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Öğe Drug Delivery with Targeted Nanoparticles: In Vitro and in Vivo Evaluation Methods(Taylor and Francis, 2021) Çapan Y.; Sahin A.; Tonbul H.Nanotechnology has the potential to change every part of our lives. Today, nanotechnology-based products are used in many areas, and one of the most important areas is drug delivery. Nanoparticulate drug delivery systems not only provide controlled delivery of drugs and improved drug solubility but also improve drug efficiency and reduce side effects via targeting mechanisms. However, compared with conventional drug delivery systems, few nanoparticle-based products are on the market and almost all are nontargeted or only passively targeted systems. In addition, obtaining targeted nanoparticle systems is quite complex and requires several evaluation mechanisms. This book discusses the production, characterization, regulation, and currently marketed targeted nanoparticle systems in a broad framework. It provides an overview of targeted nanoparticles’ (i) in vitro characterization, such as particle size, stability, ligand density, and type; (ii) in vivo behavior for different targeting areas, such as tumor, brain, and vagina; and (iii) current advances in this field, including clinical trials and regulation processes. © 2022 Jenny Stanford Publishing Pte. Ltd.Öğe Hybrid PLGA nanoparticles as advanced drug delivery and theranostic applications(Elsevier, 2023) Tonbul H.; Çapan Y.Nanoparticles are ultradispersed solid supramolecular structures made of organic or inorganic materials, preferably smaller than 500nm. These structures hold great potential for improving the pharmacokinetics and therapeutic index of several drugs including small molecules, genes, peptide- and protein-based therapeutics, and diagnostic agents. Generally, these payloads are covalently or electrostatically grafted on the surface or encapsulated within the nanocarriers. Although each nanocarrier has different advantages and drawbacks depending on its material, and none of them are fully superior to others, poly(lactic-co-glycolic acid) (PLGA)-based nanoparticles are one of the most investigated among them. To overcome the drawbacks of conventional nanocarriers, using more than one nanocarrier material or a complete nanoparticle system to obtain a single nanosystem has become a focus in the last few decades. These systems are called hybrid nanoparticle systems and generally, they have all the benefits of the source materials and component nanoparticle systems. This chapter aims to provide an overview of hybrid nanoparticles and discusses PLGA-based hybrid nanoparticles and their drug delivery and theranostic applications in depth. © 2023 Elsevier Inc. All rights reserved.Öğe Overcoming the challenges of drug resistance through combination drug delivery approach(Elsevier, 2022) Tonbul H.; Şahin A.; Çapan Y.Anticancer and antimicrobial drug resistances are the most important problems that decrease the overall success of drug treatment in the clinic. The combination of two or more different kinds of drugs in clinical practice has been generally accepted as a feasible strategy to achieve superior therapeutic efficacy. However, codelivery of drugs in free form may fail due to different solubility, pharmacokinetic behavior, and stability problems. Drug delivery systems, mainly nanoparticulate systems, hold the big potential to achieve this problem. In this chapter, different approaches used in combination therapy to overcome drug resistance are discussed. © 2022 Elsevier Inc. All rights reserved.Öğe Regulatory Guidelines of the US Food and Drug Administration and the European Medicines Agency for Actively Targeted Nanomedicines(Taylor and Francis, 2021) Çetintaş H.C.; Tonbul H.; Şahin A.; Çapan Y.Guidelines for nanomedicines that are published by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are listed later. This chapter reviews the current FDA and EMA regulatory guidelines for nanomedicines and evaluate their potential for use as reference for actively targeted nanomedicines. The FDA has recommended determining critical quality attributes that have a potential impact on product performance and utilize risk assessments that link structure–function relationships. The FDA recommends considering some points for selecting and using characterization methods. The FDA obligates to manufacture nanomaterials containing drugs in accordance with Good Manufacturing Practices similar to all drug products. The FDA states that all existing International Conference on Harmonization guidelines addressing nonclinical studies be generally applicable for nanomaterials containing drugs. The FDA states that the drug release characteristics of liposomes should be analyzed and release differences between liposomal and nonliposomal formulations should be added to the application. © 2022 Jenny Stanford Publishing Pte. Ltd.
