Poorly Soluble Drugs

Author: Gregory K. Webster
Publisher: CRC Press
ISBN: 1315340860
Format: PDF, ePub
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This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.

Nanoparticles in Life Sciences and Biomedicine

Author: Ana Rute Neves
Publisher: CRC Press
ISBN: 1351207334
Format: PDF, Kindle
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The creation of new and more efficient therapies for improving human health greatly depends on drug delivery systems. Nanotechnology has emerged as a powerful strategy for the development of nanoparticles, such as nanoemulsions, liposomes, nanocrystals, and nanocomplexes, applied in the diagnosis, treatment, or theranostics of several pathologies and diseases. This book reviews the most recent research and development in nanotechnology and, following a multidisciplinary approach, presents new strategies for drug delivery, including aspects from chemistry, physics, biology, and imaging methodologies and exploiting several administration routes, internalization pathways, site-specific delivery strategies, and the potential cytotoxicity of nanoparticles. Beginning with a description of the importance and application of nanotechnology for enhancing existing therapy, the book moves on to detailing oral, topical, pulmonary, brain, cancer, and anti-inflammatory drug delivery approaches; gene delivery approaches; theranostic approaches; and nanoparticle cytotoxicity. Practical and user friendly, it is suitable for advanced undergraduate, graduate, and postgraduate students of nanoscience and nanotechnology; researchers in nanoscience, nanotechnology, chemistry, biology, biochemistry, pharmaceutical sciences, medicine, and bioengineering, especially those with an interest in drug delivery or theranostics; and academia and university readership.

Countering the Problem of Falsified and Substandard Drugs

Author: Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Publisher: National Academies Press
ISBN: 0309269393
Format: PDF, ePub, Mobi
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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Handbook of Polyester Drug Delivery Systems

Author: M. N. V. Ravi Kumar
Publisher: CRC Press
ISBN: 1315341166
Format: PDF, ePub
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In the quest for innovative drug delivery systems attempting to meet the unmet needs in pharmaceutical space, research has taken a much more complicated path that poses a significant challenge for translation. Despite the progress made with novel materials, polyesters still remain at the helm of drug delivery technologies. This book provides a single source of reference of polyester drug delivery systems that covers a broad spectrum of materials design, manufacturing techniques, and applications.

Natural Polymer Drug Delivery Systems

Author: Saurabh Bhatia
Publisher: Springer
ISBN: 3319411292
Format: PDF, ePub
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This book describes 200 bio-polymers, including the most recent and advanced nanotechnology applications. The applications of various bio-medical and other future potential uses are covered and examined in depth. Systematic discussion of current leading natural polymers is also included.

Formulating Poorly Water Soluble Drugs

Author: Robert O. Williams III
Publisher: Springer
ISBN: 3319426095
Format: PDF, Kindle
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The objective of this volume is to consolidate within a single text the most current knowledge, practical methods, and regulatory considerations pertaining to formulations development with poorly water-soluble molecules. A pharmaceutical scientist’s approach toward solubility enhancement of a poorly water-soluble molecule typically includes detailed characterization of the compound’s physiochemical properties, solid-state modifications, advanced formulation design, non-conventional process technologies, advanced analytical characterization, and specialized product performance analysis techniques. The scientist must also be aware of the unique regulatory considerations pertaining to the non-conventional approaches often utilized for poorly water-soluble drugs. One faced with the challenge of developing a drug product from a poorly soluble compound must possess at minimum a working knowledge of each of the abovementioned facets and detailed knowledge of most. In light of the magnitude of the growing solubility problem to drug development, this is a significant burden especially when considering that knowledge in most of these areas is relatively new and continues to develop

Supercritical Fluid Chromatography

Author: Gregory K. Webster
Publisher: CRC Press
ISBN: 9814463000
Format: PDF, Mobi
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Analytical chemists in the pharmaceutical industry are always looking for more-efficient techniques to meet the analytical challenges of today’s pharmaceutical industry. One technique that has made steady advances in pharmaceutical analysis is supercritical fluid chromatography (SFC). SFC is meeting the chromatography needs of the industry by providing efficient and selective testing capabilities on the analytical and preparative scale. The supercritical fluid mobile phase, consisting mainly of CO2, facilitates cost reduction costs and helps the industry in meeting green chemistry standards. This book provides a comprehensive overview of the use of SFC in pharmaceutical analysis. Supercritical Fluid Chromatography reviews the use of SFC in drug-discovery applications and describes its application in drug development. When a drug is developed and brought to market, it is tested many times for impurities and degradants, enantiomeric purity, and analytical and preparative isolations—it is tested during discovery and development and for under-regulated and unregulated methodologies. The book describes the use of SFC for each of these applications and discusses more in-depth topics, such as the use of SFC in mass spectrometric and polarographic detection. The book also sheds light on the role of SFC in drug development from natural products and the advancement of SFC with new technologies and its use in pilot-scale operations as a chromatographic technique.

Handbook of Materials for Nanomedicine

Author: Vladimir Torchilin
Publisher: Pan Stanford Publishing
ISBN: 9814267589
Format: PDF, Kindle
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The fast developing field of nanomedicine uses a broad variety of materials to serve as delivery systems for drugs, genes, and diagnostic agents. This book is the first attempt to put under one cover all major available information about these materials, both still on experimental levels and already applied in patients.

Amorphous Solid Dispersions

Author: Navnit Shah
Publisher: Springer
ISBN: 1493915983
Format: PDF, ePub, Mobi
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This volume offers a comprehensive guide on the theory and practice of amorphous solid dispersions (ASD) for handling challenges associated with poorly soluble drugs. In twenty-three inclusive chapters, the book examines thermodynamics and kinetics of the amorphous state and amorphous solid dispersions, ASD technologies, excipients for stabilizing amorphous solid dispersions such as polymers, and ASD manufacturing technologies, including spray drying, hot melt extrusion, fluid bed layering and solvent-controlled micro-precipitation technology (MBP). Each technology is illustrated by specific case studies. In addition, dedicated sections cover analytical tools and technologies for characterization of amorphous solid dispersions, the prediction of long-term stability, and the development of suitable dissolution methods and regulatory aspects. The book also highlights future technologies on the horizon, such as supercritical fluid processing, mesoporous silica, KinetiSol®, and the use of non-salt-forming organic acids and amino acids for the stabilization of amorphous systems. Amorphous Solid Dispersions: Theory and Practice is a valuable reference to pharmaceutical scientists interested in developing bioavailable and therapeutically effective formulations of poorly soluble molecules in order to advance these technologies and develop better medicines for the future.