B, Pharmacy awarded in 2012 from Uttrakhand Technical University, Dehradun, Uttrakhand.
M. Pharmacy (Pharmaceutics) awarded in 2014 from Shoolini University, Solan, Himachal Pradesh.
Ph.D. (Pharmaceutical Sciences) awarded in 2020 from Shoolini University, Solan, Himachal Pradesh.
RESEARCH, TEACHING, or OTHER INTERESTS
Pharmacology (medical), Dermatology, General Medicine
The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines Yunes M.M.A. Alsayadi, Aditya Shiven, Atul Kabra Current Topics in Medicinal Chemistry, 2025 Introduction: Nitrosamines are genotoxic impurities formed from reactions between amines and nitrosating agents, which are commonly found in many consumer products and pharmaceuticals. Their presence poses serious risks due to their established carcinogenic potential, particularly with long-term exposure. Methods: A comprehensive literature review was conducted using PubMed, Scopus, and Web of Science to investigate the mechanisms, sources, analytical detection methods, and regulatory frameworks of nitrosamine formation. Relevant studies and guidelines were analyzed to identify risk patterns and control strategies. Results: Nitrosamines may form during the synthesis of Active Pharmaceutical Ingredients (APIs), due to excipient contamination, or through degradation during storage. Sensitive techniques, such as LC-MS and GC-MS, enable trace-level detection. Regulatory bodies, including the FDA and EMA, have established Acceptable Intake (AI) limits and mandated risk assessments and control measures. Discussion: Nitrosamine formation is influenced by factors, such as pH, heat, moisture, and the interaction of amines with nitrosating agents. The variability in excipient composition and manufacturing processes adds complexity to prevention efforts, underscoring the need for productspecific risk evaluation. Conclusion: Minimizing nitrosamine contamination requires robust risk assessment, sensitive analytical techniques, and strict adherence to evolving regulatory requirements. This review highlights the importance of proactive control throughout the formulation, manufacturing, and storage stages to ensure patient safety and pharmaceutical quality.
Innovations in the Detection of N-Nitrosamine Impurities in Pharmaceuticals: Analytical and Regulatory Challenges Yunes M. M. A. Alsayadi, Raghav Dogra, Vimal Arora, Aditya Shiven Critical Reviews in Analytical Chemistry, 2025 The emergence of N-nitrosamine impurities (NAIs) in pharmaceutical products has raised significant global concern due to their confirmed carcinogenic and genotoxic potential. Their presence in widely prescribed medications like metformin, ranitidine, and valsartan has triggered widespread recalls and prompted stringent guidelines by agencies like the USFDA and EMA. Despite technological advancements, the detection and quantification of NAIs at the trace level remain analytically challenging, primarily due to their structural diversity and exceptionally low permissible thresholds for detection. Given the recent surge in regulatory scrutiny and product recalls, this review offers an up-to-date critical evaluation of the origin, mechanism of formation, toxicological implications, and evolving regulatory framework for NAIs. Particular emphasis is placed on the state-of-the-art analytical techniques, including LC-MS, GC-MS, and emerging high-resolution mass spectrometry (HRMS) platforms, along with current practices in sample preparation and method validations. Methodological gaps, including challenges in sample preparation and instrument-specific limitations, are thoroughly analyzed to propose future strategies for robust, high-throughput, and regulatory-compliant analysis of NAIs in complex pharmaceutical matrices. A comprehensive literature search spanning 2018-2025 was performed using PubMed, Web of Science, ScienceDirect, and Scopus. Keywords, such as "nitrosamine impurities", "N-nitrosodimethylamine (NDMA)", and "regulatory guidelines" were used to select articles relevant to ongoing method optimization and harmonization to ensure consistent monitoring and mitigation of NAIs. This work also aims to serve as a valuable resource for pharmaceutical scientists, chemists, toxicologists, and regulatory professionals in their commitment to enhance drug safety and protect public health.
Identification of Natural Compounds as Potential COVID-19 Main Protease (Mpro) Inhibitors: A Comprehensive Study and In silico Evidence Arti Devi, Vagish Dwibedi, Sahil Jain, Gursharan Kaur, Zaved Ahmed Khan, Sudip Kumar Mandal, Aditya Shiven, Kamal Shah, Hitesh Kumar Dewangan, Santosh Kumar Rath Current Pharmaceutical Design, 2025 SARS-CoV-2, the virus responsible for COVID-19, has resulted in a devastating global impact with millions of lives lost. Remdesivir and 2-DG are among the few drugs authorized for emergency use against COVID-19, but concerns about their efficacy and side effects persist. Vaccines have been developed and approved, yet the emergence of viral mutations has raised questions about their effectiveness against new variants. Natural compounds with antiviral properties have shown promise in combating SARS-CoV-2. The review highlights the potential of medicinal plant compounds, particularly in targeting the virus' main protease, a crucial component for viral replication. Natural, plant-derived compounds represent a promising avenue for COVID-19 therapeutics. Further clinical validation is necessary to ascertain their efficacy and safety in treating COVID-19. This underscores the importance of continued research into alternative treatments for combating this global health crisis. This review examines the potential of natural, plant-derived compounds as safe and cost-effective alternatives for combating COVID-19. It summarizes the pathogenesis of SARS-CoV- 2 and the ongoing drug studies and identifies natural compounds with known antiviral properties. Additionally, it explores the potential of medicinal plant compounds in targeting the SARS-CoV-2 main protease through in silico and molecular docking studies.
Optimisation and in-vivo evaluation of extracted Karanjin loaded liposomal topical formulation for treatment of psoriasis in tape-stripped mouse model Aditya Shiven, Afroze Alam, Hitesh Kumar Dewangan, Kamal Shah, Perwez Alam, Deepak N. Kapoor Journal of Microencapsulation, 2024 AIM The present work is focus on development of anti-psoriasis activity of Karanjin (isolated from Pongamia pinnata seed oil) loaded liposome based lotion for enhancement of skin permeation and retention. METHOD Karanjin was isolated using liquid-liquid extraction method and characterised by HPLC analysis and partition coefficient. Further, isolated Karanjin was loaded into liposomes using thin-film hydration technique and optimised by Box-Behnken design. Selected optimised batch was characterised their mean diameter, PDI, zeta potential, and entrapment efficiency, morphology (by TEM), FTIR and ex-vivo skin retention. Additionally, Karanjin loaded liposomes were formulated into lotion and characterise their rheological, spreadability, texture, ex-vivo skin permeation & retention, stability and anti-psoriatic activity in mouse tail model. RESULT The yield of Karanjin from seed oil was 0.1% w/v and have lipophilic nature. The optimised liposomal formulation showed 195 ± 1.8 nm mean diameter, 0.271 ± 0.02 PDI, -27.0 ± 2.1 mV zeta potential and 61.97 ± 2.5% EE. TEM image revel the spherical shap of liposome surrounded by single phospholipid bilayer and no interection between drug and excipients. Further, lotion was prepared by 0.1% w/v carbopol and found to 615 mPa.sec viscosity, good thixotropic behaviour, spreadability and texture. There was 22.44% increase in drug permeation for Karanjin loaded liposomal lotion compared to pure Karanjin lotion, confirm by ex-vivo permeation and retention. While, in-vivo study revel the liposomal lotion of Karanjin was found to have 16.09% higher drug activity then 5% w/w conventional Karanjin lotion. CONCLUSION Karanjin loaded liposomal lotion have an effective anti-psoriatic agent and showed better skin permeation and retention than the conventional Karanjin lotion.
Natural and synthetic agents for the treatment of Sarcoptes scabiei: a review Aditya Shiven, A. Alam, D. Kapoor Annals of Parasitology, 2020 Sarcoptes scabiei is an ectoparasite known to infect different species of mammals. Mite is known to infect mankind since antiquity. Current scabicidal agents are becoming less effective due to resistance generated by the mite. The present review focuses on exploration of various herbal and non-herbal/synthetic agents that are proven to be efficient against scabies mite of different mammalian species. In vitro and in vivo acaricidal activities carried out for different dosage forms developed for these scabicidal agents are also discussed.
RECENT SCHOLAR PUBLICATIONS
Unconventional Non-rodent Models in Neurological Research: Exploring New Paths to Translational Insights A Devi, CS Saini, A Shiven, A Kumar, A Sharma, N Joshi, S Kour, ... Journal of Molecular Neuroscience 75 (4), 145 , 2025 2025.0
The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines YMMA Alsayadi, A Shiven, A Kabra Current topics in medicinal chemistry , 2025 2025.0 Citations: 3
Innovations in the detection of N-nitrosamine impurities in pharmaceuticals: analytical and regulatory challenges YMMA Alsayadi, R Dogra, V Arora, A Shiven Critical Reviews in Analytical Chemistry, 1-26 , 2025 2025.0 Citations: 7
Identification of Natural Compounds as Potential COVID-19 Main Protease (Mpro) Inhibitors: A Comprehensive Study and In silico Evidence A Devi, V Dwibedi, S Jain, G Kaur, ZA Khan, SK Mandal, A Shiven, ... Bentham Science Publishers , 2025 2025.0
Optimisation and in-vivo evaluation of extracted Karanjin loaded liposomal topical formulation for treatment of psoriasis in tape-stripped mouse model A Shiven, A Alam, HK Dewangan, K Shah, P Alam, DN Kapoor Journal of microencapsulation 41 (5), 345-359 , 2024 2024.0 Citations: 17
Novel Approaches to Enhance Solubility Medicine.(2023) AK Yadav, HK Pandey, A Shiven Int. J. Life Sci. Pharma Res 13 (6), P217-P233 , 2023 2023.0 Citations: 2
Natural and synthetic agents for the treatment of Sarcoptes scabiei: a review A Shiven, A Alam, DN Kapoor Annals of Parasitology 66 (4) , 2020 2020.0 Citations: 17
Simultaneous UHPLC-APCI-MS/MS Analytical Method for Screening Stress-Induced NDMA Formation in Edoxaban API YMMA Alsayadi, A Shiven, G Dubey, V Arora, R Dogra MS Analytical Method for Screening Stress-Induced NDMA Formation in Edoxaban API , 0
MOST CITED SCHOLAR PUBLICATIONS
Optimisation and in-vivo evaluation of extracted Karanjin loaded liposomal topical formulation for treatment of psoriasis in tape-stripped mouse model A Shiven, A Alam, HK Dewangan, K Shah, P Alam, DN Kapoor Journal of microencapsulation 41 (5), 345-359 , 2024 2024.0 Citations: 17
Natural and synthetic agents for the treatment of Sarcoptes scabiei: a review A Shiven, A Alam, DN Kapoor Annals of Parasitology 66 (4) , 2020 2020.0 Citations: 17
Innovations in the detection of N-nitrosamine impurities in pharmaceuticals: analytical and regulatory challenges YMMA Alsayadi, R Dogra, V Arora, A Shiven Critical Reviews in Analytical Chemistry, 1-26 , 2025 2025.0 Citations: 7
The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines YMMA Alsayadi, A Shiven, A Kabra Current topics in medicinal chemistry , 2025 2025.0 Citations: 3
Novel Approaches to Enhance Solubility Medicine.(2023) AK Yadav, HK Pandey, A Shiven Int. J. Life Sci. Pharma Res 13 (6), P217-P233 , 2023 2023.0 Citations: 2
Unconventional Non-rodent Models in Neurological Research: Exploring New Paths to Translational Insights A Devi, CS Saini, A Shiven, A Kumar, A Sharma, N Joshi, S Kour, ... Journal of Molecular Neuroscience 75 (4), 145 , 2025 2025.0
Identification of Natural Compounds as Potential COVID-19 Main Protease (Mpro) Inhibitors: A Comprehensive Study and In silico Evidence A Devi, V Dwibedi, S Jain, G Kaur, ZA Khan, SK Mandal, A Shiven, ... Bentham Science Publishers , 2025 2025.0
Simultaneous UHPLC-APCI-MS/MS Analytical Method for Screening Stress-Induced NDMA Formation in Edoxaban API YMMA Alsayadi, A Shiven, G Dubey, V Arora, R Dogra MS Analytical Method for Screening Stress-Induced NDMA Formation in Edoxaban API , 0