Research And Pharmacy

Oral Pharmacotherapy for Male Sexual Dysfunction

2009-12-26T18:15:00.002-08:00

Preface
For the generation that reached sexual maturity in the 1960s, the “pill” became synonymous with sexual freedom and started a sexual revolution. For women it meant freedom from the fear of pregnancy, and for men enhanced sexual opportunity. The new era of the pill has nothing to do with fertility, but everything to do with sex. The first orally effective prescription drug for treating erectile dysfunction (ED) was marketed in 1998. Sildenafil (Viagra®) has rejuvenated the aging male veterans of the sexual revolution, forever changed the science of sexual medicine, and transformed society’s perspective on aging and sex. This class of drugs, known as oral phosphodiesterase inhibitors (PDE-type 5), is highly effective in the treatment of ED. Since its introduction there has been a much greater awareness of ED, its comorbidities, and its effects on the quality of life. In 1997, while preparing to address the Endocrine Society on the occasion of the 92nd American Urological Association meeting, I first looked at the preclinical studies of sildenafil. I thought “this will change everything” and it clearly has—changing practice patterns in sexual medicine, and the attitudes of patients, potential patients, and their partners. Two new PDE-type 5 inhibitors, tadalafil (Cialis®) and vardenafil (Levitra®), were first approved by the European Committee for Proprietary Medicinal Products and subsequently by the Food and Drug Administration in 2003 and 2004. The new PDE-5 inhibitors have given health care providers a choice in prescribing therapy for ED, but it remains to be seen whether these or subsequent agents will provide the opportunity to treat more patients or, for that matter, to treat the same patients more effectively and safely. Pharmacological management of ED can now be given as a tablet, as a sublingual preparation, as an intraurethral pellet, as a topical gel, and as an injection. Current lines of study are looking at inhalation as a faster route of treatment delivery. These various drugs work through differing physiological mechanisms: amplifying penile blood flow elicited by sexual stimulation, enhancing neural signaling, and in some instances can even induce erection without sexual stimulation.

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Burger's Medicinal chemistry and Drug discovery, Chemotherapeutic agents

2009-12-25T03:55:00.000-08:00

Cancer is a major human health problem worldwide and is the second leading cause of death in the United States (1). Over the past 30 years, significant progress has been achieved in understanding the molecular basis of cancer. The accumulation of this basic knowledge has established that cancer is a variety of distinct diseases and that defective genes cause these diseases. Further, gene defects are diverse in nature and can involve either loss or gain of gene functions. A number of inherited syndromes associated with increased risk of cancer have been identified. This chapter will review our current understanding of the mechanisms of cancer development, or carcinogenesis, and the genetic basis of cancer. The roles of gene defects in both
germline and somatic cells will be discussed as they relate to genetic and sporadic forms of cancer. Specific examples of oncogenes, or cancer- causing genes, and tumor suppressor genes will be presented, along with descriptions of the relevant pathways that signal normal and cancer phenotypes.
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Free radicals and antioxidant protocols, methods in molecular biology

2009-12-18T05:19:00.000-08:00

Reactive oxygen and nitrogen species (RONs) affect normal physiological processes and pathological conditions. In spite of the development of analytical and technological advancements in the detection and determination of RONs, there is a growing demand to achieve more rapid and accurate detection and determination of RONs and also of redox stress. In order to satisfy such a demand, we chose to prepare this current volume which comprises 27 chapters contributed by world renowned experts on the state-ofthe- art analytical and technological aspects of the detection and determination of RONs, and oxidative, nitrative, nitrosative, and redox stresses in biological systems, in vitro and in vivo. There is a need to establish biomarkers for the oxidative stress-induced genetic damage in cellular and animal models. This need is addressed herein by offering protocols for (1) the generation of stable oxidative stress-resistant phenotypes of Chinese hamsters
fibroblasts, (2) in vivo detection and measurement of free radicals and oxygen, (3) in vivo determination of tissue and DNA damage as a result of radical exposure, and (4) in vivo and in vitro monitoring of footprints of free-radical and antioxidant reactions. In the sections dedicated to the analysis of antioxidants and their metabolites, we describe methods for the analysis of phenolic acids and flavonoids, eugenol antioxidants, and the recycling of ascorbic and lipoic acids. We also report on cellular reductive capacity, determination of glutathione, mitochondrial transmembrane potential, and cytotoxicity in cardiomyocytes under RONs stresses.

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Oxidative stress and disease

2009-12-18T05:05:00.000-08:00

Oxidative stress is a major factor in health, aging, and disease and is often defined by the redox balance established by cellular oxidants and antioxidants. The ratio of reduced to oxidized levels of major low-molecular weight protein thiols, such as cysteine and glutathione or thioredoxin and glutaredoxin, is often used as a measure of oxidative stress. Among naturally occurring thiols, the discovery of a-lipoic acid has led to an unprecedented interest in basic research because of its role in energy metabolism and as an antioxidant for the treatment of certain
diseases. a-Lipoic acid has acquired importance because of its role as a coenzyme in the maintenance of energy metabolism, on one hand, and as an antioxidant and cell redox modulator, on the other hand. The former was supported by the discovery of the essential role of lipoic acid in mitochondrial dehydrogenasedriven reactions inherent in energy metabolism and the latter is supported by reduction of supplemental a-lipoic acid to dihydrolipoic acid in mammalian cells conferring further antioxidant protection. For example, lipoic acid is an essential cofactor of a-keto acid dehydrogenase complexes in eukaryotic cells as part of the
lipoyl domain of the E2 enzymes (dihydrolipoamide acyltransferases). Also,
exogenous R- (or RS)-lipoic acid is reduced by a flavoenzyme, dihydrolipoamide
dehydrogenase, of the complex in mitochondria. Hence lipoic acid may be a mitochondrial-targeted nutrient. The cell redox status is a critical factor regulating cell proliferation, differentiation, apoptosis (programmed cell death), and necrosis, and the mitochondrion is a center of interest for its role in the generation of signaling molecules (e.g., hydrogen peroxide and nitric oxide) that, in turn, modulates the redox status of the cell.
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Pharmaceutical Compounding and dispensing

2009-12-15T23:38:00.000-08:00

This book has been written as a student guide to extemporaneous pharmaceutical compounding and dispensing. It has been designed to assist the student compounder in understanding the key dosage forms encountered within extemporaneous dispensing. Included is a summary of the key principles relating to labelling and packaging, along with a summary of the formulation of each dosage type. In addition, worked examples and questions have been included to allow the compounder to practise extemporaneous formulation exercises.
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Rheumatoid Arthritis, Current Dirrections in Autoimmune

2009-12-08T06:36:00.000-08:00

During the last decades, investigation into rheumatoid arthritis has benefited from the enormous growth in understanding principal functions of the immune system and the explosion in the knowledge of molecules involved in regulating normal and pathologic immune responses. Despite this progress, the disease has defied a unifying concept and new challenges and perspectives have emerged. Once again, it is becoming evident that research of autoimmune diseases is not a one-way street but a dialectic process between basic science and disease studies. We have learned that rheumatoid arthritis is not a single mechanism-single molecule-single gene disease. The chapters commissioned in this volume illustrate the many facets of disease pathogenesis.
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Genomics and Pharmacogenomics in Anticancer Drug Development and Clinical response

2009-12-02T17:47:00.000-08:00

Genomics and Pharmacogenomics in Anticancer Drug Development and Clinical Response provides the most comprehensive body of knowledge available on the role of genetic and genomic variation in the individualization of drug therapies in cancer patients. As a consequence of the intrinsic chromosomal and genetic instability of the tumor genome, it is generally believed that tailoring of chemotherapy in cancer patients might be achieved by molecular analysis of patient tumor DNA. In addition, to reduce the toxicity risk of patients, the tumor DNA information should be integrated with the available data on polymorphic drug-metabolizing enzyme and transporter genes mediating the exposure of patients to active drugs and/or their active metabolites. The chapters of this book clearly show how DNA information from both the host (germline) and the tumor should be taken into account for rational selection of drug therapies in cancer patients, an aspect that received little attention, despite its importance.

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Sunscreen, regulation and commercial

2009-12-01T03:53:00.000-08:00

The sunscreen industry is achieving remarkable worldwide prominence by responding to the growing need for skin protection with fast-paced innovation. Increased consumer awareness of the harmful effects of sunlight has fueled the demand for improved photo protection. The need for broad-spectrum protection from both UVA and UVB rays has inspired scientists worldwide to research new cosmetic formulations and delivery systems. More effective sunscreen actives, emollients and novel cosmetic and functional ingredients have been regularly added to the formulator’s repertoire. Creativity in innovation has been hindered only by regulatory agencies and patent restrictions worldwide. Familiarity with the current restrictive regulations and patent law infringements has become integral to any research effort attempting to provide improved protection to individuals affected by the sun’s damaging effects.

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Cosmetic formulation of skin care product

2009-11-26T00:53:00.000-08:00

The Cosmetic Science and Technology series was conceived to permit discussion of a broad range of current knowledge and theories of cosmetic science and technology. The series is composed of books written by either one or two authors or edited volumes with a number of contributors. Authorities from industry, academia, and the government participate in writing these books. The aim of the series is to cover the many facets of cosmetic science and technology. Topics are drawn from a wide spectrum of disciplines ranging from chemistry, physics, biochemistry and dermatology to consumer evaluations, safety issues, efficacy, toxicity and regulatory questions. Organic, inorganic, physical, analytical and polymer chemistry, microbiology, emulsion and lipid technology all play important roles in cosmetic science. There is little commonality in the scientific methods, processes and formulations required for the wide variety of toiletries and cosmetics in the market. Products range from hair, skin, and oral care products to lipsticks, nail polishes, deodorants, body powders and aerosols, to cosmeceuticals which are quasi-pharmaceutical over-the-counter products such as antiperspirants, dandruff shampoos, wrinkle reducers, antimicrobial soaps, acne treatments, or sun screen products.

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drug metabolisme and transport method and mechanism

2009-11-24T17:21:00.000-08:00

Preface
Two key aspects of how the body handles drugs and other chemicals are metabolism and transport. Metabolism is critical because it enables the body to process highly lipophilic molecules for further metabolism and eventual excretion, inactivates biologically active molecules, or detoxifies potentially toxic chemicals. Transport processes are critical because they determine the ability of drugs and other chemicals to gain access to sites of metabolism or to physiological or toxicological targets within tissues. The remarkable advances in molecular and cell biology and the development of novel in vitro model systems to study the various processes involved in metabolism and transport have expanded our knowledge and led to numerous, new therapeutic approaches to treatment of chemically induced toxicity and
disease. Drug Metabolism and Transport: Molecular Methods and Mechanisms, which is part of the Methods in Pharmacology and Toxicology series, presents a collection of chapters on selected aspects of metabolism and transport. The general approach of the chapters is to first present background on the topic to define the state of the science, to summarize key experimental models and methods that are used in the study of the process, and then to evaluate the utility of the various approaches and methods. Along the way, the various authors have endeavored to provide insight into why each model or approach is advantageous and discuss limitations and cautions in the application of these models or approaches. The goal here is not to provide step-by-step recipes for how to conduct specific assays, although selected procedures are outlined in some detail. Rather, the goal is to present some rationale for why certain models or approaches are used and to describe insight into how they are used to address various issues in drug metabolism and transport.
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Color atlas of Pharmacology 2nd

2009-11-24T02:24:00.000-08:00

Drug and Active Principle
Until the end of the 19th century, medicines were natural organic or inorganic products, mostly dried, but also fresh, plants or plant parts. These might contain
substances possessing healing (therapeutic) properties or substances exerting a toxic effect. In order to secure a supply of medically useful products not merely at the time of harvest but year-round, plants were preserved by drying or soaking them in vegetable oils or alcohol. Drying the plant or a vegetable or animal product
yielded a drug (from French “drogue” – dried herb). Colloquially, this term nowadays often refers to chemical substances with high potential for physical dependence and abuse. Used scientifically, this term implies nothing about the quality of action, if any. In its original, wider sense, drug could refer equally well to the dried leaves of peppermint, dried lime blossoms, dried flowers and leaves of the female cannabis plant (hashish, marijuana), or the dried milky exudate obtained by slashing the unripe seed capsules of Papaver somniferum (raw opium). Nowadays, the term is applied quite generally to a chemical substance that is used for pharmacotherapy.

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Oxidative stress and inflamatory mechanism in obesity, diabetes and metabolic syndrome

2009-11-17T04:33:00.000-08:00

In recent years, the research disciplines interested in oxidative stress have grown
and enormously increased our knowledge of the importance of the cell redox
status and the recognition of oxidative stress as a process with implications for
many pathophysiological states. From this multi- and inter-disciplinary interest
in oxidative stress emerges a concept that attests to the vast consequences of
the complex and dynamic interplay of oxidants and antioxidants in cellular and
tissue settings. Consequently, our view of oxidative stress is growing in scope
and new future directions. Likewise, the term reactive oxygen species— adopted at some stage in order to highlight non-radical oxidants such as H2O2 and 1O2— now fails to reflect the rich variety of other reactive species in free radical biology and medicine encompassing nitrogen- , sulfur- , oxygen- , and carboncentered
radicals. With the discovery of nitric oxide, nitrogen-centered radicals Oxidative Stress and Inflammatory Mechanisms gathered momentum and have matured into an area of enormous importance in biology and medicine. Nitric oxide or nitrogen monoxide (NO), a free radical generated in a variety of cell types by nitric oxide synthases (NOSs), is involved in a wide array of physiological and pathophysiological phenomena such as vasodilation, neuronal signaling, and inflammation. Of great importance is the radical–radical reaction of nitric oxide with superoxide anion. This is among the most rapid non-enzymatic reactions in biology (well over the diffusioncontrolled limits) and yields the potent non-radical oxidant, peroxynitrite. The involvement of this species in tissue injury through oxidation and nitration reactions is well documented. Virtually all diseases thus far examined involve free radicals. In most cases, free radicals are secondary to the disease process, but in some instances causality is established by free radicals. Thus, there is a delicate balance between oxidants and antioxidants in health and disease. Their proper balance is essential for ensuring healthy aging. Both reactive oxygen and nitrogen species are involved in the redox regulation of cell functions. Oxidative stress is increasingly viewed as a major upstream component in the signaling cascade involved in inflammatory responses, stimulation of cell adhesion molecules, and chemoattractant production and as an early component in age-related neurodegenerative disorders such as Alzheimer’s, Parkinson’s, and Huntington’s diseases, and amyotrophic lateral sclerosis. Hydrogen peroxide is probably the most important redox signaling molecule that, among others, can activate NFκB, Nrf2, and other universal transcription factors. Increasing steady-state levels of hydrogen peroxide have been linked to a cell’s redox status with clear involvement in adaptation, proliferation, differentiation, apoptosis, and necrosis. The identification of oxidants in regulation of redox cell signaling and gene expression was a significant breakthrough in the field of oxidative stress: the classical definition of oxidative stress as an imbalance between the production of oxidants and the occurrence of cell antioxidant defenses proposed by Sies in 1985 now seems to provide a limited concept of oxidative stress, but it emphasizes the significance of cell redox status. Because individual signaling and control events occur through discrete redox pathways rather than through global balances, a new definition of oxidative stress was advanced by Dean P. Jones (Antioxidants & Redox Signaling [2006]) as a disruption of redox signaling and control that recognizes the occurrence of compartmentalized cellular redox circuits. Recognition of discrete thiol redox circuits led Jones to provide this new definition of oxidative stress. Measurements of GSH/GSSG, cysteine/ cystine, or thioredoxin reduced /thioredoxin
oxidized provide a quantitative definition of oxidative stress. Redox status is thus dependent on the degree to which tissue-specific cell components are in the oxidized state. In general, the reducing environments inside cells help to prevent oxidative
damage. In this reducing environment, disulfide bonds (S–S) do not spontaneously form because sulfhydryl groups are maintained in the reduced state (SH), thus preventing protein misfolding or aggregation. The reducing environment is Series Preface maintained by metabolism and by the enzymes involved in maintenance of thiol/disulfide balance and substances such as glutathione, thioredoxin, vitamins E and C, and enzymes such as superoxide dismutases, catalase, and the selenium dependent glutathione reductase and glutathione and thioredoxin-dependent hydroperoxidases (periredoxins) that serve to remove reactive oxygen species (hydroperoxides). Also of importance is the existence of many tissue- and cell
compartment-specific isoforms of antioxidant enzymes and proteins. Compelling support for the involvement of free radicals in disease development originates from epidemiological studies showing that enhanced antioxidant status is associated with reduced risk of several diseases. Of great significance is the role that micronutrients play in modulation of redox cell signaling; this establishes a strong linking of diet and health and disease centered on the abilities of micronutrients to regulate redox cell signaling and modify gene expression. These concepts are anticipated to serve as platforms for the development of tissue-specific therapeutics tailored to discrete, compartmentalized redox circuits. This, in essence, dictates principles of drug development-guided knowledge of mechanisms of oxidative stress. Hence, successful interventions will take advantage of new knowledge of compartmentalized redox control and free radical scavenging.
OXIDATIVE STRESS IN HEALTH AND DISEASE
Oxidative stress is an underlying factor in health and disease. In this series of
books, the importance of oxidative stress and diseases associated with organ systems of the body is highlighted by exploring the scientific evidence and clinical applications of this knowledge. This series is intended for researchers in the basic
biomedical sciences and clinicians. The potential of such knowledge for healthy aging and disease prevention warrants further knowledge about how oxidants and antioxidants modulate cell and tissue function.
Lester Packer
Enrique Cadenas

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Pharmaceutical Suspensions

2009-11-14T20:26:00.000-08:00

The suspension dosage form has long been used for poorly soluble active ingredients
for various therapeutic indications. Development of stable suspensions over the
shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a suspension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle
size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product.
Appropriate analytical methodologies and instruments (chromatographs, viscometers,
particle size analyzers, etc.) must be utilized to properly characterize the suspension formulation. The development process continues with a successful scale-up
of the manufacturing process. Regulatory agencies around the world require clinical
trials to establish the safety and efficacy of the drug product. All of this development work should culminate into a regulatory filing in accordance with the
regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development
to Manufacturing, in its organization, follows the development approach used
widely in the pharmaceutical industry. The primary focus of this book is on the
classical disperse system – poorly soluble active pharmaceutical ingredients suspended in a suitable vehicle. After discussing various disperse systems, the theory of disperse systems and commonly used excipients, the remaining chapters in this textbook systematically explain the development of pharmaceutical suspensions, from the pre-formulation stage to clinical development, regulatory submission and commercial manufacturing. Additionally, the emerging area of nano-suspensions as applied to the pharmaceutical field is also discussed. Each of the chapters in Pharmaceutical Suspensions was written independently by scientists who are skilled in their specific areas. Contributing authors represent a cross-sections of scholars from academic, industrial and governmental affiliations. Pharmaceutical Suspensions, From Formulation Development to Manufacturing is organized in a total of ten chapters: Chapter 1 introduces various pharmaceutical disperse systems in-depth. Chapter 2 presents the general principles of suspension dosage form and Chapter 3 discusses commonly used excipients in pharmaceuticalvi Preface suspensions. Chapter 4 systematically highlights steps involved in pharmaceutical development of suspension dosage forms. Chapter 5 focuses on preclinical development of suspension formulations. Analytical tools needed to characterize pharmaceutical suspensions dosage forms are discussed in Chapter 6. The clinical development aspects of suspension drug products are discussed in Chapter 7. Chapter 8 highlights scale up and technology transfer of the development of pharmaceutical
suspensions. Chapter 9 reviews the science and regulatory perspectives of pharmaceutical suspensions. Finally, Chapter 10 deals with the pharmaceutical applications of nano-suspensions as nanomedicine, an emerging technology area.
Pharmaceutical Suspensions, From Formulation Development to Manufacturing should serve as a good resource for pharmaceutical scientists, process scientists and
chemical engineers involved in the areas of research and development of pharmaceutical suspension dosage forms, and for new and sustaining scientists of the pharmaceutical and chemical fields. The fundamental aspects together with the practical case studies should also make this a useful source for undergraduate and
graduate education.Forth Worth, TX Alok K. Kulshreshtha, Ph.D.
Onkar N. Singh. Ph.D., M.B.A.
G. Michael Wall, Ph.D.

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Pharmacology of depression

2009-11-14T19:04:00.000-08:00

PREFACE
For many years, we have taught clinical psychopharmacology to residents in
psychiatry, neurology, and medicine, as well as to medical students, nurses,
psychologists, counselors, and social workers. We have also maintained active
clinical practices and research programs. It is our hope that these experiences
have produced a book that will serve as a resource in antidepressant therapy for
clinicians from many different disciplines. The purpose of Pharmacotherapy of Depression is to provide a comprehensive overview of antidepressant therapy for clinicians. The contents have evolved from our years of seminars, lectures, and case discussions with our trainees and from our continuing medical education programs. We have tried to provide sufficient depth in reviews of the research literature to support clinical recommendations without burdening the reader with information that has little relevance to the clinical use of antidepressants. We are indebted to the outstanding clinician scientists who have contributed to this volume and to our students who have guided us in its development. We hope that the reader will find that the final product represents a solid foundation for clinicians who are, or will be, prescribing antidepressants. It comes very close to replicating the formal didactics that our trainees experience. Although in practice we supplement this with intensive supervision of patient management, we hope that Pharmacotherapy of Depression will stand alone as a guide to the use of medications for the treatment of depressive illness.
Domenic A. Ciraulo, MD
Richard I. Shader, MD

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Herbal Pharmacology in the peoples Republic of China

2009-11-13T21:40:00.000-08:00

INTRODUCTION

During the month of June 1974, twelve U.S. specialists in chemistry, medicine,
pharmacology, pharmacognosy, pharmacy, and Chinese culture visited a series of
major Chinese cities for the purpose of assessing the current status of herbal
pharmacology (both basic and clinical) in the People's Republic of China.1 We
hoped, by visiting medical schools (both traditional"2 and Western-type), research
institutes, hospitals, pharmacies, pharmaceutical plants, and plantations, to learn
something about current Chinese approaches to the use of herbal medicines and to
the detailed study of such medicines in man and animals, as well as to identify
types of plant materials that might justify prompt attention from Western scientists
and physicians interested in developing important new drugs from natural
products.

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