavailability and therapeutic effectiveness of orally administered medications, particularly those with narrow absorption windows or susceptible to gastrointestinal degradation, has spurred considerable interest. By extending gastric residence time, GRDDS offers a pathway to optimize drug absorption while minimizing dosing frequency, thereby improving patient compliance and therapeutic outcomes. This comprehensive review delves into the diverse array of gastroretentive drug delivery approaches, providing in-depth insights into their classification, mechanisms of retention, recent innovations with patented technologies, and existing marketed formulations of the domain. Furthermore, it meticulously examines the challenges inherent in GRDDS implementation and elucidates effective strategies to surmount them. From novel formulation techniques to ingenious drug-carrier systems, this review explores the multifaceted landscape of GRDDS development, shedding light on promising avenues for future research and development. By advancing current knowledge and anticipating future trends, this review serves as a valuable resource for researchers, clinicians, and pharmaceutical professionals navigating the dynamic terrain of gastroretentive drug delivery.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond the Surface: The Role of Implantable Drug Delivery Systems in Modern Medicine.","authors":"Hammad War, Sumit Sharma, Sanchit Dhankhar, Samrat Chauhan, Supriya Khanra","doi":"10.2174/0126673878369501250404184028","DOIUrl":"https://doi.org/10.2174/0126673878369501250404184028","url":null,"abstract":"<p><p>Advanced drug delivery methods have emerged mainly because of the limitations of traditional drug delivery systems like oral and intravenous routes, along with fluctuating concentrations of drugs that have compromised therapeutic outcomes. An implantable drug delivery system (IDDS) presents an attractive alternative: long-term, continuous drug release improves therapeutic efficacy while minimizing toxicity and side effects. IDDS, first presented in the 1930s as subcutaneous hormone pellets, have gained much attention recently in drug delivery due to their controlled release of drugs in a localized and sustained manner. In systemic treatments, drugs administered through IDDS evade first-pass metabolism and enzymatic degradation within the gastrointestinal tract, therefore enhancing drug bioavailability. The most suitable properties of IDDS are its application with drugs that have poor stability or solubility in oral formulations. Even though implantation is invasive, the benefits of infrequent administration, higher patient compliance, and being able to discontinue therapy when side effects are present far outweigh the disadvantages. Today, IDDSs are used in a myriad of therapeutic areas: contraception, chemotherapy, and pain management, to name a few. Future developments in such technologies, fine-tuning these systems further, will revolutionize drug therapy by bringing even better and more patient-friendly drugs with both better efficacy and sustained periods of effects.</p>","PeriodicalId":94352,"journal":{"name":"Recent advances in drug delivery and formulation","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144053914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}