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 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 patientsItem Quality-by-Design Based Development of Doxycycline Hyclate–Loaded Polymeric Microspheres for Prolonged Drug Release(Springer, 2024-02) Jindal, Anil B.This study explores a novel approach to address the challenges of delivering highly water-soluble drug molecules by employing hydrophobic ion-pairing (HIP) complexes within poly (lactic-co-glycolic acid) (PLGA) microspheres. The HIP complex, formed between doxycycline hyclate (DH) and docusate sodium (DS), renders the drug hydrophobic. The development of the microspheres was done using the QbD approach, namely, Box-Behnken Design (BBD). A comprehensive characterization of the HIP complex confirmed the successful conversion of DH. DH and the HIP complex were effectively loaded into PLGA microspheres using the oil-in-water (O/W) emulsion solvent evaporation method. Results demonstrated significant improvements in percentage entrapment efficiency (% EE) and drug loading (% DL) for DH within the HIP complex-loaded PLGA microspheres compared to DH-loaded microspheres alone. Additionally, the initial burst release of DH reduced to 3% within the initial 15 min, followed by sustained drug release over 8 days. The modified HIP complex strategy offers a promising platform for improving the delivery of highly water-soluble small molecules. It provides high % EE, % DL, minimal initial burst release, and sustained release, thus having the potential to enhance patient compliance and drug delivery efficiency.Item Implementing analytical quality by design in reversed phase-high performance liquid chromatography for simultaneous estimation of teriflunomide and quercetin: Applicability in dual drug loaded topical microemulsion(Taylor & Francis, 2024-03) Jindal, Anil B.; Paul, Atish TulshiramThe current study reports the development of a novel, robust, and sensitive reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of teriflunomide (TFD) and quercetin (QCN) in dual drug-loaded microemulsion. TFD and QCN have been reported to exhibit anti-inflammatory effects by targeting various inflammatory mediators involved in the pathogenesis of rheumatoid arthritis (RA). This analytical method employs a risk-based approach and follows the principles of analytical quality by design (AQbD). The study involved preliminary screening trials and systematic risk analysis to identify critical method attributes, that significantly impact the critical quality attributes (CQAs). For the optimization of method,a face centered central composite design was utilized, and 16 experimental runs were performed using design expert software version 7.0.0. Chromatographic conditions were carefully optimized using AQbD, falling within the design space and consisting of ammonium acetate buffer (pH 3.5) and acetonitrile (60:40, % v/v) with a flow rate of 1.0 mL/min. An analytical Hibar Lichospher 100 RP-18e column (250 × 4.6 mm, 5 µm) was employed, with detection wavelength of 280 nm and 367 nm for TFD and QCN, respectively. The optimized method underwent validation according to ICH guidelines and demonstrating applicability for evaluating topical microemulsion.Item Voices in Molecular Pharmaceutics: Meet Dr. Anil Jindal, Accomplished Educator and Drug Delivery Technologist(ACS, 2023-01) Jindal, Anil B.Item Pharmaceutical Process Engineering and Scale-up Principles(Springer, 2023) Jindal, Anil B.The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process. The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms. Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process. Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations. Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up. Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry.Item Compression(Springer, 2023-07) Jindal, Anil B.Compaction of powder involves compression and consolidation of the solids on the application of pressure. The forces involved in these processes play an important role in the design and development of solid oral dosage forms including tablets, filling of the hard-gelatin capsule, and in the handling of powders. Assessment of the forces on punches, axial forces, radial forces, frictional forces, and ejection forces gives us information regarding the compaction behaviour of the powder. Several mathematical terms to describe the compaction processes are studied such as the heckle plot. Optimizing the parameters that affect these forces would produce a product of the desired quality. In this chapter, we have discussed in detail about compression, consolidation, and forces involved in compaction and their impact on the quality of the product.Item Pan Coating(Springer, 2023-07) Jindal, Anil B.Coating a tablet provides different features to the dosage form. Pan coating is the traditional method for film, enteric, or sugar coating of tablets. The coating process is dependent upon the advances in the techniques, equipment, and material used for coating. Despite advancements in the rules for scale-up of the pan-coating process, the laboratory scale process possesses several gaps leading to differences in the results observed on large scale. The chapter describes the thermodynamic factors, pan and spray-related factors that affect the pan-coating process, and determines the quality of the product. The final section of the chapter explains the scale-up of the pan-coating process.Item Properties of Solids(Springer, 2023-07) Jindal, Anil B.Properties of solids, including particle size, particle size distribution, particle shape, particle density, surface area, porosity, surface charge, flow, and cohesiveness, play a significant role during the processing of powder and determine the quality of the product. Understanding the role of properties of solids is extremely important in optimization of pharmaceutical processes. In this chapter, we have discussed about the properties in detail and their effect on the processes involved during the preparation of dosage forms, such as mixing, drying, compression, and coating.