About Me |
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My self, Dr. Bikash Ranjan Jena currently working in Pharmaceutical Analysis & Research Division, School of Pharmacy and Life Sciences (SoPLS), Centurion University, Bhubaneswar since Jan 2021. I am Interested in Scientific & Medical Writing (Clinical Regulatory filing & Submission, Regulatory e-CTD & CTD dossier submission to various regulated markets). I have successfully obtained my Ph.D in Pharmaceutical Analysis at KLEF Deemed to be University, Vaddeswaram, Guntur, A.P. Expertised in Analytical Quality by Design (AQbD), handling of Design of Experiment (DoE) based software's like Design Expert, Chemoface, Minitab etc., and its statistical application in Analytical Research & Development. So far, I have 12.6 yrs of academic and research experience and published 80+ articles (research, review, short communications, editorial etc.) in several peer reviewed and impact journals. I have also industrial experience in the field of Regulatory Science/Affairs for 1 year and Completed Industrial Research Project in Analytical R & D at MEDREICH Ltd. (Genovo R & D Center, Bengaluru), for more than 6 months during Masters of Pharmaceutical Analysis (M.Pharm). Currently, I am having Cited Record of Google Scholar H index 9, citations 260+, Scopus Publications 26+, Research Gate score:112.7, RG h-index 9). I have authored and Edited 4 Textbooks, (published 1 Textbook (as a co-editor), under IP Innovative Publications Pvt. Ltd., New Delhi, published 1 International textbook under IIP as (an Editor) in "Iterative International Publisher (IIP, USA) and also Co-edited 1 International Textbook on aspects of Quality by Design (QbD) published in CAMBRIDGE SCHOLAR PUBLISHING, Total more than 26 international book chapters in various renowned publisher of Springer, Bentham Science, Elsevier Inc. etc. I am also serving as an Advisory and Editorial Board Member of several Web of Sci indexing journals i.e. IJLPR, JPRI & Board Member in more than 10 International Journals and also working as a Certified Peer-Reviewer of more than 14 international Journals indexed with Clarivate Analytics (Web of Sci, ESCI), Scopus, PubMed/PMC etc. Patent Published: Published one Indian Patent entitled "Nanodrug delivery of an anticancer drug and their method their of" in association with CUTM on 25th Nov 2022.
Awards: Received YOUNG ACHIEVER AWARD from Institute of Scholaars (InSc), Unit of SDPL; Received INTERNATIONAL SCIENTIST AWARD ON ENGINEERING, SCIENCE AND MEDICINE VD GOOD Professional Association (VD GOOD TM), “Faculty Incentive Award 2023 as "PERFORMER category from CUTM, received Research Incentive Award-2022 for publishing good number research articles, Book Chapters, Books & Patents in reputed Publishers. Academic Activities involved: Currently handling teaching, internship, practical classes of U. G (B.Pharm) and P. G (M.Pharm) students. & Ph.D scholars. Guiding Diploma, U.G and P.G Scholars for their research projects of final year students. In addition to academic activities at CUTM, I have also involved as a Placement Career co-ordinator, Preplacement, Career Counseling and Alumni activities of "School of Pharmacy and Life Science, Bhubaneswar Campus since Jan 2021 onwards. |
Dr. Bikash R Jena, currently works at the Dept. of Pharmacy, (Pharmaceutical Analysis & Research) Centurion University, BBSR, Odisha, India. He has earned his Ph.D at KLEF Deemed to be University, Vadeswaram, Andhra Pradesh, India. His current research subjected to Analytical Chemistry, Bioanalytical Method Development, validation of DRUG components according to ICH guidelines. He has Edited 4 Books,
published
4 Patents,
80+ papers (20+ research, 28+ reviews, 25+ book chapters, 26+ Scopus, 17+ WOS) in UGC recognized peer-reviewed IMPACT journals (indexed in Scopus, Web of Science, PubMed/PMC, Embase) of reputed Publishers like Springer, Bentham Sciences, Wiley, Elsevier Inc. Etc.
Sl. No. | Title | Issuer |
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1 | Young Researcher Award -2021 | Institute of Scholars ( Unit of SPDL) |
2 | Young Scientist Award 2021 " International Scientist Awards for engineering, Science and Medicine" | VD GOOD PROFESSIONAL ASSOCIATION |
3 | Faculty Incentive Award-2023 | Centurion University of Technology & Management, Bhubaneswar, Odisha |
4 | Research Incentive Award-2022 | Centurion University of Technology & Management, Bhubaneswar, Odisha |
Analytical quality by design based systematic development and optimization of a sensitive bioanalytical method for estimation cinacalcet HCl in rabbit serum
AQbD Driven Development of an RP-HPLC Method for the Quantitation of Abiraterone Acetate for its Pharmaceutical Formulations in the Presence of Degradants. 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.
Analytical QbD based systematic development of a novel RP-UHPLC method for the quantification of albuterol sulphate in its metered dose inhaler formulations
INDEXED : SCOPUS, WOS, PUBMED, TURKMEDLINE
Name of Journal: Journal of Research in Pharmacy, Marmara University Press
QbD-based Formulation Optimization and Characterization of Polymeric Nanoparticles of Cinacalcet Hydrochloride with Improved Biopharmaceutical Attributes
Artificial Intelligence, Robotics and Computational Fluid Dynamics: General Overview, Pharmaceutical Automation, Pharmaceutical Applications
Book Title: Pandemic Corona Virus vs. Epidemic, and Endemic Virus Diseases: Present, Past, and Future Directions
Name of Book Editor: Suryakanta Swain, Bikash Ranjan Jena, Debashish Ghose
Name of Publisher: IP Innovative Publications
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.
QbD driven formulation development, Optimization, of Rosuvastatin calium loaded floating microballons: in vitro and in vivo characterization.
Bentham Science Publishers
Chapter 9: Challenges of Nanozymes
Book Title: Emerging Environmental Applications of Nanozymes
Nova Science Publishers Inc., USA
Tittle of Chapter: BIO-CATALYSIS: A BRIEF REVIEW
Book Title: Futuristic Trends in Biotechnology
ISBN: 978-93-95632-88-1
IIP Proceedings, Volume 2, Book 27, Part 2, Chapter 1
Modern advancements, Patents and Applications of Futuristic Nanozymes: A compressive review
Name of communicated Journal and Publisher: Nano Science & Nanotechnology Asia, Bentham Science
CHAPTER 2
Computational Modelling of Drug Disposition
Title of Book: Computer Aided Drug Development
Name of Publisher: Wood Head Publishing India, Pvt. Ltd , (An ELSEVIER, Imprint)
CHAPTER 4
Computer aided biopharmaceutical characterization, computer simulations in phatrmacokinetics and pharmacodynamics and computers in Clinical development
Title of Book: Computer Aided Drug Development
Name of Publisher: Wood Head Publishing India, Pvt. Ltd , (An ELSEVIER, Imprint)
The carbon-assisted nano substances intensifies and exhilarating chemical and physical features for rapid drug delivery at cellular level. Some of the prime most carbon-based nanomaterials
(CBNs) such as graphene, carbon nanotubes, fullerenes, nanodiamonds, and carbon nanodots, have lately picked up significant
considerations from scientists of the healthcare field. Of course,
CBNs have found their place in a rigorous series of biomedical applications due to extensive study using ongoing advancements in
the technology. As of now, these materials primarily impact three
different fields of Medicine: treatments, diagnostics, and imaging.
Each of these zones has immense potential for remedy in healthcare fraternity
Genotoxic impurities in critical analysis of product development: Recent advancements, patents, and current challenges
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).
An Overview of Recent Advances in Bio-Analytical Techniques -
In the present study, a rapid, an accurate and precise Ultra Performance Liquid Chromatography (UPLC) method
was developed and validated for simultaneous estimation of paracetamol and caffeine in its capsule dosage form
(325 mg and 30 mg) by selecting chromatographic parameters. The UPLC method was developed using 2.1 × 50
mm, reverse phase C18 column (Acquity UPLC ethylene bridge hybrid (BEH) C18 1.7 µm) with mobile phases
containing 0.1% w/v H3PO4 and 100% v/v buffer as mobile phase A and methanol: Acetonitrile (50:50) as mobile
phase B and water: acetonitrile: H3PO4 (80:20:0.1) as diluent and the run considered as an isocratic elution. Flow
rate was 0.5 ml/min with PDA detection at (?max) 275 nm for paracetamol and caffeine and the injection volume was
set at 2 µL with run time 7 min. The method was validated by using various validation parameters like accuracy,
precision, linearity and specificity. These results show the method could find practical application as a quality control
tool for analysis of the drug in its capsule dosage forms in pharmaceutical industries. The developed validated
method and stability testing of new dosage forms as per ICH-Q2 (R1) and ICH-Q1C guidelines applicable for the
analysis of bulk drug and in its capsules dosage form.
Biotechnology is one of the emerging fields that can add new and better application in a wide range of sectors like health care, service sector, agriculture, and processing industry to name some. This book will provide an excellent opportunity to focus on recent developments in the frontier areas of Biotechnology and establish new collaborations in these areas. The book will highlight multidisciplinary perspectives to interested biotechnologists, microbiologists, pharmaceutical experts, bioprocess engineers, agronomists, medical professionals, sustainability researchers and academicians. This technical publication will provide a platform for potential knowledge exhibition on recent trends, theories and practices in the field of Biotechnology. Aim of the research articles are invited in the following areas of interest, but not limited to: 6 chapters including Biomarkers, Bio-separation Methods, Biocatalyst, Fermentation Technology etc.
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. 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.
The current investigation signifies, a simple, affordable, precise, and accurate UV spectrophotometric method to estimate and
validate lumefantrine concentrations in bulk and pharmaceutical formulations. Shimadzu twin beam UV-VIS spectrophotometer
operated by UV probe software was used in the study. The resulting absorbance at a maximum wavelength of 268 nm was observed
using the solvent 0.1N HCL. Numerous validation metrics, including accuracy, precision, linearity, and optical characteristics, were
used to optimise the established method. Within a concentration range of 10-60 µg/mL, the regression co-efficient (R2
) value of
0.997 was incorporated to obtain the linearity Graph. Less than 2%, of the results for accuracy and precision studies were executed,
which shows increasing accuracy and precision levels. Due to low %RSD values in the recovery exploration, no excipients were
included in the formulation of the tablet dosage form. The proposed method’s accuracy study was confirmed at (80%, 100%, 120%)
three levels, and the outcomes were validated in accordance with ICHQ2R1 guidelines. These findings indicate that the procedure
has practical value as a tool for quality control when analysing drugs in their tablet dosage forms in the pharmaceutical industry.
Keywords: Bisoprolol; Validation; Precision; Accuracy; Optical Characteristics
ntroduction: 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-?B) signaling. NF-?B stimulates the expression of matrix metalloproteinase (MMP9), inflammatory cytokines tumor necrosis factor (TNF-?), and interleukin-1? (IL-1?). Although much research targeted the NF-?B and MMP9 signaling pathways, a subsequent investigation of target mediators in the inflammatory ulcer healing and NF-?B 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-1?, tumor necrosis factor (TNF-?), and the pERK, MMP9, and NF-?B 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-?B 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-?B-mediated MMP9 and cytokines.
This review intensifies the Current advancement and applications of AI to Healthcare and Pharmaceutical fields. The review will be useful for the research fraternity for finding a overview of Artificial intelligence.
Protein and peptide-based drugs have greater therapeutic efficacy and potential application and lower toxicity compared to chemical entities in long-term use within optimum concentration as they are easily biodegradable due to biological origin. While oral administration is preferable, most of these substances are currently administered intravenously or subcutaneously. This is primarily due to the breakdown and poor absorption in the GI tract. Hence, ongoing research is focused on investigating absorption enhancers, enzyme inhibitors, carrier systems, and stability enhancers as potential strategies to facilitate the oral administration of proteins and peptides. Investigations have been directed towards advancing novel technologies to address gastrointestinal (GI) barriers associated with protein and peptide medications. The current review intensifies formulation and stability approaches for oral protein & peptide drug delivery systems with all significant parameters intended for patient safety. Notably, certain innovative technologies have been patented and are currently undergoing clinical trials or have already been introduced into the market. All the approaches stated for the administration of protein and peptide drugs are critically discussed, having their current status, future directions, and recent patents published in the last decades.
This study summarises the numerous advances, biopharmaceutical components, variations, production techniques, characterisation approaches, limitations, and opportunities for SEDDS. With this context in mind, this review compiles a current account of biopharmaceutical advancements, such as the application of quality by design (QbD) methodologies to optimise drug formulations in different excipients with controllable ratios, the presence of regulatory roadblocks to progress, and the future consequences of SEDDS, encompassing composition, evaluation, diverse dosage forms, and innovative techniques for in vitro converting liquid SEDDS to solid forms.
Quality by design (QbD) is becoming an integral element of the modern pharmaceutical and chemical development approach. In this book, the future ramifications of emergent modern applications of QbD and green analytical chemistry in drug design, process analytical technologies, and bioanalytical process development instruments are discussed. It will reveal and improve the QbD principles used in bioanalysis, process development, downstream processing, and the combination of QbD and green analytical chemistry employing eco-friendly and green solvents for product development. In addition, it will provide complete information regarding applying the QbD concept and ideology to quality control and process development.
The book will be beneficial to PhD research scholars, researchers, and postgraduate and undergraduate students of pharmacy and chemical sciences for understanding the concept of quality by design and green chemistry for drug design, as it illustrates the necessary inputs that are related to product quality and, ultimately, process sustainability.
Quality by design (QbD) is becoming an integral element of the modern pharmaceutical and chemical development approach. In this book, the future ramifications of emergent modern applications of QbD and green analytical chemistry in drug design, process analytical technologies, and bioanalytical process development instruments are discussed. It will reveal and improve the QbD principles used in bioanalysis, process development, downstream processing, and the combination of QbD and green analytical chemistry employing eco-friendly and green solvents for product development. In addition, it will provide complete information regarding applying the QbD concept and ideology to quality control and process development.
The book will be beneficial to PhD research scholars, researchers, and postgraduate and undergraduate students of pharmacy and chemical sciences for understanding the concept of quality by design and green chemistry for drug design, as it illustrates the necessary inputs that are related to product quality and, ultimately, process sustainability.
Title of Patent : Nanodrug delivery system of a anticancer drug and their Method theirof
A METHOD OF CHARACTERIZING AND EVALUATING ATARGETED DRUG DELIVERYFOR MALIGNANT TUMOURS