@nmims.edu
Assistant Professor of Pharmaceutics
Narsee Monjee Institute of Management Studies, Mumbai, Mumbai, India
Scopus Publications
Scholar Citations
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Shlok Bodke, Nachiket Joshi, Rajasekhar Reddy Alavala, and Divya Suares
Elsevier BV
Victoria Jessamine, Samir Mehndiratta, Gabriele De Rubis, Keshav Raj Paudel, Saritha Shetty, Divya Suares, Dinesh Kumar Chellappan, Brian G. Oliver, Phillip M. Hansbro, and Kamal Dua
Elsevier BV
Velisha Mehta, Y.C. Mayur, Maushmi S. Kumar, and Divya Suares
Bentham Science Publishers Ltd.
Background: Gemcitabine is a clinically valuable drug delivered intravenously. In order to explore other routes of administration for more efficacious drug delivery, its redevelopment for application through oral route with the help of nanotechnology is an ongoing thrust area. Nanotech-nology helps the drug enter into tissues at the molecular level, with increased drug localisation and cellular uptake, larger surface area with modifiable biologic properties, mediate molecular interac-tions and identify molecular changes. Objective: The objective of the study was to use Eudragit RS100 to prepare polymeric nanoparticles of gemcitabine (GEM) in order to improve its half-life, reduce dosage and increase the stability of the drug. Methods: GEM polymeric nanoparticles were prepared by nanoprecipitation technique. They were characterized for particle size, zeta potential (ZP), drug content, entrapment efficiency (EE) and in-vitro drug release. Further, they were also evaluated using TEM, DSC and FTIR spectroscopy. Mechanistic insights of the synthesized nanoparticles were explored using a protein binding study, electrophoretic mobility shift assay (EMSA) and plasma protein binding study. Docking study was carried out to check the binding of the drug and polymer with DNA and protein. Results: The synthesized GEM polymeric nanoparticles showed particle size in the range of 200-450 nm. Due to physical stability issues, optimized polymeric nanoparticles of GEM were lyophi-lized and exhibited a zeta potential of +11.9 mV, drug content 96.74% w/v and EE of 68-75% w/v. In-vitro drug release study demonstrated sustained release. Protein binding study with bovine serum albumin (BSA) revealed protein binding of GEM-loaded polymeric nanoparticles comparable with the marketed formulation (Oncogem 200, Cipla Ltd.). In addition to this, human plasma protein binding studies showed negligible interaction of GEM with plasma proteins with both formulations. EMSA displayed binding with CT-DNA. Conclusion: Lyophilized GEM nanoparticles were found to be stable and the mechanistic studies found them comparable to that of marketed formulation.
Nikhil Mehta, Divya Suares, and Saritha Shetty
Springer Nature Singapore
Srishti Shetty, Divya Suares, and Saritha Shetty
Springer Nature Singapore
Clara Fernandes, Priyanka Prabhu, Kapil Juvale, Divya Suares, and Mayur YC
Elsevier BV
Cell fusion is an integral, established phenomenon underlying various physiological processes in the cell cycle. Although research in cancer metastasis has hypothesised numerous molecular mechanisms and signalling pathways responsible for invasion and metastasis, the origin and progression of metastatic cells within primary tumours remains unclear. Recently, the role of cancer cell fusion in cancer metastasis and development of multidrug resistance (MDR) in tumours has gained prominence. However, evidence remains lacking to justify the role of cell fusion in cancer metastasis and drug resistance. Here, we highlight plausible mechanisms governing cell fusion with different cell types in the tumour microenvironment (TME), the clinical relevance of cancer cell fusion, its potential as a target for overcoming MDR and inhibiting metastasis, and putative modes of treatment.
Zubin Shah, Clara Fernandes, and Divya Suares
Elsevier BV
Clara Fernandes, Divya Suares, and Mayur C Yergeri
Frontiers Media SA
Recent developments in nanotechnology have brought new approaches to cancer diagnosis and therapy. While enhanced permeability and retention effect promotes nano-chemotherapeutics extravasation, the abnormal tumor vasculature, high interstitial pressure and dense stroma structure limit homogeneous intratumoral distribution of nano-chemotherapeutics and compromise their imaging and therapeutic effect. Moreover, heterogeneous distribution of nano-chemotherapeutics in non-tumor-stroma cells damages the non-tumor cells, and interferes with tumor-stroma crosstalk. This can lead not only to inhibition of tumor progression, but can also paradoxically induce acquired resistance and facilitate tumor cell proliferation and metastasis. Overall, the tumor microenvironment plays a vital role in regulating nano-chemotherapeutics distribution and their biological effects. In this review, the barriers in tumor microenvironment, its consequential effects on nano-chemotherapeutics, considerations to improve nano-chemotherapeutics delivery and combinatory strategies to overcome acquired resistance induced by tumor microenvironment have been summarized. The various strategies viz., nanotechnology based approach as well as ligand-mediated, redox-responsive, and enzyme-mediated based combinatorial nanoapproaches have been discussed in this review.
Pratap Chandra Acharya, Saritha Shetty, Clara Fernandes, Divya Suares, Rahul Maheshwari, and Rakesh K. Tekade
Elsevier
Abstract A typical product lifecycle stage is fraught with challenges right from the inception, i.e., early drug discovery/lead optimization to product development. Challenge includes optimization of operation process, i.e., procurement and supply of bulk materials as well as production span to develop a final commercial product. The putative reasons attributed to failure to translation of product from conception to commercialization may include but not limited to subtherapeutic efficacy, toxicity issues, commercial viability, unforeseen operational issues, and so on. Together, these issues may culminate into failures of phase-II and phase-III clinical trials. Hence, to minimize all these formulation and delivery issues during the later stages of product development and registration, there is always a need for preformulation studies before the development stage. Preformulation studies are designed to provide insights of the essential physicochemical attributes of a new chemical entity, drug-excipient compatibility, to determine kinetic rate profile of the drug and the stability indicating assay method. However, the relation between preformulation and pharmacokinetics is also needed to be understood to utilize this concept in a better way. Apart from the general information on preformulation (importance, parameters, technologies, etc.), the chapter also covers a few recent case studies on the role of preformulation in development of dosage forms such as hydrogels, liposomes, and vaccines.
Pratap Chandra Acharya, Clara Fernandes, Divya Suares, Saritha Shetty, and Rakesh K. Tekade
Elsevier
Abstract The intensive efforts undertaken to get effective drugs have resulted in the generation of candidates with unfavorable properties, i.e., greater lipophilicity, high molecular weight resulting in poor aqueous solubility. It was reported that more than 40% of the drugs discovered belong to the Biopharmaceutics Classification System Class II and IV drugs, i.e., have low aqueous solubility, poor dissolution, and low bioavailability. Thus, it can be stated that drug solubility and bioavailability enhancement approaches are the important challenges in facing the pharmaceutical scientists. In this chapter, we have discussed many methods to uplift the drug solubility which includes pH modification, crystal structure manipulation which includes polymorphs, salt formation, cocrystal, complexation, crystal structure disruption (amorphization), supersaturated solutions, prodrug strategies, size reduction, and excipient-based solubilization which includes cosolvency, polymer as excipient, surfactant as excipient, lipid, and cyclodextrin. Overall, this chapter provides the summary of the strategies which may be used to report the challenges of low solubility during drug discovery.
Pratap Chandra Acharya, Divya Suares, Saritha Shetty, Clara Fernandes, and Rakesh K. Tekade
Elsevier
Abstract Rheology is a branch of physics which signifies the flow or deformation of fluids on application of stress. Rheological features have imperative implications in diverse applications across all industries concerning food products, pharmaceutical products, polymer science, bio-printing, paints, textiles, plastics, metals, geology, concrete material, etc. In pharmaceutical products, rheology measurements govern the formulation, process, and material control factors such as blending, mixing, draining, pouring, spraying, injecting, spreading, dose uniformity, physical stability, etc. These features are of utmost importance as they directly influence the quality and stability of the pharmaceutical product. Numerous mathematical explanations have been defined by scientists to describe the relationship between viscosity of matter and other parameters. Rheology modifiers are typically incorporated in these systems to offer the anticipated flow features. This chapter describes the basis and theoretical consideration of this along with an overview of variables affecting the rheological properties of the formulations quoting various research-based case studies. This chapter also provides an overview on viscometers and rheometers, which are an integral part of rheology, as they offer measurements of simple flow to characterization of deformation behavior. Finally, the chapter also provides understanding on the applications of rheology, i.e., its contribution to the material science, geophysics, physiology, food rheology, concrete rheology, filled polymer rheology, pharmaceuticals, and an overview of dilation rheology as medical diagnostics.
Priyanka Prabhu, Vivek Dhawan, Clara Fernandes, and Divya Suares
Elsevier
Abstract Molecularly imprinted polymers are crosslinked macromolecular structures endowed with specific binding cavities for a template moiety. Their selectivity and stability against harsh conditions coupled with their easy and economical fabrication have fueled various research endeavors in a myriad of applications, such as chromatographic separation, solid phase extraction, sensors, catalysts, and drug delivery. The chapter focuses on the fabrication aspects of molecularly imprinted polymers and gives an insight into the components and various methods employed for their production. Limitations of conventional methods have driven the development of novel techniques to generate water-compatible molecularly imprinted polymers and protein imprinted polymers. The chapter further showcases recent advances in the fabrication of molecularly imprinted polymers, such as use of supercritical fluid, epitope imprinting, and surface imprinting to overcome the drawbacks associated with conventional methods of molecularly imprinted polymer fabrication.
Clara Bernard Fernandes, Divya Suares, and Vivek Dhawan
IGI Global
Recent trends in drug delivery indicate a growing trend to utilize nanotechnology to target diseased tissues with minimal adverse effects. However, in such cases, the biggest challenge encountered by the formulator is the intracellular delivery of the actives. Nevertheless, pharmaceutical nanocarriers have proven to possess distinct advantages for intracellular delivery of therapeutics over conventional approaches. They are versatile in terms of engineering and provide attractive options to deliver encapsulated or conjugated cargoes to cellular targets. In this chapter, the authors discuss important aspects of lipid-based nanocarriers for intracellular drug targeting. The chapter provides insight of different pathways to internalize lipid nanocarriers and the physicochemical factors affecting the intracellular fate of nanocarriers. Further, the chapter provides details of different types of lipid-based nanocarriers that have been explored for intracellular delivery in infectious diseases as well as cancer.
Clara Fernandes, Divya Suares, Vivek Dhawan, and Priyanka Prabhu
Elsevier
Abstract Nanoscale engineering in tissue engineered scaffolds is gaining recognition as it mimics the topographical features of the biological tissues. The most crucial elements in tissue engineering impacting cell-surface interactions, roughness and topography of the scaffold surface are the materials chemistry and scaffold architecture i.e. pore size and pore volume. Numerous literatures document the impact of the methods in introducing these nanoscale features on 2D flat surfaces, as well as nanostructuring the surface of 3D scaffolds. In this context, this book chapter will provide indepth review of the diverse techniques that have been used to fabricate nanoscale topography in both 2D surfaces and 3D scaffolds. Besides this, the review also discusses the techniques used to generate components that self-assemble into 3D scaffolds via postprocessing. To name a few, the techniques will include lithography and printing based methodologies, polymer de-mixing, chemical etching, solvent casting, electrospinning, electrospraying, thermally induced phase separation, nanoparticle based techniques.
Kartika Pidaparthi and Divya Suares
Springer Science and Business Media LLC
The objective of the study was to develop and compare the efficiency of nanoemulsion and aqueous micelle system of Paliperidone on intranasal administration. Both the formulations were evaluated for physical parameters such as globule size, pH, viscosity, conductivity and in vitro drug release studies. The reduction in spontaneous motor activity of L-dopa and Carbidopa-treated Swiss Albino mice on intranasal administration of nanoemulsion and micellar system of Paliperidone was compared with plain drug suspension. Histopathological evaluation of formulation treated nasal mucosal membrane was performed. Nasal spray device was evaluated for spray pattern and volume per actuation. Globule size of micellar system and nanoemulsion was found to be 16.14 & 38.25 nm, respectively. In vitro release of drug from micellar system was found to be 1.8-fold higher than nanoemulsion. The loading of drug in nanoemulsion was found to be superior (2.5 mg/mL) when compared to micellar system (0.41 mg/mL). The spray pattern of micellar system and nanoemulsion from the device was elliptical and circular, respectively. The locomotor activity of L-dopa and Carbidopa-treated Swiss albino mice was found to be 1096.5±78.49, 551.5±13.43 and 535.5±24.75 counts/min in case of plain drug suspension, micellar system and nanoemulsion, respectively. The intranasal administration of developed formulations showed significant difference (p<0.01) in the locomotor activity when compared to intranasal administration of plain drug. Thus it can be concluded that both the developed formulations have shown improved in vivo activity on intranasal administration and pose great potential for delivery of Paliperidone through intranasal route.
Divya Suares and Bala Prabhakar
Informa UK Limited
Abstract The present work aimed to develop and characterize sustained release cuboidal lipid polymeric nanoparticles (LPN) of rosuvastatin calcium (ROS) by solvent emulsification-evaporation process. A three factor, two level (23) full-factorial design was applied to study the effect of independent variables, i.e. amount of lipid, surfactant and polymer on dependent variables, i.e. percent entrapment efficiency and particle size. Optimized formulations were further studied for zeta potential, TEM, in vitro drug release and ex vivo intestinal permeability. Cuboidal nanoparticles exhibited average particle size 61.37 ± 3.95 nm, entrapment efficiency 86.77 ± 1.27% and zeta potential −6.72 ± 3.25 mV. Nanoparticles were lyophilized to improve physical stability and obtain free-flowing powder. Effect of type and concentration of cryoprotectant required to lyophilize nanoparticles was optimized using freeze-thaw cycles. Mannitol as cryoprotectant in concentration of 5-8% w/v was found to be optimal providing zeta potential −20.4 ± 4.63 mV. Lyophilized nanoparticles were characterized using FTIR, DSC, XRD and SEM. Absence of C=C and C–F aromatic stretch at 1548 and 1197 cm−1, respectively, in LPN indicated coating of drug by lipid and polymer. In vitro diffusion of ROS using dialysis bag showed pH-independent sustained release of ROS from LPN in comparison to drug suspension. Intestinal permeability by non-everted gut sac model showed prolonged release of ROS from LPN owing to adhesion of polymer to mucus layer. In vivo absorption of ROS from LPN resulted in 3.95-fold increase in AUC0–last and 7.87-fold increase in mean residence time compared to drug suspension. Furthermore modified tyloxapol-induced rat model demonstrated the potential of ROS-loaded LPN in reducing elevated lipid profile.
Pratap Chandra Acharya, Ruqaiya Vasi, and Divya Suares
Elsevier BV
A new method of analysis has been developed for UV inactive drug carisoprodol using FTIR spectroscopy. These methods were validated for various parameters according to ICH guidelines. The proposed method has also been successfully applied for the determination of the drug concentration in a tablet formulation. The method proved to be accurate (mean percentage recovery between 95 and 105%), precise and reproducible (relative standard deviation<2%), while being simple, economical and less time consuming than other methods and can be used for routine estimation of carisoprodol in the pharmaceutical industry. The developed method also implicates its utility for other UV inactive substances. The stability of the drug under various stress conditions was studied and the drug was found to be particularly susceptible to alkaline hydrolysis. Degradation products of the alkaline hydrolysis were detected by RP-HPLC and tentatively identified by ESI-MS.
Divya Suares and Arti Hiray
OMICS Publishing Group
The objective of this research work was to mask the intense bitter taste of fexofenadine hydrochloride using weak cation exchange resins and to formulate orodispersible tablet of taste masked drug-resin complex. Five resins indion 204, indion 234, indion 414, kyron T-114 and kyron T-314 were used. Depending on maximum drug loading capacity of resins indion 234 and kyron T-314 were finalized for further study. Drug-resin complex was optimized by considering parameters such as drug to resin ratio, soaking time of resins, stirring time, temperature and pH on maximum drug loading. The drug-resin complex was characterized by Fourier transform infrared spectroscopy. The drug-resin complex was also subjected to various evaluation studies such as taste mask evaluation by panel method, drug content and in vitro drug release at salivary and gastric pH. The orodispersible tablets of taste masked drug-resin complex for indion 234 and kyron T-314 were prepared by direct compression method. Formulated orodispersible tablets were subjected to various evaluation parameters such as diameter and thickness measurement, hardness test, weight variation test, in vitro United States Pharmacopoeia disintegration test, wetting time, test for content uniformity, assay, friability test and in vitro dissolution studies. The results indicate that orodispersible tablets of fexofenadine hydrochloride containing indion 234 and kyron T-314 are palatable and provide quick disintegration and fast drug release without addition of superdisintegrants.