Progressing nanotechnology to improve targeted cancer treatment: overcoming hurdles in its clinical implementation.

The use of nanotechnology has the potential to revolutionize the detection and treatment of cancer. Developments in protein engineering and materials science have led to the emergence of new nanoscale targeting techniques, which offer renewed hope for cancer patients. While several nanocarriers for medicinal purposes have been approved for human trials, only a few have been authorized for clinical use in targeting cancer cells. In this review, we analyze some of the authorized formulations and discuss the challenges of translating findings from the lab to the clinic. This study highlights the various nanocarriers and compounds that can be used for selective tumor targeting and the inherent difficulties in cancer therapy. Nanotechnology provides a promising platform for improving cancer detection and treatment in the future, but further research is needed to overcome the current limitations in clinical translation.

Lipid-based nanocarriers for enhanced delivery of plant-derived bioactive molecules: a comprehensive review.

Bioactive compounds derived from plants have been investigated for treating various pathological conditions. However, the utilization of these compounds has challenges such as instability, low solubility and bioavailability. To overcome these challenges, the encapsulation of bioactive molecules with in a novel nano carrier system enabling effective delivery and clinical translation has become essential. Lipid-based nanocarriers provide versatile platforms for encapsulating and delivering bioactive compounds and overcome the challenges. These novel carriers can improve solubility, stability, improved drug retention and therapeutic efficacy of plant derived bioactive compounds. The current review evaluates the challenges in delivery of plant bioactives and highlights the potential of various lipid-based nano carriers designed to improve its therapeutic efficacy.

Plants contain compounds that can be used to treat various diseases. But these compounds are hard to use as medicines because they break down easily, don't dissolve well, and are not absorbed into the body effectively. To solve these problems, scientists are studying ways to protect the plant compounds in tiny particles called 'nanocarriers'. The nanocarriers protect the plant compounds and help them work better in the body. Lipid-based nanocarriers (fats and oil-based nanocarriers) are one of the types of promising nanocarrier in overcoming these problems. First, this review defines the problems faced by the compounds and it explains how lipid-based nanocarriers may be able to overcome these challenges. The goal is to design better ways to deliver plant compounds so they can be more effective medicines.

The Role of Quality Assurance in Clinical Trials: Safeguarding Data Integrity and Compliance.

Clinical trials, which investigate the effects of drugs in humans, aim to determine safety and efficacy while identifying adverse reactions. Data consistency and subject safety are crucial factors that determine the quality of clinical trials, necessitating overall quality management. There is a growing emphasis on implementing quality systems during the planning stages of clinical trials. Regulatory frameworks have evolved to ensure patient protection and data reliability, underscoring the need for systematic quality management in health research. A clinical trial quality management plan (CTQMP) is essential to describe the tools and methods used to ensure study quality. Globalization has led to an increase in conducting clinical trials in developing nations, presenting challenges due to procedural and ethical disparities. To manage these complexities, outsourcing trial management has become common. Adherence to good clinical practice (GCP) principles, as defined by the International Conference on Harmonization (ICH), is critical for safeguarding participant rights and ensuring credible data. Quality by design (QbD) and quality risk management are now central to clinical trial management, as advocated by the FDA. Technological advancements and robust protocols further enhance trial processes. Effective QA activities, including monitoring and data management, are vital for maintaining compliance, participant safety, and data integrity, highlighting the indispensable role of QA in clinical trial success.

A Comprehensive Review on Solid Lipid Nanoparticles as a Carrier for Oral Absorption of Phyto-Bioactives.

Phyto-bioactive (PB) compounds are naturally occurring substances derived from plants that offer significant health benefits ranging from antioxidant and anti-inflammatory activities to potential cancer-fighting properties. However, their widespread application is limited by several inherent limitations, such as low bioavailability, poor biostability, limited aqueous solubility, and no site-specific target. Additionally, the necessity for high concentrations of effective PBs doses further restricts their use. Encapsulating PBs in suitable nanocarriers, particularly solid lipid nanoparticles (SLNs), can enhance their stability in biological environments, improve water solubility, enable controlled release, and allow for targeted delivery. This innovative approach increases bioavailability, reduces toxicity, and potentially lowers effective dosages. The current review examines the critical factors influencing oral PBs delivery, explores how biocompatible and biodegradable SLNs can be optimized to overcome these challenges, and discusses emerging techniques in nanoparticle design that could further enhance the efficacy of PBs delivery systems.

Enhancing Pharmaceutical Product Quality With a Comprehensive Corrective and Preventive Actions (CAPA) Framework: From Reactive to Proactive.

Corrective and preventive actions (CAPA) are crucial components of quality assurance (QA) within the pharmaceutical industry, essential for maintaining product quality, safety, and regulatory compliance. The review explores the multifaceted role of CAPA in pharmaceutical manufacturing, emphasizing its structured approach to detecting, addressing, and preventing quality issues. CAPA systems are integral to the broader quality management system (QMS), functioning as a dual-loop mechanism that is reactive and proactive approach aligned with continuous improvement principles outlined by the International Organization for Standardization (ISO) 9001:2000. It details the three distinct phases of CAPA: correction or remedial action, corrective action (CA), and preventive action (PA). It highlights the importance of root cause analysis and the necessity for immediate corrections and long-term preventive measures to avoid recurring issues. Regulatory expectations, such as those from the Food and Drug Administration (FDA) under the Code of Federal Regulations (CFR) title 21 part 820 and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q10, are discussed, underscoring the need for a comprehensive CAPA plan that integrates data analysis and ongoing process enhancements. Additionally, the paper introduces the 8D methodology as a structured problem-solving approach to complement CAPA efforts. By providing an in-depth examination of CAPA procedures and their implementation, this article aims to contribute to the understanding and effectiveness of quality systems in pharmaceutical manufacturing.

Drug Repurposing: A Leading Strategy for New Threats and Targets.

Less than 6% of rare illnesses have an appropriate treatment option. Repurposed medications for new indications are a cost-effective and time-saving strategy that results in excellent success rates, which may significantly lower the risk associated with therapeutic development for rare illnesses. It is becoming a realistic alternative to repurposing "conventional" medications to treat joint and rare diseases considering the significant failure rates, high expenses, and sluggish stride of innovative medication advancement. This is due to delisted compounds, cheaper research fees, and faster development time frames. Repurposed drug competitors have been developed using strategic decisions based on data analysis, interpretation, and investigational approaches, but technical and regulatory restrictions must also be considered. Combining experimental and computational methodologies generates innovative new medicinal applications. It is a one-of-a-kind strategy for repurposing human-safe pharmaceuticals to treat uncommon and difficult-to-treat ailments. It is a very effective method for discovering and creating novel medications. Several pharmaceutical firms have developed novel therapies by repositioning old medications. Repurposing drugs is practical, cost-effective, and speedy and generally involves lower risks when compared to developing a new drug from the beginning.