Pharmaceutical Nanosystems and Their Quality Control

Pharmaceutical Nanosystems and Their Quality Control

Kenia Palomino Vizcaino, Giovanni Palomino-Vizciano, Jose Manuel Cornejo-Bravo
DOI: 10.4018/978-1-7998-9613-5.ch002
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Nanotechnology is currently very important in developing pharmaceutical products, especially in the design, formulation, and administration of therapies. Examples of these are nanoemulsions, nanoparticles, and microemulsions that are increasingly found in the international drug market and are an integral part of new therapies against pathologies such as cancer. The research and development of these new pharmaceutical technologies are dependent on the type of excipient, physicochemical factors, and the method of obtaining it. Some of the methods used to obtain these pharmaceutical products are traditional polymerization in solution, ultrasonic, and ultra-stirring methods. This chapter focuses on the development of new nanometric formulations for the pharmaceutical market, the advantages and characteristics of each production method, and the quality control that it entails at the international research and regulation level.
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Nanoscience is an emerging area of science that has a set of disciplines that study the phenomena of materials on a nanometer scale, that relates the different scientific fields such as biology, chemistry, and technology, being the nanometer the magnitude to be evaluated, in this, the properties are different from the conventional ones.

Nanotechnology in recent years has been presented as a revolutionary branch with growing interest in the field of research and industry in different areas and with multiple applications in science, medicine, forensics, electronics, among others and focuses on creating, synthesizing, designing, applying, and reducing the sizes within the nanometric scale. It is becoming more and more important in medicine; the advance focuses on prevention, monitoring, diagnosing, and controlling pharmacotherapy in biological systems, which contributes to developing new therapies to treat and prevent diseases that significantly impact human health. The continuous advancement of nanomedicine has developed multiple delivery systems, drug administration, diagnostic methods, regenerative medicine (Oroojalian et al., 2020).

Nanosystems are considered a novel method mainly in the administration of drugs to protect, transport, release drugs or therapeutic agents in a controlled manner, providing a better route of administration, selectivity, efficacy, and biocompatibility. These focus on commonly available drugs and novel therapeutic agents, such as enzymes, proteins, nucleic acids, and contrast agents. These systems are designed to improve therapeutic agent half-life, solubility, protect against physicochemical degradation, increase absorption, lead to changes in pharmacokinetics, improve its efficiency, penetration, and intracellular distribution, decrease secondary effects applied in different routes administering these systems (Ding et al., 2020).

Pharmaceutical nanosystems should be considered biocompatible and biodegradable, and they are defined by its nanometric size around 1 to 100 nm in their dimensions. It is mainly that some damaged tissues have an increased fenestrae space of the endothelial capillary from 200 to 600 nm; some nanosystems could enter and be accumulated in the interstitial space and achieve a better effect or be toxic by acummulation (Fang et al., 2011).

Some nanomaterials are produced naturally in the environment, while others are synthetically or semi-synthetically, these to take great advantage of their size and properties. These changes in the properties at the nanoscale focus on that the properties may improve due to the increase in the relative surface area, leading to greater chemical reactivity and affecting its strength. Systems can continuously be improved, especially those focused on medicine, improving the drug's half-life, availability, the solubility of some drugs, and conferring release control capacity (Chugh et al., 2021).

When a drug enters the biological environment, this delivery system should be able to control its destination, which results in the degradation and subsequent release of the drug. However, engineered systems such as nanomaterials can cause some problems and cause toxicity, so these should be studied in the physiological environment and evaluate if they can be the cause of genetic damage, toxicity, accumulation in the organs, among others (Bondarenko et al., 2021; Remya & Mohanan, 2018).

The quality system is of the utmost importance and, at the same time, more complicated than the standard systems; the differences lie in the physical properties. The nanosystems tests are described below, where physicochemical characterizations are mentioned; the tests carried out on the nanosystems are described below; they include physicochemical characterizations that are contemplated and necessarily fulfilled to continue the process. Tests also refer to the processes to which the system will be exposed in vitro study, indicating the behavior before different simulated biological scenarios, thereby supporting the development of effective and safe nanosystems.

Key Terms in this Chapter

Stability: Understood as the ability of a system to remain unchanged over time.

Nanocomponent: Any nanomaterial.

Nanodevice: System composed of two or more nanocomponents with a defined common purpose.

Biological Compatibility: Be understood as the ability of a living being to maintain its homeostasis unchanged in the presence of a nanodevice or nanocomponent.

Nanotoxicology: Study of the toxicity of nanomaterials.

Nano-Drug Delivery Systems: System to nanometric scale design to delivery control of a drug.

Nanoparticle: Clustering of atoms on the nanometer scale.

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