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Copyright © 2008. KONGPOSH PUBLICATIONS Pvt. Ltd. |
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BOOK REVIEW
Title : Oral Lipid-Based Formulations: Enhancing the Bioavailability of Poorly Water-Soluble Drugs Author : David J. Hauss Price : $119.95 (Hardcover) Pages : 339 Publishers : Informa Healthcare Inc., New Yourk, NY 10017 Website: www.informahealthcare.com
Oral delivery of nearly one-half of the drug compounds gets thwarted owing to their high lipophilicity and consequently poor aqueous solubility. Oral bioavailability of such drugs, being function of their aqueous solubility and dissolution, tends to exhibit low magnitude and high intra- and inter-subject variability.
Oral lipid-based drug delivery systems have proved their immense potential in ameliorating the poor and inconsistent gastrointestinal absorption of poorly soluble drugs. Of late, an alarmingly high spurt of various literature instances and marketed products of such lipid-based formulations has been witnessed across the global pharma world. Despite the immense utilities of the lipid-based drug formulations, only limited reviews have been published dedicated to this specialized topic till date. The information on their diverse vistas lies mostly scattered in various texts and journals. Accordingly, the maiden attempt to bring forth the pertinent facts and figures in the form of an integrated volume is indeed a commendable and timely endeavor.
Written in lucid style, the book covers myriad aspects of lipid-based formulations and their usage in enhancing the bioavailability of poorly water-soluble drugs. The book has been divided into various chapters, each encompassing a sizable account on their design and development, in vitro characterization, in vivo animal studies, and eventually, establishment of IVIVC and IVIVR relationships. Besides, the mechanistic influence of various lipidic constituents and of such formulations during fasted and non-fasted states, and the ultimate fate of lipidic drug products in gastrointestinal milieu have been explicitly elaborated. Amongst the diverse types of self-emulsifying formulations dealt with in the book, important types include liquid SEDDS and SMEDDS, lipid-based isotropic solutions and solid dispersions, hard-capsule formats and supersaturable SEDDS. The remarkable highlight of this book is its industrial outlook that exclusively brings forth the current market status of these lipidic delivery systems, selection of various GRAS-listed excipients for their formulation development, and scaling up the prototype formulations to Phase I/II clinical trial batches.
Based on the famous adage, “a picture is worth one thousand words”, a diversity of illustrations have been immaculately presented as explicative graphs, photographs, methodology flow charts, apparatus outlines, tables, bar charts, etc. that make the book an interesting reading. Each chapter is adequately referenced to the pertinent and updated literature. Most book chapters have been contributed by a galaxy of authors, acclaimed in their respective domains of pharmaceutical technology, analytical research, pharmaceutics, process development, pathology, etc. Special inputs from industry experts tend to enrich the researchers on technical know-how of large scale production of such formulations.
The authors, however, have focused primarily on the conventional self-emulsifying formulations, missing due emphasis on the updates like positively-charged self-emulsifying drug delivery systems (SEDDS), solid SEDDS and SEDDS of traditional herbal medicines, ample information on which is currently available from literature. It would be much more pragmatic if the newer and expanded edition of the book covers other relevant precepts like federal issues and toxicity concerns (especially when the particle/globule size falls in nano or sub-nano range), application of DoE optimization of such lipidic systems, technology for modification of liquid based systems into solid ones, integration of these methodologies with controlled release ones, and work examples on these novel drug delivery technologies. Another minor peccadillo of the book is that the authors explain the prevalent global perspective of these lipid-based formulations taking instances solely from developed nations representing various continents like USA, UK and Japan. It would be more holistic and pragmatic if the current scenario in the developing nations is also taken into apt consideration.
In nutshell, as already mentioned, the book is likely to serve the acute need of the hour. It can be a pleasure to the product development scientists, pharmacy students and researchers to familiarize themselves with the principles and methodology of lipid-based drug delivery systems. The book can be an excellent addition to the library shelves of drug manufacturing houses and pharmaceutical institutes.
Reviewed by: Prof. Bhupinder Singh Bhoop - University Institute of Pharmaceutical Sciences, Punjab University
S. Bandyopadhyay - UGC Meritorious Doctoral Research Fellow (Pharmaceutics), Panjab University, Chandigarh
E-mail: bsbhoop@yahoo.com
Title : Pharmaceutical Packaging Technology Author : U K Jain, D C Goupale, S Nayak Price : Rs. 795/- Pages : 279 Publishers : PharmaMed Press E-mail: info@pharmamedpress.com
The packaging of Pharmaceuticals is as much important as the medicine or drug, which is being packed. The quality to any medicine cannot only be imparted by imparting quality in its contents but it is of immense importance how this quality is being protected with continuously changing atmospheric conditions. Proper packaging is the only way to give desired shelf-life to pharmaceuticals.
It has been seen that a large number of medicines do not give the desired therapeutic effect due to faulty packaging. Packaging technology has become a separate subject in pharmaceutical sciences due to its vital applications in preserving therapeutic efficacy of drugs. Before starting the book writing on this subject, we noticed that the subject was less understood and it has been compiled with few chapters in some books. This inspired us to present detailed account in the form of a specialized book on the subject. Also the Packaging Technology has emerged as separate subject among specialized subjects of Pharmacy curriculum of almost all Universities.
Present book comprises of 16 chapters. The starting page of each chapter consists of chapter summary, which will help the teachers, students and other co-readers in revision of contents of whole chapter in only few minutes. Further the content of each chapter is arranged to facilitate the effortless flow of information in simple, motivating, and commonsensical approach. Detailed physico-chemical information on raw material e.g., glass, plastic, polymers, metals etc., used in Pharmaceutical packaging is presented to facilitate conceptual use of raw material for a particular type of medicinal preparation. Since the raw materials are common for packaging of other products, the scientific information may further be helpful to allied persons who deal with any kind of packaging.
A positive effort has been made to cover up all individual and specialized aspects of Pharmaceutical packaging sciences. More information is provided on Pharmaceutical packaging design, based on characteristic properties of material used in packaging. Blister and strips packaging are of growing importance and so a chapter is included on this topic which would be of great value to our readers. Parenteral and ophthalmic products need sterilized packaging; therefore a chapter on sterilization, covering unique features for sterilizing packaging materials, has been included.
Because of rising role of European Union as a world center for Pharmaceutical regulation and because of the significance of international harmonization of drug standards, a new chapter on regulatory aspects of Pharmaceutical packaging has been added. Chapters on quality control and stability testing of packages would explain the shelf-life concern aspects of the active pharmaceutical ingredient (API) packed.
Title : Builders and Awareness Creators of Modern Pharmacy Author : Prof. Harkishan Singh Price : Rs. 600/- Pages : 362 Publishers : Vallabh Prakashan E-mail: mail@vallabhprakashan.com
This book of Prof. Harkishan Singh is part 2 of part 1, Volume 4 written by him in the series “History of Pharmacy and Related Aspects” now designated as “Builders and Awareness Creators of Modem Pharmacy”. The book is Volume 5 in the series.
The book for the purpose of review can be broadly divided in two important sections. Section 1 “Preface, Acknowledgements, Introduction, and Index”. And Section-2 “Profiles of twelve prominent pharmaceutical personages of yesteryears detailing their contributions and lives and presidential addresses of six of them”. To satisfy inquisitiveness of readers, it may be pointed out that Prof. Singh, in part 1, Vol. 4 of the series, has honored Prof. M.L. Shroff by projecting him as titan and icon of Modern Pharmacy. He sees him as the maker of modern pharmacy of India. His profile does not appear in the volume under review except reference wherever necessary.
In the acknowledgement the author has expressed his gratitude to the management of archives and libraries of institutions in India and abroad, numbering about one dozen wherefrom he got valuable data for his write-up. The author also contacted individuals and organizations numbering nearly four hundred for same purpose. He has gracefully acknowledged their cooperation by their mention in index and text at appropriate places.
In preface and introduction, Prof. Singh gives reason for deviation in his original plan, namely concentration on three subject oriented plan to biographies of prominent individuals who contributed to building of modern pharmacy in India. In preface and introduction the author has made mention of development of western medical systems. As against this, the author observed that the pharmacy component remained largely neglected. It is perhaps, Prof. Singh's this contention that made him change the title. Maintaining his this line of thought, he states “unfortunately pharmacy stood neglected during the British period” that is in pre-independence era. The profession of pharmacy, the author states remained in unorganized and very poor state. The condition according to him was such that to modernize the profession was an uphill task. Its solution is also suggested by the author in the introduction. He states “I had available with me introductory information on many of the professionals who had worked for the building and awareness creation of modern pharmacy, which was a new discipline for us and it required a lot of struggle for getting pharmacy accepted as a partner in the modern health care system”. The way to tread above referred uphill task, Prof. Singh mentions the professionals of yore, who gained prominence during the colonial period and continued to be professionally active in early decades of independent India, could be short listed for profiling”. For this, he had in mind, as could be seen from mid part of Introduction, two stalwarts fulfilling such requirement (i) Jyotish Chandra Ghosh and (ii) Surendra Nath Biswas. In fact, for his regard and respect, Prof. Singh has dedicated the book to J.C. Ghosh stating “Dedicated to the memory of Jyotish Chandra Ghosh, the forgotten and unsung pioneer of Pharmacy”. It seems the author had in mind a shortlist of one dozen stalwarts. For other ten Prof. Singh turned his attention to pharmaceutical forums through which these ten stalwarts jointly sow seeds of modern pharmacy. These seeds broke the ground and the profession has grown to its present state say pillars of modern pharmacy. Most of the pioneers had active professional life ranging from 25 35 years. In the initial stage, they being from different disciplines, there was possibility of difference in their approach. Perhaps in view of this, he has arranged chapters / titled in their name, in alphabetical order.
In reference to profiles of twelve pharmaceutical personages, Prof. Singh states “it is done in a way that composite personality of each one is projected properly” This is followed by presidential address at Pharmaceutical Congress of six presidents, by way of seven appendices. The profiles are paragraphed under more or less similar titles, as early life and background; professional study and education, choice of discipline; contribution and achievements etc. Period of activity is stated wherever it is necessary. As stated earlier, it ranges between end of colonial period to early decade of independent India. This period-a wide spanning period of 19 - 20 years, has no sharp cut off line i.e. formation of The Drug Enquiry Committee of 1930 - 31 to enactment of two important professional legislations viz: Drugs Act 1940 and Pharmacy Act 1948. Former sowing the seeds of modern pharmacy and later seeds breaking ground as seedings of modern pharmacy. Former at the foot of uphill task and the latter at the top of it 'dawn of modern pharmacy'. Growth and development took place from these seedings till 1986 when the last luminary Shri Sanktha Prasad breathed his last a period of about 40 years. Prof. Harkishan Singh choice of title for both the volumes is based on this background.
While some thought of pursuing their professional activity in the field of education, others preferred research, quality control, industry etc. There were some who apart from their field of choice shared their professional competence by serving as visiting faculty in teaching institutions, consultants in industries and likewise. In the earlier years, their contribution in the field was published in foreign journals and publications. Later with formation of forums they got it published in national journals like Pharma Times; Indian Journal of Pharmacy and similar other publications of pharmaceutical associations and organizations. The stalwarts were however united in the areas like professional education, growth and development of profession of pharmacy and importance of forums for common platforms to achieve such aims and objectives. It is in view of such approach that we have made phenomenal progress towards the goal of the modern pharmacy. It is for this reason, Prof. Singh has rightly projected the luminaries as “Builders and Awareness Creators of Modern Pharmacy.”
What is modern or current today would be past by the next decade. New entrants and beginners in the profession will have to shoulder the burden of progress ahead. The profiles provide help and guidance which can be of immense use to shoulder such responsibility. The details of text of appendices can also go a long way in this regard. The text of addresses gives data of progress made, difficulties encountered and possible solutions. Some have forecasted problems and likely difficulties in progress ahead. They have also suggested possible solutions, Quality and importance of details of profiles and addresses can be appreciated only by going through the details.
The path of growth and development is thorny and very demanding. Qualitative transformation can be brought by blending of interest, involvement and integrity throughout the journey. Contents of the book provide necessary details and guidance to tread the path for targeted growth and development.
I extent my heartiest congratulations to the author Prof. Harkishan Singh for this zealous and untiring effort to archive the pharmaceutical history of India in a prolific, precise and lucid manner. I strongly recommend that educational institutes and pharma organizations keep this publication in their library and promote extensive reading. This book can be a useful orientation programme menu for new entrants and aspirants to acquaint them with historical perspective of our profession.
Book Reviewed by Mr. M.R. Shastri, Director (Retired), Drugs Control Administration, Gujarat
Title : Foundations In Pharmaceutical Biotechnology Author : B.P. Nagori, Roshan Issarani Price : Rs. 195/- Pages : 285 Publishers : Pharma Book Syndicate Tel.: 040-23445666, 23445622 E-mail: info@pharmabooksyndicate.com
The field of Biotechnology, in particular, Pharmaceutical Biotechnology has evolved very rapidly since the discovery of INSULIN by Banting and Best in 1922. Currently, hundred of biotechnology based products have hit the market and numerous others are in various phases of clinical development. This textbook “Foundations in Pharmaceutical Biotechnology” has various well compiled chapters on principles of genetic engineering and its applications, bioinformatics, plant tissue culture, animal cell / tissue / organ culture, enzyme immobilization, cell immobilization and their applications etc. The fundamental concepts in all the chapters serve as a good foundation to understand and interpret the latest research and development going in the field of biotechnology.
Chapter 4 deals with fermentation technology and its applications in the field of pharmaceutical biotechnology. Chapter 7 is entirely devoted to hybridoma technology and discusses various methods for the production of Monoclonal antibodies. In chapter 14, covers legal and social issues concerning the use of biotechnology and a profile of various regulatory agencies. In addition, the chapter on halometabolites (halogenated organic compounds) is quite informative.
In the end, the authors have added a brief section on useful websites and a photo gallery which has some vivid diagrams and illustrations. The book would be of immense help to undergraduate and post graduate pharmacy, science and engineering students. We would like to congratulate the authors for such an excellent attempt to compile a book on a young discipline like Pharmaceutical biotechnology that faces a dearth of quality publications.
Book reviewed by: Dr. Rajat Sethi, Texas A&M University, USA and Raman Sehgal, (GVK Biosciences Pvt. Ltd.)
Title : Pharmaceutical and Medicinal Inorganic Chemistry Author : P. Gundu Rao Price : Rs. 450/- (in Delhi), Rs. 470/- (Outside Delhi) Pages : 486 Publishers : Vallabh Publications Tel.: 011-27342048 E-mail: mail@vallabhprakashan.com
Inorganic Pharmaceutical chemistry has not received adequate attention over the years even when many inorganic substances are being used as important medicinal / diagnostic agents and also serves as pharmaceutical aids in the pharmaceutical and chemical industry.
This textbook on “Pharmaceutical and Medicinal Inorganic Chemistry” by Prof. (Dr.) Gundu Rao consists of 18 well complied chapters. Chapter on Elements presents the reader with essential facts on elements which find application in medicine, analysis including quality control. The chapter on inorganic toxicology is a welcome addition and enables the readers to learn about hazards of improper use of inorganic salts and their possible treatment by specific antidotes. New approaches in chapters like Water as a pharmaceutical raw material, Homeopathic and Veterinary products are highly appreciated.
The author had very meticulously given information on various pharmacopeias including the IP, USP, International Pharmacopeia, British Pharmacopeia and Japanese Pharmacopeia through which an effort has been made to introduce some of the basic characteristics of the expectation from “global pharmacist”. Newer perspectives have been added to traditional topics on diagnostic agents, radiopharmaceuticals and quality control. The innovative approach in this book would receive ready acceptance by fellow academicians and students.
Following the chapters, the book also incorporates various useful appendices. Appendix 1 is a compilation of commonly used Greek / Latin prefixes and suffixes. Appendix II is a compilation of Medical terms used in the text book. Appendix III is the listing of inorganic pharmaceuticals according to their application. Appendix IV has important references and it also has a novel section on websites consulted by the authors.
The author has very aptly used his experience and his close association with the pharmaceutical industry, regulatory bodies, institutions and other fellow healthcare professionals and academicians. I would like to congratulate Prof. Gundu Rao for such an excellent compilation. The book would be of immense help to pharmacy student and related disciplines of medicine, nursing, nutrition, dentistry, etc.
Reviewed by: Dr. P. D. Sethi, Pharmaceutical Analyst
Title : Validation in Pharmaceutical Industry - Concept, Approaches & guidelines Author : Shri P.P. Sharma Price : India & Nepal Rs. 1200.00 Other Countries : US $ 50.00 Pages : 396 Publishers : Vandana Publications Pvt. Ltd. LU-56, Vishakha Enclave, Delhi- 110088.
In the present scenario of Pharmaceuticals industries, where at every step the analyst has to deal with regulatory compliance, the book titled “Validation in Pharmaceutical Industry” Concepts, Approaches & Guidelines, written by Shri. P. P. Sharma, former Dy. Drugs Controller, Govt. of NCT of Delhi, will definitely be a helpful tool for the technocrats working in the Pharmaceuticals Industries.
In this book the author has described all concepts, terminologies, guidelines and different approaches for validation: The book is divided in eleven different chapters. Chapter-1 deals with principles & terminology used in validation. In Chapter 2, definition, concept & options of validation has been defined. Chapter 3 goes deep into the Validation Master Plan (VMP), validation protocol & reports. Chapter 4 describes, organizational structure for validation process. Chapter 5 explains the qualification of premises and validation of HV AC System. Chapter 6 defines the validation of utilities. Chapter 7 & 8 deal with cleaning validation and process validation respectively. Chapter 9 is entirely devoted to validation of some special processes i.e. Aseptic and Lyophilization processes. In Chapter 10, analytical method validation is defined in detail, covering all parameters of validation as per USP & ICH guidelines and Chapter 11 is devoted to computer system validation.
I would like to congratulate Shri. P. P .Sharma for such excellent attempt to compile this unique book. The book would be helpful for analysts, production chemist/managers and pharmacy students. I would like to convey my appreciation and best regards to the Author.
About the Author: Shri P. P. Sharma is a well known authority in the pharmaceutical field. He is a M.Pharm. (Gold Medallist) from Punjab University and former Deputy. Drugs Controller & Licensing authority; Drugs Control Department, Govt. of N.C.T. Delhi. He was awarded “Best Drug Control Officer Award” at the IPC in 2004. He is a member of the Pharmacy Council of India (PCI) and Chairman, Law Committee, PC I. Shri P. P .Sharma has authored many books in pharmaceuticals fields like. How to practice GMPs, How to practice GLP and cosmetic Formulations, Mfg. & Quality Control.
Book Reviewed by Dr. R.A. Singh, Director Technical, Arbro Pharmaceuticals Ltd. New Delhi. Member Indian Pharmacopoeia Commission Committee. (IPC)
Copyright © 2008. KONGPOSH PUBLICATIONS Pvt. Ltd.
