BITS Faculty Publications

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    Lipid-based nanoformulations in onychomycosis therapy: addressing challenges of current therapies and advancing treatment
    (RSC, 2025-03) Jain, Ankit
    Onychomycosis significantly impacts approximately 20% of the global population. The physical barriers of the nail structure make fungal infections a persistent therapeutic challenge. Traditional approaches, including topical and oral antifungal agents, have limitations such as toxicities, low nail permeability, adverse effects, and high recurrence rates. Consequently, emerging lipid-based delivery systems have gained interest because of their potential to address these drawbacks. Nanostructured lipid carriers (NLCs), solid lipid nanoparticles (SLNs), liposomes, and transferosomes are innovative formulations that offer enhanced drug solubility, sustained release, and targeted delivery to the nail matrix. These lipid-mediated approaches have shown promise in overcoming the hurdles associated with conventional therapies, thereby improving treatment outcomes, patient compliance, and the overall quality of life. A comprehensive review focusing on the potential of lipid-based drug delivery systems in treating onychomycosis is lacking in the existing literature. This review explores various aspects of the clinical presentation of onychomycosis, available treatments, challenges associated with treatment, formulation science related to lipid-based vehicles and their applications, highlighted by the promising aspects of these novel formulations, and provides insights into clinical developments. In addition, the regulatory perspective is critical to such development, and approval is discussed, particularly in managing regulatory compliance complexities to ensure successful implementation. The holistic approach provides a comprehensive basis for determining lipid-based drug delivery systems' state-of-the-art and future scope.
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    Tumor-targeting with stimuli-responsive vesicular nanocarriers: basics to emerging applications
    (Elsevier, 2025-06) Jain, Ankit
    Tumour-Targeting with Stimuli Responsive Vesicular Nanocarriers: Basics to Emerging Applications not only acquaints scientists and science interns with the fundamental knowledge of the experimental aspects and state-of-the-art technology for vesicular carriers to equip their rational application in tumor targeting, but also provides a holistic understanding of regulatory concerns, patents, and clinical trials. In 15 chapters. this book provides basics and advances in stimuli-responsive vesicular carriers for tumor targeting based on findings outlined in highly organized tables, illustrative figures, and flow charts. With a focus on the extrapolation of bioengineering tools in the domain of vesicular carriers, stimuli-responsive features concerning tumors, drug delivery approaches, and associated challenges, it helps readers to define the major gaps in knowledge that can lead to significant scientific discoveries in therapy, diagnosis, and theragnosis of cancer.
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    Patents, clinical trials, and regulatory concerns with stimuli-responsive vesicular carriers
    (Elsevier, 2025) Jain, Ankit
    Vesicular carriers, including liposomes, pharmacophores, and ethosomes, have risen as promising carriers focused on cancer management. Analysts and industry partners can employ these inventive carriers’ potential and significantly affect cancer treatment by understanding the practical prospects of vesicular carriers in cancer. Exploring the complex arena of patents, clinical trials, and regulatory perspectives is vital for effective advancement and commercialization. Patents are imperative in ensuring intellectual property rights, but the apparent scene is complex and continually advancing. This chapter enlightens us on the present status and challenges associated with the grant of patents, particularly vesicular carriers. Clinical trials are vital for proving safety and efficacy, but designing and conducting these trials could be a noteworthy challenge. In this chapter, the clinical trials section looks into the different phases of trials, counting phases I–III, and exhibits the cluster of nano-formulations right now underneath examination. Regulatory aspects, comprising challenges faced by the Food and Drug Administration (FDA) and other worldwide regulations, are also summarized in the chapter, followed by a discussion on the FDA’s approach to regulating nanotechnology products taken after a global snapshot of nanomedicine direction, including the European Union, United States, United Kingdom, Canada, Japan, and India. This chapter outlines the current state of vesicular carriers in cancer, including patents, clinical trials, and regulatory aspects. It highlights the challenges and openings in this field and gives experiences for analysts and industry partners to explore this complex scene.
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    Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress
    (Springer, 2025-07) Jain, Ankit; Singhvi, Gautam
    To surpass challenges with traditional approaches to treat Rheumatoid arthritis (RA), an improved understanding of molecular-level pathogenesis brought forth targeted therapy with biologics as a great promise in halting the progression of RA. Novel biologics are being designed with the help of synthetic fusion proteins, monoclonal antibodies, and protein fragments, with or without drugs, to target various signaling pathways, including TNF-α, IL-6, JAK, Th-17, IL-family, GM-CSF, B-cell, and T-cell signaling. The journey of biologics in RA management began in 1998 with etanercept (Enbrel®). Since then, regulatory bodies have endorsed various biologics and many more are in different clinical stages. This review aims to explore RA by examining current clinical studies with focus on emerging development on molecular-level pathogenesis, prevalent conventional treatment options and their limitations, as well as recent advancements in biologically engineered therapeutics. It also includes a few relevant case studies to support these findings. Despite the progress, challenges remain, such as high costs and the need for safer, more effective delivery methods. The document also touches on the historical perspective of RA, its pathophysiology, and the role of synovial fluid pharmacokinetics in treatment effectiveness. The importance of early diagnosis and well-controlled treatment strategies for RA is paramount. The potential of emerging biological and targeted treatments to facilitate a treat-to-target approach in RA management is substantial. This review explores the key molecular pathways of rheumatoid arthritis and includes detailed figures for better understanding. It also highlights the promising potential of biologically engineered therapeutics, supported by evidence from case studies and clinical trials.
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    Lineage of lipid-based endosomal escape in cytosolic delivery to cancer: insight into an unprecedented approach
    (Elsevier, 2025-12) Jain, Ankit
    Endosomal sequestration of lipid-based systems constitutes a significant limitation that undermines the efficient intracellular delivery of therapeutics in cancer treatment. Upon administration, the intracellular fate of drug or gene constructs within lipid-based delivery systems is influenced by various factors, including p-glycoprotein-mediated efflux and lysosomal degradation, which impede sufficient therapeutic agents from reaching their intended targets. This review exhaustively discusses lipids (properties of lipids and role of pKa) and various lipid-based delivery systems facilitating the endosomal escape for cancer treatment. All aspects, such as endosomal sequestration, methods to promote endosomal escape, a mechanistic overview of endosomal escape, detection of endosomal escape, the application potential of lipid-based systems for cancer treatment, and safety of lipid-based systems, were covered in this manuscript. Existing reviews on endosomal escape have accounted for the various mechanisms,. Still, this review paper also furnishes the role of pKa and applications of molecular dynamic simulation in lipid-based drug delivery, and safety concernsof lipid-based nanosystems. This review discussed the influence of material properties on the endosomal escape of therapeutic agents.
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    Characterization of 2D nanomaterials using spectroscopic and microscopic approaches
    (Wiley, 2025-06) Jain, Ankit
    For a comprehensive understanding of 2D-NM to use in pharmaceutical and biomedical applications an accurate characterization is required, for example, modifications in shape and size, structural compositions, etc., result in significant changes in nanomaterial characteristics. Diverse characterization techniques should support the results of the characterization of various nanostructures/nanomaterials until phase certainty is proven. Structural characterization is being strengthened by XRD, TEM, and Raman techniques, and for morphological evaluations, individual methods like FE-SEM, HR-TEM, STM (conductive), DLS, AFM, and SEM are used practically. Other advancements in nanomaterial characterization include Auger electron spectroscopy, nonlinear optics NLO spectroscopy, electron energy loss spectroscopy (EELS), and thermal characterization ultimately provides information of the phase and chemical composition of nanomaterials. It is proposed that metrics such as the shape and size of particles, functionalities, multiple layers, or colloidal attributes of graphene-like materials be documented to increase repeatability and allow comparison of 2D materials manufactured or used by various organizations. This chapter summarizes a wide range of alternative characterization approaches for 2D-NM mainly carbon-based materials which are extensively used in the developing biomedical world. The researchers and developers need to evaluate the mechanical, electrical, or electromagnetic stress on such materials; hence these real-time investigations are intended to reveal new insights into material characteristics.
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    Unlocking the potential of photodynamic therapy in Psoriasis: Mechanistic insights, wide-ranging applications, challenges and future directions
    (Elsevier, 2025-10) Rao, Venkatesh K.P.; Jain, Ankit; Rao, Venkatesh K.P.
    Psoriasis is an autoimmune skin disorder involving the interaction of genetic factors and environmental stress which leads to uncontrolled proliferation of keratinocytes and activation of the immune system. Conventional treatment options, including topical therapies, phototherapy, systemic drugs, and biologics, are used based on disease severity. Recently, photodynamic therapy (PDT) has gained attention due to its unique advantages over traditional treatments. PDT relies on three key components i.e. photosensitizer (PS) administered either locally or systemically, specific light irradiation, and molecular oxygen to generate reactive oxygen species (ROS), leading to the damage of photoactivated cells through cellular apoptosis and necrosis. Recent studies have explored innovative PSs and delivery strategies to enhance the efficacy of PDT in psoriasis. Emerging research highlights the potential of PDT to suppress keratinocyte proliferation and modulate inflammatory pathways, such as JAK/STAT inhibition via ROS-mediated upregulation of SOCS1/3. Innovative delivery strategies and photosensitizers, including chlorin e6, IR820, ZnPc-F7, and 5-aminolevulinic acid (ALA), have been developed to enhance selectivity, reduce treatment-associated discomfort, and improve skin penetration. Nanocarrier systems, such as mesoporous silica nanoparticles, polydopamine-based platforms, and lipid-based nanocarriers, have enabled synergistic photochemotherapy and dual photothermal-photodynamic approaches, leading to improved therapeutic outcomes by inducing apoptosis, restoring skin barrier function, and attenuating proinflammatory signaling. This review highlights PDT principles, mechanisms, approved PSs, and emerging combinations. Despite its promising effects, PDT remains underutilized in psoriasis, demanding further research and nanotech-driven optimization for patient-friendly therapies.
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    Protein and peptide delivery by chitosan systems
    (Elsevier, 2022) Jain, Ankit
    Chitin is the most abundant amino-polysaccharide polymer found in nature. Chitosan is the main derivative of chitin, which is obtained from the alkaline deacetylation of chitin. Because chitosan has some limitations, chitosan derivatives (i.e., trimethyl chitosan and thiolated chitosan) are successfully employed to develop delivery systems for the administration of proteins. These polymers have mucoadhesive characteristics and penetration potential, so they have been effectively used to deliver proteins. Peptides or proteins as therapeutics are structurally and chemically labile substances. Parenteral is the preferred route for administering proteins and peptides. Besides parenteral route, other routes such as the oral, nasal, and pulmonary routes are also attracting the researchers for the administration of these biotherapeutics. Peptide and protein containing chitosan-based delivery systems improve cellular uptake and absorption across the mucosal sites. Because of their mucoadhesive nature, chitosan and its derivatives have the potential to open tight junctions between epithelial cells, resulting in enhanced penetration. Different chitosan-based delivery systems such as microparticles, nanoparticles, liposomes, and niosomes have been extensively used to deliver proteins. This chapter provides an overview of chitosan-based polymers for the preparation of therapeutic peptides and proteins. The physicochemical characteristics of these different carrier systems as well as their applications in protein and peptide administration through parenteral and other types of administration are discussed
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    Environmental stimuli-sensitive chitosan nanocarriers in therapeutics
    (Elsevier, 2022) Jain, Ankit
    Environmental stimuli-sensitive chitosan nanocarriers (SSCNs) have attracted attention in the area of cancer chemotherapy. Chitosan is the most commonly used natural polymer obtained by the deacetylation of chitin. It is a polymer suitable for therapeutic applications owing to its distinctive characteristics including biodegradability, biocompatibility, and nontoxicity. Chitosan consists of amino and hydroxyl groups that can be used chemically to provide stimuli-sensitive characteristics that have promising applications in the field of nanobiomedicines. It is employed for the fabrication of several nanocarriers such as liposomes, nanoparticles, dendrimers, niosomes, micelles, and microparticles. The versatile features of chitosan, such as mucoadhesion, better transfection, in situ gelation, enhancement of absorption, and permeation, have made it a promising candidate for drug delivery. This chapter discusses different types of stimulus-sensitive chitosan nanocarriers (temperature, pH, ultrasound, redox, photo, and magnetic field) along with drug release mechanisms. This strategy is used to deliver therapeutic agent(s) at the target site, which enhances the therapeutic effects with less side effects related to the drug(s). Environmental SSCNs could be a potential approach to future clinical applications
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    Role of caveolin-eNOS platform and mitochondrial ATP-sensitive potassium channel in abrogated cardioprotective effect of ischemic preconditioning in postmenopausal
    (SciELO, 2022) Jain, Ankit
    Caveolin, the protein of the caveolar membrane, interacts and binds with endothelial nitric oxide synthase (eNOS), forming a caveolin-eNOS complex leading to suppression of the eNOS activity. Caveolin, therefore, maintains eNOS in the inactivated state leading to reduced nitric oxide (NO) production. Ischemic preconditioning disrupts the caveolin-eNOS complex leading to activation of the eNOS and thus results in cardioprotection. During ischemic preconditioning, NO produces cardioprotection by the opening of the KATP channel, and the caveolin forms a suitable signalling platform facilitating the interaction of NO with the KATP channel. Estrogen deficiency has been reported to upregulate caveolin-1 expression. The article aims to review the various mechanisms that placed the women at the risk of coronary artery diseases after postmenopausal estrogen deficiency and their role in the cardioprotective effect of ischemic preconditioning