Dr. Bikash Ranjan Jena, M.Pharm., Ph.D
@cutm.irins.org
ASSOCIATE PROFESSOR IN PHARMACEUTICAL ANALYSIS RESEARCH DIVISION
Centurion University of Technology and Management, Bhubaneswar, Odisha, INDIA
Introduction: Dr. Bikash Ranjan Jena, currently works at the Department of Pharmacy, (Pharmaceutical Analysis & Research Division) Centurion University, Bhubaneswar, Odisha, India. He has successfully completed and Awarded his Ph.D at KLEF Deemed to be University, Vaddeswaram, Guntur, A.P, India. He has 12 yrs of academic & research experience subjected to Analytical Chemistry, Chemometrics, AQbD, Bioanalytical Development, Pharmacovigilance, Assay and impurity profiling of DRUG components according to ICH guidelines. He has also expertized in DoE based advanced Statistical Software's like Minitab, Design-Expert, Chemoface. He has published 48 + papers (20+ research,15+ reviews, 15+ book chapters) in UGC recognized, peer-reviewed journals (indexed in Scopus, Web of Science, PubMed/MEDLINE) of reputed Publishers of Springer, Elsevier, Bentham Science. He has Google Scholar-H index 8, citations 185 +, Scopus Publications 21+, & Research gate Interest Score (139+) to his Credentials.
EDUCATION
Ph.D Awarded, at KL Deemed to be University, Vijayawada, A.P, India, Having 12 Yrs of academic and research experience. Published more than 40 research Publications
Working as a Ph.D Research scholar and actively involving in Analytical Development. Assay, RS, Method Development, Method Validations, stability studies of novel compounds, using some sophisticated analytical instruments.
RESEARCH INTERESTS
Biotechnology, Chemistry, Medical Microbiology, Oncology, Statistics
Additional Specialties: I am very much interested for scientific writing, DoE avenue by using AQBD approach, Medical Writing, Publishing scientific manuscripts related to pharmaceutical (Analytical Research) fields with high indexing national and international journals.
Scopus Publications
Scholar Citations
Scholar h-index
Scholar i10-index
Scopus Publications
Suryakanta Swain, Bikash Ranjan Jena, Areti Anka Rao, Narender Malothu, Naga Jogayya Kothakota, and Satya Narayan Tripathy
Bentham Science Publishers Ltd.
Abstract: The current review intends to regulate and accurately evaluate genotoxic contaminants in drug substance and drug product method and formulation process development, validation, and degradation pathways. The Quality by Design (QbD) principles can be applied to the systematic evaluation and control of impurities enabled by the development of modern analytical techniques, including the performance of risk assessment, the screening of Critical Process Parameters (CPPs), and the identification of the most influential variables in the optimization of the evaluation and control methods. Current difficulties in removing genotoxic contaminants and the procedures for doing so have been outlined in this review, along with the steps necessary to acquire optimum techniques and the most acceptable formulations. In addition to this, division, characterization, assessment, quantification, and formation of genotoxic impurities sources and control strategy for genotoxic impurities, handling of nitrosamine assay content of drug products in different industrial methodologies and their chemometric prospects and associated recent patents are also explored.
Suryakanta Swain, Debashish Ghose, Chinam Niranjan Patra, Bikash Ranjan Jena, and Muddana Eswara Bhanoji Rao
Bentham Science Publishers Ltd.
Abstract: Platelet-inspired nanoparticles have ignited the possibility of new opportunities for producing similar biological particulates, such as structural cellular and vesicular components, as well as various viral forms, to improve biocompatible features that could improve the nature of biocompatible elements and enhance therapeutic efficacy. The simplicity and more effortless adaptability of such biomimetic techniques uplift the delivery of the carriers laden with cellular structures, which has created varied opportunities and scope of merits like; prolongation in circulation and alleviating immunogenicity improvement of the site-specific active targeting. Platelet-inspired nanoparticles or medicines are the most recent nanotechnology-based drug targeting systems used mainly to treat blood-related disorders, tumors, and cancer. The present review encompasses the current approach of platelet-inspired nanoparticles or medicines that have boosted the scientific community from versatile fields to advance biomedical sciences. Surprisingly, this knowledge has streamlined to development of newer diagnostic methods, imaging techniques, and novel nanocarriers, which might further help in the treatment protocol of the various diseased conditions. The review primarily focuses on the novel advancements and recent patents in nanoscience and nanomedicine that could be streamlined in the future for the management of progressive cancers and tumor targeting. Rigorous technological advancements like biomimetic stem cells, pH-sensitive drug delivery of nanoparticles, DNA origami devices, virosomes, nano cells like exosomes mimicking nanovesicles, DNA nanorobots, microbots, etc., can be implemented effectively for target-specific drug delivery.
Suryakanta Swain, Debashish Ghose, Bikash Ranjan Jena, GSN Koteswara Rao, and Abhisek Sahu
Bentham Science Publishers Ltd.
Abstract: In the last few years, nanozymes have emerged as an adequate substitute for natural enzymes. Recently, much attention has been paid to enzyme-mimic nanomaterials (nanozymes). Because of their distinct characteristics, they are a critical alternative to natural enzymes that can be produced at a subordinate cost and more efficiently. These nanomaterials have enzyme-like activity and have been cast off to detect and treat biomolecules such as DNA, proteins, cells, and tiny molecules such as glucose. Hence, the critical analysis of recent nanozyme is deemed essential for futuristic research, outcome-based results specified to current trends of analytical tools, and several disease monitoring for targeted oncology therapies like circulating tumor cells, MRI, PET, etc. In addition, the multivariate applications of nanozymes for biosensors, immunoassay formation, tumor cell detection with earlier remedies, and environmentallysound engineering technologies are discussed to climax the modern advancements. The novelty and originality of this current review is to intensify the recent advancement, types and mimicking activity, biomedical applications of nanozymes, implementation of the chemometric approach in nanozymes, and its futuristic approach. Finally, to promote the understanding of nanozymes and the development of novel and multifunctional nanozymes, we provide a comprehensive review of the nanozymes with their broadest applications and modern technologies involved in targeted drug delivery, inventory with other diversified arenas and existing patents indicating future implications.
Suryakanta Swain, Debashish Ghose, Chinam Niranjan Patra, and Bikash Ranjan Jena
Bentham Science Publishers Ltd.
Introduction: The objective of this study is to provide a rapid, sensitive, consistent, and costeffective method for quantifying isradipine using ultra-fast liquid chromatography. Methods: Quality by Design principles will form the basis of this approach, grounded on response surface analysis. Shimadzu liquid chromatographic system equipped with a photodiode array detector and LC solution software was used to conduct the RP-UFLC method development and validation. An ODS C18 (250 x 4.6 mm; 5 μm) UFLC column was used to complete the analysis. The RSM methodology utilized a central composite design to perform the optimization studies. Results: The mobile phase ratio and flow rate were considered crucial method parameters, as well as the peak area, retention time, and USP plate were considered critical analytical attributes. The optimal conditions for chromatographic separation were followed using 80% acetonitrile and water (20% v/v) as mobile phase, a 1 mL/min flow rate, an injection volume of 20 μL, 40°C of column oven temperature, and maximum absorption at λmax 254 nm using graphical optimization technique. When examining concentrations between 5 and 150 ng/mL, linearity was observed with an R2 of 0.999. The method created was validated by employing stability testing per the recommendations provided by ICH Q2 (R1). The analysis of blood serum was modified so that it could be used to examine the pharmacokinetic parameters. Conclusion: As a result, high accuracy, precision, sensitivity, linearity, and robustness were established for predicting the amount of isradipine present in its freeze-dried nano-formulations.
Suryakanta Swain, Sasikanth Kothamasu, Muddana Eswara Bhanoji Rao, and Bikash Ranjan Jena
Bentham Science Publishers Ltd.
Background: The prime intent of this study was to formulate, optimize and evaluate the floating microballoons of rosuvastatin calcium to extend the stomach or gastrointestinal residence time, dissolution rate, and bioavailability of the drug. Objective: Rosuvastatin calcium-loaded floating microballoons were prepared by solvent evapora-tion technique and systematic optimization of such formulations by response surface methodology using Box-Behnken Design, with the selected independent variables like concentration of HPMC K4M (X1), K15M (X2), and K100M (X3) and dependent variables as mean particle size in μm (R1), % entrapment efficiency (R2), and % drug released at 12h (R3). Methods: For each of the studied response variables, the trial formulations were subsequently eval-uated for in vitro floating lag time, drug content, total floating time, and drug content, and the data analysis through optimization was carried out by placing the experimental data with an appropriate mathematical model. Results: In vivo pharmacokinetics study parameters for the optimized batch showed a 4 to 5 folds elevation of peak plasma concentration (Cmax), the area under the curve (AUC) data, and reduction of time to reach peak concentration (Tmax) value compared to marketed product (p < 0.05). As per ICH guidelines, the stability study results show that floating microballoons remain stable for 6 months. Conclusion: Hence, the floating microballoons of rosuvastatin calcium are a valuable technique to improve the solubility, dissolution, and bioavailability of a poorly water-soluble drug, rosuvastatin calcium.
Siva Prasad Panda, Mahamat Sami Adam Mahamat, Malikyahia Abdul Rasool, DSNBK Prasanth, Idris Adam Ismail, Moyed Abasher Ahmed Abasher, and Bikash Ranjan Jena
Maad Rayan Publishing Company
Introduction: The mixed flavonoid supplement (MFS) [Trimethoxy Flavones (TMF) + epigallocatechin-3-gallate (EGCG)] can be used to suppress inflammatory ulcers as an ethical medicine in Ayurveda. The inflammation of the rectum and anal regions is mostly attributed to nuclear factor kappa beta (NF-κB) signaling. NF-κB stimulates the expression of matrix metalloproteinase (MMP9), inflammatory cytokines tumor necrosis factor (TNF-α), and interleukin-1β (IL-1β). Although much research targeted the NF-κB and MMP9 signaling pathways, a subsequent investigation of target mediators in the inflammatory ulcer healing and NF-κB pathway has not been done. Methods: The docking studies of compounds TMF and EGCG were performed by applying PyRx and available software to understand ligand binding properties with the target proteins. The synergistic ulcer healing and anti-arthritic effects of MFS were elucidated using dextran sulfate sodium (DSS)-induced colon ulcer in Swiss albino rats. The colon mucosal injury was analyzed by colon ulcer index (CUI) and anorectic tissue microscopy. The IL-1β, tumor necrosis factor (TNF-α), and the pERK, MMP9, and NF-κB expressions in the colon tissue were determined by ELISA and Western blotting. RT-PCR determined the mRNA expression for inflammatory marker enzymes. Results: The docking studies revealed that EGCG and TMF had a good binding affinity with MMP9 (i.e., -6.8 and -6.0 Kcal/mol) and NF-kB (-9.4 and 8.3 kcal/mol). The high dose MFS better suppressed ulcerative colitis (UC) and associated arthritis with marked low-density pERK, MMP9, and NF-κB proteins. The CUI score and inflammatory mediator levels were suppressed with endogenous antioxidant levels in MFS treated rats. Conclusion: The MFS effectively unraveled anorectic tissue inflammation and associated arthritis by suppressing NF-κB-mediated MMP9 and cytokines.
Jayanti Panda, Muddana Eswara Bhanoji Rao, Suryakanta Swain, Chinam Niranjan Patra, and Bikash Ranjan Jena
Springer Science and Business Media LLC
Abstract Background The current study expands on the use of design of experiment in developing cefuroxime axetil mucoadhesive minitablets for treating antibiotic-associated colitis. A comprehensive QbD-based product development strategy was implemented, with the target product profile defined based on the desired product quality of mucoadhesive minitablets. The identified critical quality attributes are based on the target product profile. The goal was to find the optimum levels by using the concentrations of chitosan (mg) (X1), HPMC K100M (X2) and sodium carboxymethyl cellulose (X3) as the influential variables. The response surface methodology determines the dependent variables using 33 Box–Behnken design to optimize the selected critical factors. The friability (%), drug content (%) and mucoadhesive strength (%) characteristics of cefuroxime axetil mucoadhesive minitablets were evaluated using ANOVA for the observed responses or dependent variables. Results The study demonstrated that run 8 with optimum composition chitosan, HPMC K100M and sodium carboxy methyl cellulose, which are the mucoadhesive polymers, showed a desirable and promising drug release profile up to 24 h, higher percentage of drug content, mucoadhesion and swelling index. Conclusions The optimized mucoadhesive minitablets of cefuroxime axetil demonstrated desired formulation characteristics, including improved bioavailability and high control over the drug’s release rate and increased flexibility in adjusting both the dose and the drug’s release rate. In a nutshell, the studies support the successful development of mucoadhesive minitablets of cefuroxime axetil, which could be used to treat antibiotic-associated colitis.
Bikash Ranjan JENA, Siva Prasad PANDA, Umasankar KULANDAIVELU, Rajasekhar Reddy ALAVALA, G.S.N Koteswara RAO, Suryakanta SWAIN, Gurudutta PATTNAIK, and Debashish GHOSE
Galenos Yayinevi
Objectives
Abiraterone acetate is a well-known anticancer drug and a steroidal derivative of progesterone for treatment of patients with hormone-refractory prostate cancer. Chemometrics-assisted reverse phase high performance liquid chromatography (RP-HPLC) development of the drug abiraterone acetate has been employed in this study using an analytical quality by design (AQbD) approach.
Materials and Methods
Drug separation was performed using a Princeton Merck-Hibar Purospher STAR (C18, 250 mm × 4.6 mm) i.d., 5 μm particle size) with ultraviolet detection at 235 nm. A Box-Behnken statistical experimental design with response surface methodology was executed for method optimization and desired chromatographic separation from its formulation with a few numbers of experimental trials. The impact of three independent variables, namely, composition of the mobile phase, pH, and flow rate, on response retention time and peak area was studied by constructing an arithmetic model from these variables.
Results
Optimized experimental conditions for the proposed work include the mobile phase acetonitrile and phosphate buffer (10 mM KH2PO4) (20:80 %v/v). At the concentration range of 2-100 μg/mL, a linear calibration curve was found. Recovery was performed at three concentrations and was foun to be between 98% and 102%. The 3D response surface curves revealed that mobile phase composition and flow rate were the most substantial critical factors affecting desired responses.
Conclusion
An attempt has been made to develop and validate an economical, precise, robust, stability-indicating AQbD-based RP-HPLC method that can be employed successfully for the routine analysis of abiraterone acetate in quality control labs.
ChinamNiranjan Patra, SudhanshuBhusan Routray, Suryakanta Swain, and BikashRanjan Jena
Medknow
Context: There is no straightforward method for estimating cinacalcet HCl in biological materials such as serum exists. As a result, the goal of this research is to develop a simple quality by design (QbD) enabled reverse phase-Ultra-Fast Liquid Chromatography (RP-UFLC) model for analyzing cinacalcet HCl in serum. Aim: The current study envisages the development and validation of an isocratic simple, precise, and rapid QbD enabled RP-UFLC method for the quantification of cinacalcet HCl in both solution form and blood samples. Subjects and Methods: The optimum conditions were outlined, selecting three influential factors (CMPs) i.e., mobile phase composition, flow rate, and injection volume. Systematic optimization was performed by 32-Box Benkhen experimental design using response surface methodology. The selected variables are further assessed for observed responses Critical Analytical attributes, i.e., peak area, retention time (Rt), USP Plate count. The optimized method used a chromatographic C18 (100 mm × 4.6 mm i.d) column with mobile phase (acetonitrile and Tetrabutyl Ammonium Hydrogen Sulphate [TBSH]) in the ratio of 1:1, with a flow rate of 1 mL/min with UV at λmax 223 nm. The developed method was found to be specific for cinacalcet HCl, enduring no interference of peaks with an overall analytical Rt of 4.3 min. Results: The Accuracy reported as % recovery was found to be 96.83%–101.32% and 95.18%–102.49% respectively. Inter-day precision (reproducibility) and intra-day precision (repeatability) were found to be 0.22–1.19 standard deviation (SD) and 0.14–2.12 SD respectively. The calibration curve was found to be linear with a regression equation Y = 195.8x + 21852, with R2 0.999 over a concentration range from 100 to 100,000 ng/mL. Conclusion: The required detection and quantitation limits (Limit of Detection and Limit of Quantitation) values were obtained within the acceptance limit based on S/N ratio which indicates the method was sensitive and rapidity of the method. Further, the developed QbD enabled UFLC method was approved and effectively entreated the blood tests to study the pharmacokinetic parameters which indicate a robust, accurate cost-effective method intended for quality control tool for routine systematic analysis in research labs.
Suryakanta Swain, Bikash Ranjan Jena, and Sarwar Beg
Springer Singapore
Sarwar Beg, Suryakanta Swain, and Bikash Ranjan Jena
Springer Singapore
Bikash Ranjan JENA, Siva Prasad PANDA, Umasankar KULANDAIVELU, and Rajasekhar Reddy ALAVALA
ASOS Yayinevi
Debashish GHOSE, Chinam Niranjan PATRA, Bera Varaha Venkata RAVI KUMAR, Suryakanta SWAIN, Bikash Ranjan JENA, Punam CHOUDHURY, and Dipthi SHREE
Galenos Yayinevi
Objectives
The aim of the present work was to prepare QbD enabled optimization, and to improve the oral bioavailability of freeze-dried polymeric nanoparticles of cinacalcet hydrochloride manufactured by nanoprecipitation and ultrasonication methods using polymers PLGA, and poloxamer-188.
Materials and Methods
The initial screening and optimization were carried out for the formulations by employing Taguchi and Box-Behnken Designs. The FT-IR and DSC revealed no interactions and had no incompatibility among the selected drug and polymers. The nanoparticles were characterized for % drug release, particle size analysis, zeta potential, PDI, SEM, TEM, P-XRD, TGA, DTA, in vitro, and in vivo drug release study.
Results
In vitro drug release study showed sustained release of the drug from the optimized batch by diffusion mechanism. The optimized nanoparticle formulation was recognized by numerical and graphical methods using validation of the experimental model. The optimized batch was stable as per the ICH stability guidelines for 6 months with no considerable alternation noticed in particle size, entrapment efficiency, and in vitro drug release. The pharmacokinetic parameters of AUC and Cmax data for the optimized formulation increased 3- and 2.9-folds compared to the pure-drug suspension.
Conclusion
The prepared polymeric nanoparticles formulation is an alternative delivery system for enhanced therapeutic efficacy and bioavailability potential of a model drug to manage long-term normocalcemia in patients with preliminary hyperparathyroidism.
Bikash Ranjan Jena, Siva Prasad Panda, Kulandaivelu Umasankar, Suryakanta Swain, G.S.N Koteswara Rao, D. Damayanthi, Debashish Ghose, and Debi Prasad Pradhan
Bentham Science Publishers Ltd.
Background: Quality by design based software’s in analytical research and development normally encompasses multiple objectives. For decades, this task has been attempted through trial and error, supplemented with the previous experience, knowledge, and wisdom of the analytical researchers. Objective: The study analyzes the current QbD-assisted software’s such as design-experts, minitab, fusion product development etc. and its broad implementations in an analytical research and developments. Methods: Traditional approach may fails to meet the intended purpose by trial and error procedure during the analytical research and development. However, in modern scientific technology equipped with highly advanced features associated software’s of the QbD paradigm. The impact and interactions between the critical process variables and critical method attributes such as resolution, tailing, etc. can be well understood by the screening, optimization and robustness studies based on the principles of experimental design. Result: Design of experiment assimilates statistical multi¬variate analysis instead of one factor at a time approach. This also provides a prominent, most reliable quality output, which is also essential for getting highly robust method as well as to obtain homogenous product development. Conclusion: The present review, critically discussed about the various QbD based multivariate software’s and their applications in drug development and analytical research.
Siva Prasad Panda, Uttam Prasad Panigrahy, DSNBK Prasanth, Uma Sankar Gorla, Chakravarthi Guntupalli, Deba Prasad Panda, and Bikash Ranjan Jena
Oxford University Press (OUP)
This research aimed to evaluate the antiangiogenic activity of isolated flavonoid 4a,5,8,8a‐tetrahydro‐5‐hydroxy‐3,7,8‐trimethoxy‐2‐(3,4‐dimethoxyphenyl) chromen‐4‐one (TMF) from Tabebuia chrysantha. STAT3‐MMP9 signalling is a signal transduction mechanism that promotes angiogenesis in various cancers.
Siva Prasad Panda, Uttam Prasad Panigrahy, Subhranshu Panda, and Bikash R. Jena
Elsevier BV
ETHNOPHARMACOLOGICAL RELEVANCE
The plant Tabebuia chrysantha (Jaq.) Nicholson (Bignoniaceae) is commonly known as "Golden Goddess" in the Southern part of India and "Golden Trumpet Tree " in Central America. Stems of this plant have been traditionally used for antioxidant, anti-inflammatory, antimicrobial and anticancer actions.
AIM OF THE STUDY
To evaluate the antitumor activity of methanol extract of Tabebuia chrysantha stem (METC).
MATERIALS AND METHODS
The in vivo antitumor potential of METC against Ehrlich Ascites Carcinoma (EAC) in Swiss albino mice was assessed by evaluating tumor volume, viable and nonviable tumor cell count, tumor weight, hematological parameters, biochemical parameters, and antioxidant parameters. The in vitro antitumor potential of METC at different concentrations (100, 200, 400, 800, 1000) µg/mL has been evaluated, by using the MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] and Trypan blue dilution assay for a period of 3 h treatment. Before that, the crude extract was pre-screened for cytotoxicity property using Brine shrimp lethality bioassay.
RESULTS
Phytoconstituents 2-Hydroxynaphthalene-1,4-dione, β-lapachone and 2-((dimethylamino)methyl)-3-methoxynaphthalene-1,4-dione were isolated from the METC. Their occurrence and structures were determined by HPLC chromatography, UV spectroscopy, and 1D and 2D NMR spectroscopies respectively. The extract showed a direct cytotoxic effect on EAC cells in a dose-dependent manner with IG50 value 463.27 µg/mL in MTT assay and 443.58 µg/mL in trypan blue dilution assay. The METC (300 mg/kg) and 5-FU (30 mg/kg) exhibited significant (p < 0.001) decrease in tumor volume, tumor weight and viable cell count of EAC-treated mice. Also, hematological profile, tissue parameters such as lipid peroxidation, reduced glutathione, superoxide dismutase, and catalase were reverted to the normal levels compared to the EAC control group. The Western blotting analysis demonstrated apoptosis of carcinoma was due to inhibition of soluble epidermal growth factor receptor proteins (sEGFR) expression in the blood.
CONCLUSION
The antitumor potential of the stem extract of T chrysantha was due to naphthaquinones and polyphenol content in the crude extract and so T chrysantha could be a cytotoxic plant to control tumor growth.
Suryakanta Swain, Bikash Ranjan Jena, Dayaratnam Madugula, and Sarwar Beg
Elsevier
Someshwar Komati, Suryakanta Swain, Muddana Eswara Bhanoji Rao, Bikash Ranjan Jena, and Vishali Dasi
Maad Rayan Publishing Company
Innovations in pharmaceutical research are striving for designing newer drug therapies toeradicate deadly diseases. Strategies for such inventions always flourish with keys and objectivesof minimal adverse effects and effective treatment. Recent trends in pharmaceutical technologyspecify that mucoadhesive drug delivery system is particularly appropriate than oral controlrelease, for getting local systematic delivery of drugs in GIT for an extended interval of time ata predetermined rate. However, it is somehow expensive and unpleasant sensation for somepatients, but still it is needful for getting short enzymatic activity, simple administration withoutpain and evasion of fast pass metabolism. Usually the vehicles employed in drug delivery ofmucoadhesive system have a significant impact that draws further attention to potential benefitslike improved bioavailability of therapeutic agents, extensive drug residence time at the site ofadministration and a comparatively faster drug uptake into the systemic circulation. The drugrelease from mucoadhesive multiparticulates is contingent on several types of factors comprisingcarrier need to produce the multiparticles and quantity of medication drug contained in them.Mucoadhesion is characterized by selected theories and mechanisms. Various strategiesemergent in mucoadhesive multiparticulate drug delivery system (MMDDS) by in-vitro as wellas ex-vivo description and characterization are also critically discussed. Apart from these, theprimary focus during this review is to highlight current patents, clinical status, and regulatorypolicy for enhancement of mucoadhesive multi-particulate drug delivery system in the present scenario.<br />
Suryakanta Swain, Rabinarayan Parhi, Bikash Ranjan Jena, and Sitty Manohar Babu
Bentham Science Publishers Ltd.
Background: Quality by Design (QbD) is associated with a modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also lead to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify the desired and required product performance report, such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA). Methods: This review highlighted the concepts of QbD design space, for critical material attributes (CMAs) as well as the critical process parameters that can totally affect the CQAs within which the process shall be unaffected thus, consistently manufacturing the required product. Risk assessment tools and design of experiments are its prime components. Results: This paper outlines the basic knowledge of QbD, the key elements; steps as well as various tools for QbD implementation in pharmaceutics field are presented briefly. In addition to this, quite a lot of applications of QbD in numerous pharmaceutical related unit operations are discussed and summarized. Conclusion: This article provides a complete data as well as the roadmap for universal implementation and application of QbD for pharmaceutical products.
Suryakanta Swain, Sarwar Beg, Prafulla K. Sahu, Bikash R. Jena, and Sitty M. Babu
Bentham Science Publishers Ltd.
Background: Irbesartan is an anti-hypertensive BCS class II drug exhibiting poor aqueous solubility, which makes it highly challenging for delivery through the oral route. Based on this fact, a self-microemulsifying drug delivery system (SMEDDS) was designed and characterized for augmenting the aqueous solubility and dissolution rate of irbesartan. Methods: Several blends of oil (Capmul MCM EP), surfactant (Tween 80) and co-surfactant (PEG 600) were screened from the preliminary solubility and pseudo-ternary phase diagram studies. Systematic optimization of the SMEDDS was carried out using 3-factor 3-level Box-Behnken design. Results: The optimized formulation was identified by numerical optimization technique, which revealed faster emulsification time, high percent transmittance and drug content, lower globule size < 100 nm, zeta potential and excellent thermodynamic stability. The optimal formulation unveiled more than 93.3% drug release in vitro within 60 minutes, while the pure drug exhibited only 20% drug release, respectively. Conclusion: Ex vivo permeability and in situ intestinal absorption of drugs was improved nearly 2 to 3- fold by the optimal SMEDDS formulation against the pure drug alone (p < 0.001). Overall, the proposed SMEDDS formulation of irbesartan exhibited a superior biopharmaceutical performance.
Siva Prasad Panda, Bikash Ranjan Jena, Gade Kalyani, and Uttam Prasad Panigrahy
Springer Science and Business Media LLC
Fruits of Cucumis callosus (Rottl.) Cogn. (Family: Cucurbitaceae) plant, are commonly known as “bitter cucumber” (English) and “Kachri” (Hindi) in India and have been traditionally used for antioxidant, rich source of vitamin C, antidiabetic and anticancer actions. Tribal peoples of Odissa and West-Bengal are using these fruits during worship and as a vegetable. In vitro cytotoxicity of methanolic seed extract of C. callosus (MSCC) at different concentrations (25, 50, 100, 200, 400) µg/ml and methanolic pericarp extract of C. callosus (MPCC) at (30, 60, 120, 240, 360) µg/ml on Ehrlich Ascites Carcinoma (EAC) cell line, has been evaluated by using the MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] assay and Trypan blue dye exclusion assay for a period of 3 h treatment. Acute toxicity and in vivo teratotoxicity of both extracts were also evaluated using the Zebrafish embryo developmental assay. The MSCC and MPCC showed the direct cytotoxic effect on EAC cells in a dose-dependent manner with IG50 value 273.17 and 235.08 µg/ml respectively. The MPCC in 240 and 360 µg/ml showed a strong teratotoxic effect on Zebrafish embryo in a dose-dependent manner. The cytotoxicity and teratotoxicity of MPCC were due to overexpressed CYP450 mediated apoptosis in the tissue.
RECENT SCHOLAR PUBLICATIONS
MOST CITED SCHOLAR PUBLICATIONS
RESEARCH OUTPUTS (PATENTS, SOFTWARE, PUBLICATIONS, PRODUCTS)
Expertise in Analytical Research and Development and Method Validations using statistical Multivariate analysis and Design of Experiments paradigim.
Expertise in QbD based softwares like Design Expert, Minitab, MatLab etc.
Sound knowledge of Analytical Quality by Design, Chemometrics, Various Statistical softwares and its immplementation
Handling of HPLC Instrumental softwares like Waters Empower 2, Shimadzu LC solution, n2000,
UV softwares like Win 5 and 6.2 etc.
Industry, Institute, or Organisation Collaboration
Worked at Analytical Research and Development, at Medreich Limited, Bengaluru, Karnataka.
INDUSTRY EXPERIENCE
Worked at Analytical Research and Development (A R & D), at Medreich Limited, Bengaluru, Karnataka during Dec 2011- Sept 2012.
I have worked in Celogen Pharma Pvt Ltd, Corporate Head office Navi Mumbai as Regulatory Affairs Executive from december 2012 to Dec 2013