BITS Faculty Publications
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Item Current status of Liraglutide delivery systems for the management of type 2 diabetes mellitus(Springer, 2025-09) Jindal, Anil B.Diabetes is a metabolic disorder of increasing global concern. Characterized by constantly elevated levels of glucose, severe β-cell dysfunction, and insulin resistance, it is the cause of a major burden on patients if not managed with therapeutic and lifestyle changes. The human body is slowly developing tolerance to many marketed antidiabetic drugs and the quest for the discovery of newer molecules continues. Liraglutide is a prominent GLP-1 receptor agonist which is administered daily via subcutaneous injection. In addition to lowering HbA1c levels, it is also known for promoting weight loss and improving cardiovascular outcomes. A variety of novel formulation strategies have been explored to improve its bioavailability and patient compliance. To address these limitations, various advanced drug delivery systems have been investigated, including polymeric nanoparticles, lipid-based nanocarriers, biodegradable microparticles, hydrogels, and dissolvable microneedles. These systems aim to prolong drug release, enhance mucosal penetration, increase stability, and reduce dosing frequency. While many of these platforms show promise in preclinical and early clinical studies, critical translational barriers remain. These include challenges in large-scale manufacturing, ensuring formulation sterility, achieving regulatory approval, and maintaining stability during storage and distribution.Item Quantitative UV spectrophotometric analysis of teriflunomide and quercetin in dual drug-loaded transferosomes using the absorption factor method(Springer, 2025-05) Jindal, Anil B.; Paul, Atish TulshiramThe current research focused on establishing a method for concurrently measuring teriflunomide (TFD) and querectin (QCN) accurately, precisely, and with simplicity. This method aims to be suitable for routine analysis purposes. The goal is to effectively utilize this combination effectively in the treatment of rheumatoid arthritis (RA) through a topical delivery approach. To date, there have been no reported UV-based methods for simultaneous estimation of TFD and QCN. The quantification was performed using the absorption factor method for multicomponent analysis. The developed method underwent validation in accordance with the guidelines set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). The validated method demonstrated linearity within the concentration range of 2.0 to 12.0 μg/mL for both substances, exhibiting a regression coefficient of > 0.990. The developed method validated for accuracy and precision, demonstrating a recovery rate within the range and precision with an RSD of less than 2 % for both inter and intra-day measurements. Moreover, the developed method was effectively utilized for quantification in the prepared transferosomes using absorption factor method. The greenness of the proposed methods was assessed, showing their minimal environmental impact and low level of toxicity to the environment.Item Evaluation of synergistic anti-inflammatory activity of selected natural products in combination with teriflunomide in LPS stimulated RAW 264.7 cells for rheumatoid arthritis treatment(Elsevier, 2025-09) Jindal, Anil B.Rheumatoid arthritis (RA) is an immune-mediated disorder that involves joints and synovial membrane, and requires combination therapy for effective management. Teriflunomide (TFD) belongs to Synthetic Disease-modifying antirheumatic drugs (DMARDs), prescribed either alone or in combination therapy. The combination of clinical drugs with natural products offers a promising strategy to enhance therapeutic efficacy and reduce the dose and thus ameliorate side effects. This study aims to evaluate the synergistic anti-inflammatory efficacy of TFD with selected natural products such as Andrographolide (ANG), Quercetin (QCN), Resveratrol (RES), Rutin (RUT) and Tanshinone IIA (TAN) in LPS-stimulated RAW264.7 cells. The initial screening was performed using nitric oxide (NO) assay to determine the IC50, with prior determination of the safest concentration range using the MTT assay. The study utilized a constant ratio design to assess synergy, employing the NO assay and calculating the combination index (CI), isobologram analysis, and dose reduction index (DRI). Among the tested combinations, QCN, RES, and TAN with TFD displayed low CI values and were evaluated for proinflammatory cytokines using ELISA. Notably, the combination of QCN and TFD showed significant synergistic activity with CI values of 0.470 and 0.607 (at Fa = 0.5) against TNF-α and IL-6, respectively. Intracellular reactive oxygen species (ROS) measurement with this combination revealed even greater synergistic activity, suggesting a promising approach for RA treatment.Item Recent innovations in topical delivery for management of rheumatoid arthritis: a focus on combination drug delivery(Elsevier, 2024-08) Jindal, Anil B.; Paul, Atish TulshiramRheumatoid arthritis (RA) is an immune-mediated disease that necessitates a thorough understanding of its intricate pathophysiological mechanism for precise and effective therapeutic targeting. The European League Against Rheumatism (EULAR) has established guidelines for RA treatment, endorsing monotherapy or combination therapy with corticosteroids and synthetic disease-modifying antirheumatic drugs (sDMARDs). This review delves into clinical trials and research outcomes related to combination drug delivery, with an emphasis on the role of natural products in combination with synthetic drugs. Given the significant adverse effects associated with systemic administration, topical delivery has emerged as an alternative avenue for effective management of RA.Item An insight into risk assessment and reformulation of drug products manufactured using benzene grade carbomer: a regulatory perspective(Springer, 2024-07) Jindal, Anil B.Cancer has been an enormous pain point for patients and regulatory bodies across the globe. In Dec. 2023, the US FDA released guidance on benzene-grade carbomer formulations, which triggered pharmaceutical manufacturers to assess risk, test finished products, and reformulate drug products with benzene-grade carbomer. The immediate implementation of the stoppage of finished products with benzene-grade carbomers has threatened pharmaceutical excipients and finished product manufacturers. The gravity of this situation prompted the US Pharmacopeia to extend the deadline for discontinuation from August 1, 2025, to August 1, 2026, allowing manufacturers ample time for reformulation and regulatory compliance. There is an immediate need to understand the guidance and to learn how manufacturers should do the risk assessment and approach reformulation. This review provides an in-depth analysis of the risk assessment and reformulation processes involved in various dosage forms utilizing benzene-grade carbomer, supported by specific case studies. This review offers insights into navigating the USFDA guidelines to ensure formulation safety and compliance, thus enabling pharmaceutical practitioners to uphold the highest standards of patient care and tackle life cycle management challenges.Item Formulation strategies to overcome amphotericin B induced toxicity(ACS, 2024-10) Jindal, Anil B.Fungal infection poses a major global threat to public health because of its wide prevalence, severe mortality rate, challenges involved in diagnosis and treatment, and the emergence of drug-resistant fungal strains. Millions of people are getting affected by fungal infection, and around 3.8 million people face death per year due to fungal infection, as per the latest report. The polyene antibiotic AmB has an extensive record of use as a therapeutic moiety against systemic fungal infection and leishmaniasis since 1960. AmB has broad-spectrum fungistatic and fungicidal activity. AmB exerts its therapeutic activity at the cellular level by binding to fungal sterol and forming hydrophilic pores, releasing essential cellular components and ions into the extracellular fluid, leading to cell death. Despite using AmB as an antifungal and antileishmanial at a broad scale, its clinical use is limited due to drug-induced nephrotoxicity resulting from binding the aggregated form of the drug to mammalian sterol. To mitigate AmB-induced toxicity and to get better anti-fungal therapeutic outcomes, researchers have developed nanoformulations, self-assembled formulations, prodrugs, cholesterol- and albumin-based AmB formulations, AmB-mAb combination therapy, and AmB cochleates. These formulations have helped to reduce toxicity to a certain extent by controlling the aggregation state of AmB, providing sustained drug release, and altering the physicochemical and pharmacokinetic parameters of AmB. Although the preclinical outcome of AmB formulations is quite satisfactory, its parallel result at the clinical level is insignificant. However, the safety and efficacy of AmB therapy can be improved at the clinical stage by continuous investigation and collaboration among researchers, clinicians, and pharmaceutical companies.Item Biopolymers for enzyme immobilization(Wiley, 2024-10) Jindal, Anil B.Enzyme immobilization has shown promising applications in different fields, including pharmaceuticals, chemistry, and medicine. Immobilized enzymes are more stable, recoverable, and robust than their free forms. Enzymes act as biocatalysts for several reactions, however, there is an important role of biopolymers, which act as supporting materials. Synthesis of new functionalized supporting materials from conventional polymers or using the novel technique for immobilization can serve the multiple demands of industries to ease the multi-step process of biocatalysis. In enzyme immobilization, numerous factors play a crucial role, such as the selection of support materials, optimization of pH, temperature, reaction time, and concentration of enzyme. Moreover, the present chapter provides a compiled summary of enzyme immobilization methods or techniques, biopolymers, and their features along with newer development as well as application in the same field.Item Investigating a novel therapeutic composition for dry eye syndrome management: In vitro and in vivo studies(Elsevier, 2024-12) Jindal, Anil B.Dry eye syndrome (DES) presents a significant challenge in ophthalmic care, necessitating innovative approaches for effective management. This research article introduces a multifaceted strategy to address DES through the development of ocular inserts utilizing advanced technologies such as hot-melt extrusion (HME) and the CaliCut post-extrusion system. The formulation includes key ingredients targeting different layers of the tear film and associated inflammation, including hydroxypropyl cellulose (HPC), polyethylene glycol (PEG), castor oil, and dexamethasone. The study incorporates a Design of Experiments (DoE) approach, integrating HME and the precise stretching and cutting technique of CaliCut for manufacturing consistency and dimensional control of the inserts. The developed insert(s) have been systematically characterized for their physicochemical properties, release profile, and in vivo efficacy. In silico molecular docking studies have also been conducted to assess the binding affinities of formulation components with ocular mucin, elucidating their binding affinities. Preliminary results demonstrate promising potential for the developed insert in managing DES, offering preservative-free treatment, sustained drug delivery, and improved patient compliance. This study highlights the integration of advanced technologies and formulation strategies in ocular drug delivery for effective DES management.Item Quality by design-based optimization of teriflunomide and quercetin combinational topical transferosomes for the treatment of rheumatoid arthritis(Elsevier, 2024-12) Jindal, Anil B.; Paul, Atish TulshiramRheumatoid arthritis (RA) is an immune-mediated inflammatory disease. Combination therapy is anticipated to surpass monotherapy by targeting multiple pathways involved in RA progression. The present aim is to develop a combination of Teriflunomide (TFD) and Quercetin (QCN) loaded transferosomal gel to enhance permeability and achieve localized delivery to joint tissues. TFD or QCN transferosomes were optimized employing a 3-level, 3-factorial design Box-Behnken design (BBD). The transferosomes exhibited sustained in-vitro drug release. The topical combination gel underwent thorough evaluation of rheology, and also ex-vivo studies showed enhanced permeability through rat skin. The synergistic combination of TFD and QCN effectively suppressed NO, TNF-α and IL-6 levels in in-vitro RAW 264.7 cells. The cytotoxicity in HaCaT cell lines indicates non-toxicity of the gel, further confirmed by skin irritation study conducted in rats. The in-vivo anti-arthritic activity was evaluated in complete freund’s adjuvant induced rat paw edema model illustrates the effectiveness of the combination transferosomal gel compared to other treatment groups. In conclusion, the topical delivery of TFD and QCN combination transferosomal gel demonstrated anti-arthritic activity through localized delivery whichallows for dose reduction, thereby may reduce the systemic drug exposure and mitigate the side effects associated with oral administration of TFDItem Current Status of Therapeutic Peptides for the Management of Diabetes Mellitus(Springer, 2024-02) Jindal, Anil B.Diabetes mellitus (DM) is a chronic endocrine disorder with lifelong implications. The prevalence of this condition is steadily increasing, emphasizing the need for effective management to maintain healthy blood sugar levels and mitigate associated complications. While various antidiabetic medications are available, individuals with type 1 diabetes rely on lifelong insulin therapy, and those with type 2 diabetes may also require it if other oral treatments prove ineffective. This study focuses on peptide-based therapies approved for diabetes management, including insulin, incretin mimetics (GLP-1, GLP-1 analogues, and GIP analogues), and amylin analogues. The advent of peptide-based therapeutics represents significant progress in diabetes management. Peptides consist of short sequences of amino acids and offer immense potential for treating the complicated pathophysiology of diabetes. They exhibit higher potency and specificity, although their short half-life in the body, cost, and instability are notable drawbacks. Modification of the peptide chain structure and various formulation strategies to prolong their plasma circulation time and reduce the frequency of dosing aim to minimize drawbacks associated with the peptide molecules. Continuous advancements in drug delivery strategies have also resulted in the greater therapeutic efficacy of peptides, better disease management, and improved quality of life for patients