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Synthetic lipids are today helping to enhance the effectiveness and safety of pharmaceuticals by controlling drug release and targeting specific cells or tissues, according to experts. Synthetic lipid-based drug delivery systems are, therefore, increasingly offering hope for improved patient outcomes and quality of life.
Efforts to enhance the performance of liposomal drug delivery systems are ongoing, aiming to reduce toxicity, improve efficacy, and minimise rapid clearance from the bloodstream. Researchers are exploring the use of complex multi-functional liposomal formulations in experimental studies to develop more efficient drug delivery systems.
Arun Kedia, managing director, VAV Lipids further explains, “Despite these advancements, synthetic lipid-based drug delivery systems face clinical translation obstacles due to pharma manufacturing, government regulations, and intellectual property (IP). Quality assurance and cost control pose significant challenges, as scalability of the process, reliability and reproducibility of the final product, and product stability all impact the system's complexity.”
Kedia further adds that in addition to this, IP protection for liposomal-based drug delivery systems is a challenging and expensive issue. Clinical trials of liposomal formulations are more intricate and time-consuming than chemical formulations, further contributing to the complexities of this field.
The Indian government has implemented new initiatives and incentives to support companies producing synthetic lipid nanocarriers, including budget allocations for research and development efforts. With proper support and increased awareness, the use of synthetic lipids in the pharmaceutical industry will experience significant growth worldwide over the next decade.
In the twenty-first century, synthetic chemistry has been playing a significant role in transforming the healthcare ecosystem. This area of science has facilitated drug discovery efforts, helping eliminate epidemics which wiped out towns thus saving countless lives. In recent times, synthetic lipids have emerged as a game-changing technology, enabling breakthroughs in precise drug delivery systems.
Targeted drug delivery systems (NDDS) based on synthetic lipids have the potential to deliver a wide range of therapeutics, including genes, RNAs, peptides, and diagnostic imaging agents. This technology provides new opportunities for improving several drugs' pharmacokinetics, pharmacodynamics, release profile and therapeutic index.
“Drug delivery systems based on lipids are promising for delivering drugs, biologics, and nutrients via different administration routes. Solid Lipid Carriers (SLC) and Nanostructured Lipid Carriers (NLC) also known as lipid nanoparticles (LNP) are some of the most extensively researched systems that are based on phospholipids. Their biocompatibility, slow-release rate, high stability, and low toxicity make them highly attractive,” Kedia informs.
Working with phospholipids extracted from natural sources can however be challenging. Natural phospholipids containing various unsaturated fatty acids produce different components in mixed ratios that could vary from batch to batch. This results in variations in physical, chemical, and biological properties, making it challenging to develop consistent, reproducible, and controlled-release drug delivery systems.
Modern synthetic phospholipids can overcome the challenges posed by divergent properties in natural phospholipids. Unlike natural phospholipids, synthetic phospholipids are single, well-defined molecules, which make them easier to standardise. Under suitable conditions, they can be adjusted to achieve desirable physical, chemical, sustained release and biological properties.
“Synthetic lipid nanoparticles provide stability throughout the delivery process, allowing for a more robust immunogenic response. Advancements in synthetic lipid nanoparticle-based delivery systems have resulted in the development of highly effective drug delivery systems. Recent examples of this progress can be seen in the new mRNA-based Covid-19 vaccine delivery systems. Encapsulation of the mRNA strand, which is fragile and prone to degradation, in synthetic lipid nanoparticles has proven to be an efficient vaccine delivery method. When used in the vaccine, the mRNA strand encoded with the key protein is delivered more efficiently, thus improving vaccine efficacy,” Kedia further informs.
Academia and industry worldwide have ongoing extensive research on nucleic acid drugs encapsulated in synthetic lipid nanoparticles due to their potential use in replicon-based therapeutics in oncology, protein replacement therapy, and gene-editing techniques. The use of ionisable lipids, a crucial component of the LNP, determines the potency of the LNP toward target sites and enhances its penetration in target tissues such as the liver and solid tumours.
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