Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

This book provides an update on heterocyclic compounds that serve as key components of anti-cancer agents administered in pre-clinical settings. Many of the compounds highlighted in the book are being actively investigated for the bioactive properties against a range of cancer cell lines. There is potential for heterocyclic compounds to design agents that can target specific molecules to treat different types of cancers. Chapters are contributed by experts in pharmaceutical chemistry and are written to give a general overview of the topic to readers involved in all levels of research and decision-making in pharmaceutical chemistry and anti-cancer drug design. Part II of the book set covers these topics: - Anticancer targets for heterocyclic lead compounds - Coumarin hybrids for cancer treatments - Progress in nitrogen and sulphur-based heterocyclic compounds for their anticancer activity - Imidazole as an anticancer heterocyclic ring - Morpholine for profiling anticancer lead compounds - Natural products as anticancer agents

This book provides an update on heterocyclic compounds that serve as key components of anti-cancer agents administered in pre-clinical settings. Many of the compounds highlighted in the book are being actively investigated for the bioactive properties against a range of cancer cell lines. There is potential for heterocyclic compounds to design agents that can target specific molecules to treat different types of cancers. Chapters are contributed by experts in pharmaceutical chemistry and are written to give a general overview of the topic to readers involved in all levels of research and decision-making in pharmaceutical chemistry and anti-cancer drug design. Part 1 of the book set covers these topics: - Heterocyclic anticancer compounds derived from natural sources with their mechanism of action - The role of terpenoids as anticancer compounds: an insight into prevention and treatment - Recent advances in synthesis and anticancer activity of benzothiazole hybrids as anticancer agents - Structure-activity relationship studies of novel hybrid quinoline and quinolone derivatives as anticancer agents - Tetrazoles: structure and activity relationship as anticancer agents - Progress in nitrogen and oxygen-based heterocyclic compounds for their anticancer activity: an update (2017-2020)

This book provides a comprehensive overview of the localized drug delivery system landscape. The 10 chapters provide a detailed introduction in polymers, nanostructures and nanocomposites for developing localized controlled drug delivery systems (LCDDSs) in the form of stimuli-responsive delivery systems, targeted drug delivery systems or the combination of both. A discussion on manufacturing techniques, optimization, challenges and adaptation of LCDDSs for the treatment of a wide range of diseases is also included. This simple and informative resource conveys an understanding about designing novel drug delivery systems to students in advanced pharmacology, biotechnology, materials science and biochemistry study programs. Readers will be equipped with the knowledge of regulating drug release rates to get a desired pharmacological profile, that helps a researcher to ensure a high therapeutic effectiveness. The detailed information about various drug delivery systems and a compilation of recent literature sources also paves the way for research scholars to construct a drug targeting framework for their research plans.

Osteosarcoma is a rare bone tumor that has a high incidence among children and young adults. Despite recent therapeutic developments, osteosarcoma still presents major hurdles to achieving successful results, mainly due to the presence of multi-drug-resistant cells. This monograph primarily aims to provide information about the basic science behind the treatment of osteosarcoma along with experimental results for a novel formulation that overcomes multidrug resistance, and therefore, may serve as a viable treatment option. The book starts with an updated and concise guide to the pathophysiology of the disease, while also introducing the reader to new therapies and materials (specifically chitosan, polyethyleneimine, poloxamers, poloxamines, and Pluronics®) used in the treatment process along with the aims of the experiments present subsequently. Next, the book documents the materials and methods used in developing polymeric micelles for delivering drugs to osteosarcoma sites. By explaining the basics of nanomedicine as a starting point, readers will understand how polymeric micelles act as facilitators of drug transport to cancer cells, and how one can synthesize a small stable micelle (by creating derivatives of base nanomaterials), capable of actively targeting osteosarcoma cells and overcoming multi-drug resistance. The chapter explains the synthesis and characterization techniques of the materials used to develop polymeric micelles. The results, a reflection of the conjugation of different experimental solutions initiated here, point to a modern route towards the search for a therapeutic solution for osteosarcoma. The simple, structured presentation coupled with relevant information on the subject of micelle-based nanotherapeutic drug delivery make this monograph an essential handbook for pharmaceutical scientists involved in the field of nanomedicine, drug delivery, cancer therapy and any researchers assisting specialists in clinical oncology for the treatment of osteosarcoma.

The development of a vector for the delivery of therapeutic drugs in a controlled and targeted fashion is still a major challenge in the treatment of many diseases. The conventional application of drugs may lead to many limitations including poor distribution, limited effectiveness, lack of selectivity and dose dependent toxicity. An efficient drug delivery system can address these problems. Recent nanotechnology advancements in the biomedical field have the potential to meet these challenges in developing drug delivery systems. Nanomaterials are changing the biomedical platform in terms of disease diagnosis, treatment and prevention. Nanomaterials aided drug delivery provides an advantage by enhancing aqueous solubility that leads to improved bioavailability, increased resistance time in the body, decreased side effects by targeting drugs to the specific location, reduced dose dependent toxicity and protection of drugs from early release. In this volume, the contributors have compiled reports of recent studies illustrating the promising nanomaterials that can work as drug carriers, that can navigate conventional physiological barriers. A detailed account of several types of nanomaterials including polymeric nanoparticles, liposomes, dendrimers, micelles, carbon nanomaterials, magnetic nanoparticles, solid lipid-based nanoparticles, silica nanomaterials and hydrogels for drug delivery is provided in separate chapters. The contributors also present a discussion on clinical aspects of ongoing research with insights towards future prospects of specific nanotechnologies. The book is an informative resource for scholars who seek updates in nanomedicine with reference to nanomaterials used in drug delivery systems.

The development of a vector for the delivery of therapeutic drugs in a controlled and targeted fashion is still a major challenge in the treatment of many diseases. The conventional application of drugs may lead to many limitations including poor distribution, limited effectiveness, lack of selectivity and dose dependent toxicity. An efficient drug delivery system can address these problems. Recent nanotechnology advancements in the biomedical field have the potential to meet these challenges in developing drug delivery systems. Nanomaterials are changing the biomedical platform in terms of disease diagnosis, treatment and prevention. Nanomaterials aided drug delivery provides an advantage by enhancing aqueous solubility that leads to improved bioavailability, increased resistance time in the body, decreased side effects by targeting drugs to the specific location, reduced dose dependent toxicity and protection of drugs from early release. </p> In this two-part book, the contributors have compiled reports of recent studies illustrating the promising nanomaterials that can work as drug carriers which can navigate conventional physiological barriers. A detailed account of several types of nanomaterials including polymeric nanoparticles, liposomes, dendrimers, micelles, carbon nanomaterials, magnetic nanoparticles, solid lipid-based nanoparticles, silica nanomaterials and hydrogels for drug delivery is provided in separate chapters. The contributors also present a discussion on clinical aspects of ongoing research with insights towards future prospects of specific nanotechnologies. </p> Part II covers the following topics: </p> · Solid lipid nanoparticles and nanostructured lipid carriers </p> · Silica based nanomaterials </p> · Hydrogels </p> · Metallic nanoparticles </p> · Computational and experimental binding interactions of drug and β-cyclodextrin </p> · Clinical milestones in nanotherapeutics </p> · Drug delivery systems based on poly(lactide-co-glycolide) and its copolymers </p> The book set is an informative resource for scholars who seek updates in nanomedicine with reference to nanomaterials used in drug delivery systems.

Nanomedicine is a rapidly expanding field because of its benefits over conventional drug delivery technology, as it offers site-specific and target-oriented delivery of therapeutic agents. Nanoparticles and Nanocarriers Based Pharmaceutical Preparation presents a structured summary of recent advances and discoveries in nanomedicine and nanocarrier-based drug delivery. The book covers several key topics in a very simple and easy to understand language. Readers will be familiarized with many types of nanocarriers that have been developed over the past decade, the pharmaceutical formulations composed of organic and inorganic materials as well as their clinical benefits. Chapters are written with the help of authoritative sources of knowledge with the goal of building a foundational understanding of novel drug delivery systems. Since the subject matter is interdisciplinary, it will be of interest to students, teachers and researchers in a broad range of fields, including pharmaceutical sciences, nanotechnology, biomedical engineering and material sciences.