BITS Faculty Publications
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Item An insight into risk assessment and reformulation of drug products manufactured using benzene grade carbomer: a regulatory perspective(Springer, 2024-07) Jindal, Anil B.Cancer has been an enormous pain point for patients and regulatory bodies across the globe. In Dec. 2023, the US FDA released guidance on benzene-grade carbomer formulations, which triggered pharmaceutical manufacturers to assess risk, test finished products, and reformulate drug products with benzene-grade carbomer. The immediate implementation of the stoppage of finished products with benzene-grade carbomers has threatened pharmaceutical excipients and finished product manufacturers. The gravity of this situation prompted the US Pharmacopeia to extend the deadline for discontinuation from August 1, 2025, to August 1, 2026, allowing manufacturers ample time for reformulation and regulatory compliance. There is an immediate need to understand the guidance and to learn how manufacturers should do the risk assessment and approach reformulation. This review provides an in-depth analysis of the risk assessment and reformulation processes involved in various dosage forms utilizing benzene-grade carbomer, supported by specific case studies. This review offers insights into navigating the USFDA guidelines to ensure formulation safety and compliance, thus enabling pharmaceutical practitioners to uphold the highest standards of patient care and tackle life cycle management challenges.Item Bugs as Drugs: Understanding the Linkage between Gut Microbiota and Cancer Treatment(Bentham Science, 2022) Jindal, Anil B.The commensal microbiota is known to regulate host physiology. Dysbiosis or compromised resilience in the microbial ecology is related to the impending risk of cancer. A potential link between cancer and microbiota is indicated by a lot of evidence. The current review explores in detail the various links leading to and /or facilitating oncogenesis, providing sound reasoning or a basis for its utilization as potential therapeutic targets. The present review emphasizes the existing knowledge of the microbiome in cancer and further elaborates on the factors, like genetic modifications, effects of dietary components, and environmental agents, that are considered to assess the direct and indirect effect of microbes in the process of oncogenesis and on the host’s health. Strategies modulating the microbiome and novel biotherapeutics are also discussed. Pharmacomicrobiomics is one such niche accounting for the interplay between the microbiome, xenobiotic, and host responses, which is also looked upon. The literature search strategy for this review was conducted by following the methodology of the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). The method includes the collection of data from different search engines, like PubMed, ScienceDirect, SciFinder, etc., to get coverage of relevant literature for accumulating appropriate information regarding microbiome, cancer, and their linkages.Item Nano-natural Products as Anticancer Agents(Springer, 2018-07) Paul, Atish Tulshiram; Jindal, Anil B.Cancer is one of the noxious diseases and is a major public health problem worldwide. The clinical management of cancer involves various approaches, but the most common one is chemotherapy. Natural products such as paclitaxel, camptothecin, podophyllotoxin, etc. have been used as major sources of anticancer drugs in many clinical trials. In spite of availability of these drugs for treatment of cancer, failure in chemotherapy is very common due to dose-limited toxicities and occurrence of drug resistance. In this regard, the nano-delivery systems directly target and deliver the selective drug to the cancerous sites and increase the permeability and intracellular accretion of anticancer drugs. Thus, the aim of this chapter is to focus on the application of nanotechnology to develop nano-natural products for effective treatment of cancer.