Nanopharmaceutical Advanced Delivery Systems. Группа авторов
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3.1 Introduction
The growth of nanotechnology involves different disciplines dealing with the science to design, pattern, formulate, and apply in the nanometric scale of the materials and tools that determine the influence of the pharmaceuticals [1]. Particularly in the field of cancer therapy, nanotechnology has researched a remarkable trust in the past decades. In the field of pharmacy, the major limitation in therapy of a lot many diseases is delivering the drug substance to the desired target site. On the other hand, conventional route of drug delivery is portrayed peculiarly of poor distribution, lesser efficacy, limited potency, undesired adverse reactions, and inadequacy selectivity [2]. To overcome these challenges for the past few decades, scientists are successfully working in the advancement of safe and effective mode of drug delivery by mounting non-immunogenic, biodegradable, and biocompatible nanoparticles. By modifying the drug delivery, the drug substance is transported across the biological barriers to the target site, catering shelter against quick metabolism and clearance. Enhancing the drug concentration at the receptor site consequently lowers the drug dose [3]. The fundamental approach of nanotechnology is to reduce the size of the target drug substance and delivering it by means of a suitable formulation system. This extraordinary possibility paves a way to recast other relevant fields such as cosmeceuticals, nutraceuticals, and food industries. This calls for increase in the consumer demands leading to novel delivery approaches proving nanotechnology as an effective tool in treating and preventing diseases; it has the capability to transfigure the incurred therapeutic effect [4].
Researchers have potentially discovered that nanotechnology can be utilized and proven to be an effective drug carrier in drug delivery systems. The phenomenon of size reduction and yielding a wide range of nanostructures showcasing unparalleled level of physical, chemical, and biological characteristics enhances the dosage form performance [5]. The most unique parameter of nanoparticles is the influence of size on the physical and chemical properties of the drug compounds. The peculiar feature of nanoparticles with instance of change in shape and size is utilized as an application in bioimaging. It is an interdisciplinary field of science employing manufacturing principles and engineering technologies at the molecular level. They are solid-state colloidal matters with size ranging from 10 nm to not more than (NMT) 1000 nm; preferably for nano-pharmaceutical utilization, NMT 200 nm is employed [6]. The Latin term “nano” refers to dwarf. This one milliardth (10−9) of a meter is composed of three structural layers—the outer layer surface is factionalized with a wide range of mixtures of molecules, surfactants, cosurfactants, metal ions, and polymers, then the inner shell is chemically of a different fabric material than that of the core; the fundamental key portion referred to itself as the nanoparticle [7].
By employing nanotechnology in pharmaceutical formulation development, there exist advantages such as the following: controlled drug delivery, site and target specificity, bypassing many biological membranes to reach intracellular and brain tissues, enhancing bioavailability, minimizing toxicity, maximizing permeation, minimal dose, more precise and less invasive, rapid dissolution and safe diagnosis, and stable formulation [8]. Despite these advantages, there are few disadvantages such as the characteristic physical property of providing larger surface area due to the size reduction process leads to change in the reactivity, surface energy, compatibility and solubility resulting in biological aggregation. For example, carbon nanotubes are refused by the reticular endothelial system leading to poor half-life, highly xenobiotic nature, and unsusceptible adverse drug reactions due to higher absorption resulting in chronic or acute nanotoxicity [9].
Today in pharmaceuticals, nanotechnology has many applications. The widely used marketed nanoformulation—sunscreens—contains titanium oxide and zinc oxide nanoparticles allowing the particle in white to appear transparent on application [10]. Nevertheless, researchers have proved that nanoparticles have free radicles causing serious intracellular damages providing patient compliance [11].
On the other hand, the concept of personalization and customization is trending in pharmaceutical industries modifying the available dosage forms desiring the patient needs and compliances. Depending on this phenomenon, healthcare professionals are capable of opting the best therapy for individual patients for improving the desired pharmacological outputs and reducing side effects [12]. They also have the tendency to recognize the impaired conditions at the initial stages. For better understanding of therapy, they imply the disease state of the patient to the molecular and genetic profiles enlightening the present disease condition with the past and future medical complications and medications [13]. This conception has the possibility to recognize and better manage the patient health conditions proving a high impact in the clinical and patient care research. Considering the booming science of personalization and customization in pharmaceuticals, utilizing the nanotechnology as a tool in implementing personalize and customized drug delivery can serve the advantage of achieving the desired safety and efficacy. Through this chapter we discuss the concept of personalize medicines, Nano tools and their application [14].
3.2 Concept of Personalized Medicines
Personalized Medicine Coalition was formed in 2005 to represent researchers, scientists, innovators, and healthcare professionals to encourage the inclination of understanding the concept of personalized medicines particularly in the stream of medicines to follow for the betterment of patient healthcare system. They define personalized medicines as the combination treatment of the results obtained from the diagnosis and the application of the patients’ genomic data to opt a medicine and to design a suitable facilitated delivery system at the right time to the target site knowing the predisposition condition of that disease in individual patients [15]. Personalized medicines make the practitioner to establish in-depth knowledge at the molecular level to understand the disease condition and increase the treatment outcomes to its best at the earliest. It is an advanced trend in the field of health involving the patient’s genetic data, medical and medication history, and habitat. A schematic flow of personalized/customized medicine is represented in Figure 3.1 [16]. The ultimate aim of personalized medicines is to serve the patients’ wants and treatment needs by reducing the adverse effects increasing the therapeutic action. For the effective implementation of personalize medicine the collective approach of adopting pharmacogenomics as a diagnostic tool and nanotechnology as a drug delivery tool servers added advantage to patients [17].
In the initial 21st century, Brian B&Spear gives an opinion on the clinical applications of pharmacogenetics in personalized medicines. It is well understood that appropriate safety and efficacy of drug candidates are mandatory for approval. This act of ascertaining is based on the statistical approach among the unhealthy human population. It concludes that the drug candidate is not effective or safe for every individual patient; the inherent interindividual variations among the patients significantly influence the quality, efficacy, and safety of the patient health. A case study was conducted categorizing various therapeutic areas with that of its percentage efficacy in published data summarized in Figure 3.2. The lowest percentage of responsive patients is 25% for oncology and 85% is for analgesic (COX-2 inhibitors) agents. Most of the therapeutic agents are responsive to 50% to 75% of the population only. In those few are non-responders showing no benefits, and few continue to suffer the disease symptoms. The drug safety also differs from one drug substance to another and from disease to disease, though most of the drugs exhibit secondary effects and adverse effects as important clinical indications, despite the intensified several attempts of the pharmaceutical industries in developing a safe drug moiety and the efforts of regulatory bodies to hold rigid safety profile guidelines [18].
Based on the given case study on the need for a genetic and molecular level of differentiation among the patient population, it is essential for the healthcare professionals to titer the doses