over the counter pharmaceutical formulations

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Over The Counter Pharmaceutical Formulations

Author : David D. Braun
ISBN : 0080945961
Genre :
File Size : 79. 80 MB
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This book presents formulations for over-the-counter (OTC) or nonprescription drugs. The OTC drug formulations in this book are organized according to their therapeutic effect. There are 19 categories of OTC drugs included. Each category is presented in a single chapter that consists of two parts; Part I presents the composition of brand name products, and Part II presents starting or prototype formulations contributed by suppliers of raw materials for OTC drugs. The brand name products are listed alphabetically in Part I of each chapter, followed by the name of the manufacturer, the type and.

Over The Counter Pharmaceutical Formulations

Author : David B. Braun
ISBN : UOM:39015034866304
Genre : Medical
File Size : 26. 87 MB
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Each section contains brand name and supplier's formulations. Brand name sections include manufacturer, active ingredients and concentration and other ingredients. Supplier's section includes supplier, ingredients, and mixing procedure.

Handbook Of Pharmaceutical Manufacturing Formulations

Author : Sarfaraz K. Niazi
ISBN : 0849317509
Genre : Medical
File Size : 29. 95 MB
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The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing OTC products. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.

Handbook Of Pharmaceutical Manufacturing Formulations Second Edition

Author : Sarfaraz K. Niazi
ISBN : 1420081160
Genre : Medical
File Size : 70. 90 MB
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The largest category of pharmaceutical formulations, comprising almost two-thirds of all dosage forms, compressed solids present some of the greatest challenges to formulation scientists. The first volume, Compressed Solid Products, tackles these challenges head on. Highlights from Compressed Solid Products, Volume One include: formulations for more than 200 of the most widely used drugs for all types of release profiles, offering formulators a rare opportunity to start with an optimal composition the essentials of what you need to be aware of when establishing a manufacturing process based on the formulations presented identification and inclusion of the most popular prescription products, a critical list for the selection of products

Dictionary Of Pharmaceutical Medicine

Author : Gerhard Nahler
ISBN : 3211898360
Genre : Medical
File Size : 59. 45 MB
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In the beginning was the word – and the foreword. Words are c- bined to sentences and eventually language. Words are listed in a dictionary and their meaning in building language are explained in a lexicon. In the life sciences – e. g. drug development sciences and pharmaceutical medicine – the analogies are evidenced by the - nomic library and patho-physiological function as the lexicon. In this transition from code to function integrated lexica pay a pivotal role for a faster understanding. The present updated version of this books combines dictionary and lexicon and provides the translational - derstanding of the complex drug development process. With a large number of new terms, their abbreviations and explanations in this complex interdisciplinary process a great number of different dis- plines and specialists need to be informed: they include physicians, pharmacists, biologists, chemists, biostatisticians, data managers, - formation specialists, business developers, marketing experts as well as regulators, financing specialists, healthcare providers and ins- ers in a continuous professional development mode. This lexicon is therefore a most suitable and economical tool for fast and conclusive information for all key-players in the development of medicines at the working place, in postgraduate training as well as during graduate education. This book is an indispensible aid in any medical library. Prof. Dr. med. Dr. h. c. Fritz R.

Handbook Of Pharmaceutical Manafacturing Formulations 2nd Ed Sarfaraz K Niazi 2009

Author : Informa Healthcare
Genre : Business & Economics
File Size : 41. 35 MB
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The science and the art of pharmaceutical formulation keeps evolving as new materials, methods, and machines become readily available to produce more reliable, stable, and releasecontrolled formulations. At the same time, globalization of sourcing of raw and finished pharmaceuticals brings challenges to regulatory authorities and results in more frequent revisions to the current good manufacturing practices, regulatory approval dossier requirements, and the growing need for cost optimization. Since the publication of the first edition of this book, a lot has changed in all of these areas of importance to pharmaceutical manufacturers. The second edition builds on the dynamic nature of the science and art of formulations and provides an evermore useful handbook that should be highly welcomed by the industry, the regulatory authorities, as well as the teaching institutions. The first edition of this book was a great success as it brought under one umbrella the myriad of choices available to formulators. The readers were very responsive and communicated withmefrequently pointing out to the weaknesses as well as the strengths of the book. The second edition totally revised attempts to achieve these by making major changes to the text, some of which include: 1. Complete, revised errors corrected and subject matter reorganized for easy reference. Whereas this series has six volumes differentiated on the basis of the type of dosage form and a separate inclusion of the U.S. OTC products, ideally the entire collection is needed to benefit from the myriad of topics relating to formulations, regulatory compliance, and dossier preparation. 2. Total number of pages is increased from 1684 to 2726. 3. Total number of formulations is expanded by about 30% with many newly approved formulations. 4. Novel formulations are now provided for a variety of drugs; these data are collected from the massive intellectual property data and suggest toward the future trend of formulations. While some of these formulations may not have been approved in the United States or Europe, these do provide additional choices, particularly for the NDA preparation. As always, it is the responsibility of the manufacturer to assure that the intellectual property rights are not violated. 5. A significant change in this edition is the inclusion of commercial products; while most of this information is culled out from the open source such as the FOIA (http://www.fda.gov/foi/default.htm), I have made attempts to reconstruct the critical portions of it based on what I call the generally acceptable standards. The drug companies are advised to assure that any intellectual property rights are not violated and this applies to all information contained in this book. The freedom of information act (FOIA) is an extremely useful conduit for reliable information and manufacturers are strongly urged to make use of this information. Whereas this information is provided free of charge, the process of obtaining the information may be cumbersome, in which case, commercial sources of these databases can prove useful, particularly for the non-U.S. companies. 6. Also included are the new Good Manufacturing Guidelines (2007) with amendments (2008) for the United States and similar updates for European Union and WHO; it is strongly urged that the companies discontinue using all old documents as there are significant changes in the revised form, and many of them are likely to reduce the cost of GMP compliance. 7. Details on design of clean rooms is a new entry that will be of great use to sterile product manufacturers; whereas the design and flow of personnel and material flow is of critical nature, regulatory agencies view these differently and the manufacturer is advised always to comply with most stringent requirements. 8. Addition of a self-auditing template in each volume of the series. While the cGMP compliance is a complex issue and the requirements diversified across the globe, the basic compliance remains universal. I have chosen the European Union guidelines (as these are more in tune with the ICH) to prepare a self-audit module that I recommend that every manufacturer adopt as a routine to assure GMP compliance. In most instances reading the template by those responsible for compliance with keep them sensitive to the needs of GMP. 9. OTC products cross-referenced in other volumes where appropriate. This was necessary since the regulatory authorities worldwide define this class of drug differently. It is important to iterate that regardless of the prescription or the OTC status of a product, the requirements for compliance with the cGMP apply equally. 10. OTCmonograph status is anew section added to theOTC volume and this should allow manufacturers to chose appropriate formulations that may not require a filing with the regulatory agencies; it is important to iterate that an approved OTC monograph includes details of formulation including the types and quantities of active drug and excipients, labeling, and presentation. To qualify the exemption, the manufacturer must comply with the monograph in its entirety. However, subtle modifications that are merely cosmetic in nature and where there is an evidence that the modification will not affect the safety and efficacy of the products can be made but require prior approval of the regulatory agencies and generally these approvals are granted. 11. Expanded discussion on critical factors in the manufacturing of formulations provided; from basic shortcuts to smart modifications now extend to all dosage forms. Pharmaceutical compounding is one of the oldest professions and whereas the art of formulations has been v vi Preface to the Series—Second Edition relegated to more objective parameters, the art nevertheless remains. An experienced formulator, like an artist, would know what goes with what and why; he avoids the pitfalls and stays with conservative choices. These sections of the book present advice that is time tested, although it may appear random at times; this is intended for experienced formulators. 12. Expanded details on critical steps in the manufacturing processes provided but to keep the size of the book manageable, and these are included for prototype formulations. The reader is advised to browse through similar formulations to gain more insight. Where multiple formulations are provided for the same drug, it intended to show the variety of possibilities in formulating a drug and whereas it pertains to a single drug, the basic formulation practices can be extended to many drugs of same class or even of diversified classes. Readers have often requested that more details be provided in the Manufacturing Direction sections. Whereas sufficient details are provided, this is restricted to prototype formulations to keep the size of the book manageable and to reduce redundancy. 13. Addition of a listing of approved excipients and the level allowed by regulatory authorities. This new section allows formulators a clear choice on which excipients to choose; the excipients are reported in each volume pertaining to the formulation type covered. The listing is drawn from the FDA-approved entities. For the developers of an ANDA, it is critical that the level of excipients be kept within the range generally approved to avoid large expense in justifying any unapproved level. The only category for which the listing is not provided separately is theOTCvolume since it contains many dosage forms and the reader is referred to dosage form–specific title of the series. The choice of excipients forms keeps increasing with many new choices that can provide many special release characteristics to the dosage forms. Choosing correct excipients is thus a tedious exercise and requires sophisticated multivariate statistical analysis. Whereas the formulator may choose any number of novel or classical components, it is important to know the levels of excipients that are generally allowed in various formulations to reduce the cost of redundant exercises; I have therefore included, as an appendix to each volume, a list of all excipients that are currently approved by the U.S. FDA along their appropriate levels. I suggest that a formulator consult this table before deciding on which level of excipient to use; it does not mean that the excipient cannot be used outside this range but it obviates the need for a validation and lengthy justification studies in the submission of NDAs. 14. Expanded section on bioequivalence submission was required to highlight the recent changes in these requirements. New entries include a comprehensive listing of bioequivalence protocols in abbreviated form as approved by the U.S. FDA; these descriptions are provided in each volume where pertinent. To receive approval for an ANDA, an applicant must generally demonstrate, among other things, equivalence of the active ingredient, dosage form, strength, route of administration and conditions of use as the listed drug, and that the proposed drug product is bioequivalent to the reference listed drug [21 USC 355(j)(2)(A); 21 CFR 314.94(a)]. Bioequivalent drug products show no significant difference in the rate and extent of absorption of the therapeutic ingredient [21 U.S.C. 355(j)(8); 21 CFR 320.1(e)]. BE studies are undertaken in support of ANDA submissions with the goal of demonstrating BE between a proposed generic drug product and its reference listed drug. The regulations governing BE are provided at 21 CFR in part 320. The U.S. FDA has recently begun to promulgate individual bioequivalence requirements. To streamline the process for making guidance available to the public on how to design product-specific BE studies, the U.S. FDA will be issuing product-specific BE recommendations (www.fda.gov/cder/ogd/index.htm). To make this vital information available, an appendix to each volume includes a summary of all currently approved products by the U.S. FDA where a recommendation on conducting bioequivalence studies is made available by the U.S. FDA. When filing an NDA or an ANDA, the filer is faced with the choice of defending the methods used to justify the bioavailability or bioequivalence data. The U.S. FDA now allows application for waiver of bioequivalence requirement; a new chapter on this topic has been added along with details of the dissolution tests, where applicable, approved for various dosage forms. 15. Dissolution testing requirements are included for all dosage forms where this testing is required by the FDA. Surrogate testing to prove efficacy and compliance is getting more acceptance at regulatory agencies; in my experience, a well-designed dissolution test is the best measure of continuous compliance. Coupled with chapters on waivers of bioequivalence testing, this information on dissolution testing should be great value to all manufacturers; it is recommended that manufacturers develop their own in-house specifications, more stringent than those allowed in these listings and the USP. 16. Best-selling products (top 200 prescription products) are identified with an asterisk and a brand name where applicable; in all instances, composition of these products is provided and formulation of generic equivalents. Despite the vast expansion of pharmaceutical sales and shifting of categories of blockbuster drugs, basic drugs affecting gastrointestinal tract, vascular system, and brain remain most widely prescribed. 17. Updated list of approved coloring agents in the United States, Canada, European Union, and Japan is included to allow manufactures to design products for worldwide distribution. 18. Tablet-coating formulations that meet worldwide requirements of color selection are included in the Volume 1 (compressed solids) and Volume 5 (OTC) because these represent the products often coated. 19. Guidelines on preparing regulatory filings are now dispersed throughout the series depending on where these guidelines are more crucial. However, the reader would, as before, need access to all volumes to benefit from the advice and guidelines provided. As always, comments and criticism from the readers are welcomed and these can be sent to me at [email protected] .com or [email protected] I would try to respond to any inquiries requiring clarification of the information enclosed in these volumes. I would like to express deep gratitude to Sherri R. Niziolek and Michelle Schmitt-DeBonis at Informa, the publisher of Preface to the Series—Second Edition vii this work, for seeing an immediate value to the readers in publishing the second edition of this book and allowing me enough time to prepare this work. The diligent editing and composing staff at Informa, particularly Joseph Stubenrauch, Baljinder Kaur and others are highly appreciated. Regardless, all errors and omissions remain altogether mine. In the first edition, I had dedicated each volume to one of my mentors; the second edition continues the dedication to these great teachers. Sarfaraz K. Niazi, Ph.D. Deerfield, Illinois, U.S.A

Solvent Systems And Their Selection In Pharmaceutics And Biopharmaceutics

Author : Patrick Augustijns
ISBN : 9780387691541
Genre : Medical
File Size : 31. 68 MB
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Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

Pain Management Secrets E Book

Author : Andrew Dubin
ISBN : 9780323074650
Genre : Medical
File Size : 72. 49 MB
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No matter what questions arise in practice or while preparing for boards, Pain Management Secrets, 3rd Edition has the answers. A two-color page layout, portable size, and a list of the “Top 100 Secrets in pain management help you better meet the challenges you face today. You’ll find all the features you rely on from the Secrets Series®—a question-and-answer format, lists, mnemonics, tables and an informal tone—that make reference fast and easy. Expedites reference and review with a question-and-answer format, bulleted lists, mnemonics, and practical tips from the authors. Features a two-color page layout, "Key Points" boxes, and lists of useful web sites to enhance your reference power. Presents a chapter containing "Top 100 Secrets", providing you with an overview of essential material for last-minute study or self-assessment. Fits comfortably in the pocket of your lab coat so you have it conveniently on hand at all times. Features new editors, Charles E. Argoff, MD and Gary McCleane, MD who present a thorough update on the latest in pain management. Presents a new contemporary internal design that helps you navigate the text easier.

Handbook Of Bioequivalence Testing Second Edition

Author : Sarfaraz K. Niazi
ISBN : 9781482226386
Genre : Medical
File Size : 69. 77 MB
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As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.

Pharmaceutical Lifecycle Management

Author : Tony Ellery
ISBN : 9781118265895
Genre : Medical
File Size : 46. 85 MB
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A comprehensive guide to optimizing the lifecycle management of pharmaceutical brands The mounting challenges posed by cost containment policies and the prevalence of generic alternatives make optimizing the lifecycle management (LCM) of branddrugs essential for pharmaceutical companies looking to maximize the value of their products. Demonstrating how different measures can be combined to create winning strategies, Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand explores this increasingly important field to help readers understand what they can—and must—do to get the most out of their brands. Offering a truly immersive introduction to LCM options for pharmaceuticals, the book incorporates numerous real-life case studies that demonstrate successful and failed lifecycle management initiatives, explaining the key takeaway of each example. Filled with practical information on the process of actually writing and presenting an LCM plan, as well as how to link corporate, portfolio, and individual brand strategies, the book also offers a look ahead to predict which LCM strategies will continue to be effective in the future. While the development of new drugs designed to address unmet patient needs remains the single most important goal of any pharmaceutical company, effective LCM is invaluable for getting the greatest possible value from existing brands. Pharmaceutical Lifecycle Management walks you through the process step by step, making it indispensable reading for pharmaceutical executives and managers, as well as anyone working in the fields of drug research, development, and regulation.

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