May 2014, Vol.12, No.3191Journal of Integrative Medicine

Journal Homepage: www.jcimjournal.com/jimwww.elsevier.com/locate/issn/20954964Available also online at www.sciencedirect.com. Copyright © 2014, Journal of Integrative Medicine Editorial office. E-edition published by Elsevier (Singapore) Pte Ltd. All rights reserved.

The better understanding of human biology and disease pathology has been a corner stone of the rapid advancements in the field of pharmaceutical science, including drug discovery, manufacturing and treatment procedures. Building on these important achievements, Purusotam Basnet, the editor of, and a contributing author to the book entitled Promising Pharmaceuticals (its information is shown in Table 1; cover paper is shown in Figure 1), has compiled a history of the drug development process as well as a review of how modern tools and techniques are used to generate highly reliable pharmaceuticals. While this illustrated book could be of use to all healthcare profes-sionals, it would be especially beneficial for pharmacy students, to familiarize them with modern techniques for

drug discovery and evaluation. In this book review, we have summarized the important aspects of each chapter. We believe this review could act as a guide for the university pharmacy students, as well as other healthcare professionals and researchers.

● Book Review

Promising Pharmaceuticals: edited by Purusotam BasnetRamakanta Lamichhane1, Bhakta Prasad Gaire2

1. Department of Oriental Pharmacy, College of Pharmacy, Wonkwang University, 570-749 Iksan, South Korea

2. Department of Pharmacology, College of Pharmacy and Gachon Institute of Pharmaceutical Sciences, Gachon University, 406-799 Incheon, South Korea

http://dx.doi.org/10.1016/S2095-4964(14)60026-1Lamichhane R, Gaire BP. Promising Pharmaceuticals: edited by Purusotam Basnet. J Integr Med. 2014; 12(3): 191-194. Received March 20, 2014; accepted April 12, 2014.Correspondence: Bhakta Prasad Gaire; Tel: +82-032-899-6131; E-mail: samarpanbp@gmail.com

Table 1 Basic information about the book Promising Pharma-ceuticals

Item Content

Name of the book Promising PharmaceuticalsEdited by Purusotam BasnetNumber of chapters 6Edition First, 2012Published by JanezaTrdine 9, 51000 Rijeka, CroatiaFree online version www.intechopen.comHard copy order at orders@intechopen.com

Figure 1 Cover of the book Promising Pharmaceuticals

The first chapter is written by the editor himself, and tries to encompass the history of medication, modern technique for drug discovery and formulation development. According to the author, the history of medication can be subdivided into Eastern and Western approaches. The Eastern approach to the treatment of diseases involves the use of crude

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drugs, whereas the Western approach uses purified chemical compounds. Both systems of medication have played an important role in establishing the modern methods of drug discovery, treatment and drug formulation. Some of this shared lineage can be traced to the current trend of isolating single compounds, for Western style purified single drug approaches, from raw ingredients, whose treatment properties are known from the complex herbal formulas of the Eastern tradition. Chemical modification of pharmaceutically active compounds is another common technique in drug discovery and can lead to the production of highly specific and effective drugs. Aspirin and codeine are two remarkable achievements in the history of drug development with chemical modification. Beyond exploration and produc-tion, the pharmaceutical industries also play a crucial role in the marketing and distribution of these new, effective and reliable pharmaceuticals throughout the world. The author has nicely presented the importance of different dosage forms. One important point that the author raises is that treatment selection is based on patients’ needs and interest can increase compliance tremendously. The chapter also describes how modern drugs can be made to target areas of interest. Drug discovery is very challenging in terms of knowledge, human resources and money. Nearly 800 million dollars and around 10-14 years can be invested to bring a new drug to market. This huge cost is due to high risks of failure during all stages of drug development due to clinical efficacy, toxicity, adverse effect and commercial limitations. The author points out that the bioavailability of candidate drugs is the most important parameter for drug development. The dissolution of a drug and its ability to move through biological membranes are main factors that affect the bioavailability of drugs. This chapter also discusses some of the most advanced drug delivery systems to date, such as nano drug delivery. The quest to increase the bioavailability of drugs that have dissolution problems, adverse side effects, etc., has led to the development of the nano drug delivery system.

In chapter 2, Martis and Somani describe drug design, discovery and development techniques. They discuss the historical approaches of drug discovery and provide a comprehensive illustration of the drug discovery and development processes. The important discoveries in the field of medicine from the 19th century are well discussed in this chapter. The drug discovery is a very difficult process that consumes a lot of money and time. The drug discovery process includes several stages such as identification and validation of biological targets, searching for and optimizing the active chemical compound, as well as preclinical studies. Successful preclinical studies are followed by clinical

trials, analysis and reporting of the clinical studies, and so on. The computer-aided drug design process has been nicely discussed in this chapter. Recently, molecular modeling has been a focus of interest in the drug design process. This chapter includes a detailed description of some very technical aspects of the drug design process, including molecular mechanics-force field (potential energy function), energy minimization methods, conformational analysis, structure-based and ligand-based drug design approaches, 3D pharmacophore modeling and rational drug design. Another important topic discussed is the quantitative structure activity relationship (QSAR) that includes different physical and chemical properties of the candidate compound such as hydrophobicity, electrical charge, steric effects, and so on. The other approaches of the QSAR include quantitative models, 3D-QSAR techniques, etc. Recently developed tools of drug discovery, combinatorial chemistry and high-throughput screening, are also discussed comprehensively.

The third chapter written by Dutu Ligia Elena mainly emphasizes the increasing quality of plant-based herbal formulations as described in the European Pharmacopoeia (EP). The author focuses on the necessity of quality control in production of herbal preparations to assist with their proper use. The author provides ample information about herbal drugs along with their nomenclature and types based on the EP. The chapter also includes herbal drug analysis according to the EP. The first step of herbal drug analysis starts with macroscopic and microscopic examination. Macroscopic examination takes note of size, shape, color, odor and taste, while microscopic examination evaluates chemical constituents and contaminants. This chapter also discusses the use of separation techniques such as thin- layer chromatography, high-performance liquid chroma-tography and gas chromatography for the identification of chemical constituents from the crude drug. The limitations of each analytical approach are discussed. Other aspects of drug analysis discussed in the chapter include loss on drying, soluble substances, heavy metal content, swelling index and spectrophotometric methods. Further, the iden-tification and quantification of phytochemicals like alkaloids, flavonoids and organic acids is very helpful to characterize the quality of herbal drugs. In this chapter, different techniques for quantitative analysis are discussed. Herbal drugs can become contaminated with microorganisms, fungus and their toxic products like aflatoxins and ochratoxin A. Thus, it is very important to perform tests to check whether the herbal products are contaminated with such toxins. Some of these tests are discussed in the chapter. In this way, the author provides an overview of typical methods used to check the quality of plant-based herbal drugs and to help

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produce effective herbal products.In chapter 4, Nahla S. Barakat discusses the manufacturing,

handling, packaging and storage of biological products. Some of these products are used for the prevention, treatment or cure of a disease, nutritional supplementation and experimental purposes. These are diverse products and may include virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or any other trivalent organic arsenic compound. In most of the cases these biologicals are used for medicinal purposes, thus this chapter will be of great interest to students. In this chapter, the author briefly describes the history of the biological product industry and some of its regulation. Importantly, this chapter addresses good manufacturing practices (GMP) in the biological and medicinal product industry, addressing aspects of GMP that include principle, personnel, premises and equipment. The author further describes cell culture for biological products, clarifying the phenotypic characteristics of animal cells grown in vitro; care and housing of animals used for the production of such biological is also addressed. Other important aspects of GMP include proper documentation, produc-tion controls and proper validation. The chapter also describes how antibiotics are used as preservatives for shipping and ensuring stability of biological products — explaining that selecting appropriate antibiotics for each drug, and determining the amount needed to provide adequate stability are both important considerations. Proper labelling of the biologicals is also pivotal in order to warn consumers of the dangers associated with their misuse. Moreover, care should be exercised while storing and handling the biologicals. The chapter also describes how tests for biological product stability are carried out, touching on regulatory aspects and responsibilities that affect licensed biologics manufacturer. The author describes the existing legal basis for approval of biologics and the challenges for coming years.

Chapter 5 is mostly focused on the quality improvement tools of pharmaceuticals, describing the apparent solubility and dissolution profile under “non-sink” conditions. The excipients, inactive ingredients used during manufacturing, as well as the quality of the active pharmaceutical product, are of great importance to dosage form performance. The dissolution profile of a solid dosage form, like a tablet, plays an important role in evaluating how efficient a drug formulation will be. Thus, the author describes the procedures involved in dissolution testing, the factors affecting the dissolution of tablets and how this information is used in formulation of drugs. This section also includes experimental

data illustrating the factors that affect a drug’s dissolution profile. It is evident that development of both the excipient and the active pharmaceutical ingredients is very important for formulation of a well dosage that is bioactive and bioavailable. Thus, to maximize the effectiveness of a formulation, research on the release pattern, or dissolution profile, is critical. For in vitro studies to provide useful information on the effectiveness of a drug in the body, the experimental condition should be as close to the physiological conditions in the patient. Thus, the “sink condition”, in which large amounts of a drug are solubilized using huge concentration of surfactant, may not provide bio-relevant data for drugs that are weakly water-soluble. Consequently, this chapter highlights the importance of an alternative method, the “non-sink condition”, as a more predictive tool during formulation development, as it represents more biologically relevant dissolution conditions. Although methods and equipment used in dis-solution testing can vary, there is overlap in specifications across many pharmacopeias, such as the EP, the United States Pharmacopoeia, the Japanese Pharmacopoeia and International Pharmacopoeia of World Health Organization. In this chapter a non-steroidal anti-inflammatory drug called nimesulide is used to illustrate the dissolution profile. The authors have presented a study of the dissolution pattern of nimesulide tablets manufactured by different pharmaceutical industries, which vary in excipient composition, but have same amount of active ingredient. These data show that the dissolution profile is highly affected by the excipient used in the manufacturing process. Further, the authors also emphasize the use of the “non-sink condition” for determining dissolution profile, as it more closely mimics the physiological conditions within a patient’s body. This chapter points out the importance of studying the dissolution profile and harmonizing of the procedure, so as to obtain suitable and reliable pharmaceutical dosages.

Chapter 6, written by Jaya Bir Karmacharya, explores the role of GMP in production and quality assurance of pharmaceutical products. GMP legislation ensures uniformity in manufacturing practices among pharmaceutical companies, preventing variable therapeutic or even toxic effects in products. The holder of a manufacturing authorization must manufacture quality medicines ensuring the product quality for its intended use. The objective of producing high-quality pharmaceuticals can only be achieved through careful planning and implementation of quality assurance and quality control system as well as practical implementa-tion of GMP, and must be, at its core, safeguarding the health of the patient by producing good-quality medicines. Hence harmonization of GMP across all pharmaceutical companies is mandatory. The author explains the importance

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of GMP in a healthcare system and the role of an authorized body in establishing GMP for manufacture in each country. Because technology and drug production techniques can advance rapidly, GMPs must be updated frequently, and their effectiveness must be evaluated. The author also points out that all the GMP guidelines must be aligned with the ultimate goals of safeguarding the health of the patient and producing good-quality medicine, medical devices or other pharmaceutical products. The chapter also discusses the various components of GMP, such as per-sonnel, premises, equipment, raw materials and promising pharmaceuticals, focusing on the components of GMP, that satisfy all the quality management, and quality assurance guidelines set out by oversight agencies. The manufacturers remain responsible for product quality until the end of the specified shelf life of the product. Thus, the effective implementation of GMP requires a high level of

commitment to quality at all levels of the manufacturing organization as well as numerous external entities such as government regulatory agencies, material suppliers, dis-tributors, wholesalers, retailers, medical practitioners and end users of the medicines. This is the most downloaded chapter of the book.

Although the book is written comprehensively, typo-graphical errors can still be found. For example “adminis-teration” in page 9 should be written as “administration”; “channal and invetigational” in page 10 should be “channel and investigational”; “pharmacaphore” in page 22 should be “pharmacophore”; “espress” in page 49 should be “express”. The written language of the book is British English; however there are few mix-ups with American English, such as using “favorable and favourable” in page 30. Except these minor mistakes, comprehensive information is provided in the book.

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