INTRODUCTION:Pharmacomicrobiomics is the interdisciplinary area of research arising from studies demonstrating that the microbiota in the human colon dynamically regulates the metabolism of many medications. This review paper discusses how this microbiota may explain some of the variability observed in patient responses to medication, and describes the role of gut-associated microbial communities in the metabolism, effectiveness, and safety of drugs. METHODS:Using important scientific databases, a thorough and methodical review of the literature was carried out with an emphasis on preclinical and clinical research examining microbiota-drug interactions. Microbial biotransformation pathways, enzyme-mediated metabolism (such as β- glucuronidases, azoreductases, and reductases), and the impact of dysbiosis, probiotics, and antibiotics on drug pharmacokinetics were important topics. New computational and microbiome-based prediction methods were also assessed. RESULTS:The gut microbiota has a substantial impact on drug bioavailability, metabolism, enterohepatic recirculation, and toxicity, according to mounting data. Anticancer, cardiovascular, and antidiabetic medications are among the many therapeutic classes whose pharmacokinetics are changed by microbial enzymatic activity. Clinically significant variability in drug response is caused by microbiome disruptions, such as dysbiosis brought on by antibiotics. Promising methods for forecasting microbiota-driven pharmacokinetic variations are provided by recent developments in pharmacomicrobiomic profiling and in silico modelling. DISCUSSION:These results highlight the gut microbiota as an important but little-known factor influencing pharmacokinetic behaviour and treatment effectiveness. Combining pharmacogenomic frameworks with microbiome data could improve tailored medication treatment. However, issues like interindividual microbial diversity, a lack of analytical method standardisation, and a lack of adequate translational models continue to be major obstacles. CONCLUSION:Drug metabolism and pharmacokinetic variability are significantly influenced by the gut microbiota-drug axis. Optimising therapeutic outcomes, reducing side effects, and advancing precision pharmacotherapy are all possible with the integration of microbiome-based insights into clinical decision-making and drug development.
Introduction: Fast-Dissolving Films (FDFs) are innovative oral drug delivery systems designed for a rapid onset of action, enhanced bioavailability, and ease of administration without water, making them ideal for pediatric, geriatric, and dysphagic patients. Methods: This review summarizes recent literature on FDF development, focusing on formulation strategies (hydrophilic polymers, plasticizers), preparation methods (solvent casting, hot-melt extrusion), and evaluation parameters (mechanical strength, drug content, dissolution, stability). Results: Advances in polymer science, nanotechnology, and taste-masking have significantly improved FDF performance. Their application spans pain management, allergies, GI disorders, and neurological conditions. However, limitations such as low drug-loading capacity, specialized packaging, and formulation complexity remain challenges. Discussion: FDFs offer a promising alternative to conventional oral dosage forms, particularly for populations with swallowing difficulties. Their potential is supported by ongoing innovation; however, issues such as scalability, stability, and drug uniformity require further exploration. Integration with personalized medicine also offers future growth opportunities. Conclusion: FDFs hold substantial potential to enhance therapeutic outcomes and patient adherence. Continued research into overcoming formulation and manufacturing challenges will be critical to their broader clinical and commercial success.
Globally, fungal diseases exert a considerable toll on human health, exhibiting wideranging epidemiological patterns across geographic locales. In the post-COVID era, the prevalence and risk of fungal infections have grown at an unprecedented pace, posing a colossal challenge to people with impaired immune systems owing to indiscriminate use of immunosuppressants and anti-fungal agents. In recent times, posaconazole (PCZ), a triazole with broad-spectrum activity, has emerged as a promising therapeutic option for the efficacious management of invasive fungal infections caused by Candida spp., Aspergillus spp., and Zygomycetes, with superior protection against endemic fungi such as Histoplasma capsulatum, Blastomyces dermatitidis, and Coccidioides immitis. PCZ (commercially available as Noxafil® suspension at a dose of 40 mg/ml and delayed release tablet with a daily dose of 300-600 mg) was one of the front-line therapies approved by the USFDA in 2006 for the prophylactic treatment of COVID-associated pulmonary aspergillosis or mucormycosis, especially among critically immunocompromised patients undergoing mechanical ventilation and high-dose steroid treatment for progressive pulmonary disease. In clinical settings, existing PCZ formulations (tablets/suspensions) have achieved suboptimal peak plasma drug concentrations in critically ill patients owing to poor bioavailability. Therefore, the scientific community is striving to design and fabricate novel PCZ formulations with improved pharmacokinetic performance and therapeutic efficacy compared to existing dosage forms. This comprehensive review study aims to elucidate the mechanistic corroborations on therapeutic efficacy of PCZ and its resistance, considerations in the formulation and optimization (such as drug-drug interactions, variable absorption, and potential adverse effects such as hepatotoxicity and gastrointestinal disturbances) necessitate vigilant monitoring and dose adjustments by investigating marketed products, clinical trials, patented formulations, for its enhanced pharmacokinetic performance and continued surveillance of PCZ in clinical practice.
INTRODUCTION:Nanomedicine has changed the course of oncology through drug-delivery systems that improve efficacy while reducing systemic toxicity. PEGylated liposomes have specifically revolutionized cancer treatment by enhancing pharmacokinetics, stability, and tumor-selective deposition via the enhanced permeability and retention (EPR) effect. METHODS:The keywords applied in the literature review included PEGylated liposomes, nanomedicine, and drug delivery in cancer, which were used to identify relevant studies. Data were gathered from credible databases in PubMed, ScienceDirect, and Google Scholar, with emphasis on peerreviewed, most recent publications in English. RESULTS:PEGylation has been shown to extend the circulatory lifetime, enhance drug deposition in tumors, and minimize off-target toxicity. Clinical reports indicated that PEGylated preparations were superior and better tolerated than standard chemotherapy, particularly in breast, ovarian cancer, and pancreatic malignancies. New therapeutic potential can be unlocked through gene delivery, RNA-based therapies, and combination regimens. DISCUSSION:Clinical success has been achieved, but shortcomings exist, such as the accelerated blood clearance (ABC) effect, PEG immunogenicity, and drug accumulation heterogeneity that are due to EPR. To address those challenges, more effective design solutions should be employed, including stimuli-responsive liposomes and patient-tailored methods. CONCLUSION:PEGylated liposomes are a pharmaceutically established and maturing nanomedicine technology in oncology. Their further advancement toward multifunctional, personalized, and immunologically safer designs promises to deliver cancer therapeutics.
INTRODUCTION/OBJECTIVE:Ebastine, a second-generation H1 antihistamine, exhibits poor aqueous solubility and consequently low oral bioavailability, limiting its clinical therapeutic efficacy. Novasome is an advanced vesicular nanocarrier system that offers a promising approach to enhance the solubility and dissolution behavior of a poorly water solubility drug. Therefore, this study aimed to develop, optimize, and characterize ebastine-loaded novasomes and to compress them into tablets to enhance drug solubility, dissolution, and oral bioavailability. METHODS:Ebastine-loaded novasomes were prepared and optimized, then converted into lyophilized tablets using a suitable cryoprotectant. The optimized formulation was characterized for Particle Size (PS), Polydispersity Index (PDI), Zeta Potential (ZP), and Entrapment Efficiency (EE). Solidstate properties were assessed via Differential Scanning Calorimetry (DSC) and X-Ray Diffraction (XRD), while drug-excipient compatibility was evaluated using Fourier-Transform Infrared Spectroscopy (FTIR). In-vitro release studies were performed under stimulated physiological conditions, and in-vivo pharmacokinetic evaluation was conducted in Wistar rats. RESULTS:The selected ebastine-loaded novasome exhibited a mean particle size of 189.9nm, a polydispersity index of 0.31, and an entrapment efficiency of 86.19%. In-vitro release exceeded 90% over 12 hours, significantly surpassing the dissolution profile of pure ebastine. DSC and XRD analyses confirmed amorphization of the drug within the Novasomal matrix, while FTIR revealed no evidence of drug-excipient compatibility. In-vivo studies demonstrated a 493.88% increase in relative oral bioavailability compared to free drug suspension (p < 0.05). DISCUSSION:The enhanced dissolution and bioavailability are attributable to drug amorphization, high surface area to volume ratio of the nanovesicles, and protective entrapment of ebastine within the bilayer structure, which together improved gastrointestinal solubilization and oral bioavailability. CONCLUSION:The lyophilized Ebastine-loaded novasome tablet constitutes a stable, effective, and pharmacokinetically superior oral dosage form, offering significant potential for enhance the oral bioavailability of poorly water-soluble drugs.
INTRODUCTION:The gut microbiota is a matrix ecosystem vital for the maintenance of host metabolic, immune, and neurological health. Disruption of this balance, known as gut dysbiosis, is associated with numerous diseases, including diabetes and neurological disorders. Dietary polyphenols, particularly flavonols like quercetin, have shown potential in restoring microbial balance. However, their poor solubility and low bioavailability limit therapeutic outcomes. METHODS:This review evaluates the role of dietary polyphenols in modulating gut microbiota and explores nanocarrier-based approaches to enhance their stability and targeted delivery. Literature from recent preclinical and clinical studies was analysed to highlight the interaction between polyphenols and gut microbes with the advancement of nano-delivery systems. RESULTS:Polyphenols influence gut microbiota by promoting beneficial production. Nanocarriers such as liposomes and polymeric nanoparticles improve the bioavailability and colon-targeted release of polyphenols, leading to improved gut axis function and impacting mood, cognition, and neuroprotection. DISCUSSION:Nanocarrier systems offer an innovative solution to overcome the limitations of conventional polyphenol delivery. Enhanced colonic release allows direct modulation of gut microbiota and improved systemic outcomes, particularly in metabolic and neurological conditions. CONCLUSION:Nanocarrier-based delivery of polyphenols holds promise in managing gut dysbiosis and related disorders by improving bioavailability and targeting microbial balance. This approach supports the development of microbiota-focused dietary therapeutics.
This review focused on bilberry because recognition of the high concentration of anthocyanins, flavonoids, and polyphenols, which have potent antioxidant, anti-inflammatory, and neuroprotective qualities, has made bilberries (Vaccinium myrtillus) the subject of much research. These phytoconstituents have been demonstrated to protect Retinal Ganglion Cells (RGCs), lower oxidative stress, and regulate inflammatory cytokines, all of which are important aspects of glaucoma pathophysiology. However, bilberry extract's low ocular bioavailability and poor stability when given via traditional methods are its drawbacks. Bilberry-derived substances have been incorporated into nanoparticle-based delivery systems to enhance eye penetration and therapeutic efficacy, thereby overcoming these challenges. In experimental models, bilberry anthocyanin nanoformulations have shown increased RGC protection, sustained drug release, and improved ocular permeability. Additionally, by sustaining antioxidant activity for extended periods, these formulations reduce ophthalmic oxidative damage associated with glaucoma development. Studies demonstrating better intraocular pressure regulation, less neuroinflammation, and preservation of optic nerve structure have added credence to the therapeutic promise of bilberry-based nano formulations. Nanoparticle- enhanced bilberry extracts provide better stability, targeted distribution, and more reliable therapeutic results than traditional herbal formulations. Because bilberry-focused nano-therapeutics can penetrate ocular barriers and deliver potent phytoconstituents directly to ocular tissues, they offer a promising natural approach to managing glaucoma.
The development of efficient and targeted drug delivery systems remains a significant challenge, particularly for active pharmaceutical ingredients with poor aqueous solubility. Among various nanocarrier systems, Mesoporous Silica Nanoparticles (MSNs) have emerged as promising candidates due to their high surface area, tunable pore size (2-50 nm), thermal stability, and chemical modifiability. This review comprehensively discusses the rationale behind the utilization of MSN as drug delivery systems, focusing on how the type and concentration of surfactants, along with surface functionalization strategies, influence their physicochemical characteristics and pharmacokinetic performance. The synthesis of MSNs typically involves sol-gel processes using silica precursors (e.g., tetraethyl orthosilicate) and surfactants (e.g., cetyl trimethyl ammonium bromide, Pluronic F127), which dictate the morphology, particle size, and pore architecture of the resulting nanoparticles. Furthermore, surface modifications employing functional groups such as polyethylene glycol or pH-responsive polymers enhance biocompatibility, prolong systemic circulation, and enable controlled and site-specific drug release. Evidence from recent studies demonstrates that MSNs significantly improve drug loading efficiency, enhance solubility and bioavailability, and reduce off-target toxicity. Consequently, MSNs represent a highly versatile and modifiable platform with considerable potential for addressing the limitations of conventional drug delivery systems, particularly in oncology and the treatment of chronic diseases.
Wounds can result from a variety of causes, including burns, traumas, surgeries, and long-term conditions like diabetes. The development of biofilms has detrimental consequences as well. Wound healing is also impacted by ageing, hypertrophic scarring, and recurrent injuries. With rising death rates and related costs, wound healing is a serious global concern. The severity of wound healing is caused by microbial infection, inflammation, and a lack of cell migration, proliferation, and angiogenesis. The many phases of wound healing include hemostasis, inflammation, proliferation, and remodeling to restore the integrity of the skin and subcutaneous tissue with its anti-microbial, anti-angiogenic, and anti-inflammatory effects. The development of biomaterials for wound dressings has reached a new benchmark and improved understanding. The extraordinary outcomes are caused by more recent discoveries and patents that concentrate on the wound microenvironments, such as pH, temperature, and reactive oxygen species. Because they can adjust to the current microenvironment at the injured surface, wound dressing materials that can function as theranostics also have significant advantages. The wound healing products should concentrate on cell-cell interactions, cell proliferation, cell signaling, and vascularization in order to make the therapy effective. The main advantages are also explained by the wound-healing material's penetrating effect. This review endeavored to throw light on different aspects of wounds and the latest advances in bioproducts effective for wound healing. Further, the clinical trials for wound healing products have been addressed.
INTRODUCTION:The increasing incidence of diabetes has made it essential to create more efficient, customized, and reproducible drug delivery systems. Quality by Design (QbD) is viewed as a science-driven, disciplined approach to drug development that relies more on ensuring consistent product quality through the determination of the Critical Quality Attributes (CQA), Critical Process Parameters (CPP), and development of a Design Space. Nonetheless, the sophistication of contemporary drugs and volumes of data involved tend to confine the independent effectiveness of QbD. Drug development has been transformed by Quality by Design (QbD), which has replaced reactive quality testing with proactive, scientifically based approaches. With its roots in ICH Q8-Q11 principles, QbD places a strong emphasis on defining Critical Quality Attributes (CQAs), creating Design Space, and incorporating risk management to improve the regulatory flexibility and resilience of products. METHODS:The review gives a regulatory perspective on QbD and covers important tools from AI such as artificial neural networks (ANN), support vector machines (SVM), and response surface methodology (RSM). In particular, these AI tools offer predictive modeling, pattern recognition, and optimization in support of formulation design. A comprehensive search of PubMed, Google Scholar, and ScienceDirect identified relevant articles focused on the use of AI and machine learning (ML) in diabetes care. Case studies are provided to demonstrate applications in practice, including oral insulin nanoparticles, extended-release metformin, and oral peptide formulations. RESULTS:By integrating AI with QbD, an ideal environment is created, one that will enhance formulation accuracy, reduce development times, and increase the possibility of regulatory acceptance. DISCUSSION:This review investigates the convergence of Artificial Intelligence (AI) technologies and QbD principles in advanced diabetes therapy formulation development. It evaluates how AI tools improve the efficiency, precision, and regulatory acceptability of QbD-guided pharmaceutical design, especially for diabetes therapy. CONCLUSION:Although challenges exist with data integrity, regulatory interpretation, and the necessity for a combination of scientific themes, the AI-QbD framework is a transformational journey toward intelligent, patient-focused drug design. Future directions include advances like real-time release testing (RTRT), AI-enabled personalized medicine, and the integration with digital health.
The review focuses on emulsomes, lipid-based nanocarriers that combine characteristics of emulsions and liposomes. Structurally, emulsomes consist of a solid lipid core surrounded by phospholipid bilayers, enabling the encapsulation of both hydrophilic and hydrophobic drugs. This dual encapsulation capacity makes emulsomes particularly valuable for enhancing the solubility and bioavailability of poorly water-soluble drugs, especially those classified under the Biopharmaceutical Classification System (BCS) Class II and IV. Key components of emulsomes, such as the solid lipid core, phospholipid layers, surfactants, and stabilizers like cholesterol, play crucial roles in determining their stability, drug-loading efficiency, and controlled-release capabilities. The review highlights various preparation methods, including sonication, high-pressure extrusion, and ethanol injection, each optimized to produce stable emulsomes with appropriate particle sizes and enhanced drug encapsulation. In terms of therapeutic applications, emulsomes have shown promise in delivering a wide range of drugs, including those for cancer therapy, anti-inflammatory treatments, antifungal medications, and antiviral agents. The ability of emulsomes to enhance drug targeting, retention, and sustained release makes them a versatile and effective drug-delivery platform. This review underscores the potential of emulsomes as a cutting-edge nanocarrier system, capable of advancing drug-delivery technologies and improving therapeutic outcomes across various medical fields.
Solid Lipid Nanoparticles (SLNPs) are emerging as advanced nanocarriers that combine the advantages of conventional drug delivery systems with enhanced stability, Bioavailability (BA), and targeted delivery capabilities. These features make them highly promising for therapeutic applications for the treatment of psychotic conditions. This study explores the potential of SLNPs as cutting- edge carriers for antipsychotic drug targeting, emphasising their role in overcoming challenges associated with conventional therapies. A review was conducted using multiple electronic databases, including PubMed, Scopus, official websites, Google Scholar, Google Patent, and ResearchGate. Original research and review articles published between August 31, 2009, and August 31, 2024, were analyzed. From an initial pool of over 100 publications, 60 studies, and an additional 30 relevant articles were selected for review. These results highlight the versatility of SLNPs in addressing therapeutic challenges, particularly in neurological applications like antipsychotic drug targeting. SLNPs represent a cutting-edge advancement in nanotechnology, offering a transformative approach for antipsychotic drug targeting. To enhance drug bioavailability, enable controlled release, and improve blood-brain barrier penetration, SLNPs address critical limitations of conventional therapies. This review underscores the potential of SLNPs as an innovative solution in neuropharmacology, paving the way for future research and clinical applications.
INTRODUCTION:To overcome the poor oral bioavailability of Panax Notoginseng Saponins (PNS) caused by low permeability and acid instability, this study designed bioadhesive microspheres co-loaded with PNS and N-acetyl-L-cysteine (PNS-NAC-BMS). This system aims to protect PNS from gastric degradation and enhance its intestinal permeability and oral bioavailability. METHODS:PNS-NAC-BMS were fabricated via solvent evaporation and characterized for morphology, particle size, drug loading, encapsulation efficiency, mucoadhesion, and in vitro release. Permeability was assessed using Purified Mucin Intestinal Mucus (PIM), Artificial Intestinal Mucus (AIM), and Rat Native Intestinal Mucus (RIM). Oral bioavailability was assessed through rat pharmacokinetic studies. RESULTS:PNS-NAC-BMS exhibited spherical morphology with uniform particle sizes. They achieved high encapsulation efficiency (91.55%) and intestinal adhesion (94.83%), with sustained release. The system showed high apparent permeability coefficients across three models (PIM, AIM, RIM). Pharmacokinetic studies revealed prolonged release and a 2.6-fold increase in oral bioavailability versus PNS Active Pharmaceutical Ingredients (PNS APIs). DISCUSSION:Recently, patents (US 20230338448, CN 118873498) describe PNS delivery using nanocomposites and liposomes. However, none exist for NAC-modified adhesive microspheres, underscoring the novelty of this study. The BMS system significantly improves the oral bioavailability through combined mucoadhesion and NAC-mediated penetration. NAC promotes drug transport across the mucus barrier by cleaving mucin disulfide bonds and increasing lipid solubility. However, promising long-term stability, scalable production, and mucosal safety of NAC require further study. CONCLUSION:PNS-NAC-BMS significantly enhanced intestinal adhesion and sustained drug release, thereby synergistically improving intestinal mucus permeability and oral bioavailability, demonstrating potential as an effective oral drug delivery system.
INTRODUCTION:Lycopene, a naturally occurring carotenoid found in tomatoes and other red-pigmented fruits, demonstrates strong antioxidant activity and therapeutic potential in cancer, cardiovascular disease, and inflammatory disorders. However, its clinical use is limited by poor solubility, instability, and low systemic absorption. METHODS:To overcome these limitations, various advanced drug delivery systems, including nanoemulsions, lipid-based carriers, hydrogels, and self-emulsifying systems, have been developed. Additionally, extraction techniques such as ultrasound-assisted and supercritical fluid extraction enhance lycopene recovery from natural matrices. Nanoformulations further optimize pharmacokinetics by improving solubility, stability, and targeted delivery. RESULTS:These delivery strategies significantly enhance lycopene's absorption, bioavailability, and antioxidant activity while enabling sustained and targeted release. Preclinical and clinical findings support their efficacy in conditions such as prostate cancer, cardiovascular disease, and skin disorders. DISCUSSION:The evidence highlights that optimized nanoformulations address lycopene's physicochemical limitations and broaden its translational potential. However, most data derived from preclinical studies, and limited clinical trials restricts definitive conclusions. Standardization in formulation, dosing, and evaluation remains as unexplored areas. CONCLUSION:Lycopene-based delivery systems show strong promise for therapeutic and nutraceutical applications. Future directions include harmonized protocols, long-term safety studies, and large-scale clinical validation to bridge the gap between bench and bedside.
Neurological diseases such as Alzheimer's disease, Schizophrenia, anxiety, Parkinson's disease, and migraine are serious conditions that continue to threaten mankind. The cases of brainrelated disorders are increasing worldwide and are closely related to physiological, genetic, and environmental factors. Direct drug delivery to the brain is crucial for the effective treatment and prevention of these conditions. However, due to the presence of a lipophilic barrier, i.e., the bloodbrain barrier, the entry of therapeutic agents into the brain is restricted, resulting in a lower concentration at the targeted site. As a solution to this problem, the direct nose-to-brain connection is attracting attention for its effective, precise, non-invasive delivery of drugs via the olfactory and trigeminal pathways. However, there are some limitations, like permeability across the nasal mucosa and mucociliary clearance. Therefore, to overcome these restrictions, the use of nanocarriers, particularly ethosomes, is being attempted. This review paper delves into recent research papers and reports on ethosomes developed for intranasal delivery towards the management of neurological conditions. Ethosomes demonstrated an exceptional capacity to facilitate drug accumulation at targeted sites, owing to their ability to bypass first-pass metabolism, their flexible nature, and the presence of penetration enhancers. The high ethanol content in the composition significantly increases the fluidity of the lipid bilayer, allowing for better interaction of this vesicular system with the blood-brain barrier. Furthermore, the functionalization of ethosomes can enhance the specific delivery of drugs, increase patient compliance, and minimize side effects. However, no intranasal ethosomes for direct brain delivery have progressed from preclinical testing to the bedside of patients. They are still in the experimental phase, particularly in animals or in vivo lab models. The possibilities of toxic effects, the use of high amounts of ethanol, and irregular nasal absorption are a few concerns that need to be addressed. The increasing demand for intranasal delivery suggests that ethosomes may play a pivotal role in the management and treatment of brain-related conditions, but this will only occur after a substantial number of clinical trials confirm their safety and efficacy for human consumption. This review explores such possibilities and highlights current trends and future perspectives in targeting the brain with ethosomal formulations.
INTRODUCTION:In order to address significant issues in cutaneous and transdermal drug administration, the goal of this study is to offer thorough insights into the procedures, formulation strategies, preparation techniques, and therapeutic uses of nanocrystals (NCs). METHODS:A comprehensive examination of the literature was carried out, gathering and examining information from clinical trials, peer-reviewed publications, and pharmaceutical patents. Data about the synthesis, characterisation, and therapeutic use of NCs in transdermal and cutaneous drug delivery were assessed. RESULTS:Drug loading, saturation solubility, and passive diffusion across the stratum corneum were all shown to be much improved by nanocrystals. Their larger surface area and nanoscale size boosted retention at the absorption site, promoted deeper skin penetration, and improved pharmacokinetics. The creation of stable, bioavailable NC formulations was accomplished by both top-down (such as milling and high-pressure homogenisation) and bottom-up (such as precipitation) approaches. Their therapeutic efficacy in treating ailments, including psoriasis, acne, and fungal infections, was backed by clinical and commercial data. DISCUSSION:Notwithstanding compelling preclinical data, regulatory obstacles, formulation stability issues, scale-up constraints, and a dearth of standardised testing methods continue to restrict the clinical translation of NC-based skin formulations. The development of NC-based treatments might be greatly advanced by addressing these problems. CONCLUSION:A potent next-generation method for transdermal and cutaneous medication delivery is nanocrystal technology. Although further study is needed to address translational limitations, NCs have tremendous promise in treating a variety of skin ailments due to their capacity to improve solubility, penetration, and bioavailability.
OBJECTIVE:The objective of this study is to explore the current status and therapeutic potential of nanoparticles (NPs) as a cutting-edge strategy for the treatment of tuberculosis (TB). BACKGROUND:NPs have emerged as a promising drug delivery system (DDS) due to their ability to enhance the bioavailability (BA), stability, and targeted delivery of therapeutic agents. Current advancements in nanotechnology have resulted in the development of a range of NPs, including solid lipid nanoparticles, polymeric NPs, Hybrid NPs, and Metallic Nanoparticles, which hold promise for TB treatment. METHODS:This review compiles and analyzes data from more than 100 studies on the use of NPs in TB from the past 10 years (January 1, 2015, to January 1, 2025). This review was conducted using scientific databases like PubMed, ScienceDirect, Google Scholar, NCBI, Google Patent, clinicaltrials.gov, etc. Result: The review found that NPs significantly improve drug delivery to TB-infected tissues, leading to enhanced therapeutic outcomes. CONCLUSION:Nanoparticles represent a cutting-edge therapeutic strategy with the potential to revolutionize the treatment of TB. The enhanced efficacy, specificity, and reduced toxicity of NPs-based DDs.
INTRODUCTION:Diabetic foot ulcers (DFUs) are difficult to treat due to biofilm formation, poor drug penetration, and elevated wound pH. This study aimed to develop a pH-responsive solid lipid nanoparticle (SLN)-loaded hydrogel for targeted ciprofloxacin delivery using a Quality-byDesign (QbD) approach. METHODS:SLNs were formulated via solvent emulsification-ultrasonication and optimized using a Box-Behnken design to study the effects of lipid concentration, surfactant concentration, and sonication time on particle size and entrapment efficiency. Optimized SLNs were coated with pHsensitive Eudragit L100 and incorporated into a Carbopol 974P hydrogel. The formulation was evaluated for particle size, zeta potential, entrapment efficiency, rheology, spreadability, occlusion, drug release, antimicrobial activity, and three-month stability. RESULTS:Optimized SLNs showed a particle size of 141.24 ± 2.19 nm, polydispersity index (PDI) 0.236 ± 0.019, zeta potential -26.28 ± 1.31 mV, and an entrapment efficiency of 62.55 ± 1.07%. The hydrogel exhibited pseudoplastic flow, good spreadability, and enhanced occlusivity. Drug release was sustained and pH dependent, with greater release at pH 7.4 than at pH 5.5. The SLNloaded hydrogel showed stronger antibacterial activity than the free drug gel against E. coli, S. aureus, and P. aeruginosa. The formulation remained stable for three months at 4 °C with minimal variation in physicochemical properties. DISCUSSION:The pH-responsive coating enabled targeted release in alkaline DFUs, and the SLN- hydrogel system improved drug retention, antibacterial activity, and formulation stability. CONCLUSION:A stable, pH-responsive SLN-loaded hydrogel was successfully developed, demonstrating strong potential for targeted topical treatment of biofilm-associated DFUs and future clinical application.
In recent decades, drug research has increasingly shifted toward herbal molecules instead of synthetic ones, due to their low toxicity and better compliance. Among these phytosterols, plantderived sterol compounds have garnered significant attention for their therapeutic and nutritional benefits. Specifically, β-Sitosterol (BSS) has been extensively studied because of its cholesterollowering, anti-inflammatory, and anticancer properties. However, its limited water solubility and modest absorption in the gastrointestinal tract, along with first-pass metabolism (FPM), greatly reduce its oral bioavailability, thus restricting its clinical usefulness. To address these challenges, advances in emerging drug delivery systems (NDDS)-such as nanoparticles, liposomes, micelles, and nanostructured lipid carriers-and formulation techniques like solid dispersions, hydrotropy, self-emulsifying drug delivery systems, and complexation methods, have proven effective in enhancing BSS solubility, stability, and systemic bioavailability. Innovative technologies like 3D printing-based dosage forms also offer promise for personalized and controlled drug release. The unique aspect of this review is its comprehensive approach, integrating traditional and novel strategies to improve BSS bioavailability and assessing their regulatory relevance through the Biopharmaceutics Classification System (BCS) framework. This paper not only summarizes the latest advances in NDDS for BSS but also highlights translational challenges, future prospects, and targeted delivery options, bridging the gap between laboratory research and clinical application.
INTRODUCTION:Fixed-Dose Combinations (FDCs) combine two or more active components into a single dosage form, addressing active ingredient incompatibilities and enabling diverse release profiles through innovative formulation strategies. They enhance patient compliance, target multiple disease pathways for synergistic effects, and are increasingly important for global health priorities. METHODS:This review synthesizes recent literature, regulatory updates, and clinical evidence on FDCs, focusing on advanced formulation approaches, manufacturing processes, market trends, and post-marketing evaluations. Regulatory frameworks from the USFDA, EMA, and CDSCO were compared to identify approval pathway differences and opportunities for harmonization. RESULTS:Innovative dosage forms, including co-crystallization, soft gelatin capsules with liquid actives, and cardiovascular polypills, have demonstrated improved therapeutic outcomes and costeffectiveness. In India, FDCs dominate antibiotic use both clinically and economically. Comparative regulatory analysis revealed significant procedural variations, potentially impacting global adoption. Clinical and post-market data confirm the safety, efficacy, and practicality of approved FDCs, supporting their role in addressing unmet medical needs. DISCUSSION:FDCs simplify complex regimens, improve adherence, and can facilitate the introduction of first- and best-in-class medicines. However, challenges include formulation instability, analytical difficulties in multi-component quantification, manufacturing complexity, and compliance monitoring. Balancing innovation with robust regulatory oversight and fostering international collaboration will be essential for maximizing their potential. This review provides a comprehensive understanding of the evolving FDC landscape, guiding stakeholders in strategic development and implementation for improved healthcare outcomes.
