Publications by authors named "Bala Prabhakar"

23 Publications

  • Page 1 of 1

Non-oral routes, novel formulations and devices of contraceptives: An update.

J Control Release 2022 05 1;345:798-810. Epub 2022 Apr 1.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKMs NMIMS, V.L.Mehta Road, Vile Parle (W), Mumbai, Maharashtra 400056, India. Electronic address:

Family planning enables society to prevent unintended pregnancies and helps in attaining desired spacing between the pregnancies. It is done with the use of contraceptive methods and infertility treatments. The use of contraceptives serves to ease maternal ill-health and reduce pregnancy-related deaths and helps to decrease the number of unsafe abortions and HIV transmission from mothers to newborns. The most popular contraception method is a daily dose of combined oral contraceptives pills. However, poor compliance and various adverse effects are common problems of oral contraceptives that considerably reduce their long-term use. Thus, several non-oral contraceptive options have been developed for better compliance, reduced side effects and improved therapeutic efficacy. This review presented the non-oral contraceptive formulations given by different routes such as transdermal, nasal, subcutaneous, intramuscular, intrauterine and vaginal routes. These formulations delivering contraceptives, mainly through devices, include transdermal patches and microneedles, nasal sprays, intrauterine devices and intrauterine systems, vaginal rings, contraceptive implants and contraceptive injections, which are unique in their specific advantages and drawbacks.
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http://dx.doi.org/10.1016/j.jconrel.2022.03.057DOI Listing
May 2022

3D Printed Personalized Medicine for Cancer: Applications for Betterment of Diagnosis, Prognosis and Treatment.

AAPS PharmSciTech 2021 Dec 1;23(1). Epub 2021 Dec 1.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Vile Parle (West), Mumbai, India.

Cancer treatment is challenging due to the tumour heterogeneity that makes personalized medicine a suitable technique for providing better cancer treatment. Personalized medicine analyses patient-related factors like genetic make-up and lifestyle and designs treatments that offer the benefits of reduced side effects and efficient drug delivery. Personalized medicine aims to provide a holistic way for prevention, diagnosis and treatment. The customization desired in personalized medicine is produced accurately by 3D printing which is an established technique known for its precision. Different 3D printing techniques exhibit their capability in producing cancer-specific medications for breast, liver, thyroid and kidney tumours. Three-dimensional printing displays major influence on cancer modelling and studies using cancer models in treatment and diagnosis. Three-dimensional printed personalized tumour models like physical 3D models, bioprinted models and tumour-on-chip models demonstrate better in vitro and in vivo correlation in drug screening, cancer metastasis and prognosis studies. Three-dimensional printing helps in cancer modelling; moreover, it has also changed the facet of cancer treatment. Improved treatment via custom-made 3D printed devices, implants and dosage forms ensures the delivery of anticancer agents efficiently. This review covers recent applications of 3D printed personalized medicine in various cancer types and comments on the possible future directions like application of 4D printing and regularization of 3D printed personalized medicine in healthcare.
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http://dx.doi.org/10.1208/s12249-021-02153-0DOI Listing
December 2021

Quercetin-loaded platelets as a potential targeted therapy for glioblastoma multiforme cell line U373-MG.

Biotechnol J 2021 Dec 12;16(12):e2100271. Epub 2021 Oct 12.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Mumbai, Maharashtra, India.

Over the globe, the incidence of glioblastoma multiforme (GM) is very low, that is, 1-4 cases per 100,000, but it is fatal and cancer grows very fast inside the brain tissues, namely astrocytes and oligodendrocytes. Because of the rapid growth, it is difficult to halt the dissemination of tumor in adjacent tissues. Although temozolomide (TMZ) is a currently approved standard of care, it develops resistance over the period. Therefore, there is a need to develop a novel drug delivery system. In this work, authors have developed platelets as drug delivery carriers-loaded with quercetin (QCT) for targeting GM. The effect of QCT and QCT-platelet was assessed on the U373-MG cell line. Natural human platelets were used as carriers for drug loading and drug delivery. Platelets possess an open canalicular system that allows the uptake of drug molecules in the platelet cytoplasm. The study showed that the maximum encapsulation efficiency of QCT-platelet was 93.96 ± 0.12% and the maximum drug release in 24 h was 76.26 ± 0.13% in-vitro at pH 5.5 that mimics the tumor microenvironment. In this work, there is a three-fold enhancement of solubility of QCT. The cytotoxic activity of QCT-platelets was studied in the U373-MG human astrocytoma glioblastoma cell line and the cell viability was 14.52 ± 1.53% after 48 h. Thus, platelets were proved as good carriers for therapeutic moieties and can be effectively used to target the glioblastoma tumor in the near future.
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http://dx.doi.org/10.1002/biot.202100271DOI Listing
December 2021

Strategies for the delivery of antidiabetic drugs via intranasal route.

Int J Pharm 2021 Oct 1;608:121068. Epub 2021 Sep 1.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, India. Electronic address:

Diabetes is a metabolic disorder defined by higher blood glucose levels in the body generally controlled by antidiabetic agents (oral) and insulin (subcutaneous). To avoid the limitations of the conventional routes such as lower bioavailability and pain at the site of injection in case of parenteral route modified delivery systems are proposed like transdermal, pulmonary and inhalation delivery and among the other delivery systems nasal drug delivery system that shows the advantages such as reduced frequency of dose, higher patient compliance, safety, ease of administration, prolonged residence time, improved absorption of drug in the body, higher bioavailability and stability. This review article discusses the strategies adopted for the delivery of antidiabetic drugs by the intranasal delivery system. The insulin and glucagon-like peptides on experimentation show results of improved therapeutic levels and patient compliance. The drugs are transported by the paracellular route and absorbed through the epithelial tight junctions successfully by utilising different strategies. The limitations of the nasal delivery such as irritation or burning on administration, degradation by the enzymes, mucociliary clearance, lesser volume of the nasal cavity and permeation through the nasal mucosa. To overcome the challenges different strategies for the nasal administration are studied such as polymers, particulate delivery systems, complexation with peptides and smart delivery using glucose-responsive systems. A vast scope of intranasal preparations exists for antidiabetic drugs in the future for the management of diabetes and more clinical studies are the requirement for the societal impact to battle against diabetes.
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http://dx.doi.org/10.1016/j.ijpharm.2021.121068DOI Listing
October 2021

Adsorption of Cisplatin on Oxidized Graphene Nanoribbons for Improving the Uptake in Non-small Cell Lung Carcinoma Cell Line A549.

Curr Drug Deliv 2022 ;19(6):697-705

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, Mumbai, India.

Background: Graphene nanoribbons are nanosized strips of graphene with unique physicochemical properties like higher drug loading capacity and affinity for tumor cells.

Objective: The principal objective of this research was to develop oxidized graphene nanoribbons (O-GNRs)-based delivery system for cisplatin against non-small cell lung carcinoma cell line A549 by selective endocytosis.

Methods: The O-GNRs prepared using various synthetic steps like oxidative unzipping were evaluated for various parameters like morphology, Fourier Transform Infrared (FTIR) study, % adsorption efficacy, Differential scanning colometric (DSC) study and in-vitro efficacy studies.

Results: Graphene nanoribbons with the length of 200-250 nm and width of 20-40 nm were obtained. The FTIR spectrum of drug-loaded O-GNRs exhibited a characteristic peak at 1550 cm-1 (- N-H group) of cisplatin. The DSC indicated the presence of sharp endothermic peaks at 59°C (PEG), 254°C (-C-NH) and 308.6°C (-C-Pt). The % adsorption efficiency was found to be 74.56 ± 0.798% with in-vitro release in controlled manner (63.36% ± 0.489%) for 24 h.

Conclusion: The nanoformulation showed an average inhibition of 22.72% at a lower dose of cisplatin (> 25%) by passive targeting on cell line A549 by DNA alkylation. In the near future, graphene-based systems will establish potential nanosystems in cancer treatment due to the additive effect of graphene with various therapeutic agents.
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http://dx.doi.org/10.2174/1567201818666210708124424DOI Listing
May 2022

Quality by Design Approach for Development and Optimization of Rifampicin Loaded Bovine Serum Albumin Nanoparticles and Characterization.

Curr Drug Deliv 2021 ;18(9):1338-1351

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Mumbai, Maharashtra,India.

Background: Rifampicin is one of the first-line drugs used for tuberculosis therapy. The therapy lasts for a long time. Thus, there is a need to develop a sustained release formulation of rifampicin for intravenous application.

Aim: This study is focused on preparing rifampicin-loaded bovine serum albumin nanoparticles (RIF BSA NPs) suitable for intravenous application using systematic quality by design (QbD) approach.

Objectives: The main objective of this study is optimizing particle size and entrapment efficiency of rifampicin-loaded bovine serum albumin nanoparticles (RIF BSA NPs) and making them suitable for intravenous application using QbD approach.

Methods: Quality target product profile was defined along with critical quality attributes (CQAs) for the formulation. 3 factorial design was used for achieving the predetermined values of CQAs, i.e., mean particle size <200 nm and percent entrapment efficiency>50%. Incubation time of drug with colloidal albumin solution and ratio of rifampicin to albumin, were selected as independent variables. Checkpoint analysis was performed to confirm the suitability of the regression model for optimization.

Results: The optimized RIF BSA NPs were characterized by FTIR, DSC, H NMR techniques. The NPs observed by transmission electron microscopy were spherical in shape. The rifampicin release could be sustained for 72 hours from BSA NPs matrix. RIF BSA NPs dispersion was stable at 5 ± 3°C for 72 hours. Non-toxicity of nanoparticles to RAW 264.7 cell line was proved by MTT assay.

Conclusion: Development of RIF BSA NPs with desired quality attributes was possible by implementing the QbD approach. The optimized formulation suitable for intravenous application can potentially improve the therapeutic benefits of rifampicin.
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http://dx.doi.org/10.2174/1567201818666210212090451DOI Listing
January 2022

Artificial intelligence (AI) impacting diagnosis of glaucoma and understanding the regulatory aspects of AI-based software as medical device.

Comput Med Imaging Graph 2021 01 24;87:101818. Epub 2020 Nov 24.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS (Deemed to be University), Mumbai, India. Electronic address:

Glaucoma, the group of eye diseases is characterized by increased intraocular pressure, optic neuropathy and visual field defect patterns. Early and correct diagnosis of glaucoma can prevent irreversible vision loss and glaucomatous structural damages to the eye. However, greater chances of misdiagnosis by the currently used conventional methods for diagnosis open up ways for more advanced techniques like the use of artificial intelligence (AI). Artificial intelligence coupled with optical coherence tomography imaging creates an algorithm that can be effectively used to make a model of complex data for detection as well as diagnosis of glaucoma. The present review is an attempt to provide state-of-the-art information on various AI techniques used in the diagnosis and assessment of glaucoma. The second part of the review is focused on understanding how the AI along with machine learning (ML) can be potentially used to be subjected for software as a medical device (SaMD) in precise diagnosis or early detection of disease conditions.
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http://dx.doi.org/10.1016/j.compmedimag.2020.101818DOI Listing
January 2021

Strategic consideration for effective chemotherapeutic transportation via transpapillary route in breast cancer.

Int J Pharm 2020 Aug 19;586:119563. Epub 2020 Jun 19.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, India. Electronic address:

Breast cancer is the most commonly occurring cancer in women and the second most common cancer overall. The current treatment option for breast cancer includes drug treatment (Chemotherapy and hormone therapy) or surgery (mastectomy and lumpectomy). The major drawbacks of chemotherapy include rapid metabolism, limited ductal exposure, lower bioavailability, higher elimination rate, undesirable side effects, and high dose of drug. Localized application of drug to breast achieves higher drug levels at the tumor site and reduces systemic drug distribution. Permeation of drug by local application is mainly by transepidermal and transductal routes. The multiple duct openings of mammary papilla provide a higher permeable surface for transport of drug. Various formulation approaches like conjugated nanocarriers, microemulsion, nanoemulsion, liposomes, microneedles and iontophoresis are used to achieve a tailored and targeted drug delivery to underlying breast tissue. Localized transport of drug via transpapillary route has developed a novel and effective non-invasive drug delivery approach to achieve a systemic drug level at the tumor site in the management of breast cancer.
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http://dx.doi.org/10.1016/j.ijpharm.2020.119563DOI Listing
August 2020

Phytoconstituents and pharmaco-therapeutic benefits of pitaya: A wonder fruit.

J Food Biochem 2020 07 7;44(7):e13260. Epub 2020 May 7.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, Mumbai, India.

Dragon fruit has caught the attention of many researchers in the last few years because of its vast therapeutic potential. The fruit is enriched with several phytochemical constituents having tremendous pharmacological properties. It is traditionally used as a coloring agent. Some newly explored therapeutic applications include its use as an antioxidant, antimicrobial, antidiabetic, anticancer, and nutraceutical. The phytoconstituents can be extracted from flesh, peel, and seeds of the fruit. The fruit is known to be a rich source of betacyanin, vitamin C, and lycopene. The current review is focused on phytochemical constituents of dragon fruit along with its pharmacological activities. It also sheds light on the safety aspects of the fruit. The review will pave a path for researchers to study this marvel fruit further for societal benefit. Advanced research on dragon fruit will unleash many more therapeutic benefits and can give mechanistic insight about its activities. PRACTICAL APPLICATIONS: Phytoconstituents play a vital role in the treatment of various diseases and for the improvement of human health, in general. Dragon fruit is known to be having antioxidant, anti-microbial, anti-diabetic, anti-cancer applications. The fruit can also be used as a nutraceutical (functional food). To grab all the benefits from this fruit, its phytoconstituents and pharmaco-therapeutic aspect have to be thoroughly studied. This review can be very useful for researchers across different fields like botany, agriculture, pharmacy, etc., to bridge the gap for collaborative work on dragon fruit, which will help in finding solutions for many modern diseases.
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http://dx.doi.org/10.1111/jfbc.13260DOI Listing
July 2020

Potential of Mirabegron and its Extended-release Formulations for the Treatment of Overactive Bladder Syndrome.

Curr Drug Metab 2020 ;21(2):79-88

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, India.

Background: Overactive bladder syndrome is a broadly occurring urological disorder with a distressing impact on the quality of life. The commonly used antimuscarinic drugs show poor patient compliance because of unsatisfactory potency, tolerability and high occurrence of adverse effects such as dry mouth, blurred vision, constipation, dizziness etc. Mirabegron is the first approved β3-adrenoreceptor agonist, used as mono or in combination therapies for overactive bladder syndrome.

Objective: The present review provides an insight into the mechanism, pharmacokinetics, toxicokinetics, clinical trials and the development of various conventional and modified-release dosage forms of mirabegron for the treatment of overactive bladder syndrome.

Results: The clinical trials of phase II and phase III of mirabegron demonstrated symptomatic relief from the overactive bladder without disturbing the micturition cycle. To date, mirabegron showed promising results for safety, tolerability and efficacy in patients with overactive bladder syndrome. The modified-release tablet dosage form of mirabegron appear to be a proficient and suitable replacement for antimuscarinics and revealed the tremendous potential to overcome the adverse effects of conventional antimuscarinic drugs like Oxybutyline chloride ER, Detrol LA, VESIcare, etc. Conclusion: Mirabegron shows a distinct mode of action, i.e., targeting β3-adrenoreceptors and improving bladder storage without altering void contractions. The limited side effects, high safety, efficacy and tolerability of mirabegron present an adequate substitute to antimuscarinics. However, long-term analysis and clinical studies are prerequisites for assessing the safety, tolerability and efficacy profile of mirabegron.
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http://dx.doi.org/10.2174/1389200221666200425211139DOI Listing
January 2021

Current trends in theranostics for rheumatoid arthritis.

Eur J Pharm Sci 2020 Mar 24;145:105240. Epub 2020 Jan 24.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai- 400056, Maharashtra, India. Electronic address:

The very complexity of Rheumatoid Arthritis (RA) makes its prognosis and management challenging. The manifestations pertaining to RA emerge in the late stage of the disease when the damage to bone and cartilage has already occurred. Therefore early diagnosis of RA becomes critical in order to avoid further complications and disabilities. In such a scenario, theranostics can be an ideal solution to tackle the barriers to disease management in RA patients. Nanotechnology has paved the way for emerging theranostics to achieve better targetability and high performance. The shortcomings of current diagnostic techniques and pharmacological treatment are addressed in this review. The article also summarizes the laboratory studies that have reported promising theranostic entities for RA diagnosis, treatment and discusses the outcomes of each. Novel platforms combined with newer techniques have found application in the theranostics of RA. These platforms include gold nanorods, nanoshells, nanowhiskers, magnetic nanoparticles, solid and mesoporous silica nanoparticles, etc. Photodynamic, chemo-photo responsive, magnetic field based imaging and simultaneous stimulation have been reported for the release of therapeutic moieties from these nanoplatform. Theranostics can also assist clinicians in determining the respondents and non-respondents to biological response modifiers and other treatments available for RA. This not only plays an important role in selecting the suitable therapy for every patient but also in monitoring the progress of treatment in the patient. The advantages of theranostics over current diagnosis and treatment for RA are tremendous. Hence it holds great opportunities for progress and enhancement of RA disease management.
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http://dx.doi.org/10.1016/j.ejps.2020.105240DOI Listing
March 2020

Role of Liposomes-Based Stem Cell for Multimodal Cancer Therapy.

Stem Cell Rev Rep 2020 02;16(1):103-117

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, V. L. Mehta road, Vile Parle (W), Mumbai, India.

The utilization of stem cells as novel carriers to target tissues or organs of interest is a challenging task in delivery system. The composite cellular delivery with diverse signalling molecules as therapeutics increases stem cell capability and possesses the promising potential to augment, modify or commence localized or systemic restoration for vital applications in regenerative medicine. The inherent potential of stem cells to immigrate and reside at wounded site facilitates transportation of genes, polypeptides or nanosized molecules. Liposomes are micro- to nano-lipidic vesicles formed in aqueous solutions to encapsulate complex hydrophilic and lipophilic chemical substances. Moreover, these novel nanocarriers provide safer and efficient delivery of bioactives together with their potential applications in vaccine production, cosmeceuticals, imaging and diagnostic purpose. Tissue engineering promotes rejuvenation process and involves the synchronized utilization of cells with 3D bio-material scaffolds to fabricate living structures. This strategy requires regulated stimulus of cultured cells through combined mechanical signals and bioactive agents. This review highlights and summarizes the mechanism involved in stem cell migration, strategies to enhance homing, safety and efficacy studies of stem cells in various disease models and discusses the potential role of liposomes in prolonged and localized delivery of bioactives for regenerative medicines and tissue engineering techniques. Graphical Abstract Role of PEGylated liposomes in cancer stem cell therapy.
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http://dx.doi.org/10.1007/s12015-019-09933-zDOI Listing
February 2020

Water Soluble Vitamins and their Role in Diabetes and its Complications.

Curr Diabetes Rev 2020 ;16(7):649-656

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS, V.L. Mehta road, Vile Parle (W), Mumbai-400056, India.

Background: Diabetes is a metabolic disorder associated with abnormally high levels of glucose in the blood due to inadequate production of insulin or inadequate sensitivity of cells to the action of insulin. Diabetes has become an increasing challenge in the world. The predicted diabetic population according to the World Health Organization is 8.7% between the age group 20-70 years. There are many complications linked to prolonged high blood glucose levels, such as microvascular complications and macrovascular complications. Vitamins play an important role in glucose metabolism and the potential utility of supplementation is relevant for the prevention and/or management of diabetes mellitus and its complications.

Methods: Literature search was performed using various dataset like PUBMED, EBSCO, ProQuest, Scopus and selected websites like the National Institute of Health and the World Health Organization.

Result: Water-soluble vitamins have been thoroughly studied for their activity in diabetes and diabetic complications.

Conclusion: Water-soluble vitamins like B1, B3, B6, B7, B9 and B12 have notable effects in diabetes mellitus and its related complications like nephropathy, neuropathy, retinopathy and cardiomyopathy.
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http://dx.doi.org/10.2174/1573399815666190916114040DOI Listing
September 2020

Heat Shock Proteins and their Protective Roles in Stem Cell Biology.

Stem Cell Rev Rep 2019 10;15(5):637-651

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, India.

Stem cells (SCs) are discovered long back but the idea that SCs possess therapeutic potential came up just a few decades back. In a past decade stem cell therapy is highly emerged and displayed tremendous potential for the treatment of a wide range of diseases and disorders such as blindness and vision impairment, type I diabetes, infertility, HIV, etc. SCs are very susceptible to destruction after transplantation into the host because of the inability to sustain elevated stress conditions inside the damaged tissue/organ. Heat shock proteins (HSPs) are molecular chaperones/stress proteins expressed in response to stress (elevated temperature, harmful chemicals, ischemia, viruses, etc) inside a living cell. HSPs protect the cell from damage by assisting in the proper folding of cellular proteins. This review briefly summarises different types of HSPs, their classification, cellular functions as well as the role of HSPs in regulating SC self-renewal and survival in the transplanted host. Applications of HSP modulated SCs in regenerative medicine and for the treatment of ischemic heart disease, myocardial infarction (MI), osteoarthritis, ischemic stroke, spinocerebellar ataxia type 3 (SCA3), leukemia, hepatic ischemia-reperfusion injury, Graft-versus-host disease (GVHD) and Parkinson's disease (PD) are discussed. In order to provide potential insights in understanding molecular mechanisms related to SCs in vertebrates, correlations between HSPs and SCs in cnidarians and planarians are also reviewed. There is a need to advance research in order to validate the use of HSPs for SC therapy and establish effective treatment strategies.
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http://dx.doi.org/10.1007/s12015-019-09903-5DOI Listing
October 2019

Advanced multimodal diagnostic approaches for detection of lung cancer.

Expert Rev Mol Diagn 2019 05 22;19(5):409-417. Epub 2019 Apr 22.

a Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management , Shri Vile Parle Kelavani Mandal'S Narsee Monjee Institute of Management Studies University , Mumbai , India.

Introduction: Lung cancer (LC) emerges as a principle cause of death among smokers and is also one of the most lethal forms of cancer in nonsmokers. LC is mainly classified as non-small cell lung cancer (NSCLC), small cell LC, and lung carcinoid tumor. NSCLC is the most prevalent form of LC and its early stage diagnosis is essential to reduce mortality rate of patients and provide specific therapy. The field of LC diagnostics witnessed a gradual escalation with advancement in technology. Areas covered: This comprehensive review focuses on classification of LC and advanced diagnostics for LC detection like biosensors, biomarkers, nanotechnology-based diagnostics, wearable devices, mobile health, artificial intelligence (AI), aptamers, and molecularly imprinted polymers (MIPs). Expert opinion: Liquid biopsy and breath analysis developments are the most promising and advanced technologies for the detection of biomarkers associated with LC. Wearable devices and AI are two niche areas that require development and standardization for commercialization. The upcoming technology based on nanosystems includes robots, fibers, and particles for sensitive detection of LC. In the near future, nanotechnology-based theranostics, aptamers, and MIPs will emerge in early-stage diagnosis of LC.
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http://dx.doi.org/10.1080/14737159.2019.1607299DOI Listing
May 2019

Recent therapeutic strategies targeting beta amyloid and tauopathies in Alzheimer's disease.

Brain Res Bull 2019 03 8;146:171-184. Epub 2019 Jan 8.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKMs NMIMS, V.L.Mehta Road, Vile Parle (W), Mumbai, Maharashtra, 400056, India. Electronic address:

Alzheimer's disease (AD) has been a global concern for years due to its severe implications that affects the quality of life of the patients. The available line of therapy for treating Alzheimer's includes acetylcholinesterase inhibitors, NMDA(N-methyl-D-aspartate) antagonists and their combination which gives only symptomatic relief rather than treating the root cause of AD. Senile plaques and neurofibrillary tangles are the characteristic features underlying Alzheimer's pathology. Several attempts have been made towards exploring the niceties of these hallmarks and targeting various aspects of amyloid and tau pathology at different stages to eliminate the ultimate cause. Approaches targeting cleavage and formation of toxic amyloid fragments by secretases, aggregation of amyloid monofilaments, and immunotherapy against amyloid deposits has been extensively studied to treat amyloid pathology. Similarly, for tau pathology, tau hyperphosphorylation, microtubule stabilization, anti-tau immunotherapy has been explored. This article focuses on AD pathology and current pharmacotherapy, precisely for amyloid and tau. Furthermore, preclinical and clinical studies along with potential leads discovered under these approaches have also been included in this article. However, despite extensive research in drug development, overcoming clinical barrier still remain a major challenge for Alzheimer's pharmacotherapy.
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http://dx.doi.org/10.1016/j.brainresbull.2019.01.004DOI Listing
March 2019

Emerging vistas in theranostic medicine.

Int J Pharm 2019 Mar 29;558:29-42. Epub 2018 Dec 29.

Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, SVKM's NMIMS Deemed to be University, V.L. Mehta Road, Vile Parle (W), Mumbai 400 056, India.

Recent years have witnessed a paradigm shift in the focus of healthcare towards development of customized therapies which cater to the unmet needs in a myriad of disease areas such as cancer, infections, cardiovascular diseases, neurodegenerative disorders and inflammatory disorders. The term 'theranostic' refers to such multifunctional systems which combine the features of diagnosis and treatment in a single platform for superior control of the disease. Theranostic systems enable detection of disease, treatment and real time monitoring of the diseased tissue. Theranostic nanocarriers endowed with multiple features of imaging, targeting, and providing on-demand delivery of therapeutic agents have been designed for enhancement of therapeutic outcomes. Fabrication of theranostics involves utilization of materials having distinct properties for imaging, targeting, and programming drug release spatially and temporally. Although the field of theranostics has been widely researched and explored so far for treatment of different types of cancer, there have been considerable efforts in the past few years to extend its scope to other areas such as infections, neurodegenerative disorders and cardiovascular diseases. This review showcases the potential applications of theranostics in disease areas other than cancer. It also highlights the cardinal issues which need to be addressed for successful clinical translation of these theranostic tools.
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http://dx.doi.org/10.1016/j.ijpharm.2018.12.068DOI Listing
March 2019

Anti-Arthritic Effect of Garcinol Enriched Fraction Against Adjuvant Induced Arthritis.

Recent Pat Inflamm Allergy Drug Discov 2019 ;13(1):49-56

SPP- School of Pharmacy & Technology Management, SVKM's NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai 400056, Maharashtra, India.

Background: Garcinia indica also known as kokum is used in traditional system of medicine for relieving inflammation and rheumatic pain. Garcinol, a benzophenone obtained from its fruit rind is reported to have anti-inflammatory effect via modulating arachidonic acid metabolism, suppressing iNOS expression, NF-κB activation and COX-2 expression. It has also been studied for antioxidant and anticancer activity. Apart from these, few patents claim that garcinol also has anti-obesity and hepatoprotective effect and has a potential to be used for the treatment of renal disorders, endometriosis and cardiac dysfunction.

Objective: Garcinol Enriched Fraction (GEF) from the fruit rind of Garcinia indica should be effective in the treatment of arthritis, one of the chronic inflammatory disorder owing to its anti-inflammatory property as indicated by earlier experiments.

Methods: GEF was prepared from the fruit rind of Garcinia indica and quantified using LC-MS/MS. It was found to contain 89.4% w/w of garcinol. GEF was evaluated at the dose of 10mg/kg for its efficacy against Complete Freund's Adjuvant (CFA) induced arthritis in Wistar albino rats. Paw volumes of both sides were measured by Plethysmometer and body weight was recorded on 0, 1, 5, 12 and 21st day. The hyperalgesic response was also measured by motility test and stair climbing test.

Results: GEF showed a significant reduction in paw swelling (p < 0.0001) and arthritis index (p < 0.0001) exhibiting anti-inflammatory potential. It also improves the motility and stair climbing ability of experimental animals (p < 0.05), thus reducing hyperalgesia.

Conclusion: Garcinol enriched fraction shows anti-arthritic activity in experimental animals.
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http://dx.doi.org/10.2174/1872213X12666181120091528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6778983PMC
January 2020

Current trends and emerging diagnostic techniques for lung cancer.

Biomed Pharmacother 2018 Oct 28;106:1586-1599. Epub 2018 Jul 28.

Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM'S NMIMS, V.L. Mehta Road, Vile Parle (W), Mumbai, India.

Cancer is one of most fatal forms of disease with rapid, abnormal and uncontrolled division of cells which spreads into different organs in the body. The primary aim of this review is to showcase the current and emerging diagnostic techniques that are used in lung cancer detection. Lung cancer is a leading cause of death among smokers and it has been emerging in non-smokers due to passive smoke inhalation by non-smokers. The mortality rate of patients with lung cancer is very high due to the change in lifestyle and environmental factors. It is often misdiagnosed as tuberculosis in India as tuberculosis is prevalent in India. On the contrary tuberculosis is not prevalent in the western countries Like U.S.A., U.K., Canada, etc. The major setback in lung cancer is that the symptoms of lung cancer occur at very later stages when the tumor has spread profusely. Hence, highly advanced techniques are employed for detection, accurate staging and treatment of lung cancer. The review focuses on the various novel and emerging diagnostic tools like biomarkers and biosensors, radiogenomics and artificial intelligence. This review also gives an insight of the various conventional techniques like CT-imaging, sputum cytology, biopsy and bronchoscopy which have been modified over the years for better sensitivity and accuracy. It also encompasses the regulatory provisions like IDE, CLIA-certification, etc. for manufacturing and sale of diagnostics in India, U.S.A., Japan and Australia.
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http://dx.doi.org/10.1016/j.biopha.2018.07.145DOI Listing
October 2018

Cuboidal lipid polymer nanoparticles of rosuvastatin for oral delivery.

Drug Dev Ind Pharm 2017 Feb 21;43(2):213-224. Epub 2016 Sep 21.

a Department of Pharmaceutics , Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS , Mumbai , India.

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 (2) 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, 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 AUC 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.
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http://dx.doi.org/10.1080/03639045.2016.1232726DOI Listing
February 2017

Development and evaluation of orally disintegrating tablets of cilostazol-β-cyclodextrin inclusion complexes.

Drug Dev Ind Pharm 2015 28;41(10):1589-607. Epub 2014 Oct 28.

a Department of Pharmaceutics, Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management , SVKM's NMIMS , Mumbai , India.

Context: The clinical applications of cilostazol (CLZ) are limited by its low aqueous solubility (<5 µg/ml) and high biovariability.

Objective: The aim of this study was to enhance the solubility of CLZ by forming inclusion complexes (ICs) with beta cyclodextrin (β-CD) and formulating them into oral disintegrating tablets.

Methods: Phase solubility study of CLZ with β-CD was performed in water. Job's plot was constructed to determine the stoichiometry of ICs. ICs, prepared by spray-drying technique, were characterized using Fourier transform infrared spectroscopy, differential scanning calorimetry, hot stage microscopy, powder X-ray diffraction and nuclear magnetic resonance. Molecular modeling studies were performed to understand the mode of interaction of CLZ with β-CD. The formulation process was undertaken using a reproducible design of experiment generated model, attained by variation of diluents and disintegrants at three levels. Tablets were evaluated for drug content, hardness, friability, disintegration time (DT), wetting time (WT) and dissolution profiles.

Results And Discussion: Phase solubility studies suggested an AL type curve with stability constant (Ks) of 922.52 M(-1). Job's plot revealed 1:2 stoichiometry. All analytical techniques confirmed inclusion complexation. Molecular modeling revealed dispersive van der Waals interaction energy as a major contributor for stabilization of complex. The spray-dried complexes showed higher solubility and faster dissolution compared to plain CLZ. The optimized formulation showed DT of 11.1 ± 0.8 s, WT of 8.7 ± 0.9 s and almost complete dissolution of CLZ in 15 min.

Conclusion: The prepared tablets with low DT and fast dissolution will prove to be a promising drug delivery system with improved bioavailability and better patient compliance.
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http://dx.doi.org/10.3109/03639045.2014.972413DOI Listing
June 2016

Optimization of Paclitaxel Containing pH-Sensitive Liposomes By 3 Factor, 3 Level Box-Behnken Design.

Indian J Pharm Sci 2013 Jul;75(4):420-6

School of Pharmacy and Technology Management, Shirpur Campus, NMIMS University, Shirpur-425 405, India.

The aim of this study was to investigate the combined influence of 3 independent variables in the preparation of paclitaxel containing pH-sensitive liposomes. A 3 factor, 3 levels Box-Behnken design was used to derive a second order polynomial equation and construct contour plots to predict responses. The independent variables selected were molar ratio phosphatidylcholine:diolylphosphatidylethanolamine (X1), molar concentration of cholesterylhemisuccinate (X2), and amount of drug (X3). Fifteen batches were prepared by thin film hydration method and evaluated for percent drug entrapment, vesicle size, and pH sensitivity. The transformed values of the independent variables and the percent drug entrapment were subjected to multiple regression to establish full model second order polynomial equation. F was calculated to confirm the omission of insignificant terms from the full model equation to derive a reduced model polynomial equation to predict the dependent variables. Contour plots were constructed to show the effects of X1, X2, and X3 on the percent drug entrapment. A model was validated for accurate prediction of the percent drug entrapment by performing checkpoint analysis. The computer optimization process and contour plots predicted the levels of independent variables X1, X2, and X3 (0.99, -0.06, 0, respectively), for maximized response of percent drug entrapment with constraints on vesicle size and pH sensitivity.
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http://dx.doi.org/10.4103/0250-474X.119820DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3831723PMC
July 2013

Determination of gallic acid in Phyllanthus emblica Linn. dried fruit powder by HPTLC.

J Pharm Bioallied Sci 2010 Apr;2(2):105-8

School of Pharmacy & Technology Management, SVKM's Narsee Monjee Institute of Management and Higher Studies, V.L.Mehta Road, Vile Parle (west) Mumbai, India.

Objective: Emblica (Phyllanthus emblica L.), an euphorbiaceous plant, is widely distributed in subtropical and tropical areas of India, China and Indonesia. The fruits possess antimicrobial, antioxidant, anti-inflammatory, analgesic and antipyretic properties. In the current article a new, simple, sensitive, selective, precise, and robust high-performance thin-layer chromatographic (HPTLC) method was developed and validated for the determination of gallic acid in dried fruit powder of Phyllanthus emblica.

Materials And Methods: The quantitative determination of gallic acid was performed on TLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase. The linear ascending development was carried out in a twin trough glass chamber saturated with a mobile phase consisting of toluene: ethyl acetate: formic acid: methanol (3:3:0.8:0.2) at room temperature (25 ± 2°C). Camag TLC scanner III was used for spectrodensitometric scanning and analysis, in the absorbance mode, at 278 nm.

Results: The linear regression analysis data for the calibration plots showed good linear relationship with r(2) = 0.99977 in the concentration range of 40 - 240 ng spot-1, with respect to the peak area. According to the guidelines of the International Conference on Harmonization (ICH), the method was validated for precision, accuracy, and recovery.

Conclusion: Statistical analysis of the data showed that the method was reproducible and selective for the estimation of gallic acid.
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http://dx.doi.org/10.4103/0975-7406.67012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3147091PMC
April 2010
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